Content uploaded by Ramkumar Balachandran Nair
Author content
All content in this area was uploaded by Ramkumar Balachandran Nair
Content may be subject to copyright.
© 2010 Macmillan Publishers Ltd. 1462-8732 Journal of Commercial Biotechnology Vol. 16, 4, 337–347
www.palgrave-journals.com/jcb/
INTRODUCTION
A patent is an intellectual property right
relating to inventions and is the grant
of exclusive rights, for limited period,
provided by the Government to the
patentee, in exchange of full disclosure
of his invention, for excluding others,
from making, using, selling, importing the
patented product or process producing
that product for those purpose.
1
A patent is a bunch of exclusive rights granted
by the state to an inventor or his assignee on
satisfying certain conditions. The inventor is
Original Article
Patenting of microorganisms:
Systems and concerns
Received (in revised form): 23 rd August 2010
Ramkumar Balachandra Nair
is a fi nal 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 scientifi c 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 fi elds of microbiology and biotechnology. His current research work includes studying
the various aspects of the commercial approach to the scientifi c research portfolio. The work mainly focuses on application of the
intellectual property rights to establish a benefi cial 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 fi led
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 suffi cient controversy
regarding the term ‘ microorganism ’ , which has not been clearly defi ned. 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 signifi cant human intervention on harmonized global patent systems and also elaborating
on the need for a well-accepted defi nition 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
Correspondence: Pratap Chandran Ramachandranna
Department of Biotechnology, K. V. M. College of Engineer ing and
Information Technology, Kokkothamangalam P.O., Cherthala, 688583,
Kerala, India
E-mail: drpratapchandran@yahoo.co.in
Nair and Ramachandranna
© 2010 Macmillan Publishers Ltd. 1462-8732 Journal of Commercial Biotechnology Vol. 16, 4, 337–347338
given a monopoly right over the product for
a fi xed number of years in exchange for
the public disclosure of certain details of a
machine, method or the composition of
matter. The objective of patent law is to
encourage inventions by promoting their
protection and utilization for the development
of industries, promotion of technological
innovation, and transfer and dissemination of
technology. It stimulates new inventions of
commercial utility. The patent is granted for a
limited period to the inventor and after the
period of expiry of the patent, the monopoly
goes into public domain. Patent right is
territorial in nature and patent obtained in
one country cannot be enforced in other
country.
The premise of intellectual property (IP)
law is that by recognizing and rewarding the
innovator, it fosters industrial and technical
progress paving way for a vibrant socio-
economic structure. Since invention is the life
breath of growth and development, it is
pertinent that the same must be protected
against unnecessary encroachment. This has
become more evident in context of huge
strides being made in the fi eld of
biotechnology and information technology.
With advancements in biotechnological
research and pharmaceutical industry, pressure
started mounting on policymakers to allow
patenting of basic life forms so as to
encourage research and development
initiatives, which can contribute to exploring
the unrecognized commercial utility of such
life forms. New techniques have been
developed to create novel life forms like
genetically modifi ed plants and animal species,
genes, cell lines and so on, which can be
patented as ‘ bio-patents ’ .
2 But, the laws
regulating and protecting these experiments
and their subsequent innovations continue,
however, to sputter at an inchoate stage. One
reason for the situation can be the different
economical and ethical standings of the
nations, which are being brought under the
umbrella provisions of the World Trade
Organization (WTO).
However, the debate revolves around the
limits of such protection. One strand of this
mystery is the patentability of microorganisms,
which requires a critical analysis of the present
position of law and a further rumination
with regard to its future prospects. Section 27
of TRIPS recognizes microorganisms as a
patentable subject matter and therefore
many nations have now started patenting of
microorganism through their domestic patent
laws.
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 fi ling date. As it is a
monopoly right, the grant of a patent must
fulfi ll 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 effi cacious
protection of IP rights. It specifi es 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
fi elds of technology, provided that they are new,
involve an inventive step and are capable of
industrial application. TRIPS do not defi ne the
Patenting of microorganisms
© 2010 Macmillan Publishers Ltd. 1462-8732 Journal of Commercial Biotechnology Vol. 16, 4, 337–347 339
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 included.
