Original Article

Patenting of microorganisms:
Systems and concerns
Received (in revised form): 23rd August 2010

Ramkumar Balachandra Nair

is a final year student of biotechnology doing his post graduation at K.V.M. College of Engineering & Information Technology,
Kerala, India. He intends to build a career in the areas of biotechnological research and merge the disciples of law and science to focus
the avenues of commercialization of scientific research and developments.

Pratap Chandran Ramachandranna

is an associate professor and Head of Department of Biotechnology at K.V.M. College of Engineering & Information Technology,
Kerala, India. Dr Chandran was awarded his PhD in biotechnology from the University of Kerala. He is a research guide of many
national universities and interested in the fields of microbiology and biotechnology. His current research work includes studying
the various aspects of the commercial approach to the scientific research portfolio. The work mainly focuses on application of the
intellectual property rights to establish a beneficial system of laboratory research.

ABSTRACT The Government of India permitted patenting of microorganisms in India

under the Patents (Second Amendment) Bill, 2002, which was passed by the Parliament on
14 May 2002. The Government has so far granted very few patents for microorganisms,
mainly on directives from courts. With the law permitting patenting of microorganisms,
several private sector pharmaceutical companies and research institutions have filed
applications for patenting microorganisms including fungi, bacteria and viruses. But there is
still much debate on the advisability of allowing patenting of microorganisms in India. While
the existing provisions in the patents bill permit patenting of certain life forms in line with
the Trade-related Intellectual Property Rights Agreement, there is still sufficient controversy
regarding the term ‘microorganism’, which has not been clearly defined. This article discusses
the evolution of the patenting systems in relation to microorganisms. The article also explores
the feasibility of offering statutory protection to microorganisms that are genetically altered
with significant human intervention on harmonized global patent systems and also elaborating
on the need for a well-accepted definition of the term ‘microorganism’.
Journal of Commercial Biotechnology (2010) 16, 337–347. doi:10.1057/jcb.2010.20;
published online 21 September 2010
Keywords: patent; microorganism; bacteria; invention; property

INTRODUCTION provided by the Government to the

patentee, in exchange of full disclosure
A patent is an intellectual property right
of his invention, for excluding others,
relating to inventions and is the grant
from making, using, selling, importing the
of exclusive rights, for limited period,
patented product or process producing
that product for those purpose.1
Correspondence: Pratap Chandran Ramachandranna
Department of Biotechnology, K.V. M. College of Engineering and A patent is a bunch of exclusive rights granted
Information Technology, Kokkothamangalam P.O., Cherthala, 688583,
Kerala, India
by the state to an inventor or his assignee on
E-mail: [email protected] satisfying certain conditions. The inventor is

© 2010 Macmillan Publishers Ltd. 1462-8732 J ou r n a l of C om m er c i a l B i ot ec h n ol ogy Vol. 16, 4, 337–347

