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PROJECT

INTELLECTUAL PROPERTY LAW -1

PATENTS ON MICRO - ORGANISMS

SUBMITTED TO:

DR. VIJAY KUMAR SINGH

SUBMITTED BY:

SANJANA SINGH

2019 LL.M 57

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ACKNOWLEDGEMENT

I would like to thank Prof. Dr. Vijay Kumar Singh, under whose guidance I have completed
this project work. I would like to thank him for his continuous support which directed me
towards the right path for completion of this project. I’d also like to thank all the authors,
writers and columnists whose ideas and works have been made use of in the completion of
this project. My sincere gratitude also goes out to the staff and administration of National
Law institute University for the infrastructure in the form of our library and IT lab that was a
source of great help in the completion of this project.

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TABLE OF CONTENTS

Acknowledgement....................................................................................................................2

Chapter 1 – Introduction........................................................................................................4

1.1 Introduction.........................................................................................................................4
1.2 Objective.............................................................................................................................6
1.3 Research Questions.............................................................................................................6
1.4 Hypothesis..........................................................................................................................6
1.5 Research Design.................................................................................................................6
1.6 Literature Review...............................................................................................................6

Chapter 2 – Invention or Discovery......................................................................................8

2.1 Invention.............................................................................................................................8
2.2 Invention as opposed to Discovery.....................................................................................9

Chapter 3 – International Instruments...............................................................................12

3.1 Budapest Treaty................................................................................................................12


3.2 India and TRIPs Mandate..................................................................................................15
3.3 Relationship between TRIPs and CBD.............................................................................17

Chapter 4 – Patenting Micro Organisms: Position in India.............................................19

4.1 Patent Amendment Act....................................................................................................19


4.2 Dimminaco A.G. v. Controller of Patents and Design.....................................................20
4.3 International Depository Authority in India – MTCC......................................................22

Chapter 5 – Conclusion and Suggestion.............................................................................23

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CHAPTER – 1

INTRODUCTION

1.1 Introduction

The classical view that patent law does not, to a great extent concern itself with living
material no longer accords with reality. The first patent in life forms was issued in Finland in
1843, and in the U.S. in 1873 a patent was granted for isolated yeast.1 Under U.S. law the
Plant Patent Act, limited to the protection of asexually propagated varieties, was passed in
1930 followed by the Plant Variety Protection Act, also encompassing sexually propagated
plants.2

Due to the belief that living organisms and cells were non-patentable products of nature,
patent protection for biological material was for many years restricted.3 Under the rationale
that naturally occurring organisms were not new, the assumption was that patents could not
be granted. In such a case the grant of a patent would remove from the public domain
something ‘which nature has produced and which nature has intended to be equally for the
use of all men.’ Thus, although micro-organisms related inventions were patentable, the
micro-organisms per se held non-patentable.4

Although the laws of genetics emanate from complicated physical and chemical processes,
methods of characterising the activities of the living organism and of the manipulation of
those activities have greatly improved. Therefore inventions that are the result of technology
involving biological material, i.e. any material containing genetic information which is
capable of self reproducing or of being reproduced in a biological system, could well comply
with the requirements under patent law and are now to a great extent patentable. The
improvement in the biotechnological field relevant for patentability was the possibility to
control natural forces, but because of the invention’s complexity, the existing concepts and
their boundaries under patent law need some clarification.

1
Louis Pasteur, United States Patent No. 141,072 (claiming pure yeast culture).
2
Fowler, C., “Botanical Games and their Agents in a Historical Perspective – The Rationalisation of Plant Life
Through Technology, Law and Politics.
3
In re Mancy, 499 F.2d 1289, 1291 (CCPA 1974).
4
Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, (1948).

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The patent system was developed in the late nineteenth century, in response to the problem of
protecting mechanical inventions. It was not possible to foresee the development that has
taken place in the biotechnological field, because activity in those inventions at the time was
to a considerable extent subject to casual relationships. The prevailing international patent
regulations were developed under the idea of lifeless technical inventions and therefore not
actually related to living organisms or higher animals or plants.

One factor present in some biotechnological products, but never in mechanical inventions is
their ability to reproduce, and the patent system is not modelled from the perspective of living
products. In recent years, natural sciences have developed enormously in the area of
biotechnology. Biotechnology is any technique that uses living organisms (or parts of micro
organisms) to make or modify products, to improve plants or animals or to develop micro-
organisms for specific uses. Even though this scientific field is not new, but as old as baking
bread or making wine via the activity of yeast, it challenges the assessment under patent law
in different respects.

