PROTECTION OF MICRO-ORGANISMS –

INTERNATIONAL PERSPECTIVE

ABSTRACT
Protection of biological resources and biodiversity has been an area of concern at the
international level for a long time. International forums through various laws have intended to
focus on conservation and sustainable use of biological resources. Serious attempts for the
protection of biological resources and biodiversity started when developed countries switched on
to exploitation of biological resources through intellectual property rights (IPR) that are made
available across the globe including the developing countries. There has been division of south
and north on debate and dialogue with reference to utilization and regulation of biological
resources and sustainable use and development of biological diversity. This has become very
much pertinent issue since the current global standards Advocate for vibrant promotion of IPR.
In this concern, there have been various attempts at international level on the regulation and
sustainable use of biological resources and protection of micro-organisms. The present paper
intends to present the international law on the sustainable use of biological resources and micro-
organisms. At the same time, it attempts to address the issue of regulation of IPR in biological
resources at the international level

Keywords: International forums, biological resources, micro-organisms, sustainable

development

Literature Review: Micro- organisms from the start of world played very crucial role
specifically for the human species rightly explained by the Prof. Sreenivaslu the only way to
protect and secure their life through industrial exploitation is having the IPR to each and every
micro- organisms which is been endangered. For such endeavors of utilisation of biological
resources in innovative ways resulting in the creative works intellectual property rights (IPR)
have been claimed. IPR gives various rights and protection to micro- organism for analyzing the
various international norms with reference to the issue at hand along with the international level
also there are some conventions and agreements which regulate IPR in general and over
biological resources in particular.

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Research Methodology: This Doctrinal research is descriptive and analytical in nature.
Secondary and Electronic resources have been largely used to gather information and data about
the topic. Books and other reference material have been primarily helpful in giving this project a
firm structure. Websites, dictionaries and articles have also been referred.
Hypothesis:
It is very essential to acquire protection for all the intellectual properties against all sorts of
infringement and any kind of misuse of the invention. Patents come for various types of
inventions that can range from industrial equipment to microorganisms. 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 sheltered and substantial patent system
for the protection of the research concerning microorganisms.

Introduction
Biological resources include plants, animal and microorganisms or parts thereof, their genetic
material and by-products with actual or potential use or value. The biodiversity is not the same as
biological resource although mutually, they form part of each other. The conservation of
biological diversity is distinct but related to biological resources. Biodiversity means variety and
variability of all life forms on earth. Biological resources and biodiversity are important for
survival of life, catering the health needs, ensuring food security, up keeping of aesthetic values,
maintaining ethical concerns, facilitating ecological services for promoting religious and cultural
purpose, sustainable development of indigenous knowledge and so on and so forth. In this sense,
biological resources and biodiversity are important for economic progress of the nation. At the
same time, bio resources management and utilization for human welfare is very important and is
a critical component of biodiversity. It is because the activities of the individual, communities
and commercial ventures are likely to pose threat to biological resources. Population growth
inevitably leads to an increased demand for resources and an indefinite increase in that demand
is not compatible with conserving our resources base. Invariably, to satisfy the needs of the
increased population man has started to apply the science and technology over biological
resources. Through modern techniques, such as biotechnology, genetic engineering, etc. man has
started to marshal the genes in the living beings to get more, advanced and desired results for
commercial and industrial purposes. The multinational companies from the developed countries
through science and technology started exploitation of biological resources mostly available in
the developing countries. For such endeavors of utilization of biological resources in innovative

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ways resulting in the creative works intellectual property rights (IPR) have been claimed. 1 These
rights have been granted over the biological resources in the modified form. Since the
exploitation of biological resources is going on at an accelerated pace where various IPR have
been claimed, the situation demands for regulation of IPR in biological resources. 2 Since the use
and exploitation of biological resources has been done at international level where more than one
country is directly or indirectly involved, it gives rise to the need for an international framework
for the regulation of exploitation of biological resources and the claimed IPR. At this juncture,
the current write-up attempts to analyse the various international norms with reference to the
issue at hand. At the international level, there are some conventions and agreements which
regulate IPR in general and over biological resources in particular. These conventions and
agreements have been discussed below in detail while touching upon their contribution on the
issue of use of biological resources and regulation of IPR.

