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Even in the strictest sense, biotechnology is not a new field and throughout
human history, biotechnology assets have been generated through human
ingenuity. Biotechnology has been used in the form of fermentative
processes to manufacture beer, bread, wine and cheese for generations. The
Egyptians used yeasts in bread and wine-making around 4000 B.C. Till today,
we use micro-organisms to produce many products in the food and
pharmaceutical industries. Turning biotechnology inventions into protected
intellectual property, with concomitant intellectual property rights, has also
been happening for over a century. Louis Pasteur was granted a French
patent in 1865 for yeast clones that he had isolated from mixtures of yeast
species. He had a U.S. Patent, which was issued in 1873, entitled,
“Improvement in Brewing Beer and Ale”. This covered a new method of
making beer and ale (with the process we now call pasteurization) and also
involved the production of cultures of particular yeast species.
Since then protection of products isolated from living materials and methods
to produce them became quite commonplace, Biotechnological inventions
may have a very significant effect on our future, in particular in the fields of
medicine, food, energy and protection of the environment.
In this Unit we will be discussing the issues related with intellectual property
protection in case of biotechnology area. You will be learning various tools of
intellectual property protection used in the field. Since this is an emerging
field, different countries are attempting to create mechanisms for tackling
the biotechnology related issues of intellectual property. We will briefly
discuss about these efforts citing some typical examples.
Objectives
Although not all questions have been answered yet at the international level,
a number of legal issues with respect to patent protection for
biotechnological inventions have been addressed by the TRIPS Agreement
and the EC Directive on the Legal Protection of Biotechnological Inventions.
EXISTING PROTECTION
For some, it seemed a new era was ushered in with the advent of gene
sequencing and the intellectual property assets derived from techniques
associated with the manipulation of DNA. Perhaps the public only began to
be concerned about biotechnology inventions when patents were granted to
claims involving DNA sequences. Protection of this new type of
biotechnology asset can be traced to the invention involving DNA isolated
from frogs and bacteria using genetic engineering methods invented by
Herbert Boyer and Stanley Cohen
People have long considered plant seed and animal breeding stocks to be
property. Commercial seed companies, with which we are familiar, are
commercial enterprises based on the production and selling of human-
selected plant germplasm. There are many ways of protecting this type of
asset but the methods by which plant materials can be bred or reproduced
or genetically changed can also represent intellectual property assets.
In some nations, you can protect these types of assets with a patent, but
that might not be the only mode. The U.S. Board of Appeals ruled in 1985
that new plant varieties were inventions that could be granted intellectual
property rights with the grant of a patent. The records of breeding trials,
records of experiments involving the effects of different fertilizers also
represent assets that involve creative ideas and the hand of man. Therefore,
they too can be considered intellectual property assets and can have IPRs
associated with them.
Biotechnology inventions in the field of medicine, notably therapeutic methods, such as a new
type of laser surgery to correct visual acuity or diagnostic methods used in the treatment of
diseases or methods of surgery are inventions that can be protected by patents in some nations,
whilst in other countries patent protection can be controversial. Article 52(4) of the European
Patent Convention provides that methods for treatment of the human or animal body by surgery
or therapy or diagnostic methods practiced on the human or animal body shall not be regarded as
patentable subject matter.
However the case law with regard to the way, in which this regulation is
interpreted, is quite complex and can be confusing. A fine distinction has
been put forward, in which the European Patent Office Technical Board of
Appeal has made a list of what is necessary for an invention to be called a
diagnostic method. This includes:
All of these steps must be included or this is not a diagnostic method, but
instead might be called, for example, a data acquisition or data processing
method. This data acquisition or data processing might itself be in the realm
of patentable subject matter.
If we consider other, less obvious assets, produced as a result of more recent biotechnology
investigations, (many involving practicing inventions), we see that a vast amount of information
is being produced: records from drug efficacy clinical trials, information from nucleic acid
sequencing studies or dose-response studies. This information is fuelling the production of large
databases. These databases can be collections of information, or a database in which people have
organized and annotated information. This information can be protected, quite apart from the
underlying invention. These annotated databases are especially central to stimulate the useful
application of this information for industrial purposes and to allow pharmaceutical companies
and seed companies to pass stiff regulatory hurdles. Such databases can represent a very valuable
intellectual property asset. Protection of such an asset, in a manner that also encourages
distribution of the information, requires both legal and technical skill.
The instruments most often associated with the protection of biotechnology associated
intellectual assets are:
If the asset is an invention then it would be very routine to file for patent
protection for this asset in almost any country (or most countries or a
selection of countries) in the world. Then after making sure that your
application meets the legal requirements in the country(-ies) where you have
filed, and after an examination of the claims, you will be granted a patent.
This enables you to prevent others (for the term of the grant) from making,
using or selling your invention in the country where the patent is issued,
unless they obtain a license from you.
But, because you must disclose the best mode of practicing your invention,
at the time the patent application is filed, people can then read about, look
at, and handle your invention. That is, your invention can be inspected,
perhaps even literally touched. For example, if your invention had been a
plasmid or a seed, it may be possible for others to germinate and grow the
invention, without a license, as long as the invention is not used or made in
the way it is protected in the patent claims. You may not wish this to happen
as it could give ideas to potential competitors.
Hence, alternatively you could choose to keep the invention a trade secret,
by not telling anyone (unless they had signed a confidentiality or non-
disclosure agreement). You could also license this type of trade secret, under
the conditions of a confidentiality agreement. With the trade secret route
there is no public disclosure, unless you choose to do so or someone violates
a contract.
Protection of databases presents a good example of legal differences in regulations. Under U.S.
law and in many other places, with the exception of the European Union (EU), databases are
generally protected by copyright, as compilations; a compilation being the collection and
assembling of data or other materials into a fixed mode.
Now there has been variation in the past with regard to a test as to the
amount of creativity that has gone into the construction of the database that
has to be satisfied before formal protection can be obtained. Creativity is
related to the way in which the data has been selected and arranged. The
only protection you may be able to provide your database that fails this
creativity test is to keep the information confidential as a trade secret.
Interestingly, this type of patent contains only one claim, in which the patent
owner claims the plant, based on a new characteristic that the plant exhibits.
This claim is substantiated by a drawing, a photograph or information that
clearly illustrates the new characteristic. The plant is not grown in trials, nor
is there a requirement for enablement associated with this type of patent.
Another type of protection that can be formally sought for plants is a plant
breeder’s right (PBR). Historically, the Netherlands granted a very limited
exclusive right for breeders of agriculturally important species to market the
first generation of certified seed, and also an exclusive right to market
propagating material of other species, in the Breeders’ Ordinance of 1941.
Also in Germany, after many years of limited protection for breeders based
upon seed certification, the Law on the Protection of Varieties and the Seeds
of Cultivated Plants of 1953 gave breeders the exclusive right to produce
seed of their varieties for the purposes of the seed trade and to offer for sale
and market such seed. Some patents were granted in some German states
but the likelihood of securing patent protection for plant varieties was not
generally considered to be sufficient to constitute an effective incentive for
plant breeders.