In the mid 1970s the resultant change within the biotechnological field could be seen in the
patenting of biological inventions, neither U.S. patent law nor the patent laws of the
European countries formerly included any special provisions concerning inventions in the
field of living matter. Despite the belief that such inventions as a rule could not form
patentable subject matter, inventions in the field of living matter, including plants and
animals per se, were eventually declared patentable.5

In 1975, a French company failed – though purely on a technicality – to patent a “dwarf, egg-
laying chicken hen produced by a (breeding) process” that exploited a “sex linked recessive
dwarfism gene”.6 In a landmark decision in 1980, the U.S. Supreme Court held inventions
patentable in principle even if comprised of living matter.7 However, plant related inventions
were at first presumed non patentable if covered by the plant protection laws, but this view
has now changed and clearly patents are patentable. Then patentability in principle was
further upheld by a decision concerning a genetically altered form of pacific oyster. 8 After
these rulings, ‘non-human’ multicellular organisms, whether plant or animal, that were not

5
Beier, F.K., Crespi R.S. and Straus,J., “Biotechnology and Patent Protection: An International Review”, 1985,
Paris: OECD; p.51.
6
In re Merat, 519 F.2d 1390 (CCPA 1975)
7
Diamond v. Chakrabarty 447 U.S. 303, 100 S.Ct. 2204 (1980) at 197, In re Bergy 596 F.2d 952 (CCAP 1979)
8
Ex parte Allen 2 USPQ 2d 1425 (PTO Bd. Pat. App. & Inter. 1987), 846 F.2d 77 (Fed. Cir. 1988).

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naturally occurring, were formally announced patentable by the U.S. Patent and Trademark
Office (PTO).9

1.2 Objective

T0 study the patentability of micro – organism and the conditions under which they are
patentable with the help 0f case studies.

1.3 Research Questions

The f0ll0wing research questi0ns have been taken up by the researcher while dealing with
the t0pic. With the help 0f the study the researcher has tried t0 find the answer t0 the
f0ll0wing questi0ns:

1. What are the circumstances under which micro – organisms are patentable?
2. D0es the law aff0rd sufficient pr0tecti0n t0 the patentee in reference to laws of
different countries?
1.4 Hypothesis

It is provided that the micro-organisms are patentable in every country when they fall under
the category of inventions and not naturally occurring. Some of the countries provide this
protection under the garb of invention and some have done the same under the subject matter
protection.

1.5 Research Design

The research design which is f0ll0wed in the research pr0ject is case study meth0d where the
researcher has with the help 0f vari0us case laws analysed the patentability of micro –
organisms within different countries.

1.6 Literature Review


1. Westerlund Li, Biotech Patents, Kluwer Law International, 1st edition of 2002

This book discusses the concept of patentability of biotech patents and applicability of law on
new complex biological phenomenon. The author has developed a patent law theory with
respect to biotechnological inventions by examining the contradictions between biological

9
By the Commissioner of the PTO in Quigg, D.T., Patent and Trademark Office, New Release, April 7, 1987.

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and technological realities with legal approaches and concepts. The book focuses on scope of
patents and the subsequent requirement for granting a patent and determining infringement
when applied to biotechnology.

2 Grubb Philip, Patents for Chemicals, Pharmaceuticals, and Biotechnology, Oxford


University Press, 5th edition of 2010

This book explains the practical aspect of patents related to biotechnology and
pharmaceutical matters. It discusses the concept of patents in the new technology and
establishes a very good distinction between invention and discovery. It has in detail explained
the concept of micro- organisms when being patented and when refused to be done so. This
book in detail discusses the concept of patentability of the biotechnology and subsequent
problems with access to these technologies by public.

3 Suja Senen and Haridas. M.G., Patenting of Microorganisms in India: A point to ponder,
Current Science, Vol. 100, No.2 ( 25 January 2011), pp. 159 – 162

This article elaborately explains the distinct practices of different countries with respect to
India. It elucidates that the India does not allow patenting of microorganisms which exist in
nature but genetically modified versions enhancing the efficacies are patentable. This article
throws light on the genesis of patenting and the legalities of patenting microorganisms in
India with respect to other countries.

4 Patenting Microorganisms, The British Medical Journal, Vol.4, no. 5733, 1970, pp. 503 -
503, JSTOR.

This article works as an introduction towards the medical aspect of the patents on micro-
organisms. It talks about the thin line of distinction between invention and discovery. It
elucidates the use of micro –organisms for generic drugs and the issues arising out of non
accessibility to these drugs by general public.

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CHAPTER – 2

INVENTION OR DISCOVERY

The problem issue with regard to eligibility is to identify the boundary line between
patentable and non –patentable subject matter, and not whether or not in a specific case it is
patentable or not, several factors must be focused upon. In approaching this complex problem
the central factor should be the potential effect of the continuous development of science and
technology. Other factors, such as difference between various legal system and consideration
based upon the interest of individual countries, add to the difficulty of outlining a definition
of the concept. This, combined with the influence of traditional patent practice, complicates
the definition in exact terms of the invention concept that in addition to its applicability to
patent systems around the world complies with the laws of logic. Yet, for explanatory
purposes not least, the understanding of patents to biotechnological products such as gene
sequences and living matter requires an analysis of the eligibility issue. This kind of a
theoretical definition should also prove useful as a basis for particularly analysing the
exclusions from patentability occurring under European patent laws.

2.1 Invention

Only a few countries have in their respective patent laws set forth a positive definition of the
subject matter considered to be an invention under the legal concept. U.S. patent law is an
exception in this respect, stating that: ‘Whoever invents or discovers any new and useful
process, machine, manufacture or composition of matter, or any new and useful improvement
therefore may obtain a patent therefore’.10 In addition to serving as a definition, this provision
specifies the categories of patentable invention.