MICRO-ORGANISMS: MEANING AND DEFINITION

A general definition of a microorganism is an organism that is microscopic (too small to be seen

by the naked human eye) and which can be seen only under a microscope, usually, an ordinary
light microscope. Microorganisms are incredibly diverse and include bacteria, fungi, archaea and
protists as well as some microscopic plants such as planktons and organisms such as amoeba.
Thus, it may consist of a single cell or a cell cluster.

The European Commission (EC) 19-20 directives on microorganisms define it as any

microbiological entity, cellular or non-cellular, capable of replication or transferring genetic
material. EC directives have also defined biological material as any material containing genetic
information and capable of reproducing itself or being reproduced in a biological system.
Various definitions of microorganisms could be quoted as follows:

Any of various microscopic organisms, including algae, bacteria, fungi, protozoa and viruses
(The Concise Oxford Dictionary).

Any organism, such as a virus, of microscopic size (Collins English Dictionary).

Microorganisms are microscopic life forms including microscopic fungi, protista, prokaryotes
and viruses. A microscopic organism consisting of a single cell or cell cluster, including the
viruses. Hence a quotation from an English dictionary would not be sufficient to provide a
definition of the term ‘microorganism’. A more precise and scientific definition is required for
the purposes of providing a clear definition of the scope of exceptions to patentability set out in
Article 27.3(b) of TRIPS agreement. Hence TRIPS agreement produces an ambiguity in defining
microorganisms. The more authentic decisions regarding the patentability of microorganisms

1
Sreenivasulu N.S, Kariyanna. K. S, and Viswanath B.S, Biological Diversity, Intellectual Property and Patents:
Concerns of Biological Resources, Manupatra Intellectual Property Reports, Volume: I, Part: II
2
Ibid

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were made by the US Supreme Court in 1980 (Diamond v. Chakrabarty case), when the
genetically modified bacterium was granted a patent.

Historical Perspective

Initially, microorganisms didn’t fall under the purview of patentability in all of the countries. But
after the landmark case of Diamond v. Chakraborty in 1980 the situation changed. This
judgement allowed the patentability of the microorganisms in the U.S. Dr. Ananda Chakraborty
wished to apply for a patent of a live human-made and genetically engineered bacterium which
had the capacity to break down the components of the crude oil. Initially, the controller of the
patents in the US rejected the patent claim of the microbiologist by stating that microorganisms
cannot be patented as they are readily available in nature and things that occur in nature cannot
be patented. But as soon it was appealed in the higher court the decision of the controller was
reversed by the US States Court of Customs and Patents Appeal.

The Commissioner of the Patents, Sidney A. Diamond appealed to the Supreme Court and the
decision was again made in the favour of Dr. Chakraborty which stated that the bacteria which is
human-made, which has the capability of treating oil spills, genetically engineered which
satisfies the novelty, non-obviousness and industrial use aspects of the patentability criteria of
the patents may be granted a patent as naturally occurring microorganisms fail to perform the
task. Before this decision was made by the US Court, the microorganisms were not granted
patents as a product claim per se but were only involved in the processes claims where the
microorganisms were used as a medium in inventions. The TRIPS agreement also mentions
about the patentability of microorganisms and explain about the microorganisms that are created
by the human intervention and are genetically modified or engineered by various processes in
order to create a new, non-obvious and industrially useful microorganism can be patented. Art
23(3)(b) of the TRIPS Act, 1994 states about the patentability of the microorganisms, non-
biological and microbiological processes.