The filing of a design patent can be an option to consider for the protection
of a biotechnology asset where the design, for a piece of equipment such as
a tractor, a DNA analyzer or a DNA chip, be it either ornamental or functional
is unique. The acceptable format for this type of application is usually quite
formalized and applicants are advised to follow Patent Office instructions to
the letter to avoid rejection problems.
In some countries, such as Australia, an inventor can apply for a patent
called an innovation patent. With this type of application there is no formal
examination of the claims, unless it is requested by the applicant or
contested after the patent has issued. In addition, the term of the patent is
much shorter, 8 years as compared to the usual 20-year coverage period for
utility applications. In Thailand and some other countries it is possible to get
protection for an invention using the petty patent system. Under this
system, the inventive step or the uniqueness associated with an invention is
not examined. The time period that such a patent is in force is also reduced.
Trademark law
The Trade Marks Act, 1999 replaces the Trade and Merchandise Marks Act,
1958. The Act is a consolidated effort to bring the law at par with
international practices. These changes were envisaged by India well before it
signed the General Agreement on Trade and Tariff (GATT) and the Trade
Related Intellectual Property Rights (TRIPS).
For the first time the new Act will protect service marks, and the scope of
other terms has been expanded in tune with international practices. A brief
analysis of the expanded terms is mentioned herein. The service sector,
including information technology, BPO services, hotels, hospitals, airlines and
advertisement agencies, can now protect their marks as service marks.
The provisions of the 1999 Act are not to be seen as totally new as similar
results are achieved under existing law — the Trade and Merchandise Marks
Act, 1958, and the practice followed by Indian courts in various decided
cases. The determination of a well-known trademark should be based on the
knowledge or recognition of that trademark in the relevant section of the
public, including knowledge in India obtained as a result of promotion of the
trademark.
The question of whether a trademark is known to or recognised by the
relevant section of the public is to be determined after taking into
consideration the following facts:
the business circle dealing with the goods or services, to which that mark
applies.
the duration, extent and geographical area of any use of that trademark;
The above list is not exhaustive and any other relevant fact in determining
whether the trademark in question has become well-known is to be taken
into account.
It will also be seen that it is not a single factor but the totality of the
circumstances that establish and determine whether or not a particular
trademark is well-known.
Failure to protect it, or to do so early enough, may put your business at risk.
Identify and value your IP assets and ensure they are itemised in your
business plan.
Copyright Law
1. Literary work
2. Musical work
3. Dramatic work
4. Artistic work
5. Cinematographer work
7. Computer Software
1. Exclusive license
2. 2. Non-exclusive License
3. 3. License from a Joint Owner
4. License without consideration; and
5. Implied License.
Only restriction placed in that creation of the license is that the agreement
of license has to be in writing and has to be executed by the Licensee
(owner of the work). In addition to allowing the author of the work to take
action to permit his or moral rights in the work. There are three types of
remedies for infringement of the work by any authorized persons in India: -
1. Owner Assignee
2. . Exclusive Licensee or legatees of the work may initiate a lawsuit
claiming infringement of the copyright.
3. The Plaintiff in such suit may name Defendant, the person to copyright
infringement act, the person to permit a place to be used to infringe the
copyright and persons who sells or offers to soil any product which
infringes copyright. The lawsuit can be filed in any District or High Court
but to be filed within years from the date of infringement. Monetary
damages can be recovered. Delivery has been all infringing copyright
work and injunctive reliefs are appropriate. Form of remedy for
infringement provided by the Copyright Act is imprisonment of criminal
fines and sanction including a term of imprisonment for any person that
infringes a protected work.
COPYRIGHTS IN INDIA
Under Indian law, registration or any other formality is not required either for acquiring
copyright or for enforcing it in an infringement action. In other words, registration is not a
prerequisite or a condition precedent for securing copyright protection in India. It only has
evidentiary value in showing that the person mentioned in the Register is the actual
author/owner. India is a signatory to the Universal Copyright Convention and the Berne
Convention
LEGISLATION
India's copyright law, laid down in the Indian Copyright Act, 1957, fully reflects the Berne
Convention on Copyrights, to which Indian is a party. Additionally, India is party to the Geneva
Convention for the Protection of Rights of Producers of Phonograms and to the Universal
Copyright Convention. India is also an active member of the World Intellectual Property
Organization (WIPO), Geneva and UNESCO.
The copyright law has been amended periodically to keep pace with changing requirements. The
latest amendment to the copyright law which came into force in May 1995, has ushered in
comprehensive changes and brought the copyright law in line with new developments in satellite
broadcasting, computer software and digital technology. The amended law has made provisions
for the first time, to protect performers' rights as envisaged in the Rome Convention.
Several measures have been adopted to strengthen and streamline the enforcement of copyrights.
These include the setting up of a Copyright Enforcement Advisory Council, training programs
for enforcement officers and setting up special police cells to deal with cases relating to
infringement of copyrights.
Since we last reported, developments have taken place in the field of copyright law. The
Copyright (Amendment) Act, 1994 came into force with effect from May 10, 1995 and some of
the salient features thereof are listed below:
(i) A comprehensive definition for "computer programme" (absent in the previous Act) reading
as follows has been introduced :
"computer programme" means a set of instructions expressed in words, codes, schemes or in any
other form, including a machine readable medium capable of causing a computer to perform a
particular task or achieve a particular result"
As under the earlier Act, computer programmes continue to be treated as "literary works". The
definition of "literary works" under the new Act includes "computer programmes, tables and
compilations including computer data bases".
(ii) In relation to any literary, dramatic, musical or artistic work which is computer-generated,
the person who causes the work to be created is the "author".
(iii) A new offence has been added in the Act for knowing use of infringing copy of computer
programme prescribing imprisonment for a term which shall not be less than 7 days but which
may extend to 3 years and with fine ranging from Rs 50,000 (US $ 1,500 approx.) to Rs 200,000
(US $ 6,000 approx.) However, where the computer programme has not been used for gain or in
the course of trade or business the court may not impose any sentence of imprisonment and may
instead only impose a fine up to US $ 1,500.
"communication to the public" means making any work available for being seen or heard or
otherwise enjoyed by the public directly or by any means of display or diffusion other than by
issuing copies of such work regardless of whether any member of the public actually sees, hears
or otherwise enjoys the work so made available."
In an explanation to this definition, it has been clarified that communication through satellite or
cable or any other means of simultaneous communication to more than one household or place of
residence including residential rooms of any hotel or hostel shall be deemed to be
communication to the public.
(v) Every "broadcasting organisation" has been conferred with a special right known as
"broadcast reproduction right" which shall subsist until 25 years from the beginning of the
calendar year next following the year in which the broadcast is made. The Act stipulates that
certain acts, which when done without the licence of the owner of such right, shall be deemed to
have infringed such right.