6 First patent based on
microorganisms was made by Louis Pasteur
on 28 January 1873, for the process of
fermenting beer.
7 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
purifi cation 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 modifi ed bacterium was granted a
patent.
BUDAPEST TREATY:
DEPOSITION OF
MICROORGANISMS
The Budapest Treaty on the International
Recognition of the Deposit of
Microorganisms for the Purposes of Patent
Procedure, or Budapest Treaty, is an
terms ‘ new ’ , ‘ inventive step ’ or ‘ capable of
industrial application ’ . In patent terms, ‘ novel ’
means not previously ‘ made available to the
public ’ .
4
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 fi eld of technology and whether products
are 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 fi eld 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.
5 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.
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 fi eld 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, modifi cation of
Nair and Ramachandranna
© 2010 Macmillan Publishers Ltd. 1462-8732 Journal of Commercial Biotechnology Vol. 16, 4, 337–347340
international treaty signed in Budapest,
Hungary, on 28 April 1977. It was enforced
on 9 August 1980, and was later amended on
26 September 1980. The treaty is
administered by the World Intellectual
Property Organization.
8 As of December
2008, 72 countries were party to the Budapest
Treaty. 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,
9 the Eurasian Patent
Organization (EAPO)
10 and the European
Patent Organization (EPO) have fi led a
declaration of acceptance under Article 9(1)(a)
of the Treaty.
11
The treaty allows ‘ deposits of
microorganisms at an international depositary
authority to be recognized for the purposes
of patent procedure ’ .
12 Usually, in order to
meet the legal requirement of suffi ciency
of disclosure, patent applications and patents
must disclose in their description the
subject-matter of the invention in a manner
suffi ciently clear and complete to be carried
out by the person skilled in the art.
Regarding any invention involving a
microorganism, it is impossible to describe it
completely. This is why, in the particular case
of inventions involving microorganisms, a
deposit of biological material must be made in
a recognized institution. The Budapest Treaty
ensures that an applicant, that is a person who
applies for a patent, need not deposit the
biological material in all countries where
he / she wants to obtain a patent. The
applicant needs to only deposit the biological
material at one recognized institution and this
deposit will be recognized in all countries
party to the Budapest Treaty.
INTERNATIONAL
DEPOSITARY AUTHORITY
(IDA)
The deposition of patents of microorganisms
in a culture collection recognized as an IDA
might be necessary in the realm of IP rights.
It is likely that IDAs will transform into
‘ biological resource centers ’ and further into
‘ global common genetic resources ’ , with an
internationally agreed legal basis for benefi t
sharing.
13 The deposits are made at an IDA in
accordance with the rules of the Treaty on or
before the fi ling date of the complete patent
application. Article 7 of the Budapest Treaty
outlines the requirements for a facility to
become an IDA.
12 As of 1 March 2008, there
were 37 IDAs in approximately 20 countries
worldwide.
DEPOSITABLE MATTER TO
THE IDA
IDAs have accepted deposits for biological
materials, which do not fall within a literal
interpretation of ‘ microorganism ’ . The Treaty
does not defi ne what is meant by
microorganism . It is not necessary for the entity
being deposited to be a microorganism – it
should only be required for the purposes of
disclosure and must be acceptable to the IDA.
The range of materials able to be deposited
under the Budapest Treaty includes: cells, for
example, bacteria, fungi, eucaryotic cell lines,
spores; genetic vectors (such as plasmids or
bacteriophage vectors or viruses) containing a
gene or DNA fragments;
14 organisms used for
expression of a gene (making the protein from
the DNA).
TRIPS AGREEMENT:
PATENTING
MICROORGANISMS
The agreement on TRIPS is an international
agreement administered by the WTO,
15
which sets down minimum standards for
many forms of IP regulation as applied to
other WTO members. It was negotiated at
the end of the Uruguay Round of the
General Agreement on Tariffs and Trade
16 in
1994. Apart from setting the basic minimum
standard for patentability, TRIPS obliges
member states to patent microorganisms.
17
Therefore, an understanding as to what
constitutes a microorganism is essential.