www.palgrave-journals.com/jcb/
 Nair and Ramachandranna

given a monopoly right over the product for However, the debate revolves around the
a fixed number of years in exchange for limits of such protection. One strand of this
the public disclosure of certain details of a mystery is the patentability of microorganisms,
machine, method or the composition of which requires a critical analysis of the present
matter. The objective of patent law is to position of law and a further rumination
encourage inventions by promoting their with regard to its future prospects. Section 27
protection and utilization for the development of TRIPS recognizes microorganisms as a
of industries, promotion of technological patentable subject matter and therefore
innovation, and transfer and dissemination of many nations have now started patenting of
technology. It stimulates new inventions of microorganism through their domestic patent
commercial utility. The patent is granted for a laws.
limited period to the inventor and after the
period of expiry of the patent, the monopoly BASIC PATENTABILITY
goes into public domain. Patent right is CRITERIA
territorial in nature and patent obtained in A patent is an exclusive privilege in the form
one country cannot be enforced in other of a monopoly right, granted by the State to
country. the inventor or an assignee for a certain
The premise of intellectual property (IP) period of time in return of the full disclosure
law is that by recognizing and rewarding the of the invention. A patent is thus a right to
innovator, it fosters industrial and technical exclude others from making, using, selling,
progress paving way for a vibrant socio- offering for sale or importing the patented
economic structure. Since invention is the life invention for the term of the patent, which is
breath of growth and development, it is usually 20 years from the filing date. As it is a
pertinent that the same must be protected monopoly right, the grant of a patent must
against unnecessary encroachment. This has fulfill the essential criteria of novelty, non-
become more evident in context of huge obviousness and usefulness.
strides being made in the field of The threefold requirements of patentability
biotechnology and information technology. are set out in the European Patent
With advancements in biotechnological Convention (EPC) in Article 52:3
research and pharmaceutical industry, pressure That the invention must be new; that it must
started mounting on policymakers to allow involve an inventive step; and that it must be
patenting of basic life forms so as to capable of industrial application. The same three
encourage research and development requirements are met with in one form or
initiatives, which can contribute to exploring another in the USA, Japan, and indeed in
the unrecognized commercial utility of such practically all the countries that have a patent
life forms. New techniques have been system.
developed to create novel life forms like The Trade-related Aspects of Intellectual
genetically modified plants and animal species, Property Rights (TRIPS) agreement aims at
genes, cell lines and so on, which can be reducing the distortions and impediments in
patented as ‘bio-patents’.2 But, the laws the international trade by an efficacious
regulating and protecting these experiments protection of IP rights. It specifies certain
and their subsequent innovations continue, minimum standards to be followed by the
however, to sputter at an inchoate stage. One member countries. Article 27 of the TRIPS
reason for the situation can be the different stipulates that patents shall be available for any
economical and ethical standings of the invention, whether products or processes, in all
nations, which are being brought under the fields of technology, provided that they are new,
umbrella provisions of the World Trade involve an inventive step and are capable of
Organization (WTO). industrial application. TRIPS do not define the

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 Patenting of microorganisms

terms ‘new’, ‘inventive step’ or ‘capable of plants/insects genome (transgenic plants) and
industrial application’. In patent terms, ‘novel’ the like. For over 200 years living organisms
means not previously ‘made available to the have been excluded from patent laws; life
public’.4 forms were considered a ‘product of nature’
Members can exclude from patentability, and not a human invention.
commercial exploitation that is necessary to Before 1980, Patents were given for
protect human, animal or plant life, or health inventions based on microbiological processes.
or to avoid serious prejudice to the No patent was given for the living entities
environment. Patents shall be available and per se, which were considered to be the
patent rights can be made enjoyable without products of nature. Although patent laws
discrimination as to the place of invention, were originally framed for mechanical and
the field of technology and whether products chemical inventions the patenting of life forms
are imported or locally produced. Therefore, was also included.6 First patent based on
this provision is resonant of the triple criteria microorganisms was made by Louis Pasteur
of novelty, non-obviousness and usefulness. on 28 January 1873, for the process of
However, the essence lies in non- fermenting beer.7 The claim made by him
discrimination, as patents shall be available for was: … invention produces a better quality and
any invention, unrestrained by the field of greater quantity of beer from the same quantity and
technology. quality of wort (the boiled extract of malt or other
Focusing on the general patentability material) … the yeast or pure ferment is added to
criteria in the United States, the provision of provoke or induce fermentation.
the US Patent Act determines as to what is In countries across the world the so-called
patentable subject matter. ‘Whoever invents products of nature doctrine excluded living
or discovers any new and useful process, matter from patentability. The products of
machine, manufacture or composition of matter, or nature doctrine prohibited patentability of
any new and useful improvement’ may obtain materials existing in nature, including living
a patent.5 By perforating through the various matter. Under this doctrine, one could secure
International Treaties and legal provisions in patents for fermentation processes and
major jurisdictions, it becomes amply clear purification of naturally occurring chemical or
that the triple test for patentability is the basic biological compounds as well as patents for
and immutable standard. microorganisms as a culture or in combination
with a carrier. The product claims for the
PATENTABILITY OF microorganisms, however, were not patentable
MICROORGANISMS because they comprised of living materials –
Bacteria, fungi and viruses constitute the microorganisms. The non-patentable status of
major group of microorganisms that have living organisms changed with the landmark
been exploited extensively by biotechnologists. decision of the Supreme Court, USA, in
The genetic material of these microorganisms Diamond v. Chakraborty in 1980, when the
serving as raw materials are tailored by the genetically modified bacterium was granted a
biotechnologists with the scissors of restriction patent.
endonucleases, stitched with ligases and
converted into desirable form using BUDAPEST TREATY:
sophisticated techniques of genetic DEPOSITION OF
engineering. The field of application of MICROORGANISMS
genetic engineering is broad and covers vast The Budapest Treaty on the International
areas, for example, the use of fungi in bakery, Recognition of the Deposit of
wine and antibiotic industry, bacteria for the Microorganisms for the Purposes of Patent
manufacture of vaccines, modification of Procedure, or Budapest Treaty, is an