The TRIPs provides no definition of an ‘invention’, with the consequences that in principle it
does not prevent the exclusion of naturally occurring substances, such as genes and cells,
from patent protection. What it does, though, is to extend patent protection equally to all
technologies, including biotechnological inventions. The same situation as with the TRIPs
holds good for the EC Directive on the legal protection of biotechnological inventions.11 The
EC Directive does not set forth a positive definition of the concept, while on the other hand it

10
Section 101 of the U.S. Patent Act entitled “Inventions Patentable”.
11
The Directive 98/44/EC.

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holds explicitly biotechnological inventions patentable.12With eligibility as viewed under the
EPC, it is clear that invention such as gene sequences are patentable subject matter.

India has also defined as to what shall be considered as ‘Invention’. Section 2(1) (j) of the
Indian Patent Act, 1970 defines invention as: "invention" means a new product or process
involving an inventive step and capable of industrial application. But as opposed to TRIPs
and EPC, the patent act does not list the subject matter that is patentable. However, it does list
the subject matter that is not patentable. Section 3(j) of the Indian Patent Act, 1970 reads
“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.” Section 2(1)(ja) of the Indian Patents Act, 1970 defines inventive step
as: "inventive step" means a feature of an invention that involves technical advance as
compared to the existing knowledge or having economic significance or both and that makes
the invention not obvious to a person skilled in the art. Thus, India has settled the position in
regard to micro organisms by providing the provision for its grant of patent. But the disputed
factor is which microbe would be considered as an invention and which will be a mere
discovery.

2.2 Invention as Opposed to Discovery

Surrounding the object of patentability, doctrines have been developed that exclude certain
subject matter from the patent system as regards discoveries under European Laws and
products of nature under U.S. patent law. As the legal concept of invention has developed in
the countries, however, patent law covers subject matter that could also be found in nature.
This obscure distinction between inventions and discoveries of something already existing is
essential for patent law and the possibility of protecting developments made.

For biological phenomenon which to a certain extent ‘exist in nature’, the invention concept
had to be somewhat expanded in order to cover these types of ‘inventions’. This concept
which has continuously evolved through judicial decision to include biological organisms and
parts of biological material like gene sequences, cell lines etc., which in a manner of speaking
are just waiting to be discovered will be described. Much of the debate has focused upon the
notion that it is not possible to speak of an ‘invention’ where products of nature or living
forms are concerned.

12
Article 1 of the Directive 98/44/EC.

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In Europe the eligibility question in the biotechnological field has been firmly settled by the
EC Directive, which confirms EPC case law on this point of law. U.S. case law has
established that modified living forms are patentable as composition of matter. ‘Products of
nature’ are generally considered inventions when some human intervention has been
necessary to make them available. The patenting of higher life forms, however, is still being
contested, for ethical reasons, in Europe and, even though in principle they are eligible for
protection, the matter has yet to be completely settled.

Even though under U.S. law discoveries are not explicitly held non-eligible for protection, in
the beginning it was believed that living organisms and their parts were non-patentable
products of nature. Thus, understood, living things were not considered patentable subject
matter. As the concept of inventions has evolved through judicial decisions and doctrinal
understandings, the natural product doctrine has acquired exceptions that significantly
broaden the possibility of patent protection.

Under U.S. patent law, important exceptions have developed to the natural product doctrine
for materials that are naturally made, but that are not naturally present in a form that is
‘useful’. In Funk Bros. Seed Co. v. Kalo Inoculant Co.,13 the Supreme Court was faced with
the question of whether a mixture of naturally occurring bacteria-fixing nitrogen was
patentable subject matter. The court answered the question by first stating the basic principle
that patents cannot be issued for the discovery of the phenomena of nature, since they are
manifestations of laws of nature, free to all men and reserved exclusively to none. The court
went on to emphasise that if there is to be an invention from such a discovery, it must come
from the application of law of nature to a new and useful end. Although the mixture was
found useful, patent protection was denied because only naturally occurring processes lead to
the value of the mixture. The bacteria were all naturally occurring and because nothing ‘new’,
within the meaning of no alteration or modification of something already existing, the
invention was not patentable subject matter under 35 U.S.C. 101.

The finding of non-eligibility can be explained by the fact that no new properties were
created in any of the bacteria, which is why the court regarded the mixture of naturally
occurring bacteria as a product of nature rather than an invention. In this case, what the
inventors had done was to simply recognise the natural properties of the bacteria and take

13
333 U.S. 127 (1948)

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advantage of them. Therefore, the mixture was not an invention within the legal meaning of
term.

Subsequently, under U.S. law at the time, the invention concept did not encompass naturally
occurring living subject matter in which no new property was created. The fact that human
beings had to put the four different bacteria together in a mixture which as such could not be
found in nature in order to obtain its usefulness and to solve the technical problem of fixing
nitrogen did not change the interpretation.

As the technology matured biological subject matters were created that even though
composed of biological material they had no previous natural existence. The landmark
decision for such inventions came in Diamond v. Chakrabarty,14 handed down by the U.S.
Supreme Court. This decision ushered in an interpretation which extended patent protection
to cover new organisms. The economic incentive behind the system is evident from the
reasoning. The court recognised that the capacity to exclude was not the capacity to make,
use or sell and that those potentially valuable innovations would not otherwise come into
existence.