However, the term lacks a precise scientifi c
defi nition because of which there are inherent
Patenting of microorganisms
© 2010 Macmillan Publishers Ltd. 1462-8732 Journal of Commercial Biotechnology Vol. 16, 4, 337–347 341
The European Commission (EC)
19 – 20
directives on microorganisms defi ne it as any
microbiological entity, cellular or non-cellular,
capable of replication or transferring genetic
material. EC directives have also defi ned
biological material as any material containing
genetic information and capable of
reproducing itself or being reproduced in a
biological system. Various defi nitions 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.
21
A microscopic organism consisting of a
single cell or cell cluster, including the
viruses.
22
Hence a quotation from an English dictionary
would not be suffi cient to provide a
defi nition of the term ‘ microorganism ’ . A
more precise and scientifi c defi nition is
required for the purposes of providing a clear
defi nition of the scope of exceptions to
patentability set out in Article 27.3(b) of
TRIPS agreement. Hence TRIPS agreement
produces an ambiguity in defi ning
microorganisms. The more authentic decisions
regarding the patentability of microorganisms
were made by the US Supreme Court in
1980 (Diamond v. Chakrabarty case), when
the genetically modifi ed bacterium was
granted a patent.
31
CRITERIA OF NOVELTY
FOR PATENTING
MICROORGANISMS
A microorganism exists as a part of the Nature;
hence its discovery is NOT an invention . If it is
an invention, logic of treating scientifi c
theories and principles as non-patentable
inventions gets defeated. If microorganisms
isolated from the nature for the fi rst time are
•
•
•
•
anomalies in patenting these life forms.
Although the TRIPS agreement is mandatory
for patent production of microorganisms, yet
it does not defi ne microorganisms; thus there
is no yardstick defi nition for member nations
to follow in this regard. There is no clarity
whether the term would include only
genetically modifi ed organisms or naturally
occurring substances also.
However, the term microorganism will be
understood in its widest sense to include any
biological material that is self-replicable or
replicable via a host organism. Sub-cellular
material like genes, gene sequences, plasmids,
replicons and so on will come under the
defi nition of a microorganism. Some of the
patentable micro-biological inventions
according to the TRIPS agreement are: (i)
process of producing a new microorganism;
(ii) new microorganism as produced by the
defi ned process; (iii) new microorganism per
se ; and (iv) process of cultivation or otherwise
using a known or new microorganism to: (a)
a form of multiplied microorganism itself, for
example vaccine or edible biomass, and (b) a
by-product of microbial growth, for example
an antibiotic, enzyme, toxin or an otherwise
useful industrial product. However, it
becomes obligatory to provide patents for
‘ microorganism ’ and ‘ micro-biological ’
processes. Neither microorganism is defi ned in
the TRIPS agreement nor does the agreement
specify any parameters concerning the scope
of its protection.
18
MICROORGANISMS: MEANING
AND DEFINITION
A general defi nition 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.
Nair and Ramachandranna
© 2010 Macmillan Publishers Ltd. 1462-8732 Journal of Commercial Biotechnology Vol. 16, 4, 337–347342
considered patentable, then minerals and ores
discovered from the interior of earth and deep
seabed would qualify for patenting. Thus,
microorganisms can be considered as an
invention only if the microorganism has not
been described in the literature and there is
an element of human intervention with the
discovery.
23
The general notion is that the patent
system encourages the creation of new,
previously unforeseen inventions. Therefore,
even though Chakrabarty simply shuffl ed
genes, changing bacteria that already existed,
the widest interpretation by the court lent the
broadest amplitude to patentability to the
living subject matter. Thus, the US position
could be summarized as: once the basic
patentability criteria are met, as for any other
technological invention, living matter can be
patented. The relation between invention and
products of nature does not correspond to the
relation between living and non-living things,
but between products of nature and man-
made inventions.
24 There is a wide spread
controversy regarding the consideration of
microorganisms as ‘ invention ’ or ‘ discovery ’ .
25
Extensively interpreted, therefore, the
invention concept would also encompass the
kinds of subject matter that require human
intervention in order to make them available
in a useful form by way of isolating or
purifying naturally occurring products. The
TRIPS agreement nowhere defi nes the term
microorganism, and the lack of a commonly
accepted scientifi c defi nition poses the risk of
inherently chaotic interpretations by different
jurisdictions. As far as the question of
compliance with TRIPS is concerned, most
patent laws do not deal specifi cally with the
question of whether or not a new living strain
of microorganism is itself patentable, but the
EPC
26 does not exclude the possibility.
