BT Notes

IPR
Introduction Page No. 1 / 87
10BT- 81 PROJECT MANAGEMENT & IPR

[PART B IPR]
Prepared by
Dr. K. Sumangala Bhat Professor
Department of Biotechnology
ACHARYA
INSTITUTES
ACHARYA INSTITUTE OF
TECHNOLOGY
Soldevanahalli, Chikkabanavara, Hesaraghatta

Raod
SKB, Dept. of BT AIT
IPR
Bangalore. 560 090
Contents
1.
2.
3.
4.
5.
6.
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8.
9.
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11.
12.
13.
14.
15.
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26.
Introduction & Concept of property

History of IPR in India
Laws related to IPR in India
Criteria for patentability
Paris convention & Berne convention
Madrid agreement (1891) and Rome convention (1961)
Patent Cooperation Treaty(PCT)
TRIPS agreement (1994), WIPO performance and phonograms
Patent procedure in India
Commercial potential of BT invention
Objectives, Evolution and Application of Biotechnology
R & D investments, Rationale and applications
Concept of Novelty and Inventive step in BT
Micro organisms and BT inventions
Moral issues in patenting BT invention
Case study on patent law interpretation on pharma & microbial products
Case study on patent law interpretation on environmental
issues, etc.
Justification and international position for plant variety protection
UPOV, 1961, 1978, 1991 guidelines
Plant variety protection in India
Ggeographical indications & Multi-lateral treaties
Traditional knowledge - concept, stake holder and issues
Traditional knowledge - at National & International level
Traditional knowledge digital library
Protectability of traditional knowledge
Biopyracy & Bioprospecting
03
08
11
16
18
21
22
26
31
32
32
33
40
46
48
48
49
60
63
67
78
80
81
84
86
GP L 1. INTRODUCTION & CONCEPT OF PROPERTY

Intellectual property Right (IPR) is a term used for various legal entitlements which
attach to certain types of information, ideas, or other intangibles in their expressed
form. The holder of this legal entitlement is generally entitled to exercise various
exclusive rights in relation to the subject matter of the Intellectual Property. The
term intellectual property reflects the idea that this subject matter is the product of
the mind or the intellect, and that Intellectual Property rights may be protected at
law in the same way as any other form of property. Intellectual property laws vary
from jurisdiction to jurisdiction, such that the acquisition, registration or
enforcement of IP rights must be pursued or obtained separately in each territory of
interest.
Intellectual property rights (IPR) can be defined as the rights given to people over
the creation of their minds. They usually give the creator an exclusive right over the
use of his/her creations for a certain period of time.
Concept of property
Property designates those things that are commonly recognized as being the
possessions of an individual or a group. A right of ownership is associated with
property that establishes the good as being "one's own thing" in relation to other
individuals or groups, assuring the owner the right to dispense with the property in a
manner he or she deems fit, whether to use or not use, exclude others from using, or
to transfer ownership.
Properties are of two types - tangible property and intangible property i.e. one that
is physically present and the other which is not in any physical form. Building, land,
house, cash, jewellery are few examples of tangible properties which can be seen
and felt physically. On the other hand there is a kind of valuable property that
cannot be felt physically as it does not have a physical form. Intellectual property is
one of the forms of intangible property which commands a material value which
can also be higher than the value of a tangible asset or property.
Historical Background
Marxs Theory
Karl Marx employed a labour theory of value, which holds that the value of a commodity is
the socially necessary labour time invested in it. In this model, capitalists do not pay
workers the full value of the commodities they produce; rather, they compensate the worker
for the necessary labor only (the worker's wage, which cover only the necessary means of
subsistence in order to maintain him working in the present and his family in the future as a
group). This necessary labor is, Marx supposes, only a fraction of a full working day - the
rest, the surplus-labor, would be pocketed by the capitalist. Marx theorized that the gap
between the value a worker produces and his wage is a form of unpaid labour, known as
surplus value. Moreover, Marx argues that markets tend to obscure the social relationships
and processes of production; he called this commodity fetishism. People are highly aware of
commodities, and usually don't think about the relationships and labour they represent.
This concept initiated the practice of assigning commercial value to the intellectual or
physical labour . Global Intellectual Property Trends
Over 3 million applications filed per year, trademark protection is the most sought after
form of IP worldwide with growth rates of a similar magnitude as those for patents. In
2009, one quarter of all trademark applications were filed at the China Trademark Office.
India showed the highest five-year growth (13.5%) from 2005 to 2009, whereas China had
one of the highest annual growth rates (20.8%) from 2008 to 2009. In 2009, China
accounted for 50 percent of total industrial design filing activity while growing by 12.3
percent from 2008 to 2009. India was in the 9th place. In 2009, 1,41,943 trademark
applications were filed, 34,287 patent applications were filed and 6,092 Industrial designs
applications were filed.
Intellectual Property Trends - India
During 2009-10, 34,287 patent applications were filed, 6069 examined and 6168 patents
granted. The number of applications filed by the Indian applicants was 7044. Out of the
applications filed by the Indian applicants, Maharashtra accounted for the maximum
number followed by Delhi, Tamil Nadu, Karnataka, Andhra Pradesh, West Bengal etc.
During 2009-10, 6092 design applications were filed, 6266 examined and 6025
registered. The number of applications filed by the Indian applicants was 4267. The
number of registered designs in force at the end of 2009-10 was 39008.During 2009-10,
1,41,943
trademark applications were filed, 25875 examined and 67,490 registered. The number of
applications
filed by the Indian applicants was 1,34,403. The total number of registered trademarks as of
31st March,
2010 is 8,22,825.During 2009-10, 40 Geographical indications applications were filed and
14 were
registered. A total of 120 Geographical Indications have been registered till 31st March,
2010. During 2009-10, 142 applications were received for access of bio-resources for
research/commercial use, transfer of research results, intellectual property rights and third
party transfer. Totally, 13 agreements have been signed. So far, 11 patents have been
granted on the applications cleared by NBA. The NBA has also received a royalty
amount of Rs.37.89 lakhs from the applicants who have exported bio-resources.In 2010-11,
a total of
642 applications representing 28 crops were received by the Authority for seeking plant
variety
protection under the Act. The applications belong new (395), extant (216), farmers varieties
(30) and
essentially derived variety (1) categories.
Initiatives of Government of India towards protection of IPR
1.
The Government has brought out A Handbook of Copyright Law to create

awareness of copyright laws amongst the stakeholders, enforcement agencies,
professional users like the scientific and academic communities and members of the
public.
2.
National Police Academy, Hyderabad and National Academy of Customs, Excise

and Narcotics conducted several training programs on copyright laws for the police
and customs officers.
3.
The Department of Education, Ministry of Human Resource Development,

Government of India has initiated several measures in the past for strengthening the
enforcement of copyrights that include constitution of a Copyright Enforcement
Advisory Council (CEAC), creation of separate cells in state police headquarters,
encouraging setting up of collective administration societies and organization of
seminars and workshops to create greater awareness of copyright laws among the
enforcement personnel and the general
public._____________________________________________________________________________
4. Special cells for copyright enforcement have so far been set up in
23 States and Union Territories, i.e. Andhra Pradesh, Assam,
Andaman & Nicobar Islands, Chandigarh, Dadra & Nagar Haveli,
Daman & Diu, Delhi, Goa, Gujarat, Haryana, Himachal Pradesh,
Jammu & Kashmir, Karnataka, Kerala, Madhya Pradesh, Meghalaya, Orissa,
Pondicherry, Punjab, Sikkim, Tamil Nadu, Tripura and West Bengal.
5.
The Government also initiates a number of seminars/workshops on

copyright issues. The participants in these seminars include
enforcement personnel as well as representatives of industry
organizations.
Intellectual Property
Intellectual property is an intangible creation of the human mind, usually
expressed or translated into a tangible form that is assigned certain rights of
property. Examples of intellectual property include an author's copyright on a
book or article, a distinctive logo design representing a soft drink company and
its products, unique design elements of a web site, or a patent on the process to
manufacture chewing gum.
Intellectual Property Rights
Intellectual property rights (IPR) can be defined as the rights given to people over the
creation of their minds. They usually give the creator an exclusive right over the use of
his/her creations for a certain period of time. Intellectual property (IP) refers to creations
of the mind: inventions, literary and artistic works, and symbols, names, images, and
designs used in commerce.
Categories of Intellectual Property
One can broadly classify the various forms of IPRs into two categories:
IPRs that stimulate inventive and creative activities (patents, utility models,
industrial designs, copyright, plant breeders rights and layout designs for
integrated circuits) and
IPRs that offer information to consumers (trademarks and geographical indications).
IPRs in both categories seek to address certain failures of private markets to provide for
an efficient allocation of resources. IP is divided into two categories for ease of
understanding:
1. Industrial Property
2. Copyright
Industrial property, which includes inventions (patents), trademarks, industrial designs,
and geographic indications of source; and
Copyright, which includes literary and artistic works such as novels, poems and plays,
films, musical works, artistic works such as drawings, paintings, photographs and
sculptures, and architectural designs. Rights related to copyright include those of
performing artists in their performances, producers of phonograms in their recordings,
and those of broadcasters in their radio and television programs.
i.
ii.
iii.
iv.
v.
vi.
vii.
Intellectual property shall include the right relating to:____________________________________

Literary, artistic and scientific works;
Performance of performing artists;
Inventions in all fields of human endeavour;
Scientific discoveries;
Industrial designs;
Trademarks, service marks and etc;
Protection against unfair competition.
Rights protected under Intellectual Property

The different types of Intellectual Property Rights are:
i. Patents
ii. Copyrights
iii. Trademarks
iv. Industrial designs
v. Protection of Integrated Circuits layout design
vi. Geographical indications of goods
vii. Biological diversity
viii.
Plant varieties and farmers rights
ix. Undisclosed information
a. Intellectual Property
1.
2.
3.
4.
b.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
Inventions
Trademarks
Industrial design
Geographical indications
Copyright
Writings
Paintings
Musical works
Dramatics works
Audiovisual works
Sound recordings
Photographic works
Broadcast
Sculpture
Drawings
Architectural works etc.
a.
IPR as Instruments of Development

Key drivers of economic performance in R&D based growth models
b.
Intellectual property policies do affect the extent and nature of investments

undertaken by multinational enterprises. At the same time, relative to other
factors determining foreign investment decisions, IPRs seem to be of
relatively minor importance.
Duration of Intellectual Property Rights in a nutshell

1) Term of every patent will be 20 years from the date of filing of patent application,
irrespective of whether it is filed with provisional or complete specification. Date
of
patent is the date on which the application for patent is filed.
2) Term of every trademark registration is 10 years from the date of making
of the application which is deemed to be the date of registration.
3)
Copyright generally lasts for a period of sixty years.
4)
The registration of a geographical indication is valid for a period of 10 years.
5) The duration of registration of Chip Layout Design is for a period of 10 years
counted from the date of filing an application for registration or from the date of
first commercial exploitation anywhere in India or in any convention country or
country specified by Government of India whichever is earlier.
6) The duration of protection of registered varieties is different for different crops
namely 18 years for trees and vines, 15 years for other crops and extant varieties.
References
1. www. ignou.ac.in
2. www.ipindia.ac.in
GP L 2. HISTORY OF IPR IN INDIA

George Alfred DePenning is supposed to have made the first application for a patent in
India in the year 1856. On February 28, 1856, the Government of India promulgated
legislation to grant what was then termed as "exclusive privileges for the encouragement of
inventions of new manufactures" i.e the Patents Act. On March 3, 1856, a civil engineer,
George Alfred DePenning of 7, Grants Lane, Calcutta petitioned the Government of India
for grant of exclusive privileges for his invention - "An Efficient Punkah Pulling Machine".
On September 2, DePenning, submitted the Specifications for his invention along with
drawings to illustrate its working.These were accepted and the invention was granted the
first ever Intellectual Property protection in India.
History of Copyright Law in India
Modern copyright law developed in India gradually, in a span of more than 150 years.
Copyright law entered India in 1847 through an enactment during the East India Company's
regime. According to the 1847 enactment, the term of copyright was for the lifetime of the
author plus seven years post-mortem. But in no case could the total term of copyright
exceed a period of forty-two years. The government could grant a compulsory licence to
publish a book if the owner of copyright, upon the death of the author, refused to allow its
publication. The act of infringement comprised in a persons unauthorized printing of a
copyright work for (or as a part of attempt of) "sale hire, or exportation", or "for selling,
publishing or exposing to sale or hire". Suit or action for infringement was to be instituted
in the "highest local court exercising original civil jurisdiction." The Act provided
specifically that under a contract of service copyright in "any encyclopedia, review,
magazine, periodical work or work published in a series of books or parts" shall vest in the
"proprietor, projector, publisher or conductor." Infringing copies were deemed to be copies
of the proprietor of copyrighted work. Importantly, unlike today, copyright in a work was
not automatic. Registration of copyright with the Home Office was mandatory for the
enforcement of rights under the Act. However, the Act also specifically reserved the
subsistence of copyright in the author, and his right to sue for its infringement to the extent
available in law other than the 1847 Act. At the time of its introduction in India, copyright
law had already been under development in Britain for over a century and the provisions of
the 1847 enactment reflected the learnings from deliberations during this period. In 1914,
the then Indian legislature enacted a new Copyright Act which merely extended most
portions of the United Kingdom Copyright Act of 1911 to India. It did, however, make a
few minor modifications. First, it introduced criminal l sanctions for copyright infringement
(sections 7 to 12). Second, it modified the scope of the term of copyright; under section 4
the "sole right" of the author to "produce, reproduce, perform or publish a translation of the
work shall subsist only for a period of ten years from the date of the first publication of the
work." The author, however, retained her "sole rights" if within the period of ten years she
published or authorized publication of her work a translation in any language in respect of
that language. The 1914 Act was continued with minor adaptations and modifications till
the 1957 Act was brought into force on 24th January, 1958.
History of Patent Law in India
The first legislation in India relating to patents was the Act VI of 1856. The objective of this
legislation was to encourage inventions of new and useful manufactures and to induce
inventors to disclose secret of their inventions. The Act was subsequently repealed by Act
IX of 1857 since it had
been enacted without the approval of the sovereign. Fresh legislation for granting
exclusive privileges was introduced in 1859 as Act XV of 1859. This legislation contained
certain modifications of the earlier legislation, namely, grant of exclusive privileges to
useful inventions only and extension of priority period from 6 to 12 months. The Act
excluded importers from the definition of inventor. The 1856 Act was based on the United
Kingdom Act of 1852 with certain departures including allowing assignees to make
application in India and also taking prior public use or publication in India or United
Kingdom for the purpose of ascertaining novelty.
The Act of 1859 provided protection for invention only and not for designs whereas United
Kingdom had been protecting designs from 1842 onwards. To remove this lacuna, the
Patterns and Designs Protection Act (Act XIII) was passed in 1872. This Act amended the
1859 Act to include any new and original pattern or design or the application of such
pattern to any substance or article of manufacture within the meaning of new
manufacture. The Act XV of 1859 was further amended in 1883 by XVI of 1883 to
introduce a provision to protect novelty of the invention, which prior to making application
for their protection were disclosed in the Exhibitions of India. A grace period of 6 months
was provided for filing such applications after the date of the opening of such Exhibition.
In 1888, new legislation was introduced to consolidate and amend the law relating to
invention and designs in conformity with the amendments made in the UK law. In 1911, the
Indian Patents and Designs Act, 1911, (Act II of 1911) was brought in replacing all the
previous legislations on patents and designs. This Act brought patent administration under
the management of Controller of Patents for the first time. This Act was amended in 1920
to provide for entering into reciprocal arrangements with UK and other countries for
securing priority. In 1930, further amendments were made to incorporate, inter-alia,
provisions relating to grant of secret patents, patent of addition, use of invention by
Government, powers of the Controller to rectify register of patent and increase of term of
the patent from 14 years to 16 years. In 1945, another amendment was made to provide for
filing of provisional specification and submission of complete specification within nine
months After Independence, it was felt that the Indian Patents & Designs Act, 1911 was not
fulfilling its objective. It was found desirable to enact comprehensive patent law owing to
substantial changes in political and economic conditions in the country. Accordingly, the
Government of India constituted a committee under the Chairmanship of Justice (Dr.)
Bakshi Tek Chand, a retired Judge of Lahore High Court, in 1949, to review the patent law
in India in order to ensure that the patent system is conducive to the national interest. The
Committee submitted its interim report on 4th August, 1949 with recommendations for
prevention of misuse or abuse of patent right in India and for amendments to sections 22,
23 & 23A of the Patents & Designs Act, 1911 on the lines of the United Kingdom Acts of
1919 and 1949.Based on the recommendations of the Committee, the 1911 Act was
amended in 1950 (Act XXXII of 1950) in relation to working of inventions and compulsory
licence/revocation. In 1952, an amendment was made to provide compulsory licence in
relation to patents in respect of food and medicines, insecticide, germicide or fungicide and
a process for producing substance or any invention relating to surgical or curative devices,
through Act LXX of 1952. The compulsory licence was also available on notification by
the Central Government. Based on the recommendations of the Committee, a bill was
introduced in the Parliament in 1953 (Bill No.59 of 1953). However, the bill lapsed on
dissolution of the Lok Sabha. In 1957, the Government of India appointed Justice N.
Rajagopala Ayyangar Committee to examine the question of revision of the Patent Law and
advise government accordingly. The report of the Committee, which comprised of two
parts, was submitted in September, 1959. The first part dealt with general aspects of the
patent law and the second part gave detailed note on the several clauses of the lapsed bill of
1953. The first part also dealt with evils of the patent system and solution with
recommendations in regard to the law. The committee recommended retention of the patent
system, despite its shortcomings. This report recommended major changes in the law which
formed the basis of the introduction of the Patents Bill, 1965. This bill was introduced in
the Lok Sabha on 21st September, 1965, which, however, lapsed. In 1967, an amended bill
was introduced which was referred to a Joint Parliamentary Committee and on the final
recommendation of the Committee, the Patents Act, 1970 was passed. This Act repealed
and replaced the 1911 Act so far as the patents law was concerned. However, the 1911 Act
continued to be applicable to designs. Most of the provisions of the 1970 Act were brought
into force on 20th April, 1972 with the publication of the Patents Rules, 1972. This Act
remained in force for about 24 years till December 1994 without any change. An ordinance
effecting certain changes in the Act was issued on 31st December 1994, which ceased to
operate after six months. Subsequently, another ordinance was issued in 1999. This
ordinance was later replaced by the Patents (Amendment) Act, 1999 that was brought into
force retrospectively from 1st January, 1995. The amended Act provided for filing of
applications for product patents in the areas of drugs, pharmaceuticals and agro chemicals
though such patents were not allowed. However, such applications were to be examined
only after 31st December, 2004. Meanwhile, the applicants could be allowed Exclusive
Marketing Rights (EMRs) to sell or distribute these products in India, subject to fulfillment
of certain conditions. The second amendment to the 1970 Act was made through the Patents
(Amendment) Act, 2002 (Act 38 0f 2002). This Act came into force on 20th May, 2003
with the introduction of the new Patents Rules, 2003 by replacing the earlier Patents Rules,
1972. The third amendment to the Patents Act, 1970 was introduced through the Patents
(Amendment) Ordinance, 2004 with effect from 1st January, 2005. This Ordinance was
later replaced by the Patents (Amendment) Act, 2005 (Act 15 Of 2005) on 4th April, 2005
which was brought into force from 1st January, 2005.
History of Trademark Law in India
While some form of proprietary protection for marks in India dates back several millennia,
Indias statutory Trademarks Law dates back to 1860. Prior to 1940 there was no official
trademark Law in India. Numerous problems arouse on infringement, law of passing off etc
and these were solved by application of section 54 of the Specific Relief Act, 1877 and the
registration was obviously adjudicated by obtaining a declaration as to the ownership of a
trademark under Indian Registration Act 1908. To overcome the aforesaid difficulties the
Indian Trademarks Act was passed in 1940, this corresponded with the English Trademarks
Act. After this there was an increasing need for more protection of Trademarks as there was
a major growth in Trade and Commerce. The replacement to this act was the Trademark
and Merchandise Act, 1958. This Act was to provide for registration and better protection
of Trademarks and for prevention of the use of fraudulent marks on merchandise. This Law
also enables the registration of trademarks so that the proprietor of the trademark gets legal
right to the exclusive use of the trademark. The objective of this act was easy registration
and better protection of trademarks and to prevent fraud.
The repeal of the Trademarks and Merchandise Act gave rise to the Trademark Act 1999;
this was done by the Government of India so that the Indian Trademark Law is in
compliance with the TRIPS obligation on the recommendation of the World Trade
Organisation. The object of the 1999 Act is to confer the protection to the user of the
trademark on his goods and prescribe conditions on acquisition, and legal remedies for
enforcement of trademark rights.
References
1. Handbook on intellectual property rights in India by
Rajkumar S. Adukia, http://rishabhacademy.com.
GP L 3. LAWS RELATED TO INTELLECTUAL PROPERTY RIGHTS
IN INDIA
The Rules and Laws governing Intellectual Property Rights in India are as follows:
1.
The Copyright Act, 1957, The Copyright Rules, 1958 and International
Copyright Order, 1999.
2.
The Patents Act, 1970 The Patents Rules, 2003, The Intellectual Property
Appellate Board (Patents Procedure) Rules, 2010 and The Patents (Appeals and
Applications to the Intellectual Property Appellate Board) Rules, 2011.
3.
The Trade Marks Act, 1999, The Trade Marks Rules, 2002, The Trade Marks
(Applications and Appeals to the Intellectual Property Appellate Board) Rules,
2003 and The Intellectual Property Appellate Board (Procedure) Rules, 2003.
4.
The Geographical Indications of Goods (Registration and Protection) Act, 1999

and The Geographical Indications of Goods (Registration and Protection) Rules,
2002.
5. The Designs Act, 2000 and The Designs Rules, 2001.