The eligibility issue concerned a genetically engineered bacterium capable of degrading


crude oil. Putting into a single organism cDNA’s that coded for four different enzymes, each
of which could degrade different types of oil, made the invention. The court held that the
inventors, by putting all those enzymes in one single organism, had created a “non naturally
occurring manufacture or composition of matter – a product of human ingenuity having a
distinct name, character and use”. The court reasoned that congress plainly contemplated that
the patent laws would be given wide scope and had intended patentable subject matter to
include anything under the sun that is made by man. The relevant distinction for eligibility
was set not between living and inanimate things, but between products of nature, whether
living or not, and human made inventions. Ex parte Allen15 found multi – cellular organisms
patentable subject matter.

14
447 U.S. 303, 100 S.Ct. 2204 (1980) at 303.
15
Ex parte Allen, 2 USPQ2d 1425 (PTO Bd. of App. & Inter. 1987)

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CHAPTER – 3

INTERNATIONAL INSTRUMENTS

3.1 Budapest Treaty on the International Recognition of the Deposit of Micro-organisms


for the purposes of Patent Procedure, 1977

The main feature of the Treaty is that a contracting State which allows or requires the deposit
of microorganisms for the purposes of patent procedure must recognize, for such purposes,
the deposit of a microorganism with any "international depositary authority", irrespective of
whether such authority is on or outside the territory of the said State.

Disclosure of the invention is a requirement for the grant of patents. Normally, an invention
is disclosed by means of a written description. Where an invention involves a microorganism
or the use of a microorganism, disclosure is not possible in writing but can only be affected
by the deposit, with a specialized institution, of a sample of the microorganism.16 In practice,
the term "microorganism" is interpreted in a broad sense, covering biological material the
deposit of which is necessary for the purposes of disclosure, in particular regarding
inventions relating to the food and pharmaceutical fields.

It is in order to eliminate the need to deposit in each country in which protection is sought,
that the Treaty provides that the deposit of a microorganism with any "international
depositary authority" suffices for the purposes of patent procedure before the national patent
offices of all of the contracting States and before any regional patent office (if such a regional
office declares that it recognizes the effects of the Treaty). 17 The European Patent
Office (EPO), the Eurasian Patent Organization (EAPO) and the African Regional
Intellectual Property Organization (ARIPO) have made such declarations.

What the Treaty calls an "international depositary authority" is a scientific institution -


typically a "culture collection" - which is capable of storing microorganisms. 18 Such an
institution acquires the status of "international depositary authority" through the furnishing by

16
Scott Hall, The Genie in the Bottle: The International Regulation of Genetically Modified Organisms, 1 J. Int'l
Wildlife L. & Pol'y 353 (1998).
17
Aniruddha Sen, Clear and Complete Disclosure in Biotechnology Patent Applications – A Comparison of the
Laws in the USA, Europe and India, 2 Hanse L. Rev. 91 (2006).
18
Meghna Banerjee; Yajnaseni Roy, Patentability of Incremental Innovation vis-a-vis Section 3(D) of the Indian
Patents Act: Striking a Balance, 2 NUJS L. Rev. 607 (2009).

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the contracting State in the territory of which it is located of assurances to the Director
General of WIPO to the effect that the said institution complies and will continue to comply
with certain requirements of the Treaty.

On October 1, 2018 there were 47 such authorities: seven in the United Kingdom, four in the
Republic of Korea, three in China, Italy and the United States of America, two each in
Australia, India, Japan, Poland, the Russian Federation and in Spain, and one each in
Belgium, Bulgaria, Canada, Chile, the Czech Republic, Finland, France, Germany, Hungary,
Latvia, Mexico, Morocco, the Netherlands, Slovakia and Switzerland.

The Treaty makes the patent system of the contracting State more attractive because it is
primarily advantageous to the depositor if he is an applicant for patents in several contracting
States; the deposit of a microorganism under the procedures provided for in the Treaty will
save him money and increase his security. 19 It will save him money because, instead of
depositing the microorganism in each and every contracting State in which he files a patent
application referring to that microorganism, he will deposit it only once, with one depositary
authority. The Treaty increases the security of the depositor because it establishes a uniform
system of deposit, recognition and furnishing of samples of microorganisms.

The Treaty does not provide for the institution of a budget but it does create a Union and an
Assembly whose members are the States which are party to the Treaty. The main task of the
Assembly is the amendment of the Regulations issued under the Treaty.20 No State can be
requested to pay contributions to the International Bureau of WIPO on account of its
membership in the Budapest Union or to establish an "international depositary authority".

The Budapest Treaty was concluded in 1977.

The Treaty 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.

3.1.1 International Depository Authority

An institution acquires the status of "international depositary authority" if the contracting


State in which the institute is located, furnishes to the Director General of WIPO of

19
Robyn Ott, Patentability of Plants, Animals and Microorganisms in India, 2 Okla. J.L. & Tech. 1 (2004-2005).
20
Matthew McGovern, Biotechnology and the Patenting of Living Organisms, 3 Animal L.221 (1997).

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assurances to the effect that the institution complies and will continue to comply with certain
requirements of the Treaty.