In India the protection for the microorganisms was added in the Patents Act, 1970 after the
landmark judgment of the Calcutta High Court case of Dimminaco A.G. v. Controller of Patents
and Designs. In this case, the appeal was filed against the Assistant Controller of the Patents and
Designs where the process of preparation of infectious Bursitis Vaccine was refused on the
grounds that the live virus used in the process of preparation of vaccine cannot be considered as
manufactured and cannot be treated as a substance or an inanimate object. The Calcutta High
Court reversed the order and started that the process of preparing a vendible commodity which
contains a live substance is not excluded from the purview of the word ‘manufacture’. The
product created was novel, non-obvious and was capable of industrial application thus making it
an invention. In the Supreme Court judgment in the case of Monsanto Technology Pvt. Ltd. v.
Nuziveedu Seeds, the plaintiff claimed that their patent was capable of killing the bollworms
when it was inserted in cotton as it contained a man-made chemical product called Nucleotide
Acid Sequence (NAS) which contained Bacillus Thuringiensis gene. They claimed that their

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invention did not infringe section 3(j) of the Patents Act, 1970. Nuziveedu Seeds claimed that
NAS is just a chemical composition that was incapable of reproduction and not a man-made
inventive microorganism which is capable for industrial application. The Supreme Court in this
matter restored the order of the single bench and set aside the order of the division bench and
reverted back the matter to the single bench of the Delhi High Court to be decided on the basis of
expert advice and evidence, who held that, the claims on NAS was rightly entertained by the
Patent Office and that the parties shall remain bound to their sub-lease agreement which shows
that the present scenario in India regarding microorganisms is still at its infancy stage and needs
progression.

Budapest Treaty regulates IPR in microorganisms by way of insisting deposit of

microorganism in an International Depository Authority

The Budapest Treaty 19773

Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the
Purpose of Patent Procedure entered into force on August 1977. Budapest Treaty is the
international treaty that also deals with the regulation and sustainable use of biodiversity. It
regulates IPR in microorganisms by way of insisting deposit of microorganism in an
International Depository Authority. According to this treaty, deposit is necessary to satisfy the
requirement of sufficiency of description of patent law for inventions relating to microorganisms
or the use of microorganisms. It also recognizes the deposit of microorganism in officially
approved culture collections for the purpose of patent applications in any country that is a party
to this treaty. Because of the difficulties and virtual impossibility of reproducing a
microorganism from a description of it in a patent specification, it is essential to deposit a strain
in a culture collection center for testing and examination by others. An inventor is required to
deposit the strain of a microorganism in a recognized depository, which assigns a registration
number to the deposited microorganism. This registration number needs to be quoted in the
patent application dealing with the microorganism. Obviously, a strain of microorganism is
required to be deposited before filing a patent application. It may be observed that this
mechanism obviates the need of describing a microorganism in the patent application. Further,
samples of strains can be obtained from the depository for further working on the patent. Patent
office’s across the globe demand depositing microorganisms to get patent protection on the
claimed microorganism.

3
It is a special agreement under the Paris Convention. This Treaty is basically on the international recognition of the
deposit of microorganism for the purpose of patent protection came into existence on 28th April, 1977 and
subsequently amended in 1980.

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Convention on Biological Diversity (CBD) 1992

The landmark and comprehensive convention, at the international level, on the regulation and
sustainable use of biological resources and biodiversity is the Convention on Biological
Diversity (CBD). It was negotiated and signed by nations at the UNCED Earth Summit at Rio de
Janeiro in Brazil in June 1992. The Convention came into force on 29th December, 1993. India
became a Party to the Convention in 1994. At present, there are 193 parties to this Convention.
The basic objectives of the Convention are as follows:

• Conservation of biological diversity

• Sustainable use of the components of biodiversity

• Fair and equitable sharing of benefits arising out of the utilisation of genetic resources