6.
The Semiconductors Integrated Circuits Layout-Design Act, 2000 and The

Semiconductors Integrated Circuits Layout-Design Rules, 2001.
7.
The Protection of Plant varieties and Farmers Rights Act, 2001 and The
Protection of Plant varieties and Farmers Rights Rules, 2003.
8. The Biological Diversity Act, 2002 and The Biological Diversity Rules, 2004.
9. Intellectual Property Rights (Imported Goods) Rules, 2007.
References
1. Handbook on intellectual property rights in India by Rajkumar S. Adukia,
http://rishabhacademy.com.
GPL 4. CRITERIA FOR PATENTABILITY
What is Patent?
A patent is an exclusive right granted by law to applicants / assignees to make use of and
exploit their inventions for a limited period of time (generally 20 years from filing). The
patent holder has the legal right to exclude others from commercially exploiting his
invention for the duration of this period. In return for exclusive rights, the applicant is
obliged to disclose the invention to the public in a manner that enables others, skilled in the
art, to replicate the invention. The patent system is designed to balance the interests of
applicants / assignees (exclusive rights) and the interests of society (disclosure of
invention)
Features of Patent
It is a Conditional grant.
Balance of Rights & obligations.
Subject to other Laws of the land
Granted to owner of the invention/assignee
Criteria
for
patentabi
lity .i.
Novelty
A novel invention is the one which has not been disclosed in the prior art [everything that
has been published,presented or otherwise disclosed to the public on the date of patent. It
includes documents in foreign languages also].
ii. Inventiveness (Non-obviosness)
this refers to the fact that the invention is not obvious to a person skilled in the art [i. e.
skilled in the subject matter of the patent application]. Inventiveness cannot be decided on
the material contained in unpublished patents. The complexity of simplicity of an inventive
step does not have any bearing on the grant of a patent.
iii. Usefulness (Industrial application)
The invention should possess practical utility and can be used in any Industrial process or
creating a useful product.
What is not patentable? [Patent Act 1970]
The following are Non-Patentable inventions within the meaning of Section 3 of Patents
Act,
1970 (a) an invention which is frivolous or which claims anything
obviously contrary to well established natural laws;
(b) an invention the primary or intended use or commercial exploitation of which could be
contrary to public order or morality or which causes serious prejudice to human, animal or
plant life or
health or to the environment; (For e.g. process of making brown sugar will not be
patented.)
(c) The mere discovery of a scientific principle or the formulation of an abstract theory
(or discovery of any living thing or non-living substances occurring in nature);
(d) the mere discovery of a new form of a known substance which does not result in
the enhancement of the known efficacy of that substance or the mere discovery of
any new property or mere new use for a known substance or of the mere use of a
known process, machine or apparatus unless such known process results in a new
product or employs at least one new reactant;
(e) a substance obtained by a mere admixture resulting only in the aggregation of the
properties of the components thereof or a process for producing such substance;
(f) the mere arrangement or re-arrangement or duplication of known devices each
functioning independently of one another in a known way;
(g) a method of agriculture or horticulture; (For e.g. the method of terrace farming
cannot be patented.)
(h) any process for the medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or
other treatment of human beings or any process for a similar treatment of animals to render
them free of disease or to increase their economic value or that of their products; (For e.g.
any new technique of hand surgery is not patentable).
(i) plants and animals in whole or any part thereof other than micro-organisms but including
seeds, varieties and species and essentially biological processes for production or
propagation of plants and animals.
(j) a mathematical or business method or a computer programme per se or algorithms.
(k) a literary, dramatic, musical or artistic work or any other aesthetic creation whatsoever
including cinematographic works and television productions.
(I) a mere scheme or rule or method of performing mental act or method of playing game.
(m) a presentation of information.

(n) topography of integrated circuits;
Patentability Filter
This list provides hierarchy of screening criteria for grant of patent.
S Prior publication/Prior
use/prior disclosure S Industrial
applicability S Novelty S
Inventiveness
S Not patentable________________________________________
S Written
description/enable
ment S
Application/specifi
cation/claims S
Patent prosecution
S
Maintenance/defen
se after grant
Patent System In India
The Patent System in India is governed by the Patents Act, 1970 as amended by the Patents
(Amendment) Act, 2005 and the Patents Rules, 2003, as amended by the Patents
(Amendment) Rules 2006 effective from 05-05-2006; as amended by the Patents
(Amendment) Rules 2013.
Patent Administration
Patent system in India is administered under the superintendence of the Controller General
of Patents, Designs, Trademarks and Geographical Indications. The Office of the Controller
General functions under the Department of Industrial Policy and Promotion, Ministry of
Commerce and Industry. There are four patent offices in India. The Head Office is located
at Kolkata and other Patent Offices are located at Delhi, Mumbai and Chennai.
The Controller General delegates his powers to Sr. Joint Controller, Joint Controllers,
Deputy Controllers and Assistant Controllers. Examiners of patents in each office discharge
their duties according to the direction of the Controllers.
The Patent Information system (PIS) at Nagpur has been functioning as patent information
base for the users. The PIS maintains a comprehensive collection of patent specification and
patent related literature, on a world-wide basis and provides technological information
contained in patent or patent related literature through search services and patent copy
supply services to various users of R&D establishments, Government offices, private
industries, business, inventors and other users within India.
Hierarchy of Officers in Patent office

Controller General of Patents, Designs, Trade marks & GI
Examiners of Patents & Designs
Assistant Controller of Patents & Designs
Deputy Controller of Patents & Designs
Joint Controller of Patents & Designs
Senior Joint Controller of Patents & Designs
Jurisdiction of Patent offices in India

An applicant or first mentioned applicant in case of joint applicants can file application for
patent at the appropriate Patent Office under whose jurisdiction he normally resides or has
his domicile or has a place of business or the place from where the invention actually
originated. For the applicant, who is nonresident or has no domicile or has no place of
business in India, the address for service in India or place
of business of his patent agent determines the appropriate patent office where
applications for patent can be filed.
References
Intellectual Property rights, Deborah E Bouchoux, India Edtion, Cengage

Learning 2005
ipindia.nic.in
Handbook on intellectual property rights in India by Rajkumar S.
Adukia, http://rishabhacademy.com.
GP L 5. PARIS CONVENTION AND BERNE CONVENTION
Paris Convention for the Protection of Industrial Property
The Paris Convention for the Protection of Industrial Property, signed in Paris, France, on
March 20, 1883, was one of the first intellectual property treaties. It established a Union for
the protection of industrial property. The Convention is still in force.
After a diplomatic conference in Paris in 1880, the Convention was signed in 1883 by 11
countries: Belgium, Brazil, France, Guatemala, Italy, the Netherlands, Portugal, El
Salvador, Serbia, Spain and Switzerland.
As of December 2011, the Convention has 174 contracting member countries, which makes
itone of the most widely adopted treaties worldwide. Notably, Taiwan and Kuwait are not
parties to the Convention.
The Paris Convention is administered by the World Intellectual Property
Organization (WIPO), based in Geneva, Switzerland. The Convention applies to industrial
property in the widest sense, including patents, trade marks, industrial designs, utility
models (a kind of small patent provided for by the laws of some
countries), trade names (designations under which an industrial or commercial activity is
carried on), geographical indications (indications of source and appellations of origin) and
the repression of unfair competition.
Indias membership into the convention came into force on December 7, 1998.
Berne Convention
The Berne Convention for the Protection of Literary and Artistic Works, usually known as
the Berne Convention, is an international agreement governing copyright, which was first
accepted in Bern, Switzerland in 1886.
The Convention rests on three basic principles and contains a series of provisions
determining the minimum protection to be granted, as well as special provisions available
to developing countries which want to make use of them.
The three basic principles are the following:
(a) Works originating in one of the contracting States (that is, works the author of
which is a national of such a State or works which were first published in such a
State) must be given the same protection in each of the other contracting States as
the latter grants to the works of its own nationals (principle of national treatment).
(b) Such protection must not be conditional upon compliance with any formality
(principle of automatic protection).
(c) Such protection is independent of the existence of protection in the country of
origin of the work (principle of the independence of protection). If, however, a
contracting State provides for a longer term than the minimum prescribed by the
Convention and the work ceases to be protected in the country of origin, protection
may be denied once protection in the country of origin ceases.___________________________
As of March 2012, there are 165 countries that are parties to the Berne Convention.
Indias membership into the convention came into force on April 1, 1928.
References
Handbook on intellectual property rights in India by Rajkumar S. Adukia,
GPL 6. MADRID AGREEMENT (1891) AND ROME CONVENTION (1961)
Madrid Agreement
The Agreement, concluded in 1891, was revised at Washington in 1911, at The Hague in
1925, at London in 1934, at Lisbon in 1958, and at Stockholm in 1967.This agreement is
concerned with prevention of the promotion/sale of goods bearing a false or deceptive
indication entering into market in the member countries.
Scope and Ambit:
All goods bearing a false or deceptive indication [i.e. trademark] by which one of the
countries to which this Agreement applies, or a place situated therein, is directly or
indirectly indicated as being the country or place of origin shall be seized on importation
into any of the said countries.
Seizure shall also be effected in the country where the false or deceptive indication of
source has been applied, or into which the goods bearing the false or deceptive indication
have been imported.
If the laws of a country do not permit seizure upon importation, such seizure shall be
replaced by prohibition of importation.
If the laws of a country permit neither seizure upon importation nor prohibition of
importation nor seizure within the country, then, until such time as the laws are modified
accordingly, those measures shall be replaced by the actions and remedies available in
such cases to nationals under the laws of such country. In the absence of any special
sanctions ensuring the repression of false or deceptive indications of source, the

sanctions provided by the corresponding provisions of the laws relating to marks or trade
names shall be applicable.
Application and Protection:
The applicant must indicate the goods or services in respect of which protection of the
mark is claimed and also, if possible, the corresponding class or classes according to the
classification established by the Nice Agreement concerning the International
Classification of Goods and Services for the Purposes of the Registration of Marks. If the
applicant does not give such indication, the International Bureau shall classify the goods
or services in the appropriate classes of the said classification.
The International Bureau shall register immediately the marks filed in accordance with
Article 1. The registration shall bear the date of the application for international
registration in the country of origin, provided that the application has been received by
the International Bureau within a period of two months from that date.
Members & administration:
The Agreement is open to States party to the Paris convention.The convention is
governed by WIPO. Instruments of ratification or accession is deposited with the
Director General of WIPO.
Rome Convention
International Convention for the Protection of Performers, Producers of Phonograms and
Broadcasting Organizations. Signed at Rome on October 26, 1961 ______________________________
Objective: Safeguard of Copyright of all types of creations.
Scope & ambit:

The convention lies on 3 principles and 34 articles for defining various types of copyright
and the rules for protecting them.
Governance:
Governed by an Intergovernmental Committee consisting of representatives of the
Contracting States, chosen with due regard to equitable geographical distribution. The
Committee shall elect its Chairman and officers. It shall establish its own rules of
procedure.
Madrid Agreement for the Repression of False or Deceptive Indications of Source on
Goods (1891)
This agreement sanctions prohibition of all goods bearing a false or deceptive indication of
source.The agreement makes it mandatory for th member countries to prohibit importing
such goods into their territory. As per the agreement, such goods must be seized on
importation, or such importation must be prohibited, or other actions and sanctions must be
applied in connection with such importation. The Agreement provides for the cases and the
manner in which seizure may be requested and effected. It prohibits the use, in connection
with the sale or display or offering for sale of any goods, of all indications in the nature of
publicity capable of deceiving the public as to the source of the goods.
The Agreement, concluded in 1891, was revised at Washington in 1911, at The Hague in
1925, at London in 1934, at Lisbon in 1958, and at Stockholm in 1967.
The Agreement is open to States party to the Paris Convention for the Protection of
Industrial Property (1883). Instruments of ratification or accession must be deposited with
the Director General of WIPO.
The agreement is defined through 18 articles with all amendments. Article 1 comprises the
fundamentals of the agreement and the rest define terms and conditions for dealing with
various levels of deviations arise to the fundamental terms and legal provision for tacking
such situations.
Article 1:
(1) All goods bearing a false or deceptive indication by which one of the countries to
which this Agreement applies, or a place situated therein, is directly or indirectly
indicated as being the country or place of origin shall be seized on importation into
any of the said countries.
(2) Seizure shall also be effected in the country where the false or deceptive indication
of source has been applied, or into which the goods bearing the false or deceptive
indication have been imported.
(3) If the laws of a country do not permit seizure upon importation, such seizure shall
be replaced by prohibition of importation.
(4) If the laws of a country permit neither seizure upon importation nor prohibition of
importation nor seizure within the country, then, until such time as the laws are
modified accordingly, those measures shall be replaced by the actions and remedies
available in such cases to nationals under the laws of such country.
(5) In the absence of any special sanctions ensuring the repression of false or deceptive
indications of source, the sanctions provided by the corresponding provisions of the
laws relating to marks or trade names shall be applicable.
Rome Convention (1961)
Full name of the agreement is International Convention for the Protection of Performers,
Producers of Phonograms and Broadcasting Organizations. This has been formulated and
executed at Rome on October 26, 1961.
Protection granted under this Convention is not interfering with protection of copyright in
literary and artistic works. Consequently, no provision of this Convention may be
interpreted as prejudicing such protection.
Definitions of terms protected by Rome convention:
(a) performers means actors, singers, musicians, dancers, and other persons who act,
sing, deliver, declaim, play in, or otherwise perform literary or artistic works;
(b) phonogram means any exclusively aural fixation of sounds of a performance or of other
sounds;
(c) producer of phonograms means the person who, or the legal entity which, first
fixes the sounds of a performance or other sounds;
(d) publication means the offering of copies of a phonogram to the public in reasonable
quantity;
(e) reproduction means the making of a copy or copies of a fixation;
(f) broadcasting means the transmission by wireless means for public reception of
sounds or of images and sounds;
(g)
rebroadcasting means the simultaneous broadcasting by one broadcasting

organization of the broadcast of another broadcasting organization.
References
http://www.wipo.int/treaties/en/ip/madrid/summary_madrid_source.html
http://www.wipo.int/treaties/en/ip/rome/trtdocs_wo024.html
Note: Also refer Full text of rome Convention
GPL 7. THE PATENT COOPERATION TREATY
The Patent Cooperation Treaty (PCT) is an international treaty administered by the World
Intellectual Property Organization (WIPO). The treaty was done at Washington on June 19,
1970. The PCT makes it possible to seek patent protection for an invention simultaneously
in a large number of countries by filing a single "international application with a single
patent office (i.e. receiving Office). The PCT system simplifies the process of multinational patent filings by reducing the requirement to file multiple patent applications for
multi-national patent rights. The PCT international applications do not result in the issuance
of international patents and the International Bureau (IB) does not grant patents.
The decision on whether to confer patent rights remains in the hands of the national and/or
regional patent offices, and the patent rights are limited to the jurisdiction of the patent
granting authority. The PCT procedure consists of an international phase and a
national/regional phase. The PCT international application process starts with the
international phase and concludes with the national/regional phase.
The total number of PCT filings (international patent applications filed
through the Patent Cooperation Treaty) in 2010 was approximately 164,300.
i.
The process of acquiring a patent through the PCT:

International Phase; and
ii. National Phase.

Every PCT application has to pass through the international phase before entering
the national phase. The International Phase gives the applicant a search report,
examination report and an opinion on patentability. After the International Phase,
the applicant has to file applications in each country of interest in order to enter
the National Phase. Each countrys patent office will examine the patent
application during the National Phase and will grant a patent if the invention
satisfies the patentability requirements.5
Patent law treaty:
The Patent Law Treaty (PLT) was adopted on June 1, 2000 at a Diplomatic Conference in
Geneva. The purpose of the PLT is to harmonize and streamline formal procedures in
respect of national and regional patent applications and patents. With a significant
exception for the filing date requirements, the PLT provides maximum sets of requirements
which the Office of a Contracting Party may apply: the Office may not lay down any
additional formal requirements in respect of matters dealt with by this Treaty. This means
that a Contracting Party is free to provide for requirements that are more generous from the
viewpoint of applicants and owners, but are mandatory as to the maximum that an Office
can require from applicants or owners. India is not a contracting party to this treaty.
References
Handbook on intellectual property rights in India by
Rajkumar S. Adukia, http://rishabhacademy.com.
IPR
GPL 8. TRIPS AGREEMENT (1994), WIPO PERFORMANCE AND PHONOGRAMS TREATY

(WPPT, 1996)
TRIPS
The Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) is an international
agreement administered by the World Trade Organization (WTO) that sets down minimum standards for
many forms of intellectual property (IP) regulation as applied to nationals of other WTO Members. It was
negotiated at the end of the Uruguay Round of the General Agreement on Tariffs and Trade (GATT) in 1994.
The TRIPS agreement introduced intellectual property law into the international trading system for the first
time and remains the most comprehensive international agreement on intellectual property to date.
1)
2)
3)
4)
5)
6)
7)
8)
The following Intellectual Property Rights are covered under the TRIPS Copyright;
Geographical indications;
Industrial designs;
Integrated circuit layout-designs;
Patents;
New plant varieties;
Trademarks;
Undisclosed or confidential information.
TRIPS also specifies enforcement procedures, remedies, and dispute resolution procedures. Protection and
enforcement of all intellectual property rights should meet the objectives to contribute to the promotion of
technological innovation and to the transfer and dissemination of technology, to the mutual advantage of
producers and users of technological knowledge and in a manner conducive to social and economic welfare,
and to a balance of rights and obligations.
Copyrights and related rights
Part II Section 1 (Article 9 to Article 14) of the TRIPS agreement deals with the minimum
standard in respect of copyrights.
Trademarks
Part II Section 2 (Article 15 to Article 21) of the TRIPS agreement contains the provisions for
minimum standards in respect of Trademarks.
Geographical Indications
Section 3 Part II (Article 22 to Article 24) of the TRIPS Agreement contains the provisions for
minimum standards in respect of geographical indications.
Industrial Designs
Section 4, Part II (Article 25 and Article 26) of the TRIPS Agreement contains the provisions for
minimum standards in respect of Industrial designs.__________________________________________
Patents
Section 5 Part II of the TRIPS Agreement (Article 27 to Article 34) contains the provisions for standards in
respect of Patents.
Layout Designs of Integrated Circuits
Articles 35 to 38 of Section 6 / Part II of the TRIPS agreement contain the provisions for protection of rights
in respect of Layout Designs of Integrated Circuits.
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Protection of undisclosed information

Article 39 of Section 7 Part II of the TRIPS agreement elaborates on the protections of trade secrets. A Trade
Secret or undisclosed information is any information that has been intentionally treated as secret and is
capable of commercial application with an economic interest. There is no specific legislation regulating the
protection of trade secrets. India follows common law approach of protection based on contract laws.
WIPO
The World Intellectual Property Organization (WIPO) is one of the 17 specialized agencies of the
United Nations, located in Geneva, Switzerland. The Organization has External Offices at Rio de
Janeiro in Brazil, Tokyo in Japan, Singapore and New York.
The mission of WIPO is to promote innovation and creativity for the economic, social and
cultural development of all countries, through a balanced and effective international intellectual property
system.
The origin of WIPO goes back to 1883 and 1886 when the Paris Convention for the Protection of
Industrial Property and the Berne Convention for the Protection of Literary and Artistic Works,
respectively, were concluded. Both Conventions provided for the establishment of an international
bureau. The two bureaus were united in 1893 and, in 1970, were replaced by the World Intellectual
Property Organization, by virtue of the WIPO Convention.
The WIPO Convention, the constituent instrument of the World Intellectual Property Organization
(WIPO), was signed at Stockholm on July 14, 1967, entered into force in 1970 and was amended in
1979. WIPO is an intergovernmental organization that became in 1974 one of the specialized
agencies of the United Nations system of organizations.
WIPO currently has 185 Member States, and 68 intergovernmental organizations (IGOs) and 232
International non-governmental organizations (NGOs) and 63 National NGOs that are accredited as
observers at WIPO meetings.
>
>
The core tasks of WIPO are:

working with Member States to support a balanced evolution of international IP law
administering treaties
> u assisting governments and organizations in developing the policies, structures and skills
_needed to harness the potential of IP for economic development
_
> servicing global registration systems for trademarks, industrial designs and appellations of origin
and a global filing system for patents
> delivering arbitration, mediation and other dispute resolution services
> promoting respect for IP
> providing a forum for informed debate and for the sharing of IP knowledge
> identifying IP-based solutions that can help confront global challenges and maximize the benefits of
the IP system for all.
Working of WIPO:
WIPOs Member States determine the strategic direction and activities of the Organization. They meet in the
Assemblies, committees and working groups. The WIPO Secretariat, or International Bureau, is based in
Geneva. WIPO staff, drawn from more than 90 countries, includes experts in diverse areas of IP law and
practice, as well as specialists in public policy, economics, administration and IT. The respective divisions of
the Secretariat are responsible for coordinating the meetings of Member States and implementing their
decisions; for administering the international IP registration systems; for developing and executing the
IPR
programs designed to achieve WIPOs goals; and for providing a repository of IP expertise to assist its
members. It has to present a program and a budget every 2 years about performance measures, budget
planning for all the events of the organization which requires member state approval.It is a self financing
organization and its funds are majorly used for organizing events. WIPO Arbitration and Mediation Centre
was created in 1994 for the settlement of international commercial disputes arising between private parties
located in Geneva, Switzerland and it has an office in Singapore
WPPT
Preamble of WPPT:
The Contracting Parties,
Desiring to develop and maintain the protection of the rights of performers and producers of
phonograms in a manner as effective and uniform as possible,
Recognizing the need to introduce new international rules in order to provide adequate solutions to the
questions raised by economic, social, cultural and technological developments,
Recognizing the profound impact of the development and convergence of information and
communication technologies on the production and use of performances and phonograms,
Recognizing the need to maintain a balance between the rights of performers and producers of phonograms
and the larger public interest, particularly education, research and access to information,
Have agreed as follows:
(1) Nothing in this Treaty shall derogate from existing obligations that Contracting Parties have to each
other under the International Convention for the Protection of Performers, Producers of Phonograms
and Broadcasting Organizations done in Rome, October 26, 1961 (hereinafter the Rome
Convention).
(3) This Treaty shall not have any connection with, nor shall it prejudice any rights and
obligations under, any other treaties.
Definitions:
For the purposes of this Treaty:
(a) performers are actors, singers, musicians, dancers, and other persons who act, sing,
deliver, declaim, play in, interpret, or otherwise perform literary or artistic works or
expressions of folklore;
(b) phonogram means the fixation of the sounds of a performance or of other sounds, or of a
representation of sounds, other than in the form of a fixation incorporated in a cinematographic or
other audiovisual work;1
(c) fixation means the embodiment of sounds, or of the representations thereof, from which they
can be perceived, reproduced or communicated through a device;
(d) producer of a phonogram means the person, or the legal entity, who or which takes the initiative
and has the responsibility for the first fixation of the sounds of a performance or other sounds, or
the representations of sounds;
(e) publication of a fixed performance or a phonogram means the offering of copies of the fixed
performance or the phonogram to the public, with the consent of the rightholder, and provided that
copies are offered to the public in reasonable quantity;3
1 Protection granted under this Treaty shall leave intact and shall in no way affect the protection of copyright
in literary and artistic works. Consequently, no provision of this Treaty may be interpreted as prejudicing
such protection.1
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(f) broadcasting means the transmission by wireless means for public reception of sounds or of
images and sounds or of the representations thereof; such transmission by satellite is also
broadcasting; transmission of encrypted signals is broadcasting where the means for
decrypting are provided to the public by the broadcasting organization or with its consent;
(g) communication to the public of a performance or a phonogram means the transmission to the
public by any medium, otherwise than by broadcasting, of sounds of a performance or the sounds
or the representations of sounds fixed in a phonogram. For the purposes of Article 15,
communication to the public includes making the sounds or representations of sounds fixed in a
phonogram audible to the public.
References