In India, the following two institutes have acquired the status of an international depositary
authority:

• International Depositary Authority, Microbial Culture Collection (MCC), National


Centre for Cell Science (NCCS), University of Pune Campus, Ganeshkhind, Pune-
411007, Maharashtra.
• International Depositary Authority, Microbial Type Culture Collection and Gene
Bank (MTCC), Institute of Microbial Technology (IMTECH), Council of Scientific
and Industrial Research (CSIR), Sector 39-A, Chandigarh.

3.1.2 Depositable Subject Matter

IDA's have accepted deposits for biological materials which do not fall within a literal
interpretation of "microorganism". The Treaty does not define what is meant by
"microorganism."21 The range of materials able to be deposited under the Budapest Treaty
includes:

• cells, for example, bacteria, fungi, eukaryotic cell lines, plant spores;
• genetic vectors (such as plasmids or bacterio phage vectors or viruses) containing a
gene or DNA fragments;
• organisms used for expression of a gene (making the protein from the DNA).

There are many types of expression systems:

• bacterial; yeast; viral; plant or animal cell cultures;


• yeast, algae, protozoa, eukaryotic cells, cell lines, hybridomas, viruses, plant tissue
cells, spores, and hosts containing materials such as vectors, cell organelles, plasmids,
DNA, RNA, genes and chromosomes; purified nucleic acids; or
• deposits of materials not readily classifiable as microorganisms, such as "naked"
DNA, RNA, or plasmids.

21
Philippe Cullet, Property Rights over Biological Resources: India's Proposed Legislative Framework, 4 J.
World Intell. Prop. 211 (2001).

14
3.2 India and the TRIPS Mandate

The TRIPS ensures that patent protection is available for fields of technology including
agriculture, energy and healthcare. Members of TRIPS can exclude certain inventions from
patentability if the exploitation of the invention would be affecting the morality of general
public. The TRIPS agreement also stipulates further that no member country can exclude an
invention from patentability simply because domestic law prohibits it. The TRIPS Agreement
also stated that WTO (World Trade Organization) Council for TRIPS would monitor
compliance with TRIPS provisions and oversee disputes between member countries. 22 The
WTO Council has resolved patent enforcement problems that existed before trade sanctions
were imposed. However, it tends to pass resolutions in favor of developed countries.

The TRIPs, under article 27, mandates for patenting of micro-organisms. India being a
member of the World Trade Organisation is required to provide product patents on micro-
organisms before January 1, 2004. The Indian Patent Act, in its true spirit seems to have
excluded all living beings from patentability. Section 3 of the act categorically states that an
invention which is contrary to well established principles of natural laws or the intended use
of which would be contrary to law or morality or injurious to public health are not inventions
for the purpose of granting patents.

In the TRIPs Agreement also an attempt is made to strike a balance between the conflicting
values on patenting of living beings. This is evident from the incorporation of the morality,
order public provisions in article 27(2) of the Agreement. TRIPs in article 27(2) provides that
the member countries can exclude from patentability such inventions, the prevention of the
commercial exploitation of which is contrary to protect public order, morality, human life,
animal life, plant life, health and environment.23 The operation of this clause is limited by a
proviso which says that exclusion cannot be made merely because the exploitation is
prohibited by law. But article 27(3), though allows the exclusion of plants and animals from
patentability, brings micro-organisms within its purview. 24

This in fact goes against the jurisprudential basis of article 27(2) resulting in an erosion of the
balance aimed to strike by incorporating certain basic norms for excluding even living beings

22
Swarup Kumar, Patentability of Biological Material(s) - Essentially, Therapeutic Antibodies - in India, 5
SCRIPTed 582 (2008).
23
Burke K. Zimmerman, The Case against Patents for Living Organisms, 7 APLA Q. J. 278 (1979).
24
John M. Kiernan, Diamond v. Chakrabarty: Scientist Patents Micro-organism – Life Forms Considered
Patentable Subject Matter under 35 U.S.C. 101, 7 Ohio N.U. L. Rev. 1038 (1980).

15
from patent- ability based on morality principles of sovereign states. But from the review
provision in article 27(3) it appears that the framers of the TRIPs were aware of these
conflicts. Article 27(3) provides for a review of the patentability criteria, to be made, four
years after the date of entry into the WTO Agreement, i e, January 1, 1999. As far as India is
concerned the attempt should be to bring specifically inventions on life within the coverage
of the general exclusion under article 27(2). 25

The provisions in section 3 of the Patents Act are to be analysed in the light of article 27(2) of
TRIPs. Since these provisions encompass the notion of morality in the Indian territorial
context, the TRIPs objection for making certain inventions illegal by statutory measures does
not have any bearing upon it. In fact article 27(2) of TRIPs justifies the mandate in section 3
of the Patents Act. Any attempt to interpret the above-mentioned provisions is to be made in
the light of a jurisprudential enquiry as to the notion of morality in the Indian context.