27 The
EPO does grant patents for microorganisms,
as the patentability is not explicitly excluded.
The present position is thus: microorganisms
are patentable not only in the United States,
but also Europe, Japan and all major
jurisdictions under the TRIPS obligation.
DIAMOND V. CHAKRABARTY:
OPENING A NEW AVENUE
FOR PATENTING SYSTEMS
The patenting of inventions per se seems to be
interwoven with the doctrine of product of
nature. This doctrine specifi es that potentially
patentable subject matter must be created
through human intervention. Patents are not
available for the handiwork of nature. Thus a
newly discovered mineral or plant found in
the wild is not patentable subject matter
under 35 U.S.C S.101.
28 – 30 In contrast, the
so-called purifi ed forms of natural products
may be patentable if they are suffi ciently
different from the non-purifi ed (natural) forms
so as to be novel and non-obvious. The non-
patentable status of living organisms changed
with the landmark decision of the Supreme
Court, USA, in Diamond v. Chakrabarty in
1980, when the genetically modifi ed
bacterium was granted a patent.
31 In 1972,
Ananda Mohan Chakrabarty, a genetic
engineer and a researcher of the General
Electric Company, fi led a patent application
in relation to a bacterium that was intended
to consume petroleum (oil) spills (superbug).
Chakrabarty claimed that: A bacterium from the
genus Pseudomonas containing therein at least two
stable energy-generating plasmids, each of said
plasmids providing a separate hydrocarbon
degradative pathway: Salicylate – an aromatic
hydrocarbon, and, Naphthalene – a polynuclear
aromatic hydrocarbon, was a human-made,
genetically engineered bacterium capable of breaking
down multiple components of crude oil. It was
asserted that because of this property, which is
not possessed by any naturally occurring
bacteria, the invention could treat oil spills.
The versatility of these ‘ novel ’ microorganisms
was demonstrated by the substantial extent to
which degradation of complex hydrocarbons –
such as crude oil – was achieved. Hence
Chakrabarty requested a patent for the
bacterium in the United States but was turned
down by a patent examiner, because the law
dictated that living things were not patentable.
The Board of Patent Appeals and
Interferences agreed with the original
Patenting of microorganisms
© 2010 Macmillan Publishers Ltd. 1462-8732 Journal of Commercial Biotechnology Vol. 16, 4, 337–347 343
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.
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
signifi cance. 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 defi nition 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 reaffi rmed that the bacterium
was not a handiwork of nature; rather it was
Chakrabarty ’ s own invention, hence satisfi es
the criteria for being patented.
PATENTING
MICROORGANISMS: POSITION
IN INDIA
Patent Act of India, 1970, Section 2(1)(j)
34
defi nes an invention as a new and useful
manner of manufacture or a substance produced by
manufacture. No defi nitions of manner of
manufacture or substances were given in the
Act. Hence the Patent Offi ce adopted the
practice of interpreting a manner of manufacture
decision; however, the United States Court
of Customs and Patent Appeals overturned
the case in Chakrabarty ’ s favor, writing that
‘ the fact that microorganisms are alive is
without legal signifi cance for purposes of the
patent law ’ . Sidney A. Diamond,
Commissioner of Patents and Trademarks,
appealed to the Supreme Court. In the
Supreme Court the case was argued on 17
March 1980 and decided on 16 June 1980.
32
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 fl oating on water, such
as straw, and the new bacteria.
Third, claims to the bacteria themselves.
The patent examiner allowed the claims
falling into the fi rst 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 Offi ce 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,
•
•
•
Nair and Ramachandranna
© 2010 Macmillan Publishers Ltd. 1462-8732 Journal of Commercial Biotechnology Vol. 16, 4, 337–347344
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.