http://www.wipo.int/treaties/en/ip/wppt/trtdocs_wo034.html
Intellectual Property rights, Deborah E Bouchoux, India Edtion, Cengage Learning 2005.
GPL 9. PATENT PROCEDURE IN INDIA
Patent Procedure generally refers to rules related to the process of filing and prosecuting patent applications
in a particular jurisdiction. A detailed understanding of the patent process is as important as understanding
the nuances of the patent law itself.
Steps in Patenting
The patent procedure in India can be broadly divided into the following stages:
1. Filing
2. Request for Examination
3. Publication
4. Examination
5. Opposition- Pre Grant and Post Grant
6. Registration and Renewal fee payment
1. Filing
The first question that arises with respect to filing of a patent application is - who can file a patent
application? A patent application can be filed either by a person who claims to be the true and first inventor
of the invention or it may be filed by the assignee of the true and first inventor2. The application may also be
filed by the legal representative of any deceased person who was entitled to file such an application
immediately before the death of the true and first inventor3.
Another essential inquiry before filing the patent application is where to file the patent application. The
patent office has four branch offices in India viz. Delhi, Mumbai, Kolkata and Chennai. Patent application
originating out of a particular geographical area can be filed only in a specific branch office. For example, a
patent application emerging from Karnataka can be filed only in the Chennai branch office.
India recognizes two types of patent filings-
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(a) Provisional application- A provisional application may be filed when an applicant feels that the
invention has been conceptualized but at the same time it may not be possible to define the
boundaries of the claims to be mentioned in the application. In such a scenario, the provisional
application not only helps the applicant to secure a priority date but also gives the applicant 12
months to file the complete application. It is important to describe the invention completely in the
provisional application as the law does not permit the applicant to add new matter, outside the scope
of the provisional application, at the time of filing the complete application.
(b) Complete Application- As the name itself suggests, a complete application is an application that is
complete in all respects i.e. detailed description enabling a person to practice the invention, claims,
all embodiments, best mode etc. A complete application may be filed within 12 months from the date
of filing of the provisional application. One major difference between the provisional and the
complete application is that the provisional application may be filed without claims while the
complete application compulsorily needs to have claims.
2. Request for Examination (RFE)
RFE is a mandatory requirement at the Indian Patent office. An RFE is filed at the option of the applicant
when the applicant wants his application to be examined by the Indian Patent office. Unless a RFE is filed
the Indian patent office does not take up the application for examination. The applicant has the option of
filing the RFE at any time within a non-extendable period of 48 months from the priority date of the
application.4 In case RFE is not filed with this time limit the application is considered as deemed
withdrawn.5 From a practical perspective it is advisable to file the RFE as early as possible because the
earlier the RFE is filed the earlier the application will be queued for examination.
3. Publication
A patent application gets published upon expiry of 18 months from the priority date of the application. If it is
an application for which secrecy directions are issued, publication takes place after cessation of the secrecy
directions or after eighteen months whichever is later. If it is a divisional application, it is done after eighteen
months from priority of parent application or immediately after filing divisional application whichever is
later. In case of national phase of PCT application, it will be published immediately after filing. In case the
application is not published at the end of 18 months it is considered deemed to be published and will have
the same effect as publication. The two major reasons that make the publication date a really vital one are(a) Rights of the patent applicant commence from the date of publication i.e. once the patent is granted
and the patent owner sues someone for infringement then he will receive damages/account of profits
from the date of the publication.
(b) Pre grant opposition opportunity opens up for third parties to oppose the grant of the patent from the
date of publication.
In case an applicant does not wish to wait for 18 months for the publication to occur, there is an option filing
a request for early publication. This request once filed ensures that the application will be published within
one month from the date of filing of such request.
Given the significance of the publication date, it becomes really important for an applicant to decide whether
to opt for early publication or not. At one end early publication will ensure that the rights of the applicant
will commence early while on the other hand the application will be open for opposition sooner than the
normal publication procedure.
4. Examination
As seen above a Request for Examination can be filed at any time after the patent application is filed. The
examination of the patent application will be done by the Controller in co-ordination with the patent
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examiner. After receiving a request for exam ination, the Controller will refer the application to an examiner
generally within one (1) month from the date of publication or request for examination, whichever is
earlier6. The examiner on receiving the application will review the application and make a report in respect
of the following:
a.
whether the form of application and specification are in accordance with the requirements of the
Patent Act and the Rules;
b.
whether the invention that forms part of the patent application satisfies the patentability
requirements such as subject matter, industrial applicability, novelty, inventive step and specification;
and
c.
whether the application confirms to any other requirements such as unity of invention and so on
prescribed under the Act and Rules.7
The First Examination Report (FER) will be sent to the applicant or his authorized agent. In case the request
for examination is filed by any other interested person (third party), only intimation of such examination will
be sent to such person and FER will be sent to applicant or his authorized agent. Putting application in
order for grant
Once the FER is issued by the patent office the applicant has to comply with all the requirements mentioned
in the FER and subsequent examination reports within 12 months from the date of issue of the FER. This is
known as putting the application in order for grant.8 If all the requirements are not met within these 12
months the application shall be deemed to have been abandoned. Another vital point to be learnt from this is
that the response to examination report should be filed as soon as possible in order to communicate
effectively with the patent office and meet all requirements of the subsequent examination reports. From a
practice perspective it is always advisable to request hearing in case of adverse decision on the application.
This practice ensures that the patent is not rejected without giving a hearing to the applicant.
5. Opposition- Pre Grant and Post Grant
Pre Grant Representation
Once the patent application is published it is open for the public to oppose the patent application. The pre
grant representation can be filed at any time up till the grant of patent. As per the Indian patent rules a patent
cannot be granted for at least 6 months from the date of publication of the application9. This means that
minimum period available for pre grant representation is 6 months and it is advisable to file the pre grant
representation as early as possible. Various grounds for pre grant representation can be
Patentability of the invention including Novelty, inventive step and industrial application
Non-disclosure or wrongful mentioning of the source and geographical origin of biological material
used in the invention
Anticipation of invention by knowledge, oral or otherwise available within any local or indigenous
community in India or elsewhere
Wrongful obtaining
Prior publication
Prior claiming
Prior public knowledge and use in India
Insufficiency of descrption
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Failure to disclose the information regarding corresponding foreign application or furnishing false
information
Failure to file convention application within twelve months from the date of first application made
in the convention country.
Post Grant opposition:

A Post-Grant Opposition may be filed by any interested person after the publication of patent grant and
within one (1) year from the date of such publication. Person interested includes a person engaged in, or
in promoting research in the field of the invention. Such person must have bonafide interest in the
invention and the onus of proving lies on him. For example, if X gets a patent grant on a gene sequence
responsible for diabetes, a scientist at National Institute of Nutrition, who is researching on diabetes will
be considered to be an interested person10.
The grounds of filing post grant opposition are the same as the grounds of pre grant representation. The
procedure for opposition involves constitution of the Opposition Board by the Controller. The Opposition
Board consists of three members including the Chairman. The Board conducts the examination and
submits the report to the Controller. The Controller thereafter fixes a date for the hearing and gives parties
at least ten days notice. He hears the parties and then makes the decision.
Post Grant Publication Notice of Oppositions within 12 months of publication- By Interested Person
(opponent)- Grounds Under Section 25(2)Written Statement and EvidencePatent Holder is notified
Controller constitutes Opposition Board Patent Holder can contest - Reply statement and evidence within
2 months from date of receipt of notice from controller Refers the Opposition to the Opposition
Board.Opponent can file evidence in response to the Patent Holder evidence within one month from
receipt of such evidenceReport within three months from reference - every ground of Opposition - with
joint recommendations.Hearing Notice sent by ControllerHearing (If parties want)Revoke the
PatentRequires amendment in PatentReject Opposition.
Registration and Renewal fee payment
Once the application is published and all the objections raised in the examination report are met the
application proceeds towards registration given there is no pre grant representation pending. In case there is a
pre grant representation against the application the patent is granted once the opposition is dismissed.
Upon grant of the patent renewal fee has to be paid for maintaining the patent for 20 years. At the time of
grant one of the following two situations may arise with respect to the payment of renewal fee:
a)
The patent is granted within two years from the date of filing of the patent- In this case the renewal
fee should be paid before the expiry of two years from the date of filing.
b)
The patent is granted later than two years from the date of filing of the patent- In this case the
renewal fee should be paid within 3 months from the date of recordation of the patent.
References
GP L 10. COMMERCIAL POTENTIAL OF BT INVENTIONS
Biotechnology has diverse aspects of interdisciplinary areas with possibilities for practical applications.
Major factors contributing for the commercial potential of this field include:
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1.
Possibility for development of highly innovative products [eg: GM crops, Designed antibody
drugs, etc.]
2. Large scale production of products in short supply [eg. Human insulin]

3. Quality products at lesser cost [eg. Plant sec. metabolites in cell culture, plantlets by tissue culture].
4. Safer products [eg. Cell culture vaccines like oral polio vaccine, rabies vaccine, etc.].
5. Use of abundant and cheaper raw materials for product development. [eg. Microbial products].
6.
Development of novel materials for specific uses. [eg. Biocompatible surgical devises,
biopolymers, etc.].
In addition to the diversity and safty of product range, biotechnology can address challengs in large
number of domains of human life such as healthcare, environmental sustainability, National safety, etc.
References
Commercial Biotechnology- An international Analysis Washington, D. C.: U.S. Congress, Office of
Technology Assessment, OTA-BA 218, 1984.
IPR L 11 .EVOLOUTION AND APPLICATIONS OF BIOTECHNOLOGY
Assignment
IPR L 12 .R & D INVESTMENTS, RATIONALE AND APPLICATIONS

The biotechnological inventions therefore include products and/ or processes.
Eg. Genetic engineering based technologies, methods of producing organisms, methods of isolation of
micro-organisms from culture medium, methods of mutation, cultures, mutants, transformants, plasmids,
processes for making monoclonal antibodies, cell lines for making monoclonal antibodies, etc.
Pros: Exciting processes & products!
Encouragement through govt. schemes.
Better market prospects.
Cons: High Cost
Requirement of advanced facilities & Highly skilled manpower
Long duration incubation and stringent regulatory isses..
Ethical
issues
Risks.
Even though cons are more, crucial aspects like applications in agriculture & food, healthcare and
environmental safeguard overcome, make them acceptable despite the limitations.
IPR L 13. CONCEPT OF NOVELTY AND INVENTIVE STEP IN BT
There are some issues relating to patentability of biotechnological inventions which are of serious concern to
the users of Patent System such as novelty, obviousness, industrial applicability, extent of disclosure and
clarity in claims. In addition, a few special issues have also evolved such as those relating to moral and
ethical concerns, environmental safety, issues relating to patenting of ESTs (Expressed Sequence Tags) of
partial gene sequences, cloning of farm animals, stem cells, gene diagnostics, etc. Thus, the patenting of
inventions in the field of biotechnology poses challenges to the applicants for patents as well as to the Patent
Office.
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I. Novelty
According to the Patents Act, 1970, an "invention" means a new product or process involving an inventive
step and capable of industrial application. An invention will be patentable only if it is new in the light of
prior art, or is not anticipated by prior art. The prior art includes all information and knowledge relating to
the invention, which is available in any publication before the date of priority of the patent application. For
the purpose of examination, an invention will not be new if it forms part of the prior art or has entered the
public domain. For anticipation, such publication must be before the date of priority of the patent
application. Also, any application for patent filed in India, but published after the date of filing of a
subsequent application for patent in India claiming the same subject-matter shall be treated as a prior art (i.e.
prior claiming) to the said subsequent application provided that the previous application has earlier priority
date.
1. Product-by-process claimsA claim to a product obtained or produced by a process is anticipated by any prior disclosure of that
particular product per se, regardless of its method of production.
Examples of Product-by-process claims(a) A polypeptide/compound which is the product of the method according to claim X.
(b) A transgenic microorganism obtained by the method ... .characterized in that
(c) A plasmid obtained by the method of
Such claims are admissible only if the products themselves fulfill the requirement of patentability over
the prior art. The claimed products cannot be considered novel merely due to the novelty in the
processes by which they are produced, but rather novelty can only be established, if technical
evidences are provided showing that the modifications in the processes result in other products, which
are distinct with regard to their properties over the products known in the prior art.
2. Sequence claims
A claim to a polynucleotide sequence that was available, e.g. as part of a library before the priority
date, lacks novelty, even if the sequence of the polynucleotide has not been previously determined.
A claim to a specific fragment of polynucleotide may be considered to be novel, but subject to fulfillment of
the inventive step and non-patentability under relevant clauses of Section 3 of the Act. 6
A prior disclosure of the same sequence but without any indication of its activity would prima facie
constitute anticipation to the novelty of the claimed sequence. The assumption must be that the earlier
sequence inherently possesses the activity of the claimed sequence.
If any sequence of a polynucleotide/polypeptide from a prior art does not exactly match with the
claimed sequence of polynucleotide/polypeptide, then the subject-matter of such claims cannot be said
to be anticipated by the prior art sequence. However, such sequence of polynucleotide/polypeptide of
the prior art would be relevant for deciding inventive step or nonpatentability under relevant clauses of
Section 3 of the Act.
3. Combination/composition claims:
Quite often, the claims of combination of products of biotechnology escape the question of novelty and are
dealt under the inventive step .or relevant clauses of Section 3 of the Act. However, sometimes it may
happen that the combination has already fallen in the public domain and hence, to be dealt under novelty.
Illustrative Example:
Claim: A composition useful against diphtheria toxin, comprising anti-diphtheria antibodies together with
acceptable preservatives and stabilizers, wherein the antibodies are obtained from chicken egg yolk (IgY).
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Prior art discloses a composition useful against the diphtheria toxin comprising antibodies obtained from
chicken egg yolk, physiologically acceptable carrier and other additives & adjuvants. The prior art further
discloses a process for preparing egg yolk antibodies by employing the same steps right from an
immunization of a chicken with a diphtheria antigen to antibodies purification as claimed in the present
invention.
Analysis: The claim lacks novelty, as being anticipated by the said prior art which discloses all the features
of claimed composition useful against the diphtheria toxin. Thus, the claimed subject matter lacks novelty.
II. Inventive Step:
The Manual of Patent Office Practice & Procedure has set out the guidelines for assessment of Inventive
Step of inventions (Chapter 8, Para 08.03.03) that may be referred to. An invention should possess an
inventive step in order to be eligible for patent protection. As per the Patents Act, an invention will have
inventive step if the invention involves (a) technically advanced as compared to existing knowledge or
(b) having economic significance or (c) both, and that makes the invention not-obvious to a person
skilled in the art.
ILLUSTRATVE EXAMPLE 1
Claim: An isolated DNA sequence encoding a mature human IL-3 protein having a proline residue at
position 8 of the mature polypeptide, said protein possessing bone marrow proliferation-inducing activity in
a human bone marrow proliferation assay.
Difference with prior art is that the claimed compound at position 8, there was a proline moiety whereas in
the prior art compound in the same position there was a serine molecule.
Analysis: Primate IL-3 are part of family proteins which are similar in their amino acid sequences, but are
minor variants or point mutations of each other. A single variation in the amino acid sequence does not
normally change the activity and function of the protein unless the single variation is in a critical region of
the protein. The applicant could not provide any evidence that the protein coded by the claimed DNA was
any different from that of the prior art in its chemical properties. Thus, the inventive step cannot be
acknowledged.
The claimed subject-matter would lack inventive step if it is obvious to a person skilled in the relevant art in
view of a single prior art or a mosaic of the relevant prior art documents.
ILLUSTRATIVE EXAMPLE 2:
Claim: An improved process for the production of galactooligosaccharides (GOS) of high yield and purity
comprising the steps of: (i) isolating Bullera singularis and Saccharomyces sp. (ii) immobilizing the B.
Singularis and Saccharomyces sp; (iii) hydrolysis of lactose by the immobilized microbial cells, said
reaction being carried out until galactose content being at least 65 % and (iv) optionally concentrating the
galactooligosaccharides solution.
Prior Art: D1 discloses a process for the production of galacto-oligosaccharides from lactose using
immobilized B. singularis cells. D1 does not explicitly teach the combined use of B. Singularis and
Saccharomyces sp. in the production of galacto-oligosaccharides. D2 discloses the use of Saccharomyces sp.
for the production of galacto-oligosaccharides from lactose. It further discloses that Saccharomyces sp. uses
lactose as a carbon source & approximately it removes 92% of glucose from the GOS mixture by
fermentation without losing the GOS content.
Analysis: Since it is evident from D2 that Saccharomyces sp. consume glucose, one of ordinary person
skilled in the art would be motivated to use Saccharomyces sp. in combination with B. singularis to solve
the problem of separation of saccharides and also, reducing the competitive inhibition of beta- galactosidase
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enzyme by glucose, which leading to high yield & purity of GOS. Thus, the claimed subject-matter lacks
inventive step.
Claim: A culture independent method of removal of plasmids from live and multiplying plasmid containing
bacteria comprising the following steps: (a) preparing an aqueous first suspension of sub- micronic silver
particles; (b) estimating MIC (minimum inhibitory concentration) of the silver particles for the bacteria to
determine the inhibitory concentration of the particles suspension for the bacteria; (c) adding in a reaction
vessel, the first suspension and growth medium of the bacteria to obtain a second suspension containing subMIC concentration of silver particles; (d) introducing the bacteria in the reaction vessel under conditions
favouring the multiplication of the bacteria, for 12 to 48 hrs. , to obtain subsequent generations of the
bacteria and (e) testing the bacterial generations for absence of plasmids to obtain a generation of plasmid
free bacteria.
Prior art discloses a method in which an antimicrobial activity of silver nano-particles against E. coli was
investigated as a model for Gram-negative bacteria. Bacteriological tests were performed in LB medium on
solid agar plates and in liquid systems supplemented with different concentrations of silver nano-sized
particles. To examine the effect of silver nanoparticles on Gram-negative bacteria, approximately 105
colony-forming units (CFU) of E. coli strain were cultured on LB agar plates supplemented with silver
nano-sized particles in the concentrations of 10 to 100 pg cm-3. Silver-free LB plates cultured under the
same conditions were used as a control. The plates were incubated for 24 hours at 37OC. E. coli bacteria
were grown in 100 cm3 of liquid LB medium supplemented with 10, 50, & 100 p,g of these particles per
cm3 of medium. Growth rates & bacterial concentrations were determined by measuring optical density
(OD) at 600 nm each 30 min (OD of 0.1 corresponds to a concentration of 108 cells per cm3). The size and
morphology of the silver nanoparticles were examined by transmission electron microscopy (TEM). The
results confirmed that the treated E. coli cells were damaged, showing formation of pits in the cell wall of
the bacteria, while the silver nanoparticles were found to accumulate in the bacterial membrane. A
membrane with such morphology exhibits a significant increase in permeability, which leads to leaking of
intracellular substances (that is admitted by the applicant on page 16, 3rd paragraph in the specification of
the present invention). The TEM micrograph also shows coagulation of nano-sized particles at the bacterial
surface.
Analysis: Prior art discloses each and every aspect of claimed invention right from the selection of E. coli
strain, preparation of silver nanoparticles, culturing of the bacterial strain with different concentration of
silver nanoparticles, conditions for bacterial growth and assessment of effect of silver nanoparticles on gram
negative bacteria. Prior art does not explicitly teach removal of plasmid from bacteria; however, it teaches
that the silver nanoparticles were responsible for significantly increasing the permeability of bacterial cell
membrane that leads to leaking of intracellular substances (which may include plasmids) from E. coli. Thus,
the teaching of cited art would motivate a person having ordinary skill in the art with reasonable expectation
of success to provide an alternative method for removal of plasmids from plasmid containing bacteria in
order to solve the problem faced with plasmid containing bacteria using varied concentration of silver
nanoparticles, as these particles effectively increase bacterial cell membrane permeability leading to removal
of intracellular substances, which may include plasmids. Thus, the claimed subject-matter lacks inventive
step in view of prior art.
If the claimed invention relates to a polynucleotide/polypeptide having mutation(s) in a known
sequence of polynucleotide/polypeptide, which does not result in an unexpected property
whatsoever, then the claimed subject-matter lacks inventive step. ILLUSTRATIVE EXAMPLE 1:
Claim: Pro-insulin having a C-peptide encompassing only two amino acids selected from Arg-Lys, Lys- Lys
and Lys-Arg*.
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(*Human Pro-insulin is comprised of three chains, A, B and C, in the insulin the two chains are
combined eliminating the third chain, i.e. the C-chain consisting of thirty amino acids).
Prior art discloses natural Pro-insulin having 30 amino acids C-peptide, Pro-insulin with C-peptide as short
as two amino acids (Arg-Arg).
Analysis: The claim was held to be prima facie obvious. The applicant argued that the yield of claimed Proinsulin having a C-peptide expressed in yeast is 1.6 to 2.0 mmol/l whereas the yield of the prior art Proinsulin with a C-chain of Arg-Arg is only 1.0 mmol/l. Such a difference in change did not constitute
unexpected property and hence, the subject-matter is held to be obvious.
Claim: A recombinant DNA sequence of SEQ ID NO: X encoding human interferon a2 polypeptide.
Prior art discloses a nucleic acid sequence of SEQ ID NO: X1 encoding human interferon a1 polypeptide.
Analysis: The claimed human interferon a2 is structurally close to the prior arts human interferon al.
However, the alleged invention can be held non-obvious, because of the fact that the claimed human
interferon is thirty times more potent in its antiviral activity than its prior art analogue.
3. INDUSTRIAL APPLICATION
As per the Patents Act, 1970, the expression capable of industrial application, in relation to an invention,
means that the invention is capable of being made or used in an industry. Further, Section 64 (1) (g) of
the Act provides that a patent is liable to be revoked if the invention is not useful.
To be patentable an invention must be useful and capable of industrial application. The specification
should disclose the usefulness and industrial applicability of an invention in a distinct and credible manner
unless the usefulness and industrial applicability of the invention is already established, either in explicit
or in implicit manner.
In the context of the gene sequences, it may be said that whatever ingenuity is involved in
discovering a gene sequence, one cannot have a patent for it or a protein encoded by it unless it is
disclosed how it can be used. It is therefore necessary to consider whether the invention claimed has
a useful purpose, and whether the specification identifies any practical way of using it.
Claim: A polypeptide in substantially isolated form comprising a contiguous sequence of at least 10 amino
acids encoded by the genome of hepatitis C virus (HCV) and comprising an antigenic determinant,
wherein HCV is characterized by: (i) a positive stranded RNA genome; (ii) said genome comprising an
open reading frame (ORF) encoding a polyprotein; and (iii) said polyprotein comprising an amino acid
sequence having at least 40% homology to the 859 amino acid sequence X.
Upon examination it was found that the above claim was sufficiently enabled and its use was properly
established in the specification. Therefore, claim 1 was allowable.
Another claim of the specification read as A polypeptide in substantially isolated form whose sequence is
shown in any one of SEQ IDs 1, 3 to 32, 36, 46 and 47, or whose sequence is encoded in a polynucleotide
selectively hybridisable with the polynucleotide as shown in any one of SEQ IDs 1, 3-32, 36,46 or 47."
Upon examination, it was seen that the said claim covered an almost vast number of polypeptides for
which no use was established and the said claim therefore, was not allowable on the ground that it
lacked industrial applicability.
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The use of claimed subject-matter (e.g. a gene or a protein) disclosed in the specification should
not be merely speculative, rather the said use should be specific, substantial and credible for
establishing industrial applicability of the claimed subject-matter.
Claim 1: A V28 protein (V28) having a function as a receptor (of a kind known as 7TM).
Claim 2: A method of verifying the function of a V28 protein as claimed in claim 1. 11
Analysis: The function of V28 protein as a receptor was based on prediction upon various structural
elements in the deduced amino acid sequence and homology to known 7TM receptors but the specification
disclosed no ligand. The use of the invention is disclosed in the specification, which is however based on a
proposed function of the V28 protein as a receptor that is not sufficiently disclosed in the specification.
Thus, the use disclosed in the application is speculative, i.e. is not specific, substantial and credible and as
such is not considered industrially applicable.
4. FRAGMENTS/ESTs
Fragments/ESTs (Expression Sequence Tag) are allowable if they in addition to other conditions satisfy
the question of usefulness and industrial application. An EST whose use is disclosed simply as a gene
probe or chromosome marker would not be considered to have an industrial application. A cre dible,
specific and substantial use of the EST should be disclosed, for example use as a probe to diagnose a
specific disease.
References
Guidelines for examiation of biotechnology application for patent. www.ipindia.ac.in
IPR L 14. MICROORGANISMS AND BT INVENTION
According to Section 3 (j) of the Act [SECTION 3 (J): PLANTS & ANIMALS IN WHOLE OR ANY
PART, SEEDS, VARIETIES, SPECIES OTHER THAN MICROORGANISMS & ESSENTIALLY
BIOLOGICAL PROCESSES ARE NOT PATENTABLE SUBJECT MATTER],
plants and animals in whole or any part thereof other than micro-organisms but including seeds, varieties and
species and essentially biological processes for production or propagation of plants and animals are not
patentable inventions.
Although, microorganisms are excluded from non-patentability list, a conjoined reading with Section 3
(c) of the Act implies that only modified microorganisms, which do not constitute discovery of living
thing occurring in nature, are patentable subject matter under the Act.
Patenting of inventions involving microorganisms poses a unique problem. Description alone, regardless
how elaborate it may be, is usually not sufficient enough to ensure repeatability due to inherent properties of
living organisms as such and the microorganisms in particular. The reasons may be one or more of the
following:
a)
description of a microorganism isolated from soil or any other ecological niche can never be
complete, although some properties/features can be documented.
b)
ensuring isolation of the same strain from an ecological niche is difficult and
c) an exactly identical genetic change (mutation) and selection of a desired strain
of microorganism is extremely difficult to repeat.
Depositories for microbial cultures [Microbial culture collections]
These problems may be solved by making the cultures of the microorganisms available to the practitioner of
the art. This implies that the microorganisms must be preserved by state of the art techniques, so that they
remain viable with least changes in their properties and may be supplied to parties in accordance with
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national and international laws. Patent offices of many countries insist or recommend deposit of such
cultures in culture collections recognized by them. Reasons for requiring such a deposit in a recognized
culture collection are (a) permanent nature of the facility (b) sufficient infrastructure for maintenance and
preservation and (c) expertise in relevant areas.
An inventor seeking patent protection in many countries for an invention involving microorganisms has to
deposit the relevant microorganisms in culture collections recognized by the patent office in the countries
where such protection is sought. As a result, multiple deposits are necessary and an inventor has to pay for
deposit in every country. Moreover, patent laws and procedures are different with different countries.
International Depository Authority (IDA)
In order to obviate complications in seeking patent protection for inventions involving microbes in more than
one country and to have a uniform system and guidelines, the British Government proposed in 1973 that the
World Intellectual Property Organization (WIPO), Geneva, Switzerland should take initiative to study the
feasibility of a single deposit fulfilling the need of depositing cultures in other countries where patent
applications are filed. On the recommendation of an expert committee, a conference was held in Budapest,
Hungary during April, 1977 and a treaty was adopted called the Budapest Treaty on the International
Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure. The Budapest Treaty
came into effect in 1980. Under the Budapest Treaty, certain culture collections were recognized as
International Depository Authorities (IDAs). As on July 15, 2002, there are 55 contracting states and 33
International Depository Authorities (IDA). Deposit made in any one IDA is recognized by all the
contracting states for patent procedures.
Each IDA may decide the type of microorganisms it would like to accept. For example, an IDA like the
Deutsche Sammlung von Mikroorganismen und Zell Kulturen (DSMZ, Germany) accepts bacteria, fungi,
bacteriophages, plasmids, plant viruses, plant cell cultures, human and animal cell cultures and murine
embryos. The Czech Collection of Microorganism (CCM, Czech Republic) accepts bacteria, filamentous
fungi, yeast-like microorganisms and yeasts. Procedural aspects of depositing cultures in IDAs are broadly
uniform although fees for such services may differ with collections centers.
Scenario in India
MTCC - a national facility, sponsored jointly by the Department of Biotechnology (DBT) and Council of
Scientific and Industrial Research (CSIR), located in the Institute of Microbial Technology, Chandigarh has
excellent infrastructural facilities for long term preservation of microorganisms. It maintains a database on
its collections and transactions are computerized. The MTCC has a website of its own
(http://mtcc.imtech.res.in) which provides users with access to the catalogue of cultures and related
information through internet.
On October 4, 2002 MTCC was recognized as an IDA and now microorganisms can be deposited here under
the Budapest Treaty and patent protection may be sought in contracting states. The MTCC, like other IDAs,
follows the guidelines prescribed in the rules and regulations of the Budapest Treaty on the international
recognition of the deposit of microorganisms for the purposes of patent procedures.
Deposit of Microorganisms under the Budapest Treaty
On the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedures
The MTCC was recognized by the World Intellectual Property Organization (WIPO), Geneva, Switzerland
as an International Depository Authority (IDA). The MTCC becomes the first IDA in India to acquire this
status. At present, the deposit of microorganisms in MTCC under the Budapest Treaty will be recognized to
fulfill the requirement of patent procedures in contracting states.
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The MTCC was recognized by the World Intellectual Property Organization (WIPO), Geneva, Switzerland
as an International Depository Authority (IDA). The MTCC becomes the first IDA in India to acquire this
status. At present, the deposit of microorganisms in MTCC under the Budapest Treaty will be recognized to
fulfill the requirement of patent procedures in contracting states.
1. REQUIREMENTS FOR DEPOSIT
a) Kinds of microorganisms accepted as deposits
The MTCC accepts bacteria, bacteria-containing plasmids, fungi, yeasts, bacteriophages, plasmids in
hosts and/ or as isolated DNA preparations belonging to the Hazardous Group 1 and 2 as per
classification of
Indian authority. Genetically manipulated microorganisms and isolated DNA will be accepted if they can
be processed in S1 or S2 facility or conform to Group 1 or 2 organisms. The MTCC reserves the right to
refuse in accepting a deposit if in its view the deposit may be an hazard or the MTCC may not be in a
position to process it. Deposit of bacteria and fungi pathogenic to plants and animals from other
countries, which can be processed in S1 or S2 facility, will be accepted only if cleared by appropriate
authority in India. The deposited material is generally preserved by freeze-drying or storage in liquid
nitrogen or by any other methods of long term preservation.
b) Technical requirement and procedure
c)
i) Form and Quantity
Materials for deposit should be pure (uncontaminated) and should be sent in the following form:
Bacteria and fungi (including yeasts)
10 freeze-dried ampoules and 2 active cultures (on