TRIPs in article 27(2) expressly recognises the need to protect human, animal and plant lives,
as well as health and environment. This reflects the concern regarding the long- term social
risks associated with the commercial exploitation of biotechnological inventions. Since trade
motives foster the commercialisation of biotechnology, the environment risk arguments have
a larger economic dimension. But granting private property rights stands central to all these
different arguments.26 Therefore the morality issue has a direct bearing on the environment-
based arguments against the deployment of biotechnological inventions. This again prompts a
joint reading of article 27(2) of TRIPs and section 3 of the Indian Patents Act. The reasoning
here is identical to the one which we have raised in the morality context. Section 3 of Patents
Act has to be read in consonance with article 27(2) of TRIPs thereby reasserting the strength
of 'the morality, public order, environmental protection' arguments against life patenting. Any
attempt to override or nullify these provisions violate the basic norms, which they stem from.
Therefore article 27(3) is to be restructured so as to receive universal acceptability. This
becomes easy because article 27(3) gives room for renegotiating the patentability norms in
TRIPs. 27

25
Julian Kinderlerer, Genetically Modified Organisms: A European Scientist's View, 8 N.Y.U. Envtl. L.J. 556
(2000).
26
Alexis Gorton, Edible Equivalents: An Increase in Patent Protection for Genetically Modified Organisms, 9
Wash. U. J.L. & Pol'y 321 (2002).
27
Donald G. Daus; Robert T. Bond; Shep K. Rose, Microbiological Plant Patents, 10 Pat. Trademark & Copy. J.
Res. & Ed. 87 (1966).

16
In the field of microorganisms, TRIPS does not advocate the heightened standard of Budapest
Treaty system for patent protection of microorganism; however through bilateral treaties,
countries have still entered into this administrative standard. Under bilateral agreements,
member countries must implement their own substantive provisions.28 These obligations go
beyond TRIPS standards because the Budapest Treaty obliges parties to recognize the
physical deposit of microorganisms’ samples with an international depository authority
instead of full written disclosure of invention.

3.3 Relationship between TRIPs and CBD

While WTO Members States incorporate TRIPS within their national laws, access to genetic
resources from which genetically engineered product are developed is becoming one of the
most critical areas of debate between industrialized and developing countries.

Many developing countries regard the relationship between TRIPS and CBD as one of the
opposing principles. On one side stands the principle of economic growth purported by the
TRIPS Agreement. On the other side is the principle of sustainable development served by
CBD. Industrialized countries justify globalizing and harmonizing IPRs because such rights
will strengthen the innovation and it was also argued that economic growth will result from
improving dynamic efficiency through strong IPRs. Some countries argue that there is
inherent conflict between the both, and therefore, TRIPS should be amended to remove such
conflict. Many less developed countries have held this position.29 Proponents of this view
argue that patentability of generic material under TRIPS leads to appropriation of natural
sources and materials by private parties and that it is inconsistent with the sovereign rights of
countries supported by CBD. They also argue that TRIPS does not require prior informed
consent and benefit-sharing, as provided for in CBD and their suggestion is the amendments
to exclude patentability of life forms or inventions based on traditional or indigenous
knowledge from TRIPS.30 On the contrary, developed countries including U.S. argue that
these two does not conflict with each other. Proponents of this view argue that the objectives
and purposes of TRIPS and CBD are different and granting patent rights over genetic

28
Michael Saunders, Creating Life from Scratch: The Patentability of Synthetic Organisms, 11 Tul. J. Tech. &
Intell. Prop. 75 (2008).
29
Jonathan Curci, “The new challenges to the international patentability of biotechnology”, 2 Int’l L. & Mgmt.
Rev. 1, p. 13
30
Daniel Gervais, “The TRIPS Agreement, drafting history and analysis”, 117 (2003), pp. 230-231

17
material does not conflict with provisions of CBD regarding the sovereign rights of countries
over their genetic material.31

Theses two treaties operate in manner that has generated much conflict and uncertainty.
Indeed, portions of TRIPS clash with the concept and principles provided by the CBD.
Granting IPRs to modified, unauthorized appropriations of plant and animal genetic resources
frustrates provider countries trying to implement the concept and principles provided by CBD
of control over their genetic resources. The CBD is far more favorable to conservation of
biodiversity and preservation of rights for developing countries while TRIPS is far more
aggressive about facilitating biological patentability and promoting private ownership and
exploitation of such resources. Nevertheless, the two aims are not necessarily mutually
exclusive. Most of the conflict between these two is spurred by moral and rhetorical
assumptions. One assumption claims that the patent regime is a western form of IPR, which
is totally unsuitable to the majorities of the societies in the south that have accepted TRIPS by
acceding to the WTO. Another assumption asserts that private rights are completely alien to
indigenous communities because the vast majority of their farmers, who manage biodiversity
at the local level, are accustomed to collective rights.

Legally speaking, inconsistencies between IPRs applied to life forms under TRIPS and the
obligations of CBD are multifaceted. The inconsistencies particularly reveal themselves in
following fields: the access to and fair and equitable sharing of benefits from the utilization
of genetic resources, the respect of traditional knowledge held by the indigenous
communities, and the transfer of technology.