35
THE PATENT AMENDMENT
ACTS
The Patent Amendment Act 2002 came into
force in May 2003, bringing microorganisms
within the realm of patentability. Section 3( j)
was couched in terms of Article 27(3) (b). It
states that: plants and animals in whole or any
part thereof other than microorganisms but
including seeds, varieties and species and
essentially biological processes for production
or propagation of plants and animals are not
inventions within the meaning of this Act. It
excluded microorganisms from the exceptions
to patent protection and allowed patenting of
processes pertaining to microorganisms as well
as non-biological and microbiological
processes.
Subsequently, The Patents Act, 1970 was
once again amended in the year 2005, so as
to establish congruence with TRIPS. The
amendment deleted Section 5 of the Act,
which provided for only process patents. The
provision included inventions where only
methods or processes of manufacture were
patentable. Therefore, the deletion of this
section paves way for product patents, which
is in stark opposition to US approach that
argues patenting of life forms has tremendous
advantages.
36
Despite concerns against the patenting of
microorganisms, this position may augur well
for the biotechnology industry as it is growing
at an inexorable pace.
DIMMINACO A G v.
CONTROLLER OF PATENTS
AND DESIGNS
Patentability of biotechnological process
with living end product was ascertained by
Calcutta High Court decision in the case of
Dimminaco A G v. Controller of Patents
(2002).
37 The facts of this case are that –
Dimminaco A.G., a Swiss Company applied
for patenting the process for preparation of a live
vaccine for Bursitis. Bursitis is an infectious
poultry disease and the invention involved a
live (attenuated) vaccine to combat the disease.
The Controller of Patents refused to allow
application on the ground that as the vaccine
involved processing of certain micro-organic
substances, this was only a natural process
devoid of any manufacturing activities and
hence not patentable under S.2(1)(j). This was
in consonance with the prevailing practice
that granted patents only to non-living and
tangible inventions that fulfi lled the
patentability criteria, even though the Patent
Act imposed no such limitation.
However, on appeal, the Calcutta High
Court diverted from the above position. It
rejected the contention of the controller that
a patent is given only for a process that results
either in an article, substance or manufacture
and that a vaccine with a living organism is
not an article, substance or manufacture .
38 The
Controller had claimed that the dictionary
meaning of article is a ‘ material thing, item,
a thing of a particular class or kind as
distinguished from a thing of any class of
kind ’ . The Controller said the defi nition does
not cover living things. Law does not bar
processes where the end-product is living – No
statutory bar in the Act to accept a manner of
manufacture as patentable even if the end product
contains a living organism.
Through creative judicial exposition, the
Calcutta High Court held that: ‘ The Indian
Patenting of microorganisms
© 2010 Macmillan Publishers Ltd. 1462-8732 Journal of Commercial Biotechnology Vol. 16, 4, 337–347 345
ownership, use, transfer and dissemination.
In the global scenario, the TRIPS agreement
makes it mandatory to provide patent
protection to microorganisms and non-
biological and microbiological production
of plants and animals. This makes it diffi cult
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
defi nition of microorganism. The national
rule-makers must defi ne 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 defi ning the concept of invention
and discovery. Microorganisms as such occur
in nature and their discovery cannot be called
invention. Microorganism when genetically
modifi ed falls in the category of invention
because of human input. Genetically modifi ed
microorganism may perform any number of
activities, hence patenting of this genetically
modifi ed microorganism will result in
blocking of further research on that
microorganism.
The numerous concerns raised against
patentability of microorganisms can be
addressed by defi ning the term microorganism
in a precise and scientifi c 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
statute on patents does not put any fetters on
patentability of microorganisms developed in a
controlled environment in the laboratories ’ .
Taking recourse to the normal dictionary
meaning of manufacture, the court observed
that manufacture is where ‘ the material in
question after going through the process of
manufacture has undergone any change by the
inventive process and it becomes a material
which is different from the starting material ’ .
39
The court held that this meaning of
manufacture does not exclude the process of
preparing a product that contains a living
substance from patentability.
Court also held that the process for creating
a vaccine leads to a vendible product even if
the end product contains living material.
40
The court said that if the invention results in
the production of some vendible items or
improves or restores formal conditions of
vendible item or its effect in preservations
and prevention from deterioration of some
vendible product, then such an invention
would pass the vendibility test. Therefore, as
the claim process for patent leads to a
vendible product, it is certainly a substance
after going through the process of
manufacture. The court concluded that a new
and useful art or process is an invention and
where the end product is a new article, the
process leading to its manufacture is an
invention .