slants). If freeze-dried cultures cannot be submitted,
the MTCC may do the freeze drying on payment.
Bacteriophages
5 x 2ml quantity with a minimum titre of 1 x 109 pfu

per ml.
Suitable host of the bacteriophage also needs to be
deposited in active form (2 slants)
Plasmids
5 x 20 micrograms of isolated and purified DNA

preparations.
Suitable host of the plasmid also needs to be
deposited in active form (2 slants)
The deposit should be accompanied by appropriate forms duly completed by the depositor. These forms
can be obtained from the MTCC. Separate forms need to be used for bacteria, fungi, bacteriophages and
plasmids. Fee for storage (Rule 12.1 (a)(I) of the Regulations under Budapest Treaty) must be paid for
each deposit.
ii) Time required for viability testing
MTCC will test viability as quickly as possible. Since many organisms grow quite slowly, the time
required for viability testing for different microorganisms vary. The average time required for viability
testing are as indicated below: Bacteria, yeasts, bacteriophages and plasmids : 4 days to 3 weeks Fungi :
7 days to 4 weeks
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iii) Depositor checks and renewal of stocks

The MTCC may prepare, as and when it finds necessary, new batches of lyophilized and frozen cultures
(in liquid nitrogen) by subculturing materials supplied by the depositor. Samples of the new batch will be
sent to the depositor to check authenticity of such microorganisms.
iv) Non-viability of cultures
Cultures deposited with the MTCC are preserved by methods which are known to keep the cultures viable
for a long time. However, if a culture deposited under the Budapest Treaty becomes non-viable or is
destroyed during storage, in order to maintain patent protection, the depositor needs to replace it by a
viable culture (ref. article 4 of the Budapest Treaty).
Administrative requirements and procedures i) General
Language: The language of communication with the MTCC and patent forms are in English,
Communication in Hindi is also acceptable. However, in case of any dispute, English version will prevail.
Import and/ or Quarantine Regulations
Cultures of microorganisms from outside India may require import clearance and/ or subjected to
quarantine regulations. The depositor from outside India should communicate with the MTCC regarding
such deposits before dispatching cultures.
Making the original deposit
Documents required from the depositor
A depositor will be required to send a completed BP/1 Form which is the accession form for deposit under
Budapest Treaty. For amendment of scientific description or taxonomic designation, a depositor is
required to send a completed BP/7 Form.
Official notification to the depositor
The receipt and viability statement will be issued in English on mandatory international form BP/4 and
BP/9 respectively. Attestation of receipt of amendment of scientific description or taxonomic designation
will be issued on BP/8 Form. Notification of furnishing a sample to third parties will be issued on BP/14
Form.
Unofficial notification to the depositor
If requested, the MTCC may communicate the date of deposit and accession number since the official
receipt is issued only after the viability test is completed and a positive result obtained.
Supply of information to a patent agent
If requested by the depositor, the MTCC will send copies of the receipt and viability statement to both the
depositor and his/her Patent Agent.
Converting a previous deposit
In case of deposits made with the MTCC earlier outside the provisions of the Budapest Treaty, the original
depositor may convert the same to the Budapest Treaty deposit. If the original deposit is in the general
category and is listed in MTCC catalogue (printed or electronic) and was having no restriction
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for distribution by MTCC, the depositor will be requested to authorize MTCC not to restrict distribution of
such a deposit and waive his/her right to notification of release of the sample. If this condition is not
acceptable, a fresh deposit of the material under Budapest Treaty will be required. Deposits previously made
with the MTCC for patent procedure or for safekeeping also can be converted to deposit under Budapest
Treaty. The administrative requirements and fees for such conversions will be the same as are for the
original deposit under the Budapest Treaty.
iv) Making a new deposit
For making a new deposit, completed BP/2 Form will be required along with relevant documents as
required by under Rule 6.2. Receipt and viability statement for such a deposit will be issued on BP/5 and
BP/9 Forms respectively.
2. FURNISHING OF SAMPLES
a) Request for samples
The MTCC will follow procedures, as provided under the provision of the Budapest Treaty, for furnishing
samples to third parties. For proof of entitlement BP/12 Form and for request BP/13 will be used in
furnishing samples. For hazardous microorganisms, the requesting party has to provide evidence that proper
facility is available and he/she has the requisite permission to work on such organisms. Requesting party
from outside India also has to provide an import permit for the procurement, if required The MTCC will
furnish samples prepared by it from the deposited samples.
b) Notification to the depositor
A depositor will be notified on BP/14 Form when samples of their deposit have been furnished to third
parties.
c) Cataloguing of Budapest Treaty Deposits
Cultures deposited under the Budapest Treaty will not be published in
the MTCC catalogue (printed or electronic) or displayed on internet.
FEE STRUCTURE
Bacteria, fungi, yeasts, bacteriophages and
plasmids
a) Storage under Rule 12.1(a)(I)
Indian rupees
15,000
b) Conversion of a deposit
15,000
c) Extension of duration storage beyond that

provided by Rule 9 (peryear)
2,000
d) Issue of viability statement on the basis of test

e) Issue of viability statement on the basis of last
viability test
f) Furnishing of samples
g) Communication of information under Rule 7.6
h) Attestation referred to in Rule 8.2
Steps involved in the deposit process
3,000
1,000
3,000
1,000
1,000
1. Prospective depositor contacts the MTCC.

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2.
Necessary forms are sent (normally within two working days) by

mail.
3. Properly filled forms to be sent to the MTCC by the depositor.
4. The MTCC examines acceptability of the deposit and informs the
depositor to send the cultures with appropriate fees, alternatively
information is mailed that the culture is not acceptable.
5. Cultures along with requisite fee to be paid to the MTCC.
6. The cultures are processed (normally within two working days) for
checking viability and purity (normally it may take four-ten working
days depending on the organisms).
7. If the culture is not pure or non-viable, the depositor is immediately
informed.
8. Flow chart
Pure and viable cultures
MTCC assigns an accession number Preservation (in liquid nitrogen or freeze-drying or

both depending on the type of organism)
Statement of receipt and

Safe storage
viability are sent to the depositor Supply of samples according to
regulations
1r
Supply of samples according to

regulations References
The Patent Act, 1970
Deposit of microorganisms for the purposes of Patent Procedure following the Budapest Treaty In: MTCC an International Depository Authority [mtcc.imtech.res.in/downloads/brochure.pdf]
IPR L 15. MORAL ISSUES IN PATENTING BT INVENTION
Inventions contrary to morality or which cause serious prejudice to human, animal or plant life or health
or environment.
Biotechnology deals with living subject matters and involves alteration of genomic materials of an organism.
Such change may influence or may have a deep impact upon the environment or the human, animal or plant life
or may involve serious questions about morality. Hence, adequate care should be taken while examining the
inventions vis-a-vis their primary or intended use or commercial exploitation and it should be carefully
dealt so that the subject-matter must not be contrary to public order, morality or causes serious prejudice
to human, animal or plant life or health or to the environment. A few non limiting examples may further
clarify the issues: (a) a process for cloning human beings or animals; (b) a process for modifying the germ line
of human beings; (c) a process for modifying the genetic identity of animals which are likely to cause them
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suffering without any substantial medical benefit to man or animal, and also animals resulting from such
process; (d) a process for preparing seeds or other genetic materials comprising elements which might cause
adverse environmental impact, like terminator gene technology; (e) uses of human embryos for commercial
exploitation.
Illustrative Example:
Claim: An in vitro method of determining the embryotoxicity of a compound comprising contacting human
foreskin fibroblasts, human embryonic stem cells, and human embryoid bodies with said compound and
comparing the effect of the compound on one or more characteristic of the human foreskin fibroblasts, human
embryonic stem cells, and human embryoid bodies to the one or more characteristic of control human foreskin
fibroblasts, human embryonic stem cells and human embryoid bodies that are not contacted with the compound,
wherein a difference in the effect of the compound on one or more characteristic of the human foreskin
fibroblasts, human embryonic stem cells, and human embryoid bodies compared to the one or more
characteristic of control human foreskin fibroblasts, human embryonic stem cells and human embryoid bodies
that are not contacted with the compound is indicative of an embryotoxic compound. 12
Analysis: The subject-matter falls within the scope of Section 3 (b) of the Act, as being directed to a method in
which human embryonic stem cells are commercially exploited for determining the embryotoxicity of the
compound, which is against morality. Hence, it is not patentable.
Ethical concerns.
Most countries have excluded medical methods from patentabiliy by taking into consideration, the ethics
inherent in the practice of medicine. The American Medical Association (AMA) has elucidated the ethical
issues involved in patenting medical methods in an article published in the Food and Drug Law Journalxlvi. The
AMA in that article advocates exclusion of medical methods by arguing that allowing their patentability would
undermine the traditional obligations of the medical profession, make economics rather than health care the
primary concern of doctors, restrict access to the patented methods, increase financial burden and damage
patient confidentiality and privacy. The medical profession has an obligation to share information, knowledge
and research. Their primary concern is health care of the patient. Patenting medical methods with its emphasis
on individual rewards, selective sharing and ownership would promote withholding of information, knowledge
and research for personal gain, thus undermining the sanctity of the profession. Furthermore, medical method
patents will elevate economic goals above those of patient health by making the doctor holding the patent a
business man selling methods of treatment rather than a professional sharing and disbursing quality health care.
Patenting a medical method restricts access of that method to the patient because the physician conditions
application of the method upon acquisition of a license. The patentee may restrict the number of licenses or may
even deny licenses when required. A doctors medical judgment about the appropriate method will be
influenced, as the doctor might prefer to adopt an inferior method rather than licensing the patented method or
referring the patient to a licensed doctor. Moreover, a doctors freedom to use advanced medical methods will
be seriously affected due to fear of liability for unlawful infringement of a patented method. This restricts
access to advanced methods and prevents evaluation of new methods. Patenting a method restricts peer review
of the method resulting in a decrease in quality and safety of new methods. Students and researchers will nZot
be able to get access to the method as use of a patented invention for academic and research purposes is not
allowed in some countries like USA. Patenting a medical method might lead to an increase in financial burden
over the patients as the licensing fee and litigation possibilities will add up to the fee paid by the patient. After a
patent is granted, it is not easy to monitor the use of the patented method by the physician. Determining whether
a doctor has used a patented method would result in violation of privacy rights of the patient as it would involve
searching and examining patient records. For the aforementioned reasons, the AMA concludes that it is it is
unethical for physicians to secure and enforce patents on medical methods.
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References
Guidelines for examiation of biotechnology application for patent. www.ipindia.ac.in
IPR L 16 & 17. CASESTUDIES ON PHARMA, MICROBIAL PRODUCT,

ENRIONOMENT, AGRICULTURE AND INFORMATICS
Attached separately.
IPR L 18. JUSTIFICATION AND INTERNATIONAL POSITION FOR PLANT

VARIETY PROTECTION
There are five basic methods for protection of plants and plant products under intellectual property rights.
Each country must implement such mechanisms, under TRIPS. However, certain local variations allowed, in
countries where protection of plants is excluded from patent purview [eg. India].
1. Patent Claims on Plants
In some countries (including the United States, Australia and Europe) plants can be covered by patent claims
provided that the patent applications are able to meet all of the necessary standards and requirements that exist
in that country for patentability. Under the Trade-Related Aspects of Intellectual Property Agreement which
binds World Trade Organization members, member countries that choose not to provide such mechanisms for
plants under their national patent system must provide an alternative way in which an entity may claim that it
has a legal right to intellectual property, to the partial exclusion of the rights of others, in plants and plant
products.
A. Utility Patents
The term "Utility Patent" is used to distinguish between patents and other specific forms of intellectual property
claims that exist in some jurisdictions, "Plant/Petty/Innovation Patents". Utility patents in the United States are
comparable to the standard patents that are awarded both in Australia (under the Patents Act (1990)) and in
Europe.
In most countries, plants and inventions directed to plants or plant products ( e.g. seed) are not eligible for a
patent grant, but some (including the United States and Australia) provide that an entity may make claims to a
time-limited right to exclude others from use of plants and plant products, provided that the legal criteria for
patentability are met. While the patent legislation of each jurisdiction is different, the requirements and rights
awarded to patentees are substantially similar.
i) What can be patented?
In the United States, any living organism that is the product of human intervention (such as by some breeding
process or laboratory-based alteration) qualifies as a composition of matter, which is patentable (Diamond v
Chakrabarty (1980) 447 US 303). As a result, plants are patentable subject matter (35 U.S.C. 101).
Furthermore, the United States has extended patent protection to plants produced by either sexual or asexual
reproduction and to plant parts including seeds and tissue cultures (Ex parte Hibberd (1985) 227 USPQ 433).
In Australia, the Patent Act (1990) allows all technologies to be patented (except 'human beings and the
biological processes for their production') provided that there is an "invention", defined as 'an innovative idea
which provides a practical solution to a technological problem'.
In addition or as an alternative to obtaining a patent through the patent office in individual European countries,
patent grants in nearly all European countries can be gained from filing at the European Patent Office and
registering the allowed claims in national patent offices. This means of patenting is controlled by the European
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Patent Convention (EPC). Historically, each European country was governed by their own national patent
laws, however the introduction of Directive 98/44/EC (effective in all European Union Member States 30th
July 2000) aims to harmonize protection for biotechnological inventions (including plant protection) amongst
the European Union members. Thus, each member country is required to bring their national laws in line with
the Directive, although some may not yet be fully in compliance.
ii) Types of allowable claims
Utility and standard patents may be used to claim exclusionary rights in
new varieties of plants (U.S. only),
transgenic plants,
plant groups,
individual plants and their descendants,
particular plant traits,
plant parts,
plant components (e.g. specific genes or chromosomes),
plant products (e.g. fruit, oils, pharmaceuticals),
plant material used in industrial processes (e.g. cell lines used in cultivation methods),
reproductive material (e.g. seeds or cuttings),
plant culture cells,
plant breeding methodologies, and
vectors and processes involved in the production of transgenic plants.
Note that this list provides examples and is not exhaustive.