31
http://www.botanischergarten.ch/Patents/Staffler-CBD-TRIPS.doc (last visited at 9:00 pm on 03/12/2019)

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CHAPTER – 4

PATENTING MICRO-ORGANISMS: POSITION IN INDIA

Patent Act of India, 1970, Section 2(1)(j)32 defines an invention as a new and useful manner
of manufacture or a substance produced by manufacture. No definitions of manner of
manufacture or substances were given in the Act. Hence the Patent Office adopted the
practice of interpreting a manner of manufacture as a patentable subject matter only if it
results in a tangible nonliving substance. The Section 3(j) of the Act stated that plants and
animals in whole, or in part thereof including seeds, varieties and essentially biological
process for the production of plants and animals, are excluded. India joined the Budapest
Treaty on 17 December 2001, and Microbial Type Culture Collection (MTCC) and Gene
Bank of the Institute of Microbial Technology, Chandigarh (IMTECH) acquired the status of
an IDA on 4 October 2002 marking the amendment of existing systems in India. The position
was made more clear after the 2002 amendment of the Indian Patents Act, 1970 whereby
microorganisms can be patented provided they satisfy the other requirements.33

4.1 Patent Amendments Act

The Patent Amendment Act 2002 came into force in May 2003, bringing microorganisms
within the realm of patentability. Section 3( j) was couched in terms of Article 27(3) (b). It
states that: plants and animals in whole or any part thereof other than microorganisms but
including seeds, varieties and species and essentially biological processes for production or
propagation of plants and animals are not inventions within the meaning of this Act. It
excluded microorganisms from the exceptions to patent protection and allowed patenting of
processes pertaining to microorganisms as well as non-biological and microbiological
processes. Subsequently, The Patents Act, 1970 was once again amended in the year 2005, so
as to establish congruence with TRIPS. The amendment deleted Section 5 of the Act, which
provided for only process patents. The provision included inventions where only methods or
processes of manufacture were patentable. Therefore, the deletion of this section paves way
for product patents, which is in stark opposition to US approach that argues patenting of life

32
Patent Act of India . ( 1970 ) Section 2(1) (j), http:// www.iprsonline.org (last visited on 01/12/2019)
33
The Patents Act . ( 1970 ) [39 of 1970, dt. 19-9-1970] [As amended by Patents (Amdt.) Act, 2005 (15 of
2005), dt. 4-4-2005], http://www.spicyip.com/ docs/statute-combined%20patents% 20act% 202005.pdf (last
visited on 02/12/2019)

19
34
forms has tremendous advantages. Despite concerns against the patenting of
microorganisms, this position may augur well for the biotechnology industry as it is growing
at an inexorable pace.

4.2 Dimminaco A.G. v. Controller of Patents and Designs

Patentability of biotechnological process with living end product was ascertained by Calcutta
High Court decision in the case of Dimminaco A G v. Controller of Patents (2002).35

4.2.1 Facts:

Dimminaco A.G., a Swiss Company applied for patenting the process for preparation of a
live vaccine for Bursitis. Bursitis is an infectious poultry disease and the invention involved a
live (attenuated) vaccine to combat the disease. The Controller of Patents refused to allow
application on the ground that as the vaccine involved processing of certain micro-organic
substances, this was only a natural process devoid of any manufacturing activities and hence
not patentable under S.2(1)(j). This was in consonance with the prevailing practice that
granted patents only to non-living and tangible inventions that fulfilled the patentability
criteria, even though the Patent Act imposed no such limitation. However, on appeal, the
Calcutta High Court diverted from the above position. It rejected the contention of the
controller that a patent is given only for a process that results either in an article, substance or
manufacture and that a vaccine with a living organism is not an article, substance or
manufacture.36

The Controller had claimed that the dictionary meaning of article is a ‘material thing, item, a
thing of a particular class or kind as distinguished from a thing of any class of kind’. The
Controller said the definition does not cover living things. Law does not bar processes where
the end-product is living –No statutory bar in the Act to accept a manner of manufacture as
patentable even if the end product contains a living organism. Through creative judicial
exposition, the Calcutta High Court held that: ‘The Indian statute on patents does not put any
fetters on patentability of microorganisms developed in a controlled environment in the
laboratories’. Taking recourse to the normal dictionary meaning of manufacture, the court

34
Janice , M . M .( 2000 ) An Introduction to Patent Law. New York: Aspen Publishers .
35
Michigan State University v. The Assistant Controller of Patents and the Controller General of Patents,
Trademarks, Designs and Geographical Indications, Patent Offi ce http://indiankanoon.org/ doc/918903/ (last
visited on 01/12/2019)
36
Prashant , R . D .( 2010 ) Patenting of microorganisms . indlaw.com, 15 May, http://students.indlaw.com/
display.aspx?4631 (last visited on 02/12/2019).

20
observed that manufacture is where ‘the material in question after going through the process
of manufacture has undergone any change by the inventive process and it becomes a material
which is different from the starting material’. 37

4.2.2 Decision

The court held that this meaning of manufacture does not exclude the process of preparing a
product that contains a living substance from patentability. Court also held that the process
for creating a vaccine leads to a vendible product even if the end product contains living
material. 38 The court said that if the invention results in the production of some vendible
items or improves or restores formal conditions of vendible item or its effect in preservations
and prevention from deterioration of some vendible product, then such an invention would
pass the vendibility test. Therefore, as the claim process for patent leads to a vendible
product, it is certainly a substance after going through the process of manufacture. The court
concluded that a new and useful art or process is an invention and where the end product is a
new article, the process leading to its manufacture is an invention. This decision on the
Calcutta High Court was synchronous with the position in the United States, most of the
European countries as well as Japan, as most processes in the biotechnology field will be
patentable: irrespective of whether resultant product is living or non-living. After the
Dimminaco decision, the Indian law kept pace with the needs of thriving biotechnology
industry.