This Convention is a landmark in the environment and development field, as it takes for the first
time a comprehensive rather than a frontier approach to the conservation of earth’s biodiversity
and sustainable use of biological resources. Though the Convention on Biological Diversity is
basically addressing the issue of biodiversity, number of CBD provisions, documents and
decision taken by the Conference of the Parties has addressed substantive issues related to IPR
over biodiversity. This convention indirectly, while promoting conservation of biodiversity, also
promotes and regulates IPR in biological resources and biodiversity. It imposes obligation on the
member countries to obtain prior informed consent before obtaining IPR over the biological
resources and biodiversity from where it originate. Further, it imposes duty upon the member
countries to share the benefit arising out of the utilisation of biological resources. Transfer of the
technology is one of the modes of sharing of benefits arising out of the utilisation of resources.
Thus, technology transfer is highlighted as a method for achieving one of the convention’s three
objectives and IPR are identified as a significant aspect of technology transfer. Apart from this
following articles of CBD also regulate IPR in biodiversity and biological resources. Article 8(J)
of the convention states; “subjects to its national legislation, respect, preserve and maintain
knowledge, innovation and practice of indigenous and local communities embodying traditional
lifestyles relevant for the conservation and sustainable use of biological diversity and promote
their wider application with the approval and involvement of the holder of such knowledge,
innovations and practices and encourage the equitable sharing of the benefits arising from the
utilisation of such knowledge, innovation and practice.”

Article 15(6) of the Convention states “each contracting party shall endeavor to develop and
carry out scientific research, based on genetic resources provided by other contracting parties
with the full participation of, and where possible in, such contracting parties.” Further, Article
16(1) requires each party to provide or facilitate access and transfer to other parties of
technologies, including biotechnology, which are the relevant for the sustainable use that make

6
use of genetic resources and are not significantly threatening environment. Further, Clause (3)
states that each contracting party shall take appropriate measure, with the aim that contracting
parties, in particular those that are developing countries, which provide genetic resources are
provided access to and transfer of technology which make use of those resources on mutually
agreed term, including technology protected by patents and other IPR. Similarly, Article 19(1)
states each contracting party shall take legislative, administrative or policy measures, as
appropriate, to provide for the effective participation in biotechnological research activities by
those contracting parties, especially developing countries, which provide the genetic resources
for such research, and where feasible in such contracting parties shall promote international
technical and scientific cooperation in the field of conservation and sustainable use of
biodiversity. In transfer of technology, it may include following class of technology.

1) Technology relevant to biodiversity conservation: this includes techniques for surveying

ecosystems, classifying organisms and monitoring changes in biodiversity forest replanting
technique, etc.

2) Technology necessary to do genetic research generally; such as genetic engineering,

laboratory techniques, screening tests, and laboratory equipment itself.

3) Technology that enables imitation of existing biotechnology invention which includes

techniques, or drugs, or agricultural products.

Apart from the above provisions to a certain extent Conference of the Parties (COP) to the CBD
has been addressing IPRs issues. Since conference of the Parties No 2, in 1995, it has taken
following decisions relating to IPR.

1) Decision II/12 of COP 2, III/17, IV24 A, and VI 24 C, 31 speaks about IPR and genetic
resources and benefit sharing.

(2) Decision V/16, V/5, VI/5 of Cop 4 speaks about IPR and traditional knowledge.

(3)Decision III/17 of the COP 3 speaks about Intellectual Property and coordination with
relevant organisation.