iii) Inclusions and Exclusions
Natural source material should not be coverable by patents as exclusionary rights in any country in the world,
because natural source material is not novel (see below).
In the U.S. and Australia individual plant varieties are patentable. In Europe, individual plant varieties per se
are not patentable, however, a plant which is characterized by a particular gene (as opposed to its whole
genome) is not included in the definition of a plant variety and is therefore patentable.
In Europe, transgenic plants are patentable if they are not restricted to a specific plant variety, but represent a
broader plant grouping. The European Directive considers plant cells to be "microbiological products" and as a
result are patentable.
EXAMPLE
While bushwalking, Amy discovers a plant which nobody has ever previously seen or documented. Can Amy
obtain a patent for the plant?
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No. Amy can not patent the plant as it is natural source material and is not novel.
iv) Standards of patentability and the rights granted
The legal criteria for patentability are substantially similar across all jurisdictions. In order to show that the
plant, plant technology or plant product of interest is an invention, the patent application must show:
1) novelty
2) non-obviousness, or an inventive step
3) usefulness (United States) or industrial applicability (Europe, Australia)
4) enablement
5) claim clarity
6) written description
7) best mode (United States only)
From the date that a patent is granted, the patent holder has the exclusive right to exploit the invention or
authorize another person to do so until the patent expires. Patent rights are considered personal property and
may be assigned to other parties.
A utility patent grants the owner the right to exclude others from:
1) making,
2) using,
3) selling or offering for sale or
4) importing
the protected invention for a 20 year period from the earliest file date.
EXAMPLE
John is the sole owner of a patent for herbicide resistant corn plants. He becomes aware that his former coworker Julie is making and selling the same patented corn plant. What can John do?
John, as the patent owner has the exclusionary right to stop others from making and selling his invention.
Julie is therefore infringing John's patent, and John can bring a lawsuit for infringement or ask that Julie take
out a license.
v) Exemptions
Exemptions to patent infringement that are relevant to patenting of plants are provided in some jurisdictions.
In United States case law, an 'experimental use exception' to patent infringement was thought to exist
which allowed researchers free access to the invention in order to use it for experimental purposes. However,
based on the decisions in recent cases the doctrine certainly no longer exists and it is highly doubtful
whether the doctrine ever actually existed.
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In Australia, limited exemptions are defined within the legislation. The 'prior use' exemption allows
someone who was utilizing the patented product or process before the priority date of a claim to continue
using the patented product without infringement. The use of a patented product on board a foreign vessel
that accidentally comes into the patent area is also exempted from infringement.
The EU Directive 98/44/EC provides a 'farmer's privilege'. Under the Directive, farmers are allowed to use
patent protected seeds freely for their own use and the resulting plant material is free from protection. Farmers
are not permitted however, to re-sell the patented seed. Member States are able to define their own
exemptions to patent infringement (see, for example, Patents Act 1977 (UK), s60 (5))
Although not an exemption per se, in the United States but not in Australia or Europe, an inventor has a grace
period allowing for retrospective application for a patent. Patent rights are not automatically foregone by
public disclosure, such as publication or commercialisation, provided that a patent is applied for within 12
months of the disclosure. Note that other countries (e.g., Japan) have a limited grace period, and other
countries are considering instituting one.
EXAMPLE
Tom, a U.S. resident, was the first person to extract oil from sunflower plants. He presents his findings at a
biotechnology conference. It is not until after his presentation he realises that his sunflower oil may be of
commercial significance. Is it too late for him to patent his invention?
Tom can still obtain a patent in the United States provided he applies within twelve months of the
conference and the oil or its method of extraction meets the requirements for patentability.
B) Plant Patents
Specific plant patents are only available in very few countries.
The Plant Patent Act was enacted by US congress in 1930. It was introduced primarily to benefit the
horticulture industry by encouraging plant breeding and increasing plant genetic diversity.
i) Limited types of plants are eligible for protection
The Plant Patent Act 1930 (35 U.S.C. 161) provides for:
patent protection of all asexually reproduced plants
EXCEPT:
1) tuber-propagated plants and
2) plants found in an uncultivated state.
Plant patents encompass newly found plant varieties as well as cultivated spores, mutants, hybrids and newly
found seedlings on the proviso that they reproduce asexually. Asexual reproduction is defined as any
reproductive process that does not involve the union of individuals or germ cells. It is the
propagation of a plant to multiply the plant without the use of genetic seeds. Modes of
asexual reproduction in plants include grafting, bulbs, apomictic seeds, rhizomes and tissue
culture.
Specifically excluded from protection under the Plant Patent Act are tuber-propagated plants and
plants found in an uncultivated state.
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ii) Patentability requirements are less stringent for plant patents

The requirements that must be fulfilled in order to obtain a Plant Patent are the same as those for
utility patents (see Patents (iv) above). However, the IMPLEMENTATION of these requirements is
LESS STRINGENT.
For example, the Plant Patent Act provides that plant patents will not be rejected or invalidated if the
plant is not fully described or enabled. It does however, require that the new variety is described as
complete as reasonably possible.
It is also not necessary to deposit the claimed plant at an official depositary.
The ordinary test of 'non-obviousness' is not applied to plant patents. This is primarily due to the fact
that it is extremely challenging to develop a new plant variety that is stable and can be preserved by
asexual reproduction.
iii) Plant patents confer an exclusionary right
A plant patent gives the patent holder the right to:
exclude others from asexually reproducing, using, selling, offering for sale or importing into the
United States the patented plant (or any of its parts) 1 for a period of 20 years.
In contrast to utility patents, plant patents only protect a single plant or genome and the protection
conferred is quite limited. It does not protect the plant characteristics, mutants of the patented plant
nor technologies associated with its cultivation. Because plant patents are granted on the entire plant,
it follows that only one claim per plant patent is permitted.
U.S. courts have held that a twelve month grace period also applies to plant patents (35 U.S.C102(b))
whereby a disclosure of a new plant variety or a granted patent of the new variety in a foreign
jurisdiction does not destroy patentability provided that the disclosure or foreign patent occurred less
than 12 months prior to the plant patent application being lodged in the U.S. If publication has
occurred in any other country prior to the 12 month grace period, the plant patent application will be
refused (Ex parte Thomson, 25 USPQ 2d 1618 (BPAI 1992)). This interpretation of the law has met
with proposals to increase the grace period to 10 years on the basis that often times plants from
foreign jurisdictions are held in quarantine by the USDA for a period of more than 12 months, thereby
nullifying patentability. To date this idea remains a proposal.
It is possible to obtain protection for the same plant under both a utility patent and a plant patent in the United
States at the same time, provided that the requirements for patentability for both types of patents are fulfilled.
EXAMPLE
Marc and Crystal want to obtain protection in the U.S. for their new variety of asexually reproducing plant.
They also wish to protect a special aluminum device that contains specific amounts of hormones and other
nutrients needed to ensure the plants survival. What types of protection are available?
Marc and Crystal can obtain a plant patent for the new variety plant provided they meet the requirements for
patentability. However the device required to guarantee survival of the plant is unable to be protected by this
1
The Plant Patent Act was amended on 27 October 1998 to extend the exclusive right to plant parts
obtained from protected varieties but it is not applied retroactively.Dual protection is allowed
A utility patent and a plant patent can both be obtained to protect the same plant.
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system. Utility patents would provide protection to BOTH the special device and the plant variety provided
the criteria for patentability are fulfilled.
2. Plant Breeder's Rights* (PBRs)
While in the U.S. plant varieties can be protected under the patent system, in the majority of jurisdictions
including Australia, the protection of plant varieties under the patent legislation is not permitted. Having a
form of protection in place that is available to new plant varieties is thought to be important in order to
encourage and promote plant breeding, encourage the importation of foreign varieties, promote the
exportation of plant varieties and generally benefit the market place.
* The term Plant Breeder's Rights is synonymous with Plant Variety Rights.
Requirement for plant protection under TRIPs
Members of the World Trade Organisation (WTO) are bound by their membership to adhere to the
Agreement on Trade-Related Aspects of Intellectual Property (TRIPs). The Agreement sets out the
minimum standards of intellectual property protection the member countries are required to provide.
One of the most controversial provisions of the Agreement surrounds protection of plant varieties.
Article 27(3)(b) of the Agreement allows countries to exclude plants and essentially biological processes for
their production from their patent system of protection. The same Article however, states that countries must
"provide for the protection of plant varieties either by patents or by an effective sui generis system or by any
combination thereof'. Under the Agreement, a country can implement more than one form of plant protection.
The meaning of "sui generis" is one of the contentious issues surrounding the agreement. It is enerally
believed that the term enables member countries to design their own system of protection for plant varieties if
they have opted not to use their patent system for plant protection.
3. Trade Secrets
A. A trade secret is confidential information

A trade secret is commonly regarded as: any formula, pattern, device, or compilation of information that is
used in a business and gives that business an opportunity to obtain advantages over competitors.
The information is kept from the public and from competitors, usually by the use of confidentiality
agreements with employees. These agreements confer an obligation on the employees to keep the information
secret. These agreements can be enforced by the court.
Generally for a trade secret to exist there must have been:
Secrecy: in the form of a confidentially agreement or covenant. External forms of protection such as security
systems etc also impart the necessary requirement of secrecy.
Novelty: The subject of the secrecy must have been novel.
Value: The subject of the trade secret must be of some value or give some advantage over competitors.
For a breach of a trade secret to occur, there must have been an improper taking. That is there must have been
a breach of the secrecy whether by theft or the breaking of a confidentiality agreement.
One advantage of using trade secret law to protect an invention is the unlimited time for protection.
Some disadvantages however are that trade secret protection does not prevent competitors from legally
reverse engineering a product to determine the secret or from independently duplicating the information.
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Inventions involving the use of DNA are now unlikely to be protected by trade secrets due to the ability to
reverse engineer.
B. Trade Secret laws can be used to protect plants

Plants can be protected provided that reasonable efforts have been made to keep the plant variety
confidential, secret and out of the public domain. In the United States, trade secrets have been used for
decades to protect parental lines of hybrid corn.
Recently a United States court recognized that "genetic messages" of inbred plant varietal lines may be
protected by trade secret law subject to the provision that reasonable effort has been taken to preserve the
secrecy of the gene sequence (Pioneer Hi-Bred case). In the Pioneer Hi-Bred case it was held that the
accidental inclusion of inbred seed in bags of commercially available first generation seed by Pioneer HiBred was not enough to destroy the secrecy surrounding its "genetic message". Reasonable precaution had
been taken to keep the "genetic message" contained in the inbred seed out of the public domain.
Under Australian law it is theoretically possible that specific varieties of plants may be afforded protection
under the doctrine of confidential information or trade secrets, however to date, no cases involving the
doctrine and plant varieties have been brought before the courts. As a result it is currently unclear as to the
extent of protection available under the doctrine of trade secrets.
4. Genetic Mechanisms
A. Hybrids
In some cases, specialized plant breeding can present an alternative to intellectual property protection.
Breeders often select individual plants that display beneficial or attractive traits such as a fast growth rate in
comparison to other plants or an increase in either herbicide or disease resistance etc. The breeder then
crosses these plants with individual plants of different varieties that also demonstrate attractive traits. The
resulting progeny are called hybrids.
Seeds resulting from hybrids show an extremely poor ability to reliably reproduce the trait of interest in their
progeny or next generation.
It therefore becomes necessary for the farmer to purchase new seed for subsequent plantings. Hybrid selection
therefore becomes a way for the plant breeder to protect their varieties from exploitation as they are safe in the
knowledge that the farmer or purchaser can only access the trait reliably for one generation. Farmers and others
must obtain more seed from the breeder if they wish to continue to use the same hybrid plants.
Hybridisation therefore serves as a way of not only creating new plant varieties with attractive traits but
ensuring some sort of protection for new commercial plant varieties. Although this method of protection is
inexpensive and is not subject to legal requirements or restrictions, the breeder has no enforceable remedy
available to him/her, except under trade secret law (see above) or by contractual agreement.
B. Genetic Use Restriction Technologies (GURTs)
Genetic Use Restriction Technologies (GURTs) is technology that allows the control of gene expression of an
organism, further allowing constraints or restrictions on the use of the organism or trait. The term GURT was
developed by the Lead Author (CAMBIA's CEO) of the first study commissioned by the United Nations
Convention on Biological Diversity (CBD).
There are two main types of GURTs: variety-level GURT (v-GURT) and trait- level GURT (t-GURT).
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v-GURT causes the seeds of the affected plant variety to be sterile in contrast to t-GURT which results in the
expression of a selected trait. t-GURT introduces a mechanism for trait expression into the variety which can
only be turned on, or off, by treatment with specific chemical inducers. The gene of interest can thus be
expressed at particular stages or generations of the crop.
In addition to intellectual property rights, plant breeders in principle are able to use GURTS to strengthen the
protection of newly developed plant varieties. The use of v-GURTs requires farmers to buy seeds from the
breeder each season and therefore could be used as a way of avoiding the farmers privilege exception to
patentability that exist in Europe. However, in some situations v-GURTS are advantageous to farmers as they
reduce the need for tillage and do not sprout inappropriately. t-GURTs require the farmer to purchase chemical
inducers from the breeder in order for the farmer to be able to make use of the specific traits of the variety ie
herbicide resistance.
5. Contracts
The following types of agreements are all governed by contract law as opposed to intellectual property law.
There are no international agreements that regulate the law of contracts.
A. Material Transfer Agreements
Material Transfer Agreements (MTAs) are legal agreements made between a provider and a recipient party
when research material is being transferred between institutions.
Material most often transferred includes plant varieties, transgenic plants, cell lines, germplasm, vectors,
chemicals, equipment or software.
The MTA itself contains a written description of the material to be transferred and any limits on the material
that the provider wishes. For example some providers may limit the use of the transferred material to noncommercial situations or to a specific field of research. In some cases where publication of results occurs which
involve the material it may be necessary to acknowledge the source of the material.
The terms and conditions of the MTA also usually outline the ownership rights, confidentiality provisions and
any third party transfer restrictions that the provider of the material wishes to impose.
The agreement acts as a contractual agreement that is often used to protect the rights of ownership of the
provider and also to protect the material from unauthorized use.
B. Bag Labels
Bag label contracts are another form of legal protection which can be applied to plants, especially seeds. An
explicit contract is described on a bag label which is normally sewn into the seal of a bag. By opening the
bag and breaking the seal, the purchaser agrees to comply with the contract.
These contracts are similar to what is commonly known as "shrink wrap licenses" in software. As yet the
strength of protection conferred by the bag label is not firmly established.
C. Technology Use Agreements
A technology use agreement is an agreement most commonly between technology suppliers and farmers
which usually controls the right to plant a given seed on a specific area of land often for a certain period of
time.
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The agreement provisions can also include restrictions on the use of proprietary traits in the creation of new
varieties and also gives permission for the technology supplier to access the farmers property to check for
violations.
This form of property right enforcement has been implemented by producers of agronomic traits in the U.S.
and other countries. In some cases, the producers reserve the right to inspect the field of the contracting
farmer and to take samples to ensure the compliance of the farmer with the TUA.
A breach of a Technology Use Agreement gives rise to a claim for damages if a breach of contract occurs.
Protection of Plant varieties in India
In compliance to its obligation under section 27.3 (b) of the Trade Related Aspects of Intellectual Property
Agreement (TRIPs), India enacted Protection of Plant Varieties and Farmers Right Act (PPV&FR Act) in the
year 2001 and its Rules in 2003.
The Protection of Plant Varieties and Farmers Right Authority was established in the year 2005. The
Authority invited applications for registration of Plant Varieties belonging to first set of 12 crop species from
November 2006 and formal registration of varieties started from 20 l February 2007.
In the PPV & FR Act there is a provision of registering of extant varieties within three years from the date the
species is notified and opened for registration.
In case of farmers' variety the Government of India has extended the time period to five years instead of three
years stipulated for extant varieties looking to poo r progress in registration of farmers varieties. New
varieties are to be registered within one year of its release or before the first commercialization of its
propagating materials in the country of origin.
Table: Plant Varieties Registered till 31.10.2010 in India
Sl.No.
Crop
No. of varieties
1
2
3
4
5
6
7
8
9
10
11
12
13
14
Rice
Bread Wheat
Pearl Millet
Sorghum
Maize
Black Gram
Field Pea
Green Gram
Lentil
Kidney Bean
Garden Pea
French Bean
Chick Pea
Cotton
11
48
29
13
45
9
15
20
9
3
5
2
2
7
Registration of crop varieties under PPV & FR Act 2001 confers legalownership on the breeder over his
developed variety and grants him exclusive commercial right for a limited period of (15-18
years
depending type of crop species) of time (3). Breeder can exploit his exclusive right (known as breeder right)
to derive financial benefit from the commercialization of his protected variety. This provides scope of getting
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back his investment in plant breeding research and to generate some profit. egistration of a variety also helps
in checking bio-piracy and mis-utilisation by unauthorized users.
Like institutional varieties, farmers' varieties can be registered in the name of farmer, a group of farmers or
community and the farming community can be benefited from the commercialization of the protected varieties
and benefit sharing provision in the Act.
Appendix
Extant Variety: A variety
(i) notified under section 5 of the Seeds Act, 1966 (54 of 1966); or
(ii) a farmers variety; or
(iii) a variety about which there is common knowledge; or
(iv) any other variety which is in the public domain.
Farmers Variety: A variety which(i) has been traditionally cultivated and evolved by the farmers in their fields; or
(ii) is a wild relative or land race of a variety about which the farmers possess the common knowledge;
where farmer means any person who (i) cultivates crops by cultivating the land himself; or (ii) cultivates
crop by directly supervising the cultivation of land through any other person; or (iii) conserves and
preserves, severely or jointly, with any person any wild species or traditional varieties.
or adds value to such wild species or traditional varieties through selection and identification of their useful
properties.
References
www.plantauthority. gov. in
http://www.patentlens.net/daisy/bios/
http://www.indianpatents.org.
IPR L 19. INTERNATIONAL UNION FOR PROTECTION OF NEW PLANT

VARIETIES (UPOV)GUIDELINES
The International Union for the Protection of New Varieties of Plants (UPOV) was established by the
International Convention for the Protection of New Varieties of Plants ("UPOV Convention"). The UPOV
Convention was adopted on December 2, 1961, by a Diplomatic Conference held in Paris.
The UPOV Convention came into force on August 10, 1968, having been ratified by the United Kingdom,
the Netherlands and Germany. The UPOV Convention has been revised on November 10, 1972, on
October 23, 1978, and on March 19, 1991, in order to reflect technological developments in plant
breeding and experience acquired with the application of the UPOV Convention.
States and certain intergovernmental organizations wanting to accede to the UPOV Convention have laws
on plant variety protection in line with the 1991 Act of the Convention.
Guidelines
Article 1: Definitions
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For the purposes of this Law:

(i) breeder means the person who bred, or discovered and developed, a variety, [the person who
is the employer of the aforementioned person or who has commissioned the latters work,] or
the successor in title of the first [or second] aforementioned person, as the case may be;
(ii) breeders right means the right of the breeder provided for in this Law ; (iii) variety means a
plant grouping within a single botanical taxon of the lowest known rank, which grouping,
irrespective of whether the conditions for the grant of a breeders right are fully met, can be
defined by the expression of the characteristics resulting from a given genotype or combination
of genotypes, distinguished from any other plant grouping by the expression of at least one of
the said characteristics and considered as a unit with regard to its suitability for being
propagated unchanged;
(iv) [name of the authority];
(v) UPOV means the International Union for the Protection of New Varieties of Plants founded by
the International Convention for the Protection of New Varieties of Plants of 1961 and further
mentioned in the Act of 1972, the Act of 1978 and in the 1991 Act;
(vi) member of UPOV means a State party to the UPOV Convention of 1961 / Act of 1972 or the Act
of 1978 or a Contracting Party to the 1991 Act; [(vii) territory] (for intergovernmental
organizations)
Article 2: Purpose
(1) The purpose of this Law is to grant and protect breeders rights. (2) The [name of the authority] is the
authority entrusted with the task of granting breeders rights.
Article 3: Genera and Species to be Protected
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(Option 1) [This Law shall be applied on the date of its coming into force to all plant genera and species.]
(Option 2) [This Law shall be applied to the plant genera and species designated by [decisions of the
Minister/the regulations], and by the expiration of a period of [five]/[10] years from the date of coming into
force of this Law at the latest, to all plant genera and species.]
Article 4 : National Treatment
[(1)] [Treatment] Without prejudice to the rights specified in this Law, nationals of a member of UPOV as
well as natural persons resident and legal entities having their registered offices within the territory of a
member of UPOV shall, insofar as the grant and protection of breeders rights are concerned, enjoy within
the territory of [name of the State/ Intergovernmental Organization] the same treatment as is accorded by
this Law to the nationals of [name of the State/Intergovernmental Organization]. The said nationals, natural
persons or legal entities of a member of UPOV shall comply with the conditions and formalities imposed on
the nationals of [name of the State/Intergovernmental Organization].
[(2)] [ Nationals ] For the purposes of paragraph [(1)], nationals means, where the member of UPOV is
a State, the nationals of that State and, where the member of UPOV is an intergovernmental organization,
the nationals of the States which are members of that organization.
Article 5: Conditions of Protection
(1) [Criteria to be satisfied] The breeders right shall be granted where the variety is (i) new, (ii)
distinct, (iii) uniform and (iv) stable.
(2) [Other conditions] The grant of the breeders right shall not be subject to any further or different
conditions, provided that the variety is designated by a denomination in accordance with the
provisions of Article [20], that the applicant complies with the formalities provided for in this Law
and that he pays the required fees.
Article 6 : Novelty
[(1)] [Criteria] The variety shall be deemed to be new if, at the date of filing of the application for a
breeders right, propagating or harvested material of the variety has not been sold or otherwise disposed of
to others, by or with the consent of the breeder, for purposes of exploitation of the variety (i) in the territory
of [name of the State/Intergovernmental Organization] earlier than one year before the date of filing of the
application and (ii) in a territory other than that of [name of the State/Intergovernmental Organization]
earlier than four years or, in the case of trees or of vines, earlier than six years before the said date.
[(2)] [Varieties of recent creation] (optional provision - see NOTES - ARTICLE 6(2)) [(3)] [ Territory in
certain cases] (for members of UPOV which are member States of one and the same intergovernmental
organization)
Article 7: Distinctness
The variety shall be deemed to be distinct if it is clearly distinguishable from any other variety whose
existence is a matter of common knowledge at the time of the filing of the application. In particular, the
filing of an application for the granting of a breeders right or for the entering of another variety in an
official register of varieties, in any country, shall be deemed to render that other variety a matter of common
knowledge from the date of the application, provided that the application leads to the granting of a
breeders right or to the entering of the said other variety in the official register of varieties, as the case
may be.
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Article 8: Uniformity
The variety shall be deemed to be uniform if, subject to the variation that may be expected from the
particular features of its propagation, it is sufficiently uniform in its relevant characteristics.
Article 9: Stability
The variety shall be deemed to be stable if its relevant characteristics remain unchanged after repeated
propagation or, in the case of a particular cycle of propagation, at the end of each such cycle.
Referenes
UPOV/INF/6/1 , 2009. http://www.upov.int/upovlex/en/upov
IPR LL 20. PLANT VARIETY PROTECTION IN INDIA
Introduction
In compliance to its obligation of the Trade Related Aspects of Intellectual Property Agreement (TRIPs),
India enacted Protection of Plant Varieties and Farmers Right Act (PPV&FR Act) in the year 2001 and its
Rules in 2003. The Protection of Plant Varieties and Farmers Right Authority was established in the year
2005. The Authority invited applications for registration of Plant Varieties belonging to first set of 12 crop
species from November 2006 and formal registration of varieties started from 20 th February 2007. In the
meanwhile 4 years have passed since the registration of varieties started in our country and it needs
assessment and introspection.
In November 2006, the Authority notified 12 crop species (Rice, Bread Wheat, Pearl Millet,
Sorghum, Maize, Pigeon Pea, Chick Pea, Green Gram, Black Gram, Kidney Bean / French bean,
Lentil and Field Pea / Garden Pea) and opened their registration. Later four species of cotton and
two species of Jute were included to this list. As of now as many as thirty species are opened for
registration under PPV & FR Act 2001 in India. The species which were opened for registration in
third phase are Sugarcane, Ginger, Turmeric, Black Pepper, Small Cardamom, Sun Flower,
Soya bean, Indian Mustard, Rape seed. Potato, Tomato, Brinjal, Garlic, Onion, Okra, Cabbage, Cauliflower,
Rose and Mango are included in the fourth phase for registration.
Objectives of Protection of Plant Varieties and Farmers Rights Act in India
The objectives of the Protection of Plant Varieties and Farmers Rights Act are:
(i) to stimulate investments for research and development both in the public and the private sectors for
the developments of new plant varieties by ensuring appropriate returns on such investments;
(ii) to facilitate the growth of the seed industry in the country through domestic and foreign investment
which will ensure the availability of high quality seeds and planting material to Indian farmers; and
(iii) to recognize the role of farmers as cultivators and conservers and the contribution of traditional,
rural and tribal communities to the countrys agro biodiversity by rewarding them for their
contribution through benefit sharing and protecting the traditional right of the farmers.
More importantly this act provides safeguards to farmers by giving farmers rights while providing for an
effective system of protection of plant breeders rights. The Act seeks to safeguard researchers rights as
well. It also contains provisions for safeguarding the larger public interest. The farmers rights include his
traditional rights to save, use, share or sell his farm produce of a variety protected under this Act provided
the sale is not for the purpose of reproduction under a commercial marketing arrangement.
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Varieties protectable under the plant variety Act

1. A new variety if it conforms to the criteria of novelty, distinctiveness, uniformity and stability.
2. An extant variety if it conforms to criteria of distinctiveness, uniformity and stability.
An Extant Variety means a variety, which is(i) notified under section 5 of the Seeds Act, 1966 (54 of 1966); or
(ii) a farmers variety; or
(iii) a variety about which there is common knowledge; or
(iv) any other variety which is in the public domain.
Farmers Variety means a variety which(i) has been traditionally cultivated and evolved by the farmers in their fields; or
(ii) is a wild relative or land race of a variety about which the farmers possess the common
knowledge; where farmer means any person who (i) cultivates crops by cultivating the land
himself; or (ii) cultivates crop by directly supervising the cultivation of land through any other
person; or (iii) conserves and preserves, severely or jointly, with any person any wild species or
traditional varieties or adds value to such wild species or traditional varieties through selection and
identification of their useful properties.
Essentially Derived Variety is a variety which is predominantly derived fr om another variety (protected
or otherwise) and conforms to the initial variety in all aspects except for the differences which result from
the act of derivation, and yet is clearly distinguishable from such initial variety
Novelty, distinctiveness, uniformity & stability of plants
A) Novelty - Plant variety is novel if at the date of filing of the application for registration for
protection, the propagating or harvested material of such variety has not been sold or otherwise
disposed of by or with the consent of breeder or his successor for the purpose of exploitation of
such variety(i) in India earlier than one year or
(ii) outside India , in the case of trees or vines earlier than six years or in any other case, earlier than
four years,
before the date of filing such application:
Provided that a trial of a new variety which has not been sold otherwise disposed of shall not affect the
right to protection.
Provided further that the fact that on the date of filing the application for registration, propagating or
harvested material of such variety has become a matter of common knowledge other than through the
aforesaid manner shall not affect the criteria of novelty for such variety.
B) Distinctiveness - New plant variety will be considered distinct if it is clearly distinguishable by at
least one essential characteristic from any other variety whose existence is a matter of common
knowledge in any country at the time of filing of the application.
C) Uniformity - New plant variety will pass uniformity test, if subject to the variation that may be
expected from the particular features of its propagation, it is sufficiently uniform in its essential
characteristics.
D) Stability - New plant variety will be considered stable if its essential characteristics remain
unchanged after repeated propagation or, in the case of a particular cycle of propagation, at the end
of each such cycle.
Compulsory Plant Variety denomination: After satisfying the above four essential criteria every applicant
shall assign a single and distinct denomination to a variety with respect to which he is seeking
registration.
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Farmers rights
The farmers rights as defined in the Act are:
(i) a farmer who has bred or developed a new variety shall be entitled for registration and other
protection in like manner as a breeder of a variety under this Act;
(ii) the farmers variety shall be entitled for registration if the application contains declaration as
specified in clause (h) or sub-section (1) of section 18;
(iii) a farmer who is engaged in the conservation of genetic resources of land races and wild relatives
of economic plants and their improvement through selection and preservation shall be entitled in
the prescribed manner for recognition and reward from the Gene Fund.
Provided that material so selected and preserved has been used as donors of genes in varieties registrable
under this Act;
(iv) a farmer shall be deemed to be entitled to save, use, sow, resow, exchange, share or sell his farm
produce including seed of a variety protected under this Act in the same manner as he was entitled
before the coming into force of this Act.
Note: Branded seed means any seed put in a package or any other container and labelled in a manner
which gives indication that such seed is of a variety protected under this Act.
In addition to the above, where any propagating material of a variety registered under this Act has been
sold to a farmer or a group of farmers or any organization of farmers, the breeder of such variety shall
disclose to the farmer or the group of farmers or the organization of farmers, as the case may be, the
expected performance under given conditions, and if such propagating material fails to provide such
performance under such given conditions, the farmer or the group of farmers or the organization of
farmers, as the case may be, may claim compensation in the prescribed manner before the Authority and
the Authority shall, after giving notice to the breeder of the variety and after providing him an opportunity
to file opposition in the prescribed manner and after hearing the parties, direct the breeder of the variety to
pay such compensation as it deems fit, to the farmer or the group of farmers or the organization of
farmers, as the case may be.
Plant varieties which can not be protected under this Act
A plant variety which is :(i) not capable of identifying such variety; or
(ii) consists solely of figures; or
(iii) is liable to mislead or to cause confusion concerning the characteristics, value, identify of such
variety, or the identity of breeder of such variety;
(iv) is likely to deceive the public or cause confusion in the public regarding the identity of such variety;
(v) is comprised of nay matter likely to hurt the religious sentiments respectively of any class or
section of the citizens of India;
(vi) is prohibited for use as a name or emblem for any of the purposes;
(vii)
is comprised of solely or partly of geographical name.
Term of plant variety protection
(i) in the case of trees and vines, eighteen years from the date of registration of the variety;
(ii) in the case of extant varieties, fifteen years from the date of the notification of that variety by the
Central Government under section 5 of the Seeds Act,1966
(iii) in the other cases, fifteen years from the date of registration of the variety.
Initially the certificate of registration shall be valid for nine years in the case of trees and vines and six
years in the case of other crops and may be revived and renewed for the remaining period on payment of
fees as may be fixed by the rules.
Fees for registering a plant variety
No.
1
Action
Conducting tests
Official fee
Dependent on the nature and type of test subject
to a maximum of Rs. 50,000 per entry
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Fees for registration of essentially derived

varieties
Renewal fee per year
Application for benefit sharing
Individual - Rs. 5,000/Educational - Rs. 7,000/Commercial - Rs. 10,000/Individual - Rs. 5,000/Educational - Rs. 7,000/Commercial - Rs. 10,000/Rs. 5,000/-
Plant Varieties Registered in India till 31.10.2010

Sl. No
1
2
3
4
5
6
7
8
9
10
11
12
13
14
Crop
Rice
Bread Wheat
Pearl Millet
Sorghum
Sorghum
Black Gram
Field Pea
Green Gram
Lentil
Kidney Bean
Garden Pea
French Bean
Chick Pea
Cotton
Total
No. of Varieties
11
48
29
13
45
9
15
20
9
3
5
2
2
17
217
References
http://www.indianpatents.org.in/
Baburam Singh. 2011. Protection of Plant Varieties in India : An Overview
IPR LL 21. GEOGRPHICAL INDICATIONS & MULTILATERAL TREAIES

Introduction
Geographical indications refers to the high reputation associated with a product based on its place of origin
and thus may be valuable commercial assets. For this very reason, they are often exposed to
misappropriation, counterfeiting or forgery, and their protection at national as well as international levels
becomes highly desirable.
Champagne, Cognac, Roquefort, Chianti, Pilsen, Porto, Sheffield, Havana, Tequila,
Darjeelingare some well-known examples for names which are associated throughout the world with
products of a certain nature and quality. when we hear these names we think of.
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With the exception of design law, there is probably no category of intellectual property law where there
exists such a variety of concepts of protection as in the field of geographical indications. This is maybe
best demonstrated by the term geographical indication itself, which is relatively new and appeared only
recently in international negotiations.
The Paris Convention for the Protection of Industrial Property does not contain the notion of geographical
indication. Article 1 paragraph (2) defines as subjects of industrial property, inter alia, indications of source
and appellations of origin. This is the terminology traditionally applied and still officially used in the
conventions and agreements administered by WIPO. According to this terminology, the following
distinction is made between indications of source and appellations of origin: indication of source means
any expression or sign used to indicate that a product or service originates in a country, a region or a
specific place, whereas appellation of origin means the geographical name of a country, region or
specific place which serves to designate a product originating therein the characteristic qualities of which
are due exclusively or essentially to the geographical environment, including natural or human factors or
both natural and human factors.
It is important to highlight the difference between indications of source and appellations of origin. The use
of an appellation of origin requires a quality link between the product and its area of production. This
qualitative link consists of certain characteristics of the product which are exclusively or essentially
attributable to its geographical origin such as, for example, climate, soil or traditional methods of
production. On the other hand, the use of an indication of source on a given product is merely subject to
the condition that this product originates from the place designated by the indication of source.
Appellations of origin can be understood as a special kind of indication of source. According to the
terminology traditionally applied, the term indication of source comprises all appellations of origin, but,
in its general use, it has become rather a designation for those indications of source which are not
considered to be appellations of origin.
2.691 The term geographical indication has been chosen by WIPO to describe the subject matter of a
new treaty for the international protection of names and symbols which indicate a certain geographical
origin of a given product. In this connection, the term is intended to be used in its widest possible meaning.
It embraces all existing means of protection of such names and symbols, regardless of whether they
indicate that the qualities of a given product are due to its
geographical origin (such as appellations of origin), or they merely indicate the place of origin of a
product (such as indications of source). This definition also covers symbols, because geographical
indications are not only constituted by names, such as the name of a town, a region or a country
(direct geographical indications), but may also consist of symbols. Such symbols may be capable
of indicating the origin of goods without literally naming its place of origin. Examples for such
indirect geographical indications are the Eiffel Tower for Paris, the Matterhorn for Switzerland or the
Tower Bridge for London.roducts rather than the places they designate.
When considering geographical indications as a special kind of distinctive sign used in commerce
and thus as a particular category of intellectual property, it is important to distinguish them from
trademarks: whereas a trademark identifies the enterprise which offers certain products or services on
the market, a geographical indication identifies a geographical area in which one or several
enterprises are located which produce the kind of product for which the geographical indication is
used. Thus, there is no owner of a geographical indication in the sense that one person or enterprise
can exclude other persons or enterprises from the use of a geographical indication, but each and
every enterprise which is located in the area to which the geographical indication refers has the right
to use the said indication for the products originating in the said area, but possibly subject to
compliance with certain quality requirements such as prescribed, for example, in administrative
decrees governing the use of appellations of origin.
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Protection of Geographical Indications [GIs]