DABUR Research Foundation, part of Dabur Pharma Ltd, has been granted a patent for a
strain of yeast, after the Government permitted patenting of microorganisms in India under
the Patents (Second Amendment) Bill 2002. This is the first ever patent granted for a
microorganism in India since the law came into effect. The Company has obtained both a
product patent for strain as well as a process patent that protects the manufacturing
procedure, thus giving exclusivity.

37
Manpreet , K .( 2010 ) Patentability of microorganisms . IPR-Indlaw.com, 15 May, http://ipr
.indlaw.com/search/articles/?c09721d8-3644-4ceb-b9d7- 303558cb0182 , (last visited on 02/12/2019).
38
The Patent Offi ce . ( 2008 ) Draft Manual of Patent Practice and Procedure, 3rd edn. India: The Patent Offi ce
, http://www.patentoffi ce.nic.in/ipr/patent/ DraftPatent_Manual_2008.pdf (last visited on 03/12/2019).

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4.3 International Depository Authority in India – MTCC

For the purpose of patenting of microorganisms, it is a requirement under the Budapest


Treaty to build an internationally recognized depository of microorganisms strict following
the regulations of the treaty. India has already joined the Budapest Treaty and sufficient funds
have been sanctioned to refurbish a culture collection depository, it is an expensive process.

The Microbial Type Culture Collection (MTCC) and Gene Bank- a national facility, jointly
established by the Department of Biotechnology (DBT), Government of India, and Council of
Scientific and Industrial Research (CSIR), is located in the Institute of Microbial Technology,
Chandigarh, for upgradation to India’s first DNA. This could be used by Indian scientists and
foreign scientists, especially from neighbouring countries to deposit their patentable cultures
at less expensive rates. 39 On October 4, 2002, MTCC was recognized by the World
Intellectual Property Organization (WIPO), Geneva, as an International Depository Authority
(IDA), and now microorganism can be deposited here under the Budapest Treaty.

The MTCC like other IDAs follows the guidelines prescribed by Budapest Treaty on the
international recognition of the deposit of microorganisms for the purposes of Patent
procedure. It has excellent facilities for long term preservation of microorganisms and it also
reserves the right to refuse in accepting a deposit if in its view it may be a hazard or the
MTCC may not be in a position to process it. Deposit from other countries will be accepted
only if it cleared by the Authority of India. The depositor from outside India should
communicate with the MTCC regarding deposits before dispatching cultures.40

39
P Sands, “Microbial diversity and the 1992 Convention on Biological Diversity”, B Kirsop and D L
Kawksworth, (eds.), (WFCC, UNEP), 1994, pp. 9-27
40
http://74.125.153.132/search?q=cache:yeOly3jSWn4J:mtcc.imtech.res.in/downloads/brochure.pdf+microorgan
isms+patent+india&cd=3&hl=en&ct=clnk&gl=in (last visited on 04/12/2019).

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CHAPTER -5

CONCLUSION AND SUGGESTIONS

Patenting of life forms may have many dimensions that relate to the use of intellectual
property rights concept in the industrialized world and its appropriateness in the aspect of
rights on knowledge, their ownership, use, transfer and dissemination. In the global scenario,
the TRIPS agreement makes it mandatory to provide patent protection to microorganisms and
non biological and microbiological production of plants and animals. This makes it difficult
for the developing countries to exclude inventions within this category altogether. Hence, the
strategy should be how to limit the scope of these provisions. As far as the patent protection
of microorganism is concerned, TRIPS does not provide a definition of microorganism. The
national rule-makers must define microorganism in such a way as to include the following:
bacteria, virus, and fungus and algae.

Another important limitation in the scope of patent protection to biological materials is the
lack of defining the concept of invention and discovery. Microorganisms as such occur in
nature and their discovery cannot be called invention. Microorganism when genetically
modified falls in the category of invention because of human input. Genetically modified
microorganism may perform any number of activities, hence patenting of this genetically
modified microorganism will result in blocking of further research on that microorganism.

The numerous concerns raised against patentability of microorganisms can be addressed by


defining the term microorganism in a precise and scientific manner; substantiating the
differences between discovery and invention; by granting patents to only those inventions,
which involve substantial human intervention (for example, genetic engineering).

From Diamond v. Chakrabarty to TRIPS and beyond, manifests huge interest of biotech
industry for constant innovation and endeavour, paving way for increased inventions that aim
at human welfare. The criterion of utility is deeply embedded behind the rationale of
patenting microorganisms, whether it is the usefulness of those microorganisms in treating oil
spills, preventing an infectious disease or the creation of new drugs to combat life-threatening
diseases. Without an efficacious patent protection, the vast reservoir of such information may
remain a trade secret, without being brought into public domain. This proves the need for a

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sheltered and substantial patent system for the protection of the research concerning
microorganisms.

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