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 Nair and Ramachandranna

international treaty signed in Budapest, ‘biological resource centers’ and further into
Hungary, on 28 April 1977. It was enforced ‘global common genetic resources’, with an
on 9 August 1980, and was later amended on internationally agreed legal basis for benefit
26 September 1980. The treaty is sharing.13 The deposits are made at an IDA in
administered by the World Intellectual accordance with the rules of the Treaty on or
Property Organization.8 As of December before the filing date of the complete patent
2008, 72 countries were party to the Budapest application. Article 7 of the Budapest Treaty
Treaty. The accession to the Treaty is open outlines the requirements for a facility to
to States party to the Paris Convention for become an IDA.12 As of 1 March 2008, there
the Protection of Industrial Property of 1883. were 37 IDAs in approximately 20 countries
The African Regional Industrial Property worldwide.
Organization,9 the Eurasian Patent
Organization (EAPO)10 and the European DEPOSITABLE MATTER TO
Patent Organization (EPO) have filed a THE IDA
declaration of acceptance under Article 9(1)(a) IDAs have accepted deposits for biological
of the Treaty.11 materials, which do not fall within a literal
The treaty allows ‘deposits of interpretation of ‘microorganism’. The Treaty
microorganisms at an international depositary does not define what is meant by
authority to be recognized for the purposes microorganism. It is not necessary for the entity
of patent procedure’.12 Usually, in order to being deposited to be a microorganism – it
meet the legal requirement of sufficiency should only be required for the purposes of
of disclosure, patent applications and patents disclosure and must be acceptable to the IDA.
must disclose in their description the The range of materials able to be deposited
subject-matter of the invention in a manner under the Budapest Treaty includes: cells, for
sufficiently clear and complete to be carried example, bacteria, fungi, eucaryotic cell lines,
out by the person skilled in the art. spores; genetic vectors (such as plasmids or
Regarding any invention involving a bacteriophage vectors or viruses) containing a
microorganism, it is impossible to describe it gene or DNA fragments;14 organisms used for
completely. This is why, in the particular case expression of a gene (making the protein from
of inventions involving microorganisms, a the DNA).
deposit of biological material must be made in
a recognized institution. The Budapest Treaty TRIPS AGREEMENT:
ensures that an applicant, that is a person who PATENTING
applies for a patent, need not deposit the MICROORGANISMS
biological material in all countries where The agreement on TRIPS is an international
he/she wants to obtain a patent. The agreement administered by the WTO,15
applicant needs to only deposit the biological which sets down minimum standards for
material at one recognized institution and this many forms of IP regulation as applied to
deposit will be recognized in all countries other WTO members. It was negotiated at
party to the Budapest Treaty. the end of the Uruguay Round of the
General Agreement on Tariffs and Trade16 in
INTERNATIONAL 1994. Apart from setting the basic minimum
DEPOSITARY AUTHORITY standard for patentability, TRIPS obliges
(IDA) member states to patent microorganisms.17
The deposition of patents of microorganisms Therefore, an understanding as to what
in a culture collection recognized as an IDA constitutes a microorganism is essential.
might be necessary in the realm of IP rights. However, the term lacks a precise scientific
It is likely that IDAs will transform into definition because of which there are inherent