United Nations Convention on Law of the Sea (UNCLOS), 1994

The United Nations Convention on the Law of the Sea (UNCLOS) also called as the Law of the
Sea Convention or the Law of the Sea Treaty is the international agreement that resulted from the
third United Nations Conference on the Law of the Sea (UNCLOS III) which took place from
1973 through 1982. The UNCLOS replaces the older and weaker “freedom of the seas” concept,
dating 17th century; where national rights were limited to a specified belt of water extending
from a nation’s coastlines, usually three nautical miles. Now it can be extended up to 200
nautical miles. The Law of the Sea Convention defines the rights and responsibilities of nations
in their use of the world’s oceans, establishing guidelines for businesses, the environment, and

7
the management of marine natural resources. The Convention, concluded in 1982, replaced four
treaties adopted in 1958. The UNCLOS convention came into force in 1994. Presently, it has 161
states as well as, the European Community. It gives sovereign rights and imposes obligation on
the coastal states on their territorial marine areas. The researcher must obtain prior informed
consent from the coastal state before conducting research activity. The researcher must provide
access to the data collected by them in respect of the research to the coastal state. Further, Article
241 of the convention would seem expressly to preclude patenting the result of marine scientific
research.

Trade-related Aspect of Intellectual Property Rights (TRIPS)

The World Trade Organization (WTO) is the international organization dealing with the rules of
trade between nations. In becoming Members of the WTO, countries undertake to adhere to the
18 specific agreements annexed to the Agreement establishing the WTO, among those
agreements, Trade-related Aspects of Intellectual Property Rights (TRIPS) is also one
Agreement, which has been in force since 1995 and is till date the most comprehensive
multilateral agreement on intellectual property. The TRIPS Agreement introduced global
minimum standards for protecting and enforcing nearly all forms of IPR. The TRIPS Agreement
now requires all WTO members, with few exceptions, to adapt their laws to the minimum
standards of IPR protection. This TRIPS Agreement introduced detailed obligations for the
enforcement of IPR. Though the objective of the TRIPS Agreement is to recognize IPR over new
invention, some provisions regulate IPR over biological resources and biodiversity by excluding
some invention from the purview of the IPR.

Article 27(3)(b) stipulates that “member may exclude from patentability, plants and animals
other than microorganisms, and essentially biological processes for the production of plants or
animals other than non-biological and microbiological process”. However, members shall
provide for the protection of plant varieties either by patents or by an effective sui-generis
system or by any combination thereof.” Though Article 27(3) (b) excludes patent protections to
plant and animals and biological process, it allows protection microorganisms and
microbiological or non-biological process. Microorganisms include viruses, algae, bacteria, fungi
and protozoa and genes, gene sequences. IPR could be obtained over microorganism. As per the
TRIPS agreement, though it is not compulsory to grant patents for plants, animals and biological
process, members can choice either patent or enact their own sue generis system for protection of
plant verities. With regard to patents on genes extracted from the plants, animals,
microorganisms the Agreement is silent. It is up to the member countries to decide whether to
grant patent or exclude them from the patent monopoly. Further, Article 27(2) excludes certain
inventions from patentability, to protect human, animal, or plant life or health or to avoid serious
prejudice to the environment. Further, it imposes obligation upon the member countries to give
geographical indication rights to the goods, including natural, agricultural and manufactured
goods where a given quality, reputation or other characteristics of the goods is essentially
attributable to its geographical origin. Thus, this protection gives IPR over agricultural and

8
natural products developed or produced with a particular or deferent quality attributable to its
origin. The people who are producing or working on agricultural or natural products get
monopoly control over such products developed in a particular region with a given quality.

The relationship between the TRIPS and CBD is multifaceted and complex. However, there
are four categories of views expressed by member states regarding this conflict:

(1) There is no conflict and national government can implement the two in a mutually supportive
way;

(2) There is no conflict, yet further study regarding the patent system is required;

(3) There is no inherent conflict; however, international intervention is needed in to ensure that
the two agreement are mutually supportive;

(4) There is inherent conflict, thus requiring an amendment to TRIPS to resolve the conflict