What is meant by protection of geographical indications? First of all, protection means the right to
prevent unauthorized persons from using geographical indications, either for products which do not
originate from the geographical place indicated, or not complying with the prescribed quality
standards. The second aspect related to the issue of protection is the question of protecting
geographical indications against becoming generic expressions: in that case they have lost all their
distinctiveness and, consequently, will lose their protection. The question whether a geographical
indication is a generic term and void of any protection is, in the absence of an international
agreement, to be determined by national law. It might well be that a geographical name is regarded in
one country as a geographical indication and is protected accordingly, whereas it is considered to be a
generic or semi-generic term in another country. Notorious examples for such diverging treatment of
geographical names are the French names Champagne and Chablis which, in France, are only
allowed to be used for products originating from a certain geographical area and produced according
to certain quality standards, whereas, in the United States of America for example, they are regarded
as being semi-generic names, and therefore may be also used for wines not originating from the
French area of production. This aspect of protection is especially important in the context of
international protection of geographical indications and is dealt with, for example, by the Lisbon
Agreement for the Protection of Appellations of Origin and their International Registration.
Protection of Geographical Indications on the National Level
As regards the various forms of protection of geographical indications on the national level, three main
categories can be distinguished. The first category comprises all possibilities of protection which are not
based on a decision taken by the competent authority establishing protection with respect to a particular
geographical indication, but which result from the direct application of legislative provisions or principles
established by jurisprudence. The second category covers the protection of geographical indications
through registration of collective marks (including agricultural labels) or certification marks (or guarantee
marks). The third category includes all special titles of protection of geographical indications which result
from a decision made by the competent overnment authority establishing the protection. This category, in
particular, comprises the protection of appellations of originwhether they result from a registration with
the industrial property office, as under the new Russian law, or from the adoption of decrees, as is the
practice in France since the adoption, in 1919, of a special law for the protection of appellations of origin.
Special Titles of Protection
Already early in this century it was felt that the protection of indications of source against false or
deceptive use was insufficient. In addition, the need for the protection and the encouragement of local,
traditional methods of production emerged. It was in France where the first statute was enacted which
provided for the protection of geographical indications through a special title of industrial property,
namely appellations of origin.
The French Law of May 6, 1919, recognized the existence of appellations of origin and laid down
conditions for their protection. According to this law, an appellation of origin consists of the name of a
country, region or locality that serves to designate a product originating therein, the quality and
characteristics of which are due to the geographical environment, including both natural and human
factors. This means that only such products are protected under this special title which originate from a
specific area and which owe their specific quality to their place of origin. In order to ensure that the
products possess the specified qualities, a control mechanism has been set up by the competent
authorities, and quality controls are carried out regularly. Only products which comply with the quality
standards are protected by an appellation of origin. Initially, appellations of origin only concerned wines
and spirits, but later the concept was extended to include other products (such as dairy products, mainly
cheese and butter), poultry and plant products.
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Because of the success of the French appellations of origin, the same or a similar system was introduced
also in other countries, mainly in the sector of wines and spirits. Registration of Collective Marks or
Certification Marks
The protection of a given geographical indication may not only be based on a public or administrative
act, but may also result from a private initiative. With regard to the latter approach, collective marks or
certification marks provide a means for the protection of geographical indications independent of
statutory or judicial measures. The concepts of collective mark and certification mark (or, in some
countries, guarantee mark) differ from country to country. Depending on the applicable national law, a
collective mark or certification mark may serve to indicate, inter alia, the origin of goods or services, and
therefore may to some extent be suitable for the protection of a geographical indication.
A collective mark is a mark the use of which is only allowed to the members of a collective body. Such a
body can be an association or cooperative of manufacturers, producers or traders.
The collective mark is owned by the association which exclusively grants its members the right to use it.
The association may be a domestic one or a foreign one. Normally, the use of the collective mark is
governed by regulations which have to be submitted to the industrial property office together with the
application for registration. The question whether a geographical indication is registrable as a collective
mark depends entirely on a given national law. Some national trademark laws exclude the registration of
geographical indications as collective marks, although, more recently, that exclusion has been abolished
by some countries.____________________________________________________________________
Once a geographical indication has been registered as a collective mark, the association that owns it has the
right to prohibit its use by persons who are not members of the association. However, in case of conflict with
a senior right, the members of the association may be excluded from using the collective mark. Moreover,
the registration of a geographical indication as collective mark may not, per se, prevent the mark from
becoming a generic term. Furthermore, the laws of some countries contain strict use requirements which
may result in the cancellation of the registration of the collective mark in case it is not continuously used.
In contrast to collective marks, certification marks and guarantee marks are not owned by a collective body
such as an association of producers, but by a certification authority. Such authority may be a local council or
an association which is not engaged in the production or the trade of the products concerned. The latter is of
particular importance because it is the owner of the certification mark who must ensure that the goods
bearing the certification mark possess the certified qualities. A certification mark may be used to certify,
inter alia, the origin of products or services. The application for the registration of a certification mark has to
be accompanied by regulations which govern the use of the certification mark. Regarding the registrability
of geographical indications as certification marks and guarantee marks, the same principles as for the
registration of collective marks apply.
Where a geographical indication has been registered as a certification mark or guarantee mark, it may
normally be used by everybody whose products comply with the requirements set out in the regulation. Such
right to use, however, may not exist in case of conflict with a senior right. The institution which owns the
registered certification mark or guarantee mark has the right to prohibit the use of that mark by persons
whose products do not comply with the requirements set out in the regulations. In general, the protection of
a geographical indication through registration as certification mark or guarantee mark is equivalent to that
conferred by registration as a collective mark.
A special form of protected geographical indication resembling the concept of collective marks is the French
agricultural label (in French label agricole). An agricultural label is a collective mark that certifies that a
foodstuff or a non-nutritious and non-transformed agricultural product (such as cereal seeds) possesses a
combination of specific characteristics and a level of quality which is higher than that of similar products.
An agricultural label can be a national label (known as red label) or a regional label, the latter referring to
characteristics which are specific, traditional or representative of a region. Products in respect of which an
appellation of origin has been established and some categories of wines (even if not benefitting from an
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appellation of origin) may not be the subject of protection by way of an agricultural label. The agricultural
label is registered in the name of the entity that controls its use. The application of the Decree is not limited
to French products, but so far only little use has been made of the possibility of applying the Decree to
foreign products. An example of a foreign product is the label for Scottish salmon.
The Law of Unfair Competition
The use of a certain geographical indication for goods or services not originating from the respective area
may be misleading and thus may deceive consumers. Furthermore, such use may constitute a
misappropriation of the goodwill of the person who is truly entitled to use the geographical indication. An
action for unfair competitionwhich, depending on the national law, is either based on statutory provisions,
as interpreted by court decisions, or on common lawcan be instituted in order to prevent competitors from
resorting, in the course of trade, to such___________________________________________________
misleading practices.
Although the conditions for a successful action for unfair competition vary from country to country, the
following basic principles appear to be generally recognized. In order to be protectable, a given
geographical indication must have acquired a certain reputation or goodwill. In other words, the potential
buyers of the product must associate the geographical indication with the place of origin of the goods or
services. Such an action further requires that the use of the geographical indication on goods or services
not originating from the respective geographical area is misleading, so that consumers are deceived as to
the true place of origin of the products or services. Under some national laws, proof of damages or the
likelihood of damages caused by such misleading practices is required.
Whereas the principle that misleading use of a geographical indication may give rise to an action for
unfair competition is generally recognized, the outcome of such an action is uncertain. In particular, the
extent to which the geographical indication in question must have acquired a reputation may vary from
country to country. It may be required that the geographical indication must have been used in the course
of trade for a certain time and that an association between the geographical indication and the place of
origin of the products and services must have been created amongst the relevant circles. Therefore, a
geographical indication, the reputation of which is not yet established on the market, may not be
protectable against misleading use by competitors through an action for unfair competition. Furthermore,
a geographical indication which has not been used for a certain time may lose its reputation and therefore
may no longer be protectable by an action for unfair competition. Geographical indications which become
generic terms in a particular country lose their distinctive character and are no longer protectable in that
country.
Protection of Geographical Indications on the International Level through Multilateral Treaties
Three multilateral treaties administered by WIPO contain provisions for the protection of geographical
indications: the Paris Convention for the Protection of Industrial Property, the Madrid Agreement for the
Repression of False or Deceptive Indications of Source on Goods (hereinafter referred to as the Madrid
Agreement), and the Lisbon Agreement for the Protection of Appellations of Origin and their International
Registration (hereinafter referred to as the Lisbon Agreement). Chapter 2 - Fields of Intellectual Property
Protection 125
i.
The Paris Convention for the Protection of Industrial Property
Several provisions of the Paris Convention deal specifically with indications of source or appellations of
origin: Article 1(2) contains a reference to indications of source and appellations of origin in the list
of objects of industrial property; Article 10 deals with t he protection of indications of source; Article 9
provides for certain sanctions which are applicable, inter alia, in cases of direct or indirect use of false
indications of source; and Article 10ter reinforces the provisions of Articles 9 and 10.
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Article 1(2) provides that the protection of industrial property has as its object, among others, indications
of source or appellations of origin. The obligation to protect indications of source is specifically
provided for in Article 10, but there are no special provisions in the Paris Convention for the protection of
appellations of origin. Nevertheless, Articles 9, 10 and 10ter are applicable to appellations of origin since
each appellation of origin by definition constitutes an indication of source.
Article 10(1) is the basic provision of the Paris Convention on indications of source. It provides that the
sanctions prescribed by Article 9 in respect of goods unlawfully bearing a trademark or trade name apply
to any use of a false indication of the source of a product. This means that no indications of source may
be used that refer to a geographical area from which the products in question do not originate. For the
provision to be applicable, there is no need for the false indication to appear on the product, since any
direct or indirect use, for example in advertising, is sanctionable. However, Article 10(1) does not apply to
indications which, without being false, may mislead the public, or at least the public of a certain country:
for example, where certain geographical areas in different countries have the same name but only one of
those areas is internationally known for particular products, the use of that name in connection with
products originating from another area may be misleading, but not sanctionable.
As regards the sanctions in the case of the use of a false indication of source, Article 9 establishes the
principle that seizure upon importation must be provided for, or at least prohibition of importation or
seizure inside the country but, if those sanctions do not exist in a particular country, the actions and
remedies available in such cases are to be applied.
Article 9(3) and Article 10(2) determine who may request seizure on importation or the imposition of
other sanctions: the public prosecutor, any other competent authority, any interested party. Article 10(2)
defines what is meant by interested party, stipulating that any producer, manufacturer, or merchant,
whether a natural person or a legal entity, engaged in the production or manufacture of or trade in such
goods and established either in the locality falsely indicated as the source, or in the region where such
locality is situated, or in the country falsely indicated, or in the country where the false indication of
source is used, shall in any case be deemed an interested party.
Article 10bis concerns the protection against unfair competition and as such provides a basis for
protection against the use of confusing, false or misleading geographical indications.
Article 10bis obliges countries of the Paris Union to assure effective protection against unfair competition,
sets a general definition of what constitutes an act of unfair competition and contains a non-exhaustive list
of three types of acts which, in particular, must be prohibited.
Article 10ter is also relevant inasmuch as it obliges countries of the Union to provide, on the one hand,
appropriate legal remedies and to permit, on the other, federations and associations representing interested
industrialists, producers or traders to take action, under certain conditions, with a view to the repression of
false indications of source.
126 WIPO Intellectual Property Handbook: Policy, Law and Use
The main advantage of the protection afforded by the Paris Convention to indications of source lies in the
extent of the territorial area covered by the member countries of the Paris Union; information on the
number of member countries can be found in the appropriate document inserted in the back flap of this
publication. On the other hand, the question of indications which, in countries other than the country of
origin, are generic names of a product in other countries is not dealt with in the Paris Convention, so that
member States of the Paris Union can be entirely free in that respect. Finally, sanctions, although
specifically mentioned in the Paris Convention, are not in all cases mandatory and apply only to false but
not to misleading indications of source.
The Madrid Agreement for the Repression of False and Deceptive Indications of Source on Goods
The Madrid Agreement for the Repression of False or Deceptive Indications of Source on___________
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Goods is a special agreement within the framework of the Paris Union. The Agreement aims at the
repression not only of false, but also of deceptive, indications of source.
Article 1(1) of the Madrid Agreement provides that any product bearing a false or deceptive indication by
which one of the States party to the Madrid Agreement or a place situated therein is directly or indirectly
indicated as being the country or place of origin, must be seized on importation into any of the States
party to the Madrid Agreement.
The other paragraphs of Articles 1 and 2 specify the cases and the manner in which seizure or similar
measures may be requested and carried out. There is no express provision to the effect that private
individuals may request seizure directly. Thus, member States are free to provide that such persons
have to apply through the public prosecutor or any other competent authority.
Article 3 authorizes a vendor to indicate his name or address on goods coming from a country other
than that in which the sale takes place, but obliges him, if he does so, to have his name or address
accompanied by an exact indication in clear characters of the country or place of manufacture or
production, or by some other indication sufficient to avoid any error as to the true source of the wares.
Article 3b is obliges the States party to the Madrid Agreement to prohibit the use, in connection with
the sale or display or offering for sale of any goods, of all indications capable of deceiving the public
as to the source of the goods.
Article 4 provides that the courts of each country have to decide what appellations, on account of their
generic character, do not fall within the provisions of the Madrid Agreement. Only regional appellations
concerning the source of products of the vine are excluded from the reservation inherent in the provision.
The reservation substantially limits the scope of the Madrid Agreement, in spite of the important
exception constituted by the case of regional appellations concerning the source of products of the vine,
for which protection is absolute.
A list of States that are party to the Madrid Agreement for the Repression of False or Deceptive
Indications of Source on Goods can be found in the appropriate document inserted in the back flap of this
publication.
The Lisbon Agreement for the Protection of Appellations of Origin and their International
Registration
The limited geographical scope of the Lisbon Agreement for the Protection of Appellations of Origin
and their International Registration is due to particular characteristics of the substantive provisions of
the Agreement.
Article 2(1) contains a definition according to which appellation of origin means the geographical name
of a country, region or locality which serves to designate a product originating therein, the quality and
characteristics of which are due exclusively or essentially to the geographical environment, including
natural and human factors. It follows that only names conforming to the definition may be protected by
virtue of the Lisbon Agreement. Simple indications of source (which can be used for products whose
characteristics do not result from the geographical environment) are excluded from its purview. This
limitation has prevented the accession of countries which do not know the concept of appellation of
origin.
The first element of the definition is that the appellation must be the geographical name of a country,
region or locality. The second element of the definition is that the appellation of origin must serve to
designate a product originating in the country, region or locality referred to. The third element of the
definition is that there must be a qualitative link between the product and the geographical area: the
quality and characteristics must be due exclusively or essentially to the geographical environment; if the
qualitative link is insufficient, that is, if the characteristic qualities are not due essentially, but only to a
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small extent, to the geographical environment, the name is not an appellation of origin but merely an
indication of source; as for the geographical environment, it includes natural factors, such as soil or
climate, and human factors, such as the special professional traditions of the producers established in the
geographical area concerned.
Even if interpreted broadly, the definition of appellation of origin in Article 2(1) has a serious drawback
for countries whose denominations typically do not apply to agricultural products or products of
handicraft but to products of industry. The difficulty arises from the fact that Article 2(1) requires the
existence of a qualitative link between the geographical environment and the product, even though the
presence of purely human factors would be considered sufficient.
This link, which may have existed at the start of the manufacture of an industrial product, may
subsequently have been stretched to the point that its existence is difficult to prove. Moreover, traditions in
manufacture and skilled staff can be shifted from one geographical area to another, in particular in view of
the increasing mobility of human resources in all parts of the world.
Article 1(2) provides that the countries party to the Lisbon Agreement undertake to protect on their
territories, in accordance with the terms of the Agreement, the appellations of origin of products of the
other countries party to the Lisbon Agreement, recognized and protected as such in the country of origin
and registered at the International Bureau of WIPO. Therefore, in order to be protected under the Lisbon
Agreement, the appellation of origin must fulfill two conditions. The first condition is that the appellation
of origin must be recognized and protected as such in the country of origin (the latter being defined in
Article 2(2)). This condition means that it is not sufficient for the country in question to protect its
appellations in a general way. Each appellation still has to benefit from distinct and express protection,
deriving from a specific official act (a legislative or administrative provision, or a judicial decision, or a
registration). Such an official act is required because the specific elements of the object of protection (the
geographical area, the lawful users of the appellation of origin, the nature of the product) must be
determined. Those elements must be indicated in the application for international registration in
accordance with Rule 1 of the Regulations under the Lisbon Agreement.
The second condition laid down by Article 1(2) is that the appellation of origin must be registered with the
International Bureau of WIPO. Articles 5 and 7 of the Agreement itself and the Regulations set forth the
procedure for international registration.
Article 2(2) defines the country of origin as being the country whose name, or the country in which is
situated the region or locality whose name, constitutes the appellation of origin which has given the
product its reputation.
Article 5(1) and the corresponding provisions of the Regulations issued under the Lisbon Agreement
define the procedure for international registration. International registration must be applied for by the
competent Office of the country of origin, and therefore may not be requested by interested parties. The
national Office, however, does not apply in its own name for___________________________________
international registration, but in that of any natural persons or legal entities, public o r private, having a
right to use (in French, titulaire du droit duser) the appellation, according to the applicable national
legislation. The International Bureau of WIPO has no competence to examine the application with respect
to substance; it may only make an examination as to form. Under Article 5(2) of the Lisbon Agreement,
the International Bureau notifies the registration without delay to the Offices of the countries party to the
Lisbon Agreement and publishes it in its periodical Les Appellations dorigine (Rule 7 of the
Regulations).
In accordance with Article 5(3) to (5), the Office of any State party to the Lisbon Agreement may, within a
period of one year from the receipt of the notification of registration, declare that it cannot ensure the
protection of a given appellation. Apart from the time limit mentioned, the right of refusal is subject to
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only one condition: the grounds for refusal must be indicated. The grounds which may be so indicated are
not restricted by the Lisbon Agreement; this in fact gives each country the discretionary power to protect
or refuse to protect a registered appellation of origin. In all countries not having made a declaration of
refusal, the registered appellation enjoys protection. However, if third parties have been using the
appellation in a given country prior to the notification of the registration, the Office of that country may,
under Article 5(6) of the Lisbon Agreement, grant them a maximum of two years in which to terminate
such use.
The protection conferred by international registration is unlimited in time. Article 6 provides that an
appellation which has been granted protection cannot be deemed to have become generic, as long as it is
protected as an appellation of origin in the country of origin. Article 7 provides that the registration need
not be renewed and is subject to payment of a single fee. An international registration ceases to have
effect only in two cases: either the registered appellation has become a generic name in the country of
origin, or the international registration has been canceled by the International Bureau at the request of the
Office of the country of origin.
The content of the protection afforded to an appellation of origin registered under the Lisbon Agreement,
according to Article 3 of the Agreement, is very extensive. Any usurpation or imitation of the appellation
is prohibited, even if the true origin of the product is indicated or if the appellation is used in translated
form or qualified by terms such as kind, type, make, imitation, or the like.
With regard to the enforcement of the protection of an appellation of origin registered under the Lisbon
Agreement, Article 8 refers to national legislation. It specifies that the right to take action belongs to the
competent Office and the public prosecutor, on one hand, and to any interested party, whether a natural
person or a legal entity, whether public or private, on the other.
In addition to any sanctions applicable pursuant to the Paris Convention and the Madrid Agreement
(Article 4), all the sanctions provided for in national legislation, whether civil (injunctions restraining or
prohibiting unlawful acts, actions for damages, etc.), penal or administrative, are to be applied. However,
the Lisbon Agreement does not establish a standard with respect to the sanctions to be provided for by the
States party to it.
A list of the countries party to the Lisbon Agreement can be found in the appropriate document inserted in
the back flap of this publication.
Chapter 2 - Fields of Intellectual Property Protection 129
Protection of Geographical Indications at the International Level through the
Provisions of Bilateral Agreements
A further possibility of international protection of geographical indications is the conclusion of bilateral
agreements between two states. A number of countries have entered into such agreements. In general,
such bilateral agreements consist of lists of geographical indications which were drawn up by the
contracting parties and an undertaking to protect the geographical indications of the respective contracting
parties. The agreement usually also specifies the kind of protection that is to be granted. Although in
general useful, bilateral agreements cannot constitute an entirely adequate solution to the problem of the
lack of international protection because of the multiplicity of negotiations required and, resulting
therefrom, an inevitable diversity of standards.
ii. Provisions of The TRIPS Agreement on Geographical Indications
Part II, Section 3 of the TRIPS Agreement is dedicated to geographical indications. The
general norm of protection is provided by Article 22.2, which reads as follows:
2. In respect of geographical indications, Members shall provide the legal means for
interested parties to prevent:
- the use of any means in the designation or presentation of a good that indicates or
suggests that the good in question originates in a geographical area other than the
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true place of the origin in a manner which misleads the public as to the geographical
origin of the good;
any use which constitutes an act of unfair competition within the meaning of Article 10bis
of the Paris Convention (1967).
Article 22.2 is supplemented by Article 22.3 and 22.4. Article 22.3 deals specifically with the registration
of trademarks, containing or consisting of a geographical indication, for goods not originating in the
territory indicated, if the use of those trademarks for such goods would be misleading as to the true place
of origin of the goods. The remedy that must be available in that situation is refusal or invalidation of the
trademark registration, either ex officio, if the applicable law so allows, or at the request of an interested
party.
Article 22.4 stipulates that the protection under Article 22.1 to 3 must also be made available in respect of
the use of deceptive geographical indications, i.e., geographical indications that are literally true, although
they falsely represent to the public that the goods on which they are used originate in a different territory.
Article 23.1 provides for additional protection for geographical indications for wines and spirits.
It reads as follows:
Each Member shall provide the legal means for interested parties to prevent use of a geographical
indication identifying wines for wines not originating in the place indicated by the geographical indication
in question or identifying spirits for spirits not originating in the place indicated by the geographical
indication in question, even where the true origin of the goods is indicated or the geographical indication
is used in translation or accompanied by expressions such as kind, type, style, imitation or the like.
Article 23.1 has a footnote with the following wording:
Notwithstanding the first sentence of Article 42, Members may, with respect to these obligations,
instead provide for enforcement by administrative action. 2.743 Article 23.1 is supplemented by a
paragraph dealing specifically with the registration of trademarks for wines
containing or consisting of a geographical indication for wines, and the registration of a trademark for
spirits containing a geographical indication for spirits, where the
wines and spirits in question do not have the indicated geographical origin. Registration of
trademarks falling under that provision has to be refused or canceled, either ex officio if the
applicable law so allows, or at the request of an interested party.
Article 24 contains a number of exceptions to the obligations under Articles 22 and 23.
Broadly speaking, there are three categories of exceptions, namely, continued and similar use of
geographical indications for wines and spirits, prior good faith trademark rights, and generic designations.
The first exception (Article 24.4) gives the right to WTO Members to allow continued and similar use of a
particular geographical indication of another Member identifying wines or spirits, in connection with
goods or services by any of its nationals or domiciliaries who have used that geographical indication in a
continuous manner with regard to the same or related goods or services in the territory of that Member,
either for at least 10 years preceding April 15, 1994, or in good faith preceding that date.
The second exception relates to rights in trademarks (Article 24.5). It basically states that the
implementation of the Section on geographical indications by a WTO Member is without prejudice to the
registration of trademarks identical with or similar to geographical indications, to the application for
registration of such trademarks, or the right to use such trademarks, if the following conditions are
fulfilled: an application for the registration of such a trademark must have been filed, or the trademark
must have been registered, or, where the right to the trademark was acquired by use, that trademark must
have been used, in good faith, in the WTO Member concerned, before the TRIPS Agreement became
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applicable in that Member, or before the geographical indication in question is protected in its country of
origin.
The third exception (Article 24.6) is related to geographical indications of a WTO Member which are
considered by another WTO Member to be a term customary in common language as the common name
for goods or services or, where the geographical indication is used for products of the vine, it is identical
with the customary name of a grape variety existing in the territory of that Member as of the date of entry
into force of the TRIPS Agreement.
References
WIPO Intellectual Property Handbook: Policy, Law and Use.
IPR L 22 - 25. PATENTING TRADITIONAL KNOWLEDGE