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 Patenting of microorganisms

anomalies in patenting these life forms. The European Commission (EC)19–20

Although the TRIPS agreement is mandatory directives on microorganisms define it as any
for patent production of microorganisms, yet microbiological entity, cellular or non-cellular,
it does not define microorganisms; thus there capable of replication or transferring genetic
is no yardstick definition for member nations material. EC directives have also defined
to follow in this regard. There is no clarity biological material as any material containing
whether the term would include only genetic information and capable of
genetically modified organisms or naturally reproducing itself or being reproduced in a
occurring substances also. biological system. Various definitions of
However, the term microorganism will be microorganisms could be quoted as follows:
understood in its widest sense to include any
biological material that is self-replicable or • Any of various microscopic organisms,
replicable via a host organism. Sub-cellular including algae, bacteria, fungi, protozoa
material like genes, gene sequences, plasmids, and viruses (The Concise Oxford Dictionary).
replicons and so on will come under the • Any organism, such as a virus, of
definition of a microorganism. Some of the microscopic size (Collins English Dictionary).
patentable micro-biological inventions • Microorganisms are microscopic life forms
according to the TRIPS agreement are: (i) including microscopic fungi, protista,
process of producing a new microorganism; prokaryotes and viruses.21
(ii) new microorganism as produced by the • A microscopic organism consisting of a
defined process; (iii) new microorganism per single cell or cell cluster, including the
se; and (iv) process of cultivation or otherwise viruses.22
using a known or new microorganism to: (a)
a form of multiplied microorganism itself, for Hence a quotation from an English dictionary
example vaccine or edible biomass, and (b) a would not be sufficient to provide a
by-product of microbial growth, for example definition of the term ‘microorganism’. A
an antibiotic, enzyme, toxin or an otherwise more precise and scientific definition is
useful industrial product. However, it required for the purposes of providing a clear
becomes obligatory to provide patents for definition of the scope of exceptions to
‘microorganism’ and ‘micro-biological’ patentability set out in Article 27.3(b) of
processes. Neither microorganism is defined in TRIPS agreement. Hence TRIPS agreement
the TRIPS agreement nor does the agreement produces an ambiguity in defining
specify any parameters concerning the scope microorganisms. The more authentic decisions
of its protection.18 regarding the patentability of microorganisms
were made by the US Supreme Court in
MICROORGANISMS: MEANING 1980 (Diamond v. Chakrabarty case), when
AND DEFINITION the genetically modified bacterium was
A general definition of a microorganism granted a patent.31
is an organism that is microscopic (too small
to be seen by the naked human eye) and CRITERIA OF NOVELTY
which can be seen only under a microscope, FOR PATENTING
usually, an ordinary light microscope. MICROORGANISMS
Microorganisms are incredibly diverse and A microorganism exists as a part of the Nature;
include bacteria, fungi, archaea and protists hence its discovery is NOT an invention. If it is
as well as some microscopic plants such as an invention, logic of treating scientific
planktons and organisms such as amoeba. theories and principles as non-patentable
Thus, it may consist of a single cell or a cell inventions gets defeated. If microorganisms
cluster. isolated from the nature for the first time are

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 Nair and Ramachandranna

considered patentable, then minerals and ores DIAMOND V. CHAKRABARTY:

discovered from the interior of earth and deep OPENING A NEW AVENUE
seabed would qualify for patenting. Thus, FOR PATENTING SYSTEMS
microorganisms can be considered as an The patenting of inventions per se seems to be
invention only if the microorganism has not interwoven with the doctrine of product of
been described in the literature and there is nature. This doctrine specifies that potentially
an element of human intervention with the patentable subject matter must be created
discovery.23 through human intervention. Patents are not
The general notion is that the patent available for the handiwork of nature. Thus a
system encourages the creation of new, newly discovered mineral or plant found in
previously unforeseen inventions. Therefore, the wild is not patentable subject matter
even though Chakrabarty simply shuffled under 35 U.S.C S.101.28–30 In contrast, the
genes, changing bacteria that already existed, so-called purified forms of natural products
the widest interpretation by the court lent the may be patentable if they are sufficiently
broadest amplitude to patentability to the different from the non-purified (natural) forms
living subject matter. Thus, the US position so as to be novel and non-obvious. The non-
could be summarized as: once the basic patentable status of living organisms changed
patentability criteria are met, as for any other with the landmark decision of the Supreme
technological invention, living matter can be Court, USA, in Diamond v. Chakrabarty in
patented. The relation between invention and 1980, when the genetically modified
products of nature does not correspond to the bacterium was granted a patent.31 In 1972,
relation between living and non-living things, Ananda Mohan Chakrabarty, a genetic
but between products of nature and man- engineer and a researcher of the General
made inventions.24 There is a wide spread Electric Company, filed a patent application
controversy regarding the consideration of in relation to a bacterium that was intended
microorganisms as ‘invention’ or ‘discovery’.25 to consume petroleum (oil) spills (superbug).
Extensively interpreted, therefore, the Chakrabarty claimed that: A bacterium from the
invention concept would also encompass the genus Pseudomonas containing therein at least two
kinds of subject matter that require human stable energy-generating plasmids, each of said
intervention in order to make them available plasmids providing a separate hydrocarbon
in a useful form by way of isolating or degradative pathway: Salicylate – an aromatic
purifying naturally occurring products. The hydrocarbon, and, Naphthalene – a polynuclear
TRIPS agreement nowhere defines the term aromatic hydrocarbon, was a human-made,
microorganism, and the lack of a commonly genetically engineered bacterium capable of breaking
accepted scientific definition poses the risk of down multiple components of crude oil. It was
inherently chaotic interpretations by different asserted that because of this property, which is
jurisdictions. As far as the question of not possessed by any naturally occurring
compliance with TRIPS is concerned, most bacteria, the invention could treat oil spills.
patent laws do not deal specifically with the The versatility of these ‘novel’ microorganisms
question of whether or not a new living strain was demonstrated by the substantial extent to
of microorganism is itself patentable, but the which degradation of complex hydrocarbons –
EPC26 does not exclude the possibility.27 The such as crude oil – was achieved. Hence
EPO does grant patents for microorganisms, Chakrabarty requested a patent for the
as the patentability is not explicitly excluded. bacterium in the United States but was turned
The present position is thus: microorganisms down by a patent examiner, because the law
are patentable not only in the United States, dictated that living things were not patentable.
but also Europe, Japan and all major The Board of Patent Appeals and
jurisdictions under the TRIPS obligation. Interferences agreed with the original

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 Patenting of microorganisms

decision; however, the United States Court Harry Blackmun, William Rehnquist and
of Customs and Patent Appeals overturned John Paul Stevens. Burger wrote the
the case in Chakrabarty’s favor, writing that interpretation of 35 U.S.C. 101, which says:
‘the fact that microorganisms are alive is
Whoever invents or discovers any new
without legal significance for purposes of the
and useful process, machine, manufacture,
patent law’. Sidney A. Diamond,
or composition of matter, or any new and
Commissioner of Patents and Trademarks,
useful improvement thereof, may obtain a
appealed to the Supreme Court. In the
patent therefore, subject to the conditions
Supreme Court the case was argued on 17
and requirements of this title.
March 1980 and decided on 16 June 1980.32