This decision on the Calcutta High Court
was synchronous with the position in the
United States, most of the European countries
as well as Japan, as most processes in the
biotechnology fi eld will be patentable:
irrespective of whether resultant product is
living or non-living. After the Dimminaco
decision, the Indian law kept pace with the
needs of thriving biotechnology industry.
CONCLUSION
Patenting of life forms may have many
dimensions that relate to the use of
intellectual property rights concept in the
industrialized world and its appropriateness in
the aspect of rights on knowledge, their
Nair and Ramachandranna
© 2010 Macmillan Publishers Ltd. 1462-8732 Journal of Commercial Biotechnology Vol. 16, 4, 337–347346
creation of new drugs to combat
life-threatening diseases. Without an
effi cacious 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.
ACKNOWLEDGEMENTS
We sincerely thank our Director, Dr V. V.
Pyarelal, for providing necessary facilities and
support. We express our heartfelt gratitude to
our principal Dr K. N. James and
administrative offi cer Professor S. Vijayan
Nair for their constant inspiration during the
course of this study. Encouragement from all
the faculty members and students are duly
acknowledged.
REFERENCES
1 . Nair , A . S . ( 1999 ) Intellectual property rights (IPR):
Indian scenario . Everyman’s Science 34 (2) : 58 – 61 .
2 . Ammen , J . and Swathi , N . ( 2010 ) Patenting life
the American European and Indian way . Journal of
Intellectual Property Rights 15 : 55 – 65 .
3 . European Patent Convention (EPC) . ( 1973 ) Article
52, patentable inventions . 2 March, http://www
.epo.org/patents/law/legal-texts/html/epc/1973/e/
ar52.html , accessed 5 March 2010 .
4 . Philip , M . W . ( 2006 ) Patenting of microorganisms .
Nature Reviews Drug Discovery 13 (5) : 45 – 56 .
5 . United States Patent and Trademark Offi ce 35
U.S.C. 101 Inventions patentable
– Patent Laws,
18 December, http://www.uspto.gov/web/offi ces/
pac/mpep/documents/appxl_35_U_S_C_101.htm ,
accessed 15 April 2010 .
6 . Sekar , S . and Kandavel , D . ( 2002 ) Patenting
microorganisms: Towards creating a policy
framework . Journal of Intellectual Property Rights 7 :
211 – 221 .
7 . Debr é , P . and Forster , E . ( 1998 ) Louis Pasteur .
Baltimore, MD: Johns Hopkins University Press .
8 . The World Intellectual Property Organization
(WIPO) . ( 2010 ) Agency of the United Nations ,
http://www.wipo.int/portal/index.html.en , accessed
24 April 2010 .
9 . African Regional Intellectual Property Organization
(ARIPO) . ( 1976 ) http://www.aripo.org/index
.php?option=com_content & view=frontpage & Itemid
=28 , accessed 26 March 2010 .
10
. Eurasian Patent Organization . ( 1995 ) http://www
.eapo.org/rus/ea/index.html , accessed 22 April 2010 .
11 . WIPO web site . ( 2010 ) Budapest treaty on the
international recognition of the deposit of
microorganisms for the purposes of patent
procedure . 15 March, http://www.wipo.int/
treaties/en/registration/budapest/trtdocs_wo002
.html#P120_14461 , accessed 9 March 2010 .
12 . Depositary institutions having acquired the status
of International Depositary Authority under the
Budapest Treaty, Rule 13.2 (a) – List of international
depositary authorities, 1 April, http://www.wipo.int/
export/sites/www/treaties/en/registration/budapest /
pdf/ida.pdf , accessed 5 April 2010 .
13 . Sekar , S . and Kandavel , D . ( 2004 ) The future of
patent deposition of microorganisms . Trends in
Biotechnology 22 (5) : 213 – 218 .
14 . Ames , D . ( 2004 ) Patenting our human heritage:
The threats posed by patenting DNA . 10 January,
http://www.scienceinafrica.co.za/2004/january/
patenting.htm , accessed 2 April 2010 .
15 .
WTO ( 2010 