(vi) The Act specifies certain acts which do not constitute infringement of copyright the
important one being "the making of copies or adaptation of a computer programme by the lawful
possessor of a copy of such computer programme, from such copy (i) in order to utilise the
computer programme for the purpose for which it was supplied; or (ii) to make back-up copies
purely as a temporary protection against loss, destruction or damage in order only to utilise the
computer programme for the purpose for which it was supplied".
An amendment to the Copyright Act, 1957, the Copyright (Amendment) Act, 1999 has recently
come into force. In compliance with Article 14 of TRIPS it extends copyright protection to
performers from the present twenty-five years to at least fifty years computed from the end of the
calendar year in which the performance took place. It further empowers the Government to
extend the provisions of the Copyright Act to broadcasts and performances made in other
countries provided those countries extend similar protection to broadcasts and performances
made in India.
In terms of the International Copyright Order, 1991 (promulgated by the Indian Government)
"foreign works" first published in a country which is a member of either of the
Conventions would be accorded the same copyright protection in India as Indian works
without undergoing any formalities. This is on the assumption that the home country
accords "national treatment" to Indian works, i.e., recognises the criterion of reciprocity.
This has led to a somewhat peculiar situation in the Indian Copyright Registry. If an
application for registration of copyright is filed by an applicant who is a member of either
of the Conventions, the Registry is inclined to return the application on the ground that
since copyright protection would be afforded to the applicant automatically, there is no
need for registration therefore. It appears that in the process the Registry is trying to
reduce its paper work. Thus, in case of infringement, the applicant can rely on the
copyright registration certificate issued by his home country and on the basis thereof
enforce his rights in India through the International Copyright Order, 1991.
• Paris Convention signed in 1883, came into effect on July 7, 1884. It was
subsequently revised in 1900 at Brussels, in 1911 at Washington, in 1925
at the Hague, in 1934 at London, in 1958 at Lisbon and in 1967 at
Stockholm.
• The convention touches on the issue of the use of marks in Article 5C (1),
(2) and (3).
The TRIPS agreement is built on the principles of Paris and Bern Conventions
INTRODUCTION
Objectives
HISTORY OF IP LEGISLATION
Patents
The first Indian statute on patents was passed in 1856 granting some
exclusive rights to inventors for 14 years. It had to be re-enacted with some
modification as the Act of 1859. It granted to inventors of ‘new manufacture’
exclusive rights to make, sell and use the invention in India, or to authorise
some one to do so. Its scope was expanded to include designs, under ‘the
new manufacture’ in the Patents and Designs Protection Act 1872. Then
came the Inventions and Designs Act of 1888, and later the Indian Patents
and Designs Act 1911, (which was modelled largely on the British Patents
and Designs Act 1907). After independence in 1947, the Government felt
the need for a more effective patent legislation. The existing situation with
regard to patents was reviewed by two expert committees: one, headed by
Justice Rajagopal Iyengar, and another headed by Bakshi Tek Chand. It was
revealed that the MNCs, who owned 90% of all patents in India, had misused
patents largely to ensure a protected market in India for their products,
denying availability of many essential goods to people at competitive prices.
The Patents Bill following the reports of these Committees was debated for a
decade when finally the Indian Patents Act 1970 was enacted. It was highly
acclaimed by, amongst others, UNCTAD, as a most progressive patent law
and inspired similar legislation in many developing countries. It clearly
codified inventions that could not be patented, permitted patenting of only
process, not products, of manufacture in the fields of food, drugs and
medicines and substances produced by chemical processes. The term of
patent was in the case of process relating to food, medicines and drug, 5
years from the sealing of the patent or 7 years from the date of patent
whichever was earlier; in case of other process patents, it was 14 years; it
had provision for ‘licences of right’ and compulsory licensing in some
circumstances; it provided for use of inventions for government purposes,
acquisition of invention by Central Government and revocation of patents in
public interest.
Following India’s membership of the WTO and her obligations under the
TRIPS Agreement, the Indian Patents Act 1970, was amended by Patents
(Amendment) Act 1999 and Patents (Amendment) Act 2002, which came into
force on May 2, 2003. The Provisions of the present Act are in line with the
TRIPS Agreement.
Trademarks
Designs
Copyright
You will study the details of the individual Acts dealing with specific IP
instruments – patents, copyright, trademarks, industrial designs etc. – in
relevant Units. Here we will refer to some general features, specially those
pertaining to the administration and enforcement of IPRs in India, that define
IP Laws in India.
The law relating to patents is laid down in the Indian Patents Act (1970) as
amended by Patents (Amendment) Act, 1999 and Patents (Amendment) Act,
2002. Some of the more significant changes introduced by these
amendments in the original Act of 1970 are as follows:
The Act defines various categories of works in which copyright subsists, and
has inter alia, provisions for determination of first ownership of copyright, the
scope of rights conferred; assignment and licensing of copyright; compulsory
licensing and the circumstances in which it could be granted; performing
rights of societies; broadcasting rights; authors special rights; international
copyrights. The Act sets out in detail what constitutes infringement and
what does not; civil and criminal remedies against infringement and
remedies against threat of legal proceedings without any ground.
The Indian copyright law is in conformity with the provisions of the TRIPS
Agreement of the WTO. It is also in line with the provisions of the Berne
Convention for the Protection of Literary and Artistic Works (Brussel Text,
1948), and the Universal Copyright Convention (1952); India is a member of
both conventions.
The Trade Marks Act, 1999 lays down the law governing trade marks in India.
Several measures have been taken to simplify trade mark law and
procedure, offer better protection and make enforcement more effective,
e.g. a single application for registration in more than one class; increasing
the term of protection from 7 years to 10 years; enhancing punishment to
bring it at par with the copyright law; making trade mark offences
cognisable.
The Act inter alia defines ‘original’ and enlarges the scope of definitions of
‘article’ and ‘design’; it spells out what designs shall not be registered, brings
in the internationally followed system of classification in place of the Indian
system, provides for restoration of lapsed designs and maintaining the
register of designs on computer; the two year period of secrecy of a
registered design is revoked and any document for transfer of right in a
registered design is required to be compulsorily registered. More grounds
have been added for cancellation of registration and cancellation
proceedings are to be initiated before the Controller of Designs instead of a
High Court. Infringement attracts heavier penalties; the initial period of
registration is enhanced from 5 years to 10 years, extendable by a further
period of 5 years. It provides for control of anti-competitive practices in
contractual licences. Appeal against an order of the control lies to the High
Court.
Appeal Mechanism
All the IP Laws provide for (i) a fully empowered administrative machinery to
grant and register claims for IPRs in a fair and transparent manner, (ii) a
mechanism for appeal against administrative decisions if necessary, and (iii)
a procedure for legal enforcement of IPRs.
The Appellate Board sits in the following cities: Ahmedabad, Chennai, Delhi,
Mumbai, Kolkata. The Board fixes its own procedure, place and time of
sittings.
Pursuing a case before a trade mark Appellate Board or the Copyright Board
(which can also have sittings all over India) can be frustrating and difficult
experience.
The procedure for appeal in the case of copyright is different. The appeal
against a decision of the Registrar of Copyrights lies with the Copyright
Board. The Copyright Board, constituted by the Central Government,
consists of a Chairman who is or has been or has the qualifications to be a
judge of High Court, and two to fourteen members. The Registrar of
Copyrights is the secretary of the Board. A further appeal against the
decision of the Copyright Board lies with the High Court of appropriate
jurisdiction.
Under the Designs Act, 2000, the appeal against a decision of the Controller
of Designs lies with the High Court. The Semiconductor Integrated Circuits
Lay-out Designs Act, 2000, provides for a Layout Design Appellate Board,
and an appeal against its decision lies with the High Court. The appellate
authority under the Protection of Plant Varieties and Farmers’ Rights Act
2001, is the Plant Varieties Protection Appellate Tribunal. The Biological
Diversity Act 2002 provides for a appeal against the orders of the national
biodiversity authority or a state biodiversity board, to the High Court. The
Information Technology Act provides for appeal to a cyber Appellate Tribunal
against one order of the Controller of Certifying Authority or an adjucating
officer.
Thus, the situation in respect of appeal related to various kinds of IPRs may
do with some streamlining.
The diversity of appellate authorities and procedures for different IPRs seems
unnecessary. There could be a case to have only one Intellectual Property
Appellate Tribunal to hear appeals cases of all category of IPRs. The Tribunal
and its benches may also shed the roving character and have fixed places
for hearings to make it easy, convenient and less costly for litigants to
pursue their cases.
Unit 2
A. Background:
A patent is a form of industrial property which may be broadly described as a monopoly right
conferred by the state to an inventor to industrially and commercially exploit his invention at the
cost of making a complete disclosure of the details of his invention. A patent is thus a statutory
privilege granted by the Government to an inventor, and to other persons deriving their rights
from the inventor, for a fixed period of years, to exclude other persons from manufacturing,
using or selling a patented product, or from utilising a patented method or process. At the
expiration of the period of the patent, the patented invention is available to the general public or
as it is sometimes put, falls into the public domain.
In the case of Bishawanath Prasad Radhey Shyam v. Hindustan Metal Industries1, the apex court
outlined the objectives of patent law as under:
1
Bishwanath
‘[T]he object of patent law is to encourage scientific research, new technology and industrial
progress. Grant of exclusive privilege to own, use or sell the method or the product patented for
a limited period stimulates mew inventions of commercial utility. The price of the grant of
monopoly is the disclosure of the invention at the Patent Office, which after expiry of the fixed
period of monopoly, passes into the public domain.’
C. Requirements of Patentability:
A patent confers a statutory privilege on an inventor i.e. that there is no common law of patents.2
As seen above, India became a signatory to the TRIPS Agreement in 1995 and as such was
bound to embody the principles contained therein into its domestic intellectual property
legislation.
Keeping in mind its obligations under TRIPS, the Patents Act, 1970 came to substantially
amended in 2002 and again in 2005. In light of the TRIPS Agreement, the Patent Act, 1970
prescribes that an invention must satisfy the trinity requirements of novelty, innovativeness and
usefulness in order to receive a patent under the Act.
As stated above, India as a signatory to TRIPS, has adopted the trinity requirements as specified
therein in order to ascertain the patentability of an invention. Before considering these
requirements in detail and whether the invention satisfies these requirements, let us consider
some pertinent definitions under the Act.
patent: patent means a patent for any invention granted under this Act2
invention: invention means a new product or process involving an inventive step and capable of
industrial application3
2
Section 2(1) (m) of the Act.
3
inventive step: 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 art4
new invention: any invention or technology which has not been anticipated by publication in any
document or used in the country or elsewhere in the world before the date of filing of patent
application with complete specification, i.e. the subject matter has not fallen in public domain or
that it does not form part of the state of the art6
(1) novelty
(3) utility
1. Novelty:
The first ingredient for an invention is that it must be new product or a new process. Novelty
means what is new and original, never seen or done before. An invention is taken to be new if it
does not form a part of the state-of-the-art. In order to be patentable, the new subject must
involve invention over what is old. It is not essential that the invention should be anything
complex or complicated. It must merely be of such nature that it involves a technical advance as
4
.
5
6
compared to the existing knowledge. As observed by Cotton LJ in Blakey & Co. v. Lathem &
Co.7
‘To be new in the patent sense, the novelty must be shown in the invention. It is not enough that
the purpose is new or that there is novelty in the application, so that the article produced is in
that sense new. There must be novelty in the mode of application.’
In view of this principle, the Court of Appeal in England in Fomento v Mentomore8 denied patent
rights to a designer of an improved design of a ball-point pen, on the grounds that the inventor
himself had published a description of making ball point pens and had made two pens
embodying the invention available to the members of the public before filing the patent
application.
2. Inventive step:
As seen above, an ‘inventive step’ is one which makes the invention ‘non-obvious to a person
skilled in the art’. In other words, if the invention is obvious to the person skilled in the art, it
cannot be said to involve an inventive step. After the Amendment in 2005, the definition of
inventive step has been enlarged to include economic significance of the invention as well.
The test to ascertain whether an invention involves an inventive step is expressed in Halsbury
Laws of England as: ‘was it for practical purposes obvious to the skilled worker, in the field
concerned, in the state of knowledge existing at the date of the patent to be found in the
literature then available to him, that he should or would make the invention the subject of the
claim concerned.’ In other words, the question to be answered in determining inventive step is
‘Would a non-inventive mind have thought of the alleged invention?’ If the answer is ‘no’, then
the invention is non-obvious. If the patent claimed merely includes the development of some
existing trade, in the sense that it is a development as would suggest itself to an ordinary person
skilled in the art, it would fail the test of non-obviousness.
7
8
In order to ascertain whether an invention subscribes to the requirements of an ‘inventive step’, a
two pronged approach may be adopted. Firstly, ascertaining what was the state of the art before
the relevant date of the complete specification filed pursuant to an application for a patent, and
secondly having regard to the state of the art, ascertaining whether the alleged inventive step
would have been obvious to a person skilled in the art.9
For an invention to be judged as novel, the disclosed information should not be available in the
‘prior art’. This means that there should not be any prior disclosure of any information contained
in the application for patent (anywhere in the public domain, either written or in any other form,
or in any language) before the date on which the application is first filed i.e. the ‘priority date’.
Although the term ‘prior art’ has not been defined under the Indian Patents Act, it shall be
determined by the provisions of section 13 read with the provisions of sections 29 to 34 of the
Act.
The following has been indicated as ‘prior art’ vide the Act10:
(a) anticipation by publication before the date of the filing of the application in any of the
specification filed in pursuance of application for patent in India on or after the 1st day of
January 1912;
(b) anticipation by publication made before the date of filing of the application in any of the
documents in any country;
(c) claim in any claim of any other complete specification filed in India which is filed before
the application but published after said application;
(d) anticipation having regard to the knowledge, oral or otherwise, available within any local
or indigenous community in India or elsewhere.
9
Molnlycke A.B. v Procter and Gamble 1994 RPC 49; Hoechst Celanese Corp. v B.P Chemicals 1997 FSR 547,
562.
10
From the above it is clear that in order for an invention to be anticipated by virtue of a patent, the
patent must have been granted in India alone.11 Thus, a patent granted in any other country would
not constitute ‘prior art’ for the purposes of the Act.12 However, if the patent is anticipated by
publication, it is irrelevant whether the publication occurred in India or elsewhere.
An invention is not considered ‘new’ if the claimed invention is publicly known or publicly used
in India before the priority date.13 As observed by the Supreme Court in Monsanto:
‘Publicly known does not mean that it must be published in a document, although not found in a
book, it may form a part of the common knowledge among the public concerned. It also does not
mean that it should be widely used to the knowledge of the consumer. It is sufficient if it is known
to persons who are engaged in the pursuit of knowledge of the patented product or process,
either as men of science or men of commerce or as consumers.’14
The Supreme Court in Bishwanath Prasad’s case observed that prior public knowledge of the
alleged invention would disqualify the grant of a patent. Publications concerning the invention
whether through word of mouth or through books or media would, therefore nullify any
subsequent attempt to secure a patent.
A skilled person would be a person who ‘has experience of the field in question and he may be
one who have available assistants who would carry out tests’.15 In order to pass the test of
obviousness, the prior art referred above must be of such nature as to inform the skilled person as
to how the invention derived from the prior art is to be performed. In other words, the person
11
12
13
14
15
skilled in the art must have the necessary information (through the prior art) to take the inventive
step in question.16
b. Keep in mind a normally skilled, but unimaginative person having common general
knowledge of the concerned art as at the priority date will be the date from which the
objector to the patent would allege inventive step was obvious
c. Through the spectacles of the aforesaid skilled person identify differences, if any,
between the matter cited as being known or used and the alleged invention;
d. Finally, without considering the alleged invention, consider whether the differences
would see to the aforesaid skilled person such as leading obviously to the alleged
invention or that a degree of invention would be necessary to obtain the invention.
16
17
In Bishwanth Prasad’s case, the apex court reiterated the above test and suggested three
alternative conceptions of the same:
a. Whether the alleged invention lies so much out of the track of what was known before as
not natural to suggest itself to a person thinking on the subject, it must not be the obvious
or natural suggestion of what was previously known;
b. Had the document been placed in the hands of a competent draftsman, or engineer, (as
distinguished from a mere artisan), endowed with the common general knowledge at the
‘priority date’, who was faced with the problem solved by the patentee, but without
knowledge of the patented invention, would he have said, this gives me what I want?
c. Was it for practical purposes obvious to a skilled worker n the field concerned, in the
state of knowledge existing at the date of the patent, to find in literature then available to
him; that he would or should make the invention the subject of the claim concerned.
3. Utility:
It is pertinent to note that utility was not a requirement for patentability under the Patents and
Designs Act, 1911. In Bishwanath Prasad’s case, the Supreme Court recognised utility as one of
the grounds on which a patent can be revoked. The usefulness of an alleged invention depends
not on whether by following the directions in the complete specification all the results not
necessary for commercial success can be obtained, but on whether by such directions the effects
that the application/patentee professed to produce could be obtained. The usefulness of the
invention is to be judged, by the reference to the state of things at the date of filing of the patent
application, if the invention was then useful, the fact that subsequent improvement have replaced
the patented invention render it obsolete and commercially of no value, does not invalidate the
patent.
Thus, novelty, non-obviousness, industrial applicability and utility form the essential
requirements of patentability. These conditions have been universally accepted as the essential
prerequisites of patentability.
Despite protection afforded to computer software through copyright law, it is submitted that
copyright protection is not always ideal. Problems arise when, in a particular invention, software
and hardware co-exist. Would, in such circumstances, copyright protection extend to the
invention itself? That seems unlikely, as copyrights being restricted to literary and artistic works
cannot be held to extend to machines. Hence, some amount of protection is conferred
Section 3 of the Act contains a list of ‘what are not inventions’.4 If the ‘invention’ for which the
patent is sought falls within the provisions of Section 3, no patent would be granted, even if it
otherwise satisfies the requirements of patentability outlined above.
Section 3 (k) of the Act thus clearly lays down that computer programmes are not patentable.20
However, this was not always the case. The provisions concerning patentability of software have
18
19
20
been amended a number of times. The original unamended Act did not exclude explicitly patents
for computer related inventions, as computer technology at that point of time was relatively
unknown, but the definition of the term ‘invention’6 itself excluded patents for computer
programmes.
A major amendment was introduced in Section 3 with respect to the patentability of computer
programs through the Patents (Amendment) Ordinance on December 27, 2004. The Ordinance
split the sub-section 3k into two- sub-section 3(k) and 3(ka). The excluded subject matters as
originally contained in Sub-section 3(k) were provided in the new Sub-section 3(ka). They
included ‘a mathematical method or a business method or algorithms’. The amended Section
3(k) read as follows:
‘(k) a computer programme per se other than its technical application to industry or a
combination with hardware.’
The key expressions contained in the above amendment are ‘technical application to industry’
and ‘combination with hardware’. The legislative intent behind these words was clear. If an
invention is directed at computer software having technical application to industry or coupled to
hardware – then it is patentable.7 The law as it stands now however reverts to the original
position of excluding computer program per se from patentability.
From the above discussion it follows that if a patent is sought only for the software tools21 i.e. a
patent is sought only for a computer program per se, then a patent would not be available for the
invention, as it would be hit by the provisions of Section 3 (k) elucidated above. However, if the
patent is sought for a combination of software and hardware, then it would not be a computer
application per se, and hence might be patentable.22 As observed in Gales’ case:
‘Although those instructions are not patentable as such, that is not the end of the matter.
Computer instructions may represent, for instance, a technical process. What is recorded in the
instructions may be the means for carrying out a technical process with the aid of a computer. In
such a case the process is not barred from patentability by reason of the use of a computer as a
medium by which it is carried out.’8
21
22
Analogy may also be drawn to the Diamond v. Diehr9, where the US Supreme Court granted a
patent for a rubber curing process controlled by software as the patent was for the ‘rubber curing
process and not the computer software per se.’
From the above, it may be concluded that in ascertaining the patentability of an invention, the
invention must be looked at a whole. A claim directed to a technical process which process is
carried out under the control of a program (whether by means of hardware or software), cannot
be regarded as relating to a computer program per se. An invention consisting of a combination
of hardware and software may be considered patentable, if it satisfies the other requirements
prescribed by the Act.
Unit 3
INTRODUCTION
Objectives
After studying this unit, you should be able to:
• understand the action-options available to an owner of IPR aggrieved by
infringement;
• know some special evidential aspects in cases of infringement of patents
and trademarks; and
• know the remedies available under different options.
CIVIL PROCEEDINGS
Clearly the owner of the IPR is the aggrieved party if infringement of his IPR
takes place and he is to initiate the proceedings as the plaintiff. If the IP is a
patent or a trademark an exclusive licensee also can initiate proceedings.
The Defendant
You have read in the previous Unit what constitutes infringement in the case
of a specific category of IP. A person who commits an act of infringement
becomes the ‘defendant’, if the plaintiff brings infringement proceedings for
such an act of infringement. Additionally, anyone else who may join the
infringer in a common design to perpetrate the act of infringement will also
be jointly liable to be sued. The liability is, however, to be judged in relation
to the territorial jurisdiction. If a person, outside the jurisdiction of a
country’s courts, supplies a protected article to a party again outside the
jurisdiction, he is not guilty of infringement. But if he is working in a common
design with a person who resides within the jurisdiction and commits the
infringing act, the first person in this case jointly shows the liability with the
infringer.
The Court
National laws clearly specify, the court which will be competent and have
jurisdiction in relation to a case of infringement. The issue of jurisdiction
becomes complex in cases involving international aspects in a case of
infringement.
Besides IP laws, redressal can in certain cases be available under common law liability for
economic torts, particularly passing off and injurious falsehoods.
Civil Procedure
Damages are meant to compensate the owner of the IP for the loss in money
terms suffered by him due to infringement of the IPR.
Civil action can offer remedies also for acts which are themselves not
infringement but may be preparatory for completing the infringing act e.g.
supplying part for illegally making a patented invention, or consequential to
an illegal act e.g. importing or marketing infringing goods. In such
‘secondary’ acts the liability is dependent to a great degree on whether the
defendant knew that infringing goods were involved.
The civil procedure may come to the help of the owner of the IPR in securing
evidence of infringement through what is generally known as Anton Piller
Order and Mareva injunction. These have already been discussed in Unit 1,
Section 1.5. An Anton Piller Order from a competent Court authorises a
plaintiff, after a hearing in camera for pre-trial relief in the form of a search
order of the defendant’s premises, with some safeguards for liberties and
prevention of abuse, for discovery of incrementing material or documents.
The Mareva injunction directs the defendant to retain the infringing material.
The experience with the enforcement of patent rights shows wide variation
from country to country in terms of complexity of the proceedings, duration
of a case in courts and the cost of litigation.
The patent infringement cases are full of technical complexities and receive
divergent interpretations at different courts. The USA has established in
1982 the United States Court of Appeals for the Federal Circuit to deal with
the issue of complexity in an attempt to provide uniform interpretation of
patent claims.
CRIMINAL PROCEEDINGS
The penalties for infringement in a criminal case are tougher than in civil
proceedings. Criminal penalties involve a real prospect of imprisonment for
a substantial term. Thus recourse to criminal proceedings, in a case of
infringement of IP, can be more effective and have more of a ‘deterrent
value’ than a case under civil proceedings. However, the standards to prove
a liability in a criminal action are more stringent than in a civil suit.
The legal framework and guidelines provided under the TRIPS Agreement
aim at making enforcement of IP in criminal proceedings more effective.
Recourse to criminal proceedings in cases of violation of IPR is becoming
more popular. Several countries have made criminal proceedings more
effective and pursue infringement of IPRs with seriousness. In Malaysia,
Business Software Alliance assists the government in fighting software
piracy. Penalties include imprisonment up to 5 years, China, Hong Kong,
Singapore, India are all on hot pursuit of counterfeiters and pirates.
Establishments raided include largely those producing auto-parts, fake
medicines, music CDs/cassettes, books etc. and large stocks of counterfeit
and pirated goods have been seized. An interesting development in the
administration of law pertaining to the violation of IPRs is seen in Thailand.
As the IPR law is highly complex and requires specific knowledge for
competent interpretation, needing specially qualified judges, Thailand has
set up a Central Intellectual Property and International Trade Court with
exclusive jurisdiction in both Civil and Criminal matters relating to
enforcement of IPRs.
ADMINISTRATIVE PROCEDURE
Apart from court, administrative agencies can and do take effective steps in
case of violation of IPRs. Such action may include seizing infringing goods at
the borders by customs authorities; confiscation of offending goods by excise
authorities; action by appropriate authorities to test quality and standards
etc. Administrative actions to stop infringement have high visibility.
EVIDENTIAL ASPECTS
Patent – Infringement
Trademark Infringement
Patents
Trademarks
Industrial Designs
It may be noted that national laws may contain remedies against groundless
threats of infringement proceedings from the owner of the design by means
of advertisements, or publication of views, or circulars, or otherwise.
Semiconductor Layout-Design and Geographical Indicator
The more common technological methods deployed for IPR enforcement are
based on optical technology and electronic technology. They are briefly
discussed. Some measures based on biotechnology and chemical technology
have also made their appearance.
Holograms are the most widely used optical measures. A hologram is a two-
or three-dimensional device which reflects an image, sometimes associated
with some movement. Copying a hologram is very difficult and costly.
Several electronic devices are available e.g. the magnetic strip as the one on
a credit card which stores a large amount of coded data, readable with a
scanner; the smart card, incorporating a computer chip which can carry a
large amount of data upon access; encryption, where electronic signal is
scrambled, but is readable through an authorised key.
Unit 4
As of December 2008, 72 countries were party to the Budapest Treaty. [1] The
accession to the Treaty is open to States party to the Paris Convention for
the Protection of Industrial Property of 1883. The African Regional Industrial
Property Organization (ARIPO), the Eurasian Patent Organization (EAPO) and
the European Patent Organisation (EPO) have filed a declaration of
acceptance under Article 9(1)(a) [2] of the Treaty.
PATENTING OF MICRO-ORGANISMS
The main provision of the Treaty is that a Contracting State which allows or
requires the deposit of micro-organisms for the purposes of patent procedure
must recognize, for such purposes, the deposit of a micro-organism with any
international depositary authority (Article 3(1) (a)), irrespective of whether
such authority is on or outside the territory of the said State. In other words,
one deposit, with one international depositary authority, will suffice for the
purposes of patent procedure before the national patent offices of all of the
Contracting States and before any regional patent office (e.g., the European
Patent Office).
The security of the depositor is increased by the fact that, for an institution
to become an international depositary authority, solemn assurances as to
the seriousness and continued existence of that institution must be given.
Such assurances must be given by a State or by an intergovernmental
organization and they are addressed to all the member States of the
Budapest Union. Consequently, it may be expected that the assurances will
be strictly respected, all the more so since, if they are not so respected, the
member States may take away from the defaulting institution the status of
international depositary authority.
Unit -5
Biocontainment
Biosafety level
A biosafety level is the level of the biocontainment precautions required to
isolate dangerous biological agents in an enclosed facility. The levels of
containment range from the lowest biosafety level 1 to the highest at level 4.
In the United States, the Centers for Disease Control and Prevention (CDC)
have specified these levels.[1] In the European Union, the same biosafety
levels are defined in a directive.[2]
History
The first prototype Class III cabinet was fashioned in 1943 by Hubert Kaempf,
then a U.S. Army soldier, under the direction of Dr. Arnold G. Wedum,
Director (1944–69) of Industrial Health and Safety at the United States Army
Biological Warfare Laboratories, Fort Detrick, Maryland. Kaempf was tired of
his MP duties at Detrick and was able to transfer to the sheet metal
department working with the contractor, the H.K. Ferguson Co.[3]
Over the first ten years, the biological safety conferences grew to include
representatives from all federal agencies that sponsored or conducted
research with pathogenic microorganisms. By 1966 it grew to include
representatives from universities, private laboratories, hospitals, and
industrial complexes. Throughout the 1970s participations in the conferences
continued to grow, and by 1983 discussions began considering the creation
of a formal organization.[6]
Levels
Biosafety level 1
This level is suitable for work involving well-characterized agents not known
to consistently cause disease in healthy adult humans, and of minimal
potential hazard to laboratory personnel and the environment (CDC,1997).[7]
This level is similar to Biosafety Level 1 and is suitable for work involving
agents of moderate potential hazard to personnel and the environment.[7] It
includes various bacteria and viruses that cause only mild disease to
humans, or are difficult to contract via aerosol in a lab setting, such as C.
difficile, hepatitis A, B, and C, influenza A, Lyme disease, dengue fever,
Salmonella, mumps, measles, HIV,[8] scrapie, MRSA, and VRSA. Genetically
modified organisms have also been classified as level 2 organisms, even if
they pose no direct threat to humans. This designation is used to limit the
release of modified organisms into the environment. Approval by the FDA is
required to release these organisms. An example is genetically modified food
crops. BSL-2 differs from BSL-1 in that:
Biosafety level 3
It is recognized, however, that some existing facilities may not have all the
facility features recommended for Biosafety Level 3 (i.e., double-door access
zone and sealed penetrations). In this circumstance, an acceptable level of
safety for the conduct of routine procedures, (e.g., diagnostic procedures
involving the propagation of an agent for identification, typing, susceptibility
testing, etc.), may be achieved in a biosafety level 2 facility, providing
1. the filtered exhaust air from the laboratory room is discharged to the
outdoors,
2. the ventilation to the laboratory is balanced to provide directional airflow into
the room,
3. access to the laboratory is restricted when work is in progress, and
4. the recommended Standard Microbiological Practices, Special Practices, and
Safety Equipment for Biosafety Level 3 are rigorously followed.
Biosafety level 4
The Galveston National Laboratory BSL-4 lab on the Campus of the University of
Texas Medical Branch
This level is required for work with dangerous and exotic agents that pose a
high individual risk of aerosol-transmitted laboratory infections, agents which
cause severe to fatal disease in humans for which vaccines or other
treatments are not available, such as Bolivian and Argentine hemorrhagic
fevers, Marburg virus, Ebola virus, Lassa fever, Crimean-Congo hemorrhagic
fever, Smallpox, and other various hemorrhagic diseases. When dealing with
biological hazards at this level the use of a Hazmat suit and a self-contained
oxygen supply is mandatory. The entrance and exit of a Level Four biolab will
contain multiple showers, a vacuum room, an ultraviolet light room, and
other safety precautions designed to destroy all traces of the biohazard.
Multiple airlocks are employed and are electronically secured to prevent both
doors opening at the same time. All air and water service going to and
coming from a biosafety level 4 lab will undergo similar decontamination
procedures to eliminate the possibility of an accidental release.
Agents with a close or identical antigenic relationship to Biosafety Level 4
agents are handled at this level until sufficient data is obtained either to
confirm continued work at this level, or to work with them at a lower level.
Within work areas of the facility, all activities are confined to Class III
biological safety cabinets, or Class II biological safety cabinets used with one-
piece positive pressure personnel suits ventilated by a life support system.
The Biosafety Level 4 laboratory has special engineering and design features
to prevent microorganisms from being disseminated into the environment.
The laboratory is kept at negative air pressure, so that air flows into the
room if the barrier is penetrated or breached. Furthermore, an airlock is used
during personnel entry and exit.
Australia,
Australian Animal
Victoria, 4
Health Laboratory
Geelong
One of the
premier
research
institute &
conducts
studies on
All India Institute of India, New major
1-4 1993
Medical Sciences Delhi pathogenic
organisms.
Has been
contributed in
discovering
novel strains
& vaccines.
This facility
National JALMA
deals with the
Institute for
Mycobacterial
Leprosy & Other
India, Agra 3 2002 strains & their
Mycobacterial
pathogenicity
Diseases
&
(NCJILOMD), Agra
epidemiology.
National High
Security
Laboratory
Operates
Australia,
under the
National High Victoria,
4 auspice of the
Security Laboratory North
Victoria
Melbourne
Infectious
Diseases
Reference
Laboratory.
Australia,
Curtin University of Western
3
Technology Australia,
Bentley
It is unclear
whether this
facility
operates as a
University of São Brazil, São
3 BSL-4. Brazil
Paulo Paulo
doesn't have
any BSL-4
facilities[citation
needed]
The British
Columbia
Centre for
British Columbia Canada, Disease
Centre for Disease British 3 Control,
Control Columbia operates
three
biosafety
level 3 labs.
Located at
Centre National de Canada, the Institut
Biologie Quebec, 3 national de la
Expérimentale Laval recherche
scientifique.
University of
Saskatchewan
's Vaccine and
Infectious
Disease
Organization
is a pre-
eminent
research
institute
investigating
the
Canada,
Vaccine and pathogenesis
Saskatchew
Infectious Disease 2 1975 N/A of infectious
an,
Organization (VIDO) diseases and
Saskatoon
the
development
of effective
therapeutic
and
prophylactic
methods to
control
infectious
diseases of
humans and
animals.
Located at
the Centrum
biologické
Center of Biological Czech ochrany
4
Protection Republic Těchonín
(Center of
Biological
Protection)[9]
Document
from National
National Institute Finland, Institute for
for Health and Hermanni, 3 Health and
Welfare Helsinki Welfare that
mentios the
facility.[10]
Document
from National
National Institute Finland, Institute for
for Health and Tilkanmäki, 3 Health and
Welfare Helsinki Welfare that
mentios the
facility.[10]
Jean Mérieux
laboratory is a
co-operation
between the
Pasteur
France, Institute and
Laboratoire P4 Jean
Rhône- 4 1999-03-05 INSERM. Note
Mérieux
Alpes, Lyon that in
France, it is
P4 for
Pathogen or
Protection
level 4.[11]
This facility is
operated by a
research
organization
Centre International
supported by
de Recherches
Gabon 4 the French
Médicales de
government,
Franceville
operates
West Africa's
only BSL-4
lab.[12]
The facility
was licenced
for
Robert Koch Germany, construction
4
Institute Berlin by City of
Berlin on
November 30,
2008.
Bernhard Nocht
Germany,
Institute for 4
Hamburg
Tropical Medicine
The facility is
licenced to
Philipps University Germany, work with
4 2008
of Marburg Marburg genetically
modified
organisms
Wehrwissenschaftli
Germany,
ches Institut für 3
Munster
Schutztechnologien
Greece,
Evangelismos 3 2003
Athens
This facility
deals
especially to
High Security zoonotic
India,
Animal Disease 4 1998 organisms
Bhopal
Laboratory (HSADL) and emerging
infectious
disease
threats.
Operated by
Institute of
Tropical
Indonesia, Disease -
Institute of Tropical
East Java, 3 2008 Airlangga
Disease (ITD)
Surabaya University,
Build
Cooperation
with Japan.
A university
hospital in
Polo
Azienda Universitario;
Italy,
Ospedaliera it contains
Lombardy, 4
Ospedale Luigi two special
Milano
Sacco vehicles for
transporting
infectious
persons.
This facility is
able to
conduct
research and
Institute for Medical Malaysia, tests on
Research (IMR), Kuala 3 acarology,
Ministry of Health Lumpur bacteriology,
medical
entomology,
parasitology
and virology.
Located at
National
Institute for
Infectious
Diseases,
Department
of Virology I;
this lab has
the potential
National Institute Japan,
of operating
for Infectious Kantō, 3
as a BSL-4,
Diseases Tokyo
however it is
limited to
perform work
on only BSL-3
agents due to
opposition
from local
residents and
communities.
Wuhan
Institute of
Virology
already hosts
a BSL-3
laboratory. A
distinct BSL-4
facility is
currently
People's being built
Wuhan Institute of
Republic of based on P4
Virology of the
China, 3-4 2010 (P4) standards,
Chinese Academy
Hubei, the original
of Sciences
Wuhan technology for
confinement
developed by
France.[13][14] It
will be the
first at level 4
in China,
under the
direction of
Shi Zhengli.[15]
Defence
Science
Organization
goal is to
conduct
autopsies
during a
potential
deadly
Defence Science epidemic
Singapore 4
Organization (DSO) outbreak.
Singapore
also has a
mobile BSL-4
autopsy
facility,
perhaps the
only one of its
kind in the
world.[16]
National
Institute for
Communicabl
e Diseases of
Special
National Institute South Africa, Pathogens
for Communicable Johannesbur 4 Unit is one of
Diseases g only two BSL-
4 facilities in
Africa but the
only suit
laboratory on
the continent.
Swedish
Institute for
Swedish Institute Infectious
Sweden,
for Infectious 4 Disease
Solna
Disease Control Control is
Scandinavia's
P4 facility.
This facility
only deals
with animal
diseases
Institute of Virology which do not
Switzerland,
and transmit to
Mittelhäuser 4 2007-02-01
Immunoprophylaxis humans, and
n
(IVI) is the only P4
facility where
complete
isolation suits
are not used.
Preventive Medical
Republic of
Institute of ROC
China 4
Ministry of National
(Taiwan)
Defense
Part of the
Kwen-yang
Republic of Department
Laboratory (昆陽實
China 4 of Health
驗室) Center of
(Taiwan) Republic of
Disease Control
China.
United Under
4
Kingdom construction.
Currently
operates in
United
two buildings.
Centers for Disease States of
One of two
Control and America, 4
facilities in
Prevention Georgia,
the world that
Atlanta
officially hold
smallpox.
United
Is an older
States of
Georgia State design
America, 4
University "glovebox"
Georgia,
facility.
Atlanta
Under
construction.
This facility
will be
operated by
National
United
Institute of
States of
Integrated Allergy and
America, 4
Research Facility Infectious
Maryland,
Diseases
Fort Detrick
(NIAID), it is
planned to
begin
operating at
2009 at the
earliest.
Located on
United
the NIH
States of
National Institutes Campus, it
America, 4
of Health (NIH) currently only
Maryland,
operates with
Bethesda
BSL-3 agents.
Under
construction
by Boston
United
University,
National Emerging States of
building and
Infectious Diseases America, 4
staff training
Laboratory (NEIDL) Massachuset
complete,
ts, Boston
waiting for
regulatory
approval.
Under
United construction,
NIAID Rocky States of it is planned
Mountain America, 4 to begin
Laboratories Montana, operation in
Hamilton 2009 at the
earliest.
United University of
States of Cincinnati
University of
America, 3 Medical
Cincinnati
Ohio, Sciences
Cincinnati Building
United
States of
Battelle Memorial
America, 3
Institute
Ohio, West
Jefferson
Opened in
Galveston National United 2008, facility
Laboratory, States of is operated by
National America, 4 the University
Biocontainment Texas, of Texas
Facility Galveston Medical
Branch.[17]
Operated by
United
the University
States of
of Texas
Shope Laboratory America, 4
Medical
Texas,
Branch
Galveston
(UTMB).
This facility is
part of the
Department
United of General
Division of States of Services of
Consolidated America, 4 the
Laboratory Services Virginia, Commonwealt
Richmond h of Virginia.
It is so called
"surge" BSL-4
capacity.
Facility to be
operated by
the
United Department
States of of Homeland
America, Security, and
National Bio and
Kansas replace the
Agro-Defense 4
State Plum Island
Facility (NBAF)
University, Animal
Manhattan, Disease
Kansas Center.
Planned to be
operational by
2014.
Saint Louis
University's
United new center
Saint Louis States of for biomedical
University Doisy America, 3 research.
Research Building Missouri, St. Monkeypox is
Louis the primary
BSL-3 agent
studied.
The UC
Berkeley BSL3
Facility is
currently
housed in a
United
single location
States of
University of but will be
America, 3
California, Berkeley expanded in
California,
2011 to
Berkeley
include a
second site
(in a building
under
construction).
United
University of
States,
California, Los 3
California,
Angeles
Los Angeles
Popular culture
The beginning of the movie Outbreak (1995) walks the audience through
each biosafety level, giving examples of diseases in each category;
unfortunately, the diseases used are often incorrectly categorized, and
numerous egregious violations of biosafety level protocol are witnessed. The
introduction to the book The Hot Zone is similar to the beginning of
Outbreak.