India has played a pivotal role in the decade old efforts of developing countries on the global
platform for bringing the protection of traditional knowledge at the centre stage of the International
Intellectual Property System. These efforts have resulted inter alia in setting up of an InterGovernmental Committee (IGC) on Intellectual Property, Traditional Knowledge,
Genetic Resources and Folklore by WIPO and the Doha Ministerial Declaration of the year 2001
wherein it was decided to establish a relationship between the TRIPS Agreement and the UN
Convention on Biological Diversity (CBD) on the issue of Access to Genetic Resources and the fair
and equitable sharing of the benefits arising from their utilization. Further, India has been able to
conclude TKDL Access (Non-Disclosure) Agreements with several international patent offices
including USPTO, EPO, JPO etc. Consequently, many patent applications concerning India's
traditional knowledge have either been cancelled or withdrawn or claims have been amended in
several international patent offices. Negotiations are also under way for establishing an international
legally binding instrument on protection of TK.
Indian law has adequate provisions for the protection of TK and Biological Resources.
Traditional knowledge, by its very definition, is in the public domain and hence, any application for
patent relating to TK does not qualify as an invention under section 2 (1) (j) of the Patents Act, 1970,
which defines that "invention means a new product or process involving an inventive step and
capable of industrial application". Further, under section 3(e) of the Patents Act "a substance obtained
by a mere admixture resulting only in the aggregation of the properties of the components thereof or
process for producing such substances" is not an invention and hence, not patentable. The Indian
Patents Act also has a unique provision under Section 3 (p), wherein "an invention which, in effect, is
traditional knowledge or which is an aggregation or duplication of known properties of traditionally
known component or components" is not an invention and hence, not patentable, within the meaning
of the Patents Act. Additionally, sections 3 (b), (c), (d), (f), (h), (i) and (j) are of relevance with
respect to the patent applications related to TK and/or biological material.
On the issue of Biological resources, section 6 (1) of the Biological Diversity Act, 2002
provides very clearly that "no person shall apply for any intellectual property right, by whatever name
called, in or outside India for any invention based on any research or information on a biological
resource obtained from India without obtaining the previous approval of National Biodiversity Authority
before making such application; provided that, if a person applies for a patent, permission of the
National Biodiversity Authority may be obtained after the acceptance of the patent but before the sealing
of the patent1 by the patent authority concerned; provided further that the National Biodiversity
Authority shall dispose of the application for permission made to it within a period of ninety days from
the date of receipt thereof. The Indian Patent Law complements this provision of the Biological
Diversity Act, 2002 by making it mandatory for the applicant of a patent to submit a
declaration under Form-1 (Application for Grant of Patent) of the Patent Rules 2003 to the
effect that "the invention as disclosed in the specification uses the biological material from
India and the necessary permission from the Competent Authority shall be submitted by me/us
before the grant of patent to me/us." The Biological Diversity Act, 2002 has a penal provision
in this regard under section 55 (1) which provides that "whoever contravenes or attempts to
contravene or abets the contravention of the provisions of the section 3 or section 4 or
section 6 shall be punishable with imprisonment for a term which may extend to five years,
or with fine which may extend to ten lakh rupees and where the damage caused exceeds ten
lakh rupees such fine may commensurate with the damage caused, or with both."
Moreover, applications for patents based on TK and/or biological material contravening the provisions of law
can be refused under section 15 or in pre-grant opposition under clauses (d), (f) and (k) of Section 25 (1) and
granted patents can be revoked in post-grant opposition under clauses (d), (f) and (k) of Section 25 (2) of the
Patents Act, 1970. Nondisclosure or wrong mention of the source or geographical origin of biological material
used for an invention in the complete specification also forms a ground for pre- and post- grant opposition
under clause (j) of Sections 25 (1) and 25 (2) respectively of the Patents Act, 1970.
In view of the above facts and the sensitivity and importance of the issue, it is imperative that due care
and diligence be exercised while processing patent applications relating to TK and/or biological
materials and in post-grant proceedings thereto. Accordingly, the following guidelines are issued for
strict compliance by all Examiners and Controllers:
Screening:
It should be ensured that all patent applications relating to Traditional Knowledge (TK) are correctly
identified, screened and classified as "Traditional Knowledge" by RECS Section.
The RECS in-charge should take due care that no case relating to TK is wrongly screened and
classified. Additionally, the person in-charge of screening should accord appropriate IPC
classification for such TK applications so that these applications can be properly routed for
examination to the respective groups such as Chemistry, Pharmaceuticals, Agrochemicals,
Biotechnology, Microbiology, Biochemistry, Food, Mechanical, etc. e.g., C07D, C07G5/00 (for
Chemical), A61K, A61L (for Pharmaceuticals), A01N (for Agrochemcials), C12S, C12N,
C07K4/00; 14/00 (for Biotechnology), C12N, C12P, C12Q (for Microbiology), C12F, C12G (for
Biochemistry), A23C, A23L (for Food), B25F (for Mechanical), etc. The screening of an application as
Traditional Knowledge is an administrative process for facilitating the examination and to indicate that
the subject-matter of the application is important and has relevance in the context of traditionally known
substances, articles or processes for preparing them or their use.
In the rare situation that the screening and/or classification by the RECS Section is not found to
be appropriate in respect of applications relating to TK during allotment/examination, it should
be immediately brought to the notice of the Group Leader by the concerned Examiner/Controller
and re-screening and/or re-classification should be done by the Group Leader (GL) forthwith.
If an application is wrongly screened and classified as "Traditional Knowledge", only the Technical
Head shall be competent for re-screening and/or re-classification of the same to any other screening
field on the recommendation of the concerned Group Leader.
System Administrator should create separate screening fields in the Module namely,
TK-Chemical, TK-Biotechnology and TK-Mechanical.
Allotment:
In the concerned Group, the Group Leader shall himself/herself act as the Controller for all applications
related to TK. The Group Leader/Controller shall ensure that the provisions related to the protection of
TK and/or biological material are fully complied with. The____________________________________
concerned Group Leader shall select one suitable Examiner from within his/her Group for dealing with all
applications relating to TK. The concerned Group Leader/Controller and Examiner should endeavor to
continuously upgrade their knowledge about TK and/or Biological Resources.
Any application/case already under process including pre-grant opposition relating to TK shall be re-allotted
to the identified pair in the respective Group. Whenever any Examiner/Controller comes across a case
related to TK, he/she shall bring to the notice of GL for re-allotment.
Examination:
In every case related to TK and/or biological material, the Examiner shall carry out a thorough search for
anticipation in TKDL and/or other databases. If any citation is made from TKDL database, then copy of the
citation (English translated) should be sent along with the examination report.
Assessment of Novelty and Inventive step:
The patents Act warrants that the subject-matter claimed in a patent application must be novel.
The inventive step is another cardinal principle of patentability. Often it is said to be the final gate keeper of
the patent system. While considering the traditional knowledge based inventions, the following guiding
principles must be followed in assessing the novelty and inventive step:
Guiding Principle 1: If the subject-matter as claimed relates to extracts/alkaloids and/or isolation of
active ingredients of plants, which are naturally/inherently present in plants, such claims cannot be
considered as novel and/or inventive when use of such plants is pre-known as part of teachings of
Traditional Knowledge.
When the subject-matter of claims relate to extracts of plant materials containing undefined
active ingredients, such claims cannot be said to be novel if the use of such plants or plant
materials is pre-known as a part of teaching of TK. However, if the claims relate to alkaloids
and/or active principles obtained from the plant materials and structures of the said alkaloids
and/or active principles are characterized, which do not form the part of the prior art, such
claims cannot be said to involve an inventive step, since the use of said plant materials and
their therapeutic effects are known from the teaching of TK. Thus, the prior art motivates the
person skilled in the art to isolate the individual ingredients such as alkaloids, flavonoids, phytosteroids,
etc.
Illustration 1: Patent application claims relate to an extract of Withania plant for the management of stress.
Prior art (TKDL): Discloses use of Withania somnifera roots and not Withania plant extract for the
treatment of stress related disorders in Ayurveda and Unani systems of medicine.
Analysis: The claims of alleged invention relate to an extract of Withania plant. Based on the prior art, it can
be objected that the extract of Withania somnifera would be useful in treatment of chronic stress disorders
such as insomnia, gastric ulcers, hyperacidity, restlessness and depression. Therefore, the subject-matter of
claims is not considered as novel over the teaching of prior art obtained from TKDL.
Illustration 2: Patent application claims relate to an alkaloid, Chamaemeloside, derived from
Roman or German chamomile for the treatment of Cancer, Diabetes mellitus, Arthritis, Acne
vulgaris, Eczema and for wound healing.
Prior art (TKDL): Discloses use of German chamomile (from which Chamaemeloside is derived) in
wound healing and for the treatment of cancer, diabetes mellitus, arthritis, acne vulgaris and eczema in
Ayurveda and Unani systems of medicine. The prior art does not disclose the Chamaemeloside.
Analysis: The claims of alleged invention relate to Chamaemeloside derived from Roman or
German chamomile. Based on the prior art, it can be objected that German or Roman chamomile
(from which Chamaemeloside is derived) has already been used alone or in combination with
other ingredients for afore-mentioned indications and therefore, the prior art motivates the person
skilled in the art to isolate and identify the active ingredient such as Chamaemeloside, which has
the same therapeutic effects. Hence, the isolation and characterization of the same cannot be
considered to involve an inventive step in the light of prior art obtained from TKDL.
Guiding Principle 2: Combination of plants with known-therapeutic effect with further plants with the
same known-therapeutic agents wherein all plants are previously known for treating the same disease
is considered to be an obvious combination.
Illustration 1: Patent application claims relate to a composition comprising of Calendula
officinallis, Aloe vera and Centellae asiatica as healing agent and for treatment of wound.
Prior art (TKDL): Discloses independent use of Calendula officinallis, Aloe vera and Centellae
asiatica for the treatment of wound and as a Cicatrizant/healing agent in Ayurveda and Unani systems
of medicine.
Analysis: The claims of alleged invention were on a composition. Based on the prior art, it can be
objected that the combination of these plants would be obvious for the treatment of skin diseases
and healing of wounds. The combination of a plant with a known therapeutic effect with further
plants with the same known therapeutic effect, wherein all plants are previously known for
treating the same disease is considered to be an obvious combination. It would normally be
expected that such combinations of medicinal plants would be more effective than each of the
medicinal plants when applied separately (additive effect).
Illustration 2: Patent application claims relate to a composition comprising Ginger, Radish,
Celery and Black seed for enhancing male fertility.
Prior art (TKDL): Discloses independent use of Ginger, Radish, Celery and Black seed as
Aphrodisiac and Spermatogenic in Ayurveda and Unani systems of medicine.
Analysis: The claims of alleged invention relate to a composition. Though none of the prior arts disclose a
composition comprising a combination of the four extracts as claimed in the present application, it can be
objected from prior art documents that the use of the single ingredients ginger, radish, celery and black seed
as aphrodisiac and/or spermatogenic is well-known in the prior art.
Guiding Principle 3: In case an ingredient is already known for the treatment of a disease, then it
creates a presumption of obviousness that a combination product comprising this known active
ingredient would be effective for the treatment of same disease.
Illustration 1: Patent application claims relate to a combination of five constituents, one of these
being a 1:2 watery extract of Cucumis melo containing catalase and superoxide dismutase; along
with Pimiemta racemosa, Citrus aurantifolia, Coenzyme Q-10 and Pyridoxine Chlorhydrate for the
treatment of vitiligo.
Prior art (TKDL): Discloses usefulness of only one of the constituents, watery extract of Cucumis
melo for its anti-vitiligo property in the Unani system of medicine.
Analysis: The claims of alleged invention relate to a composition. Though none of the prior arts
disclose a composition comprising a combination of the four extracts as claimed in the present
application, it can be objected from prior art documents that the use of the single ingredients ginger,
radish, celery and black seed as aphrodisiac and/or spermatogenic is well-known in the prior art.
Guiding Principle 3: In case an ingredient is already known for the treatment of a disease,
then it creates a presumption of obviousness that a combination product comprising this
known active ingredient would be effective for the treatment of same disease.
Illustration 1: Patent application claims relate to a combination of five constituents, one of these
being a 1:2 watery extract of Cucumis melo containing catalase and superoxide dismutase; along
with Pimiemta racemosa, Citrus aurantifolia, Coenzyme Q-10 and Pyridoxine Chlorhydrate for the
treatment of vitiligo.
Prior art (TKDL): Discloses usefulness of only one of the constituents, watery extract of Cucumis
melo for its anti-vitiligo property in the Unani system of medicine.
Analysis: The claim of alleged invention relates to a composition comprising five constituents and
not on a single constituent, the watery extract Cucumis melo for its anti-vitiligo property.
Based on said cited documents, it can be objected that if one ingredient here, Cucumis melo, was
already known for the treatment of vitiligo, then it is necessarily expected that a combination
comprising this known active ingredient must be effective for treating vitiligo as long as no
surprising (superior) effect of the claimed combination vis-a-vis the already known product
comprising Cucumis Melo, inventive merits can not be acknowledged.
Guiding Principle 4: Discovering the Optimum or Workable Ranges of Traditionally known
ingredients by Routine experimentation is not inventive.
In case of inventions relating to selection of optimum or workable range of ingredients, this is to be
borne in mind that the selection of a particular range of known ingredients is not inventive since the
selection of optimum or workable range is well within the expectation of a person skilled in the art.
Illustration 1: Patent application claims relate to a formulation comprising at least two of the
following: an extract of Pongamia pinnata (in the range of 2 to 20%), an extract of Lawsonia alba (in
the range of 5 to 15%), an extract of Dhatura alba (in the range of 2 to 20%) and an extract of of Cocos
nucifera (in the range of 20 to 60%) for the management of chronic ulcer, diabetes ulcer, and the
management of bleeding in cuts and wounds.
___________________________________________________________________________________
Prior art (TKDL): Discloses use of said plants for the treatment of ulcer/wound in Ayurveda, Unani
and Siddha systems of medicine.
Analysis: The claims of alleged invention relate to a composition comprising plant parts in a specified
ratio. The claims can be objected as unpatentable in so far as the alleged invention is obvious over
Agasthiyar (TKDL) which taught a composition of extracts of two of the claimed plants, Karanj and
Heena formulated as oil for topical treatment of ulcers and wounds.
Although cited art does not specifically teach adding the ingredients in the percentages claimed by the
applicant, however the amount of specific ingredient in a composition is clearly a result effective
parameter that a person of ordinary skill in the art would routinely optimize.
Guiding Principle 5: In case multiple ingredients are known to have the same therapeutic activity as per
traditional knowledge, taking out one single component out of them cannot be considered as inventive.
Illustration 1: Patent application claims relate to an extract of Zingiber zerumbet (bitter ginger) for
inflammation and also for allergic disorder like Asthma.
Prior art (TKDL): Discloses use of Zingiber zerumbet (bitter ginger) along with few other ingredients
for the treatment of inflammation and Asthma in Unani system of medicine.
Analysis: The claims of alleged invention relate to an extract of Zingiber zerumbet. As per the prior art
disclosure, the multi-component formulation comprising Zingiber zerumbet have the same therapeutic
activity (i.e. anti-bronchial asthmatic), therefore it is not surprising that one single component namely
Zingiber zerumbet taken out of them again would have the same therapeutic activity. Hence, a person skilled
in the art would have been motivated to arrive at the invention without exercise of inventive skills and thus,
the claims of alleged invention can be objected for lacking in inventive step.
Guiding Principle 6: In case individual ingredients are already known for the treatment of a disease as
a part of Traditional Knowledge, then it is obvious that a combination product comprising these
known ingredients with further plants with the same known therapeutic effect would be more effective
than each of the medicinal plants when applied separately (additive effect).
Illustration 1: Patent application claims relate to a composition comprising of Calendula
officinallis, Aloe vera and Centellae asiatica as healing agent and for treatment of wound.
Prior art (TKDL): Discloses use of said plants for the treatment of wound and as a
Cicatrizant/healing agent in Ayurveda and Unani systems of medicine.
Analysis: The claim of alleged invention relates to a composition. In view of the prior art, the
combination of these plants would be obvious for the treatment of skin diseases and healing of wounds.
The combination of a plant with a known therapeutic effect with further plants with the same known
therapeutic effect, wherein all plants are previously known for treating the same disease is considered to
be an obvious combination. It would normally be expected that such combinations of medicinal plants
would be more effective than each of the medicinal plants when applied separately (additive effect).
Illustration 2: Patent application claims relate to a composition comprising of theanine (Tea) and a herb
selected from Sankhapuspi, Satavari or a mixture thereof for the treatment of a disease (cold and/or
influenza) related to reduced immunity.
Prior art (TKDL): Discloses independent use of said plants for the treatment of cold and influenza and as
immuno-potentiator in Ayurveda and Unani systems of medicine.
Analysis: The claims of alleged invention relate to a composition. In view of the prior art, the use of
theanine comprised in tea and extracts thereof, for prevention and/or treatment of cold and/or influenza was
known from popular medicine since ages. The
immunoadjuvant/immunomodulatory potential of Asparagus racemosus (Satavari), aqueous
exctracts/Evolulus alsinoides (Sankhapuspi) was also disclosed in prior art documents.
Therefore, nothing inventive could be seen in the additional use of immunopotentiating herbs to treat these
diseases. A combination of these plants would be obvious as an immunopotentiator and for the treatment of
common cold and a variety of other diseases.
While deciding the patentability of the claimed subject matter, the relevant clauses of section 3, particularly
sections 3 (c), (e), (i), (j) and (p) of the Patents Act, for TK and/or biological material should be strictly
followed.
The applications related to TK and/or biological material shall also be critically examined
with respect to requirements of full and particular disclosure of the invention, its operation or
use and the method by which it is to be performed along with the best method of performing
the invention by way of working examples known to the applicant in the complete
specification as provided under Section 10 (4) (a) & (b) of the Patents Act,If the source and geographical
origin of the biological material used in the invention is not disclosed in the specification, an objection
shall be raised thereof in conformity with section 10 (4) (a) & (b) of the Patents Act.
NBA permission:
In Form-1 of the Patent Rules 2003, the applicant is required to furnish a declaration "the invention as
disclosed in the specification uses the biological material from India and the necessary permission from the
competent authority shall be submitted by me/us before the grant of patent to me/us". This provision of
declaration in paragraph 9 (in) of Form-1 came into force from 01-01-2005 and every application submitted
thereafter should mandatorily have either the affirmative or cancelled out declaration. Where the applicant
leaves the declaration unattended, the RECS section should insist upon a fresh Form-1 wherein it should be
clearly indicated. If such omission is noted during any stage of processing of the application, the
Examiner/Controller should raise an objection in this regard.
If the above declaration in Form-1 regarding the use of biological material from India is affirmative, the
Examiner/Controller should raise the objection in the FER about the requirement of permission from NBA in
the matter, if already not submitted. If the objection has not been raised in the FER, the same may be raised
at any stage thereafter. In any case, the patent should not be granted unless the NBA permission is submitted
by the applicant.
On the other hand, if the declaration in Form-1 regarding the use of biological material from India is
cancelled out by the applicant and the specification also states that the source and geographical origin of the
biological material is not from India, the specification should be amended by way of incorporation of a
separate heading/paragraph at the beginning of the description that the biological material used in the
invention is not from India and should clearly specify the country of source and geographical origin of the
same. Where the declaration in Form-1 is cancelled out but the disclosure in the specification is that the
source and/or the origin of the biological material is from India, then NBA permission is required._____
Therefore, no patent shall be granted without the necessary permission from the National Biodiversity
Authority in cases where the invention uses biological material from India or the source and/or the origin of
the biological material is from India as per the disclosure in the specification.
The directions given in circular No. 1 of 2012 by CGPDTM should be strictly followed, which is reproduced
herein below:
It has been observed that during the examination of applications pertaining to the Biological materials
diverse yardsticks are adopted by different Patent Officer/Controller as regards the exemption from
obtaining permission from NBA in r/o the claimed biological resource in the present application. In view of
this, the following directions are issued for strict compliance of the concerned Controllers and Examiners:
Exemption to medicinal plants from the provisions of the Biological Diversity Act, 2002 given by the
notification issued by the Ministry of Environment and forests Notification dated 26th October 2009 is
available only if they are traded as commodities and the said provisions are very much applicable if the
biological resources are used as ingredients for medicine. As such, any interpretation by the
Controllers/Examiners of the Office of CGPDTM to see this as an exemption from the Biological Diversity
Act would be wrong.
Controllers/Examiners are directed to ensure strict compliance with the aforesaid order and approval of
NBA should be sought for any biological resources derived from India and used in an invention for which
patent application is filed.
Publication of list of TK related patent applications:
The System Administrator shall publish the list of all pending patent applications
related to TK, which are published under section 11 (A) of the Patents Act, in a separate link on the
official website of CGPDTM. This list should be updated automatically on the website as per screening
field in the module on real time basis. The list should display at least the following fields: application
number, date of filing, title of the invention and name of applicant (indexed in the order of date of
filing).
A list of patents granted on applications related to TK should also be published on the website for all such
patents granted from 1st July 2012. This list should also be updated automatically on the website as per
screening field in the module on real time basis. The list should display at least the following fields:
application number, patent number, date of filing, date of grant, title of the invention and name of patentee
(indexed in the order of date of grant).
References
http://www.indianpatents.org.in
IPR L 26. BIOPYRACY & BIOPROSPECTING
Biopiracy is the term used to refer to the use of bio-resources by multinational companies and other
organisations without proper authorisation from the countries and people concerned without compensatory
payment. Most of the industrialised nations are rich financially but poor in biodiversity and traditional
knowledge. In contrast the developing and the underdeveloped world is rich in biodiversity and traditional
knowledge related to bio-resources. Traditional knowledge related to bioresources can be exploited to develop
modern applications and can also be used to save time, effort and expenditure during their commercialisation.
There has been growing realisation of the injustice, inadequate compensation and benefit sharing between
developed and developing countries. Therefore, some nations are developing laws to prevent such
unauthorised exploitation of their bio-resources and traditional knowledge.
With the 1992 United Nations Convention on Biological Diversity humanity's ongoing search for biological
resources became subject to global regulation. The collection of biological materials for use in agriculture and
medicine by one nation from another became conditional on criteria of informed consent, benefit-sharing, and
the preservation of environments. This practice has become known as bioprospecting.
This concept of using biological materials for an industrial or synthetic use is the root of bioprospecting.
According to Eric J. Mathur, bioprospecting is the exploration of biodiversity for commercially valuable
genetic and biochemical resources. 7 In theory, bioprospecting provides a powerful engine to research
valuable drugs, crops, and compounds while learning from and gaining an appreciation for the world around
us. Between January 1981 and June 2006 an estimated 47% of cancer drugs and 34% of small molecules were
developed from natural products directly or derived from them.
Despite its many positive aspects, current bioprospecting practices often degrade into biopiracy, or the
unauthorized extraction of biological resources and/or the patenting on processes based on traditional
knowledge from indigenous communities. 28 Biopiracy manifests as companies searching for natural
resources fail to recognize the claims of indigenous people, to provide compensation for extracted natural
resources, or to preserve the bioprospecting site. One such example of this biopiracy is the case of cyclosporin,
which is a drug that is used to treat infections in organ-transplant patients and garners an annual profit of $1
billion. The soil samples from which the drug was produced came from Norway, yet Norway has never
received any form of compensation for it. 7
The Indian Parliament has recently cleared the second amendment of the Indian Patents Bill that takes such
issues into consideration, including patent terms emergency provisions and research and development
initiative.
Current status
Bioprospecting is a valuable process that can positively benefit the global community. In fact, medicines from
bioprospecting generate $43 billion in the world market and are used to treat hundreds, if not thousands of
maladies and diseases.12 Despite these benefits, the system of bioprospecting and interactions between
research firms and host countries have many flaws that need to addressed. To resolve some of the problems,
we need an international multilateral agreement or contract that carries the authoritative power of TRIPs, but
the ideologies and regulations of the CBD (see the International Solutions page for a more extensive
description of these two agreements). A stronger and more regulated international system would then ensure
benefit-sharing between the developing countries and pharmaceutical companies and help to preserve our
worlds valuable biodiversity.
Examples of important drugs produced from plants:
S.No.
Drug
Plant source
Action/Clinical use(s)
Atropine
Atropo belladonna
Anticholinergic
2
3
Codeine
Cynann
Papaver somniferum
Cynora scolymus
Analgesic, antitussive
Choterectic
1
5
Digitoxin 'Digoxin
tphednne
Digitalis purpurea
Ephedra vulgaris
Cardiotonic
Sympathomimetic
6
7
Hyoscyamine
Methyl salicylate
Hyoscyarnus ntger
Gaulthena procumbens
Anticholinergic
Rubelacient
8
9
Morphine
Nicotine
Papaver somniferum
Nicotrana tabacuum
Analgesic
Insecticide
10
Physostigmme
Physosbgma venenosum
Cholinesterase inhibitor
11
Podophyllotoxin
Podophyllum peUatum
Anti neoplastic
12
Quimdtne
Cinchona ledgenana
Antiarrhythmic
13
14
Theophylline
Tubocnranne
Theobroma cacao
Chondodendron tomeniosurn
Diuretic, vasodilator
Skeletal muscle relaxant
15
Vincristine
Catharanthus roseus
Anti-neoplastic
16
Yohimbine
Pausinystaha yohimbe
Alpha-: adrenoceptor blocker
Source of Table: Sandhu, H.S. Bioprospecting: Pros and Cons. Punjab Agricultural
University. Web. 5 May 2011. <http://www.hillagric.ernet.in/edu/covas/vpharma/winter
%20school/lectures/21%20Bioprospecting%20Pros%20and%20cons.pdf>.
USEFUL TERMINOLOGY
Bioprospecting- the exploration of biodiversity for commercially valuable genetic and biochemical
?? 1
resources. 7
Biopiracy- the unauthorized extraction of biological resources and/or the patenting on processes based on
traditional knowledge from indigenous communities. 28
Traditional Knowledge- the knowledge of indigenous people about the culture, nature, climate, and beliefs of
a given region.
Benefits sharing- agreements between researchers, their institutions or companies, and a source country that
return benefits to the source country when the results of cooperative research lead to the development of
something that is commercially valuable. 1
Concessions Contract- another name for a benefits sharing agreement
Source country- The country from which natural resources are extracted; also known as a host country.
References
http://textbook. s-anand.net/ncert/
http://www.princeton.edu/~aolivero/Bioprospecting/Home_Sweet_Home
http://wrap.warwick.ac.uk/1122/

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IPR

Introduction Page No. 1 / 87

10BT- 81 PROJECT MANAGEMENT & IPR

Soldevanahalli, Chikkabanavara, Hesaraghatta

SKB, Dept. of BT AIT

Introduction Page No. 2 / 87

Bangalore. 560 090

SKB, Dept. of BT AIT

Introduction & Concept of property

GP L 1. INTRODUCTION & CONCEPT OF PROPERTY

The Government has brought out A Handbook of Copyright Law to create

National Police Academy, Hyderabad and National Academy of Customs, Excise

The Department of Education, Ministry of Human Resource Development,

The Government also initiates a number of seminars/workshops on

Intellectual property shall include the right relating to:____________________________________

Rights protected under Intellectual Property

IPR as Instruments of Development

Intellectual property policies do affect the extent and nature of investments

Duration of Intellectual Property Rights in a nutshell

GP L 2. HISTORY OF IPR IN INDIA

The Geographical Indications of Goods (Registration and Protection) Act, 1999

5. The Designs Act, 2000 and The Designs Rules, 2001.

The Semiconductors Integrated Circuits Layout-Design Act, 2000 and The

(m) a presentation of information.

Hierarchy of Officers in Patent office

Jurisdiction of Patent offices in India

Intellectual Property rights, Deborah E Bouchoux, India Edtion, Cengage

sanctions ensuring the repression of false or deceptive indications of source, the

Scope & ambit:

Rome Convention (1961)

rebroadcasting means the simultaneous broadcasting by one broadcasting

Note: Also refer Full text of rome Convention

GPL 7. THE PATENT COOPERATION TREATY

The process of acquiring a patent through the PCT:

ii. National Phase.

Introduction Page No. 34 / 87

GPL 8. TRIPS AGREEMENT (1994), WIPO PERFORMANCE AND PHONOGRAMS TREATY

Introduction Page No. 35 / 87

Protection of undisclosed information

The core tasks of WIPO are:

Introduction Page No. 36 / 87

Introduction Page No. 37 / 87

Handbook on intellectual property rights in India by Rajkumar S. Adukia,

Introduction Page No. 38 / 87

Introduction Page No. 39 / 87

Introduction Page No. 40 / 87

Post Grant opposition:

Introduction Page No. 41 / 87

2. Large scale production of products in short supply [eg. Human insulin]

IPR L 12 .R & D INVESTMENTS, RATIONALE AND APPLICATIONS

Introduction Page No. 42 / 87

Introduction Page No. 43 / 87

Introduction Page No. 44 / 87

Introduction Page No. 45 / 87

Introduction Page No. 46 / 87

IPR L 14. MICROORGANISMS AND BT INVENTION

Introduction Page No. 47 / 87

Introduction Page No. 48 / 87

10 freeze-dried ampoules and 2 active cultures (on

5 x 2ml quantity with a minimum titre of 1 x 109 pfu

5 x 20 micrograms of isolated and purified DNA

Introduction Page No. 49 / 87

iii) Depositor checks and renewal of stocks