So the Convention on Biological Diversity and TRIPS have conflicting objectives. The CBD
intends to conserve biological diversity, the sustainable use of its components and the fair and
equitable sharing of the benefits arising out of the utilisation of genetic resources. On the other
hand, TRIPS is intended to provide private rights over products and process on innovations from
all the fields of science and technology including the innovations resulted out of the utilisation of
biological resources. It is felt that convention on Biological Diversity supports the view point
and interest of developing countries. The TRIPS on the other hand respect the interest of the
corporate sector, the most visible face of which is the life sciences industry. The Convention on
Biological Diversity gives sovereign rights to the member state over their biological resources.
Wherein, state has the right to regulate access to biological resources and knowledge, and to
determine access to biological resources and benefit sharing agreements. It means that the
respective country has every right to decide whether or not to allow biological resources to be
covered under patent law or not, TRIPS overlooks this right by prescribing patent protection on
microorganism, non-biological and microbiological process, as well as patent and sue generis
protection on plant verities. The CBD gives recognition to the efforts made by the traditional
communities in the conservation of biodiversity and insist for the protection of traditional
knowledge relevant for the conservation of biodiversity. It states “subject to its national
legislation, respect, preserve and maintain knowledge, innovations and practices of indigenous
and local communities embodying traditional lifestyles relevant for the conservation and
sustainable use of biological diversity and promote their wider application with the approval and
involvement of the holders of such knowledge, innovations and practices and encourage the
equitable sharing of the benefits arising from the utilization of such knowledge, innovations and
practices.” On the other hand, TRIPS based on western style patents has no system for
recognising or protecting biological resources. The CBD requires that free prior informed
consent be obtained from contracting parties providing access to genetic resources. In this
connection, the “Bonn Guidelines on Access to Genetic Resources and Fair and Equitable

9
Sharing of the Benefits Arising Out of their Utilisation” are voluntary guidelines and were
recently adopted by parties to elaborate on their obligations and rights with respect to genetic
resources. The Bonn Guidelines encourage parties to ensure that free prior informed consent is
obtained from communities for gaining access to genetic resources. Further, it insists for the
sharing of the benefits arising out of the utilisation of biological resources. But TRIPS prevents
government’s action for sharing of the benefits of the use of biodiversity and ensuring such
utilisation in sustainable way while conserving biodiversity in an equitable manner since it
obliges states to protect monopolies. Article 22(1) of the CBD provides that the conventions
provisions shall not affect rights and obligation deriving from any existing international
agreement, except where the exercise of those rights and obligations would cause a serious
damage or threat to biological diversity. However, it is not clear how the said article would apply
in the case of conflict with the TRIPS Agreement.

The TRIPS Agreement itself contains no explicit reference to the CBD or any other
environmental agreements. Convention on Biological Diversity states that developing countries
supplying genetic material must be involved in biotechnological research. But in TRIPS no direct
reference to the involvement of developing countries in biotechnological research activities has
been made. Though there are above said conflicts between the CBD and TRIPs agreements some
developed countries, including US, Japan and EU viewed that CBD and TRIPS do not conflict
with each other and the two treaties can be implemented in a mutually supportive way. With
regard to access biological resources, benefit sharing and prior informed consent, the TRIPS
Agreement does not prevent the parties from adopting a sui generis regime or any system
providing the sharing of the benefits. As far as CBD is concerned, the treaty does not prohibit
patents on innovations using genetic material but recognise the rights over innovations
incorporating genetic resources.

PATENTABILITY OF MICROORGANISMS

Bacteria, fungi and viruses constitute the major group of microorganisms that have been
exploited extensively by biotechnologists. The genetic material of these microorganisms serving
as raw materials are tailored by the biotechnologists with the scissors of restriction
endonucleases, stitched with ligases and converted into desirable form using sophisticated
techniques of genetic engineering. The field of application of genetic engineering is broad and
covers vast areas, for example, the use of fungi in bakery, wine and antibiotic industry, bacteria
for the manufacture of vaccines, modification of plants/insects genome (transgenic plants) and
the like. For over 200 years living organisms have been excluded from patent laws; life forms
were considered a ‘product of nature’ and not a human invention. Before 1980, Patents were
given for inventions based on microbiological processes. No patent was given for the living
entities per se, which were considered to be the products of nature. Although patent laws were
originally framed for mechanical and chemical inventions the patenting of life forms was also

10
included.6 First patent based on microorganisms was made by Louis Pasteur on 28 January 1873,
for the process of fermenting beer. The claim made by him was: … invention produces a better
quality and greater quantity of beer from the same quantity and quality of wort (the boiled extract
of malt or other material) … the yeast or pure ferment is added to provoke or induce
fermentation.