CHAKRABARTY’S PATENT SUPERBUG: DISCOVERY OR

CLAIMS INVENTION
The patent claims made by Chakrabarthy The Court of Customs and Patent Appeals
were of three types: emphasized that the issue was not whether
the claimed bacterium was living or
• First, process claims for the method of inanimate, but whether it constituted an
producing the bacteria. invention made by human intervention. In
• Second, claims for an inoculum comprised the court’s view, the fact that Chakrabarty’s
of a carrier material floating on water, such bacterium was alive was without legal
as straw, and the new bacteria. significance. On the question as to in which
• Third, claims to the bacteria themselves. category would the invention fall, the
Supreme Court held that the genetically
The patent examiner allowed the claims engineered petroleum-consuming bacterium
falling into the first two categories, but could be categorized either as a composition of
rejected claims for the bacteria. The decision matter or a manufacture. The court read the
rested on two grounds: term manufacture in S.101 in accordance
with its dictionary definition to mean the
1. that microorganisms are products of nature, production of articles for use from raw
and or prepared materials by giving to these
2. that as living things they are not patentable materials new forms, qualities, properties or
subject matter under 35 U. S. C. 101.33 combinations, whether by hand labor or by
machinery. In a landmark decision, the US
The Patent Office Board of Appeals reiterated Supreme Court reaffirmed that the bacterium
the examiners decision on the ground that was not a handiwork of nature; rather it was
microorganisms do not fall within the ambit Chakrabarty’s own invention, hence satisfies
of 35 U. S. C. 101, as they are living things. the criteria for being patented.

DECISION AND RULING PATENTING

In a 5–4 ruling, the court ruled in favor of MICROORGANISMS: POSITION
Chakrabarty, and upheld the patent, holding IN INDIA
that: A live, human-made microorganism is Patent Act of India, 1970, Section 2(1)(j)34
patentable subject matter under [Title 35 defines an invention as a new and useful
U.S.C.] 101. Respondent’s microorganism manner of manufacture or a substance produced by
constitutes a ‘manufacture’ or ‘composition of manufacture. No definitions of manner of
matter’ within that statute. manufacture or substances were given in the
Chief Justice Warren E. Burger wrote the Act. Hence the Patent Office adopted the
decision, and was joined by Potter Stewart, practice of interpreting a manner of manufacture

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 Nair and Ramachandranna

as a patentable subject matter only if it results Despite concerns against the patenting of
in a tangible nonliving substance. microorganisms, this position may augur well
The Section 3(j) of the Act stated that for the biotechnology industry as it is growing
plants and animals in whole, or in part thereof at an inexorable pace.
including seeds, varieties and essentially
biological process for the production of plants DIMMINACO A G v.
and animals, are excluded. India joined the CONTROLLER OF PATENTS
Budapest Treaty on 17 December 2001, and AND DESIGNS
Microbial Type Culture Collection (MTCC) Patentability of biotechnological process
and Gene Bank of the Institute of Microbial with living end product was ascertained by
Technology, Chandigarh (IMTECH) acquired Calcutta High Court decision in the case of
the status of an IDA on 4 October 2002 Dimminaco A G v. Controller of Patents
marking the amendment of existing systems in (2002).37 The facts of this case are that –
India. The position was made more clear after Dimminaco A.G., a Swiss Company applied
the 2002 amendment of the Indian Patents for patenting the process for preparation of a live
Act, 1970 whereby microorganisms can be vaccine for Bursitis. Bursitis is an infectious
patented provided they satisfy the other poultry disease and the invention involved a
requirements.35 live (attenuated) vaccine to combat the disease.
The Controller of Patents refused to allow
THE PATENT AMENDMENT application on the ground that as the vaccine
ACTS involved processing of certain micro-organic
The Patent Amendment Act 2002 came into substances, this was only a natural process
force in May 2003, bringing microorganisms devoid of any manufacturing activities and
within the realm of patentability. Section 3( j) hence not patentable under S.2(1)(j). This was
was couched in terms of Article 27(3) (b). It in consonance with the prevailing practice
states that: plants and animals in whole or any that granted patents only to non-living and
part thereof other than microorganisms but tangible inventions that fulfilled the
including seeds, varieties and species and patentability criteria, even though the Patent
essentially biological processes for production Act imposed no such limitation.
or propagation of plants and animals are not However, on appeal, the Calcutta High
inventions within the meaning of this Act. It Court diverted from the above position. It
excluded microorganisms from the exceptions rejected the contention of the controller that
to patent protection and allowed patenting of a patent is given only for a process that results
processes pertaining to microorganisms as well either in an article, substance or manufacture
as non-biological and microbiological and that a vaccine with a living organism is
processes. not an article, substance or manufacture.38 The
Subsequently, The Patents Act, 1970 was Controller had claimed that the dictionary
once again amended in the year 2005, so as meaning of article is a ‘material thing, item,
to establish congruence with TRIPS. The a thing of a particular class or kind as
amendment deleted Section 5 of the Act, distinguished from a thing of any class of
which provided for only process patents. The kind’. The Controller said the definition does
provision included inventions where only not cover living things. Law does not bar
methods or processes of manufacture were processes where the end-product is living – No
patentable. Therefore, the deletion of this statutory bar in the Act to accept a manner of
section paves way for product patents, which manufacture as patentable even if the end product
is in stark opposition to US approach that contains a living organism.
argues patenting of life forms has tremendous Through creative judicial exposition, the
advantages.36 Calcutta High Court held that: ‘The Indian

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 Patenting of microorganisms

statute on patents does not put any fetters on ownership, use, transfer and dissemination.
patentability of microorganisms developed in a In the global scenario, the TRIPS agreement
controlled environment in the laboratories’. makes it mandatory to provide patent
Taking recourse to the normal dictionary protection to microorganisms and non-
meaning of manufacture, the court observed biological and microbiological production
that manufacture is where ‘the material in of plants and animals. This makes it difficult
question after going through the process of for the developing countries to exclude
manufacture has undergone any change by the inventions within this category altogether.
inventive process and it becomes a material Hence, the strategy should be how to limit
which is different from the starting material’.39 the scope of these provisions. As far as the
The court held that this meaning of patent protection of microorganism is
manufacture does not exclude the process of concerned, TRIPS does not provide a
preparing a product that contains a living definition of microorganism. The national
substance from patentability. rule-makers must define microorganism in
Court also held that the process for creating such a way as to include the following:
a vaccine leads to a vendible product even if bacteria, virus, and fungus and algae.
the end product contains living material.40 Another important limitation in the scope
The court said that if the invention results in of patent protection to biological materials is
the production of some vendible items or the lack of defining the concept of invention
improves or restores formal conditions of and discovery. Microorganisms as such occur
vendible item or its effect in preservations in nature and their discovery cannot be called
and prevention from deterioration of some invention. Microorganism when genetically
vendible product, then such an invention modified falls in the category of invention
would pass the vendibility test. Therefore, as because of human input. Genetically modified
the claim process for patent leads to a microorganism may perform any number of
vendible product, it is certainly a substance activities, hence patenting of this genetically
after going through the process of modified microorganism will result in
manufacture. The court concluded that a new blocking of further research on that
and useful art or process is an invention and microorganism.
where the end product is a new article, the The numerous concerns raised against
process leading to its manufacture is an patentability of microorganisms can be
invention. addressed by defining the term microorganism
This decision on the Calcutta High Court in a precise and scientific manner;
was synchronous with the position in the substantiating the differences between
United States, most of the European countries discovery and invention; by granting patents
as well as Japan, as most processes in the to only those inventions, which involve
biotechnology field will be patentable: substantial human intervention (for example,
irrespective of whether resultant product is genetic engineering).
living or non-living. After the Dimminaco From Diamond v. Chakrabarty to TRIPS
decision, the Indian law kept pace with the and beyond, manifests huge interest of biotech
needs of thriving biotechnology industry. industry for constant innovation and
endeavor, paving way for increased inventions
CONCLUSION that aim at human welfare. The criterion of
Patenting of life forms may have many utility is deeply embedded behind the
dimensions that relate to the use of rationale of patenting microorganisms,
intellectual property rights concept in the whether it is the usefulness of those
industrialized world and its appropriateness in microorganisms in treating oil spills,
the aspect of rights on knowledge, their preventing an infectious disease or the

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 Nair and Ramachandranna

creation of new drugs to combat 10. Eurasian Patent Organization. (1995) http://www
.eapo.org/rus/ea/index.html, accessed 22 April 2010.
life-threatening diseases. Without an
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