In countries across the world the so-called products of nature doctrine excluded living matter
from patentability. The products of nature doctrine prohibited patentability of materials existing
in nature, including living matter. Under this doctrine, one could secure patents for fermentation
processes and purification of naturally occurring chemical or biological compounds as well as
patents for microorganisms as a culture or in combination with a carrier. The product claims for
the microorganisms, however, were not patentable because they comprised of living materials –
microorganisms. The non-patentable status of living organisms changed with the landmark
decision of the Supreme Court, USA, in Diamond v. Chakraborty in 1980, when the genetically
modified bacterium was granted a patent.

BASIC PATENTABILITY CRITERIA

A patent is an exclusive privilege in the form of a monopoly right, granted by the State to the
inventor or an assignee for a certain period of time in return of the full disclosure of the
invention. A patent is thus a right to exclude others from making, using, selling, offering for sale
or importing the patented invention for the term of the patent, which is usually 20 years from the
filing date. As it is a monopoly right, the grant of a patent must fulfill the essential criteria of
novelty, non-obviousness and usefulness.

The threefold requirements of patentability are set out in the European Patent Convention (EPC)
in Article 52:3

That the invention must be new; that it must involve an inventive step; and that it must be
capable of industrial application. The same three requirements are met with in one form or
another in the USA, Japan, and indeed in practically all the countries that have a patent system.

The Trade-related Aspects of Intellectual Property Rights (TRIPS) agreement aims at reducing
the distortions and impediments in the international trade by an efficacious protection of IP
rights. It specifies certain minimum standards to be followed by the member countries. Article 27
of the TRIPS stipulates that patents shall be available for any invention, whether products or
processes, in all fields of technology, provided that they are new, involve an inventive step and
are capable of industrial application. TRIPS do not define the terms ‘new’, ‘inventive step’ or
‘capable of industrial application’. In patent terms, ‘novel’ means not previously ‘made available
to the public’. Members can exclude from patentability, commercial exploitation that is
necessary to protect human, animal or plant life, or health or to avoid serious prejudice to the
environment. Patents shall be available and patent rights can be made enjoyable without
discrimination as to the place of invention, the field of technology and whether products are

11
imported or locally produced. Therefore, this provision is resonant of the triple criteria of
novelty, non-obviousness and usefulness. However, the essence lies in non-discrimination, as
patents shall be available for any invention, unrestrained by the field of technology.

Focusing on the general patentability criteria in the United States, the provision of the US Patent
Act determines as to what is patentable subject matter. ‘Whoever invents or discovers any new
and useful process, machine, manufacture or composition of matter, or any new and useful
improvement’ may obtain a patent. By perforating through the various International Treaties and
legal provisions in major jurisdictions, it becomes amply clear that the triple test for patentability
is the basic and immutable standard.

CHAKRABARTY’S PATENT CLAIMS

The patent claims made by Chakrabarthy were of three types:

First, process claims for the method of producing the bacteria.

Second, claims for an inoculum comprised of a carrier material floating on water, such as straw,
and the new bacteria.

Third, claims to the bacteria themselves.

The patent examiner allowed the claims falling into the first two categories, but rejected claims
for the bacteria. The decision rested on two grounds:

1-that microorganisms are products of nature, and

2-that as living things they are not patentable subject matter under 35 U. S. C. 101.33

The Patent Office Board of Appeals reiterated the examiners decision on the ground that
microorganisms do not fall within the ambit of 35 U. S. C. 101, as they are living things.

DECISION AND RULING

In a 5–4 ruling, the court ruled in favor of Chakrabarty, and upheld the patent, holding that: A
live, human-made microorganism is patentable subject matter under [Title 35 U.S.C.] 101.
Respondent's microorganism constitutes a ‘manufacture’ or ‘composition of matter’ within that
statute. Chief Justice Warren E. Burger wrote the decision, and was joined by Potter Stewart,
Harry Blackmun, William Rehnquist and John Paul Stevens. Burger wrote the interpretation of
35 U.S.C. 101, which says:

Whoever invents or discovers any new and useful process, machine, manufacture, or
composition of matter, or any new and useful improvement thereof, may obtain a patent
therefore, subject to the conditions and requirements of this title.

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SUPERBUG: DISCOVERY OR INVENTION

The Court of Customs and Patent Appeals emphasized that the issue was not whether the
claimed bacterium was living or inanimate, but whether it constituted an invention made by
human intervention. In the court's view, the fact that Chakrabarty's bacterium was alive was
without legal significance. On the question as to in which category would the invention fall, the
Supreme Court held that the genetically engineered petroleum-consuming bacterium could be
categorized either as a composition of matter or a manufacture. The court read the term
manufacture in S.101 in accordance with its dictionary definition to mean the production of
articles for use from raw or prepared materials by giving to these materials new forms, qualities,
properties or combinations, whether by hand labor or by machinery. In a landmark decision, the
US Supreme Court reaffirmed that the bacterium was not a handiwork of nature; rather it was
Chakrabarty's own invention, hence satisfies the criteria for being patented.

PATENTING MICROORGANISMS: POSITION IN INDIA

Patent Act of India, 1970, Section 2(1)(j) 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.

Conclusion
Intellectual property comes in various types and various forms. It is very essential to acquire
protection for all the intellectual properties against all sorts of infringement and any kind of
misuse of the invention. Patents come for various types of inventions that can range from
industrial equipment to microorganisms. The product to be patented should satisfy the
patentability criteria such as novelty, non-obviousness and industrial usage capability. The
product should not fall under the criteria mentioned in the section 3 of the Patents Act, 1970.

Worldwide there has been recognition of the patents patentability acceptance for the
microorganisms and all the patent offices in the world and international organisations are now
recognising the importance of patenting their developed microorganisms which perform certain
industrial work. Unlike naturally occurring microorganisms, the developed manmade, genetically
manufactured or engineered microorganisms can be patented which are developed by human
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intervention and do not occur naturally in nature. These genetically modified microorganisms are
used by various pharmaceutical industries, microbiologists, scientists, etc. to conduct various
experiments and solve problems that can be solved with the help of microorganisms. These
genetically modified microorganisms can be the future scope for developing eco-friendly
solutions for the various problems that exist in our world currently and patenting it can
encourage the inventors and scientists to develop various new variations of microorganisms. It
will promote sustainable solutions and will have long lasting effects in the field of science. All
the countries in the world are rapidly adopting the new inventions in the field of microbiology
and pharmaceutical industries. India should also build its policies that promote these sectors and
develop rapidly similarly to the developing world around us. 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 endeavor, 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 sheltered and substantial patent system
for the protection of the research concerning microorganisms.

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REFERENCES:

Copyright Amendment Bill http://copyright.gov.in/Documents/ CopyrightAmendmentBill.pdf

The Indian Performing Rights Society Ltd., http://www.iprs.org/FAQs.asp

http:// www.ipo.gov.uk/ipreview-c4e-sub-alcs.pdf

Berne Convention For The Protection Of Literary And Artistic Works, art. 11 (Paris Text 1971).

Agreement On Trade-Related Aspects Of Intellectual Property Rights, Article 13, 15th April,
1994, 1869 U.N.T.S. 299, 33 I.L.M. 1197 (1994)

http://untreaty.un.org/cod/avl/ha/uncls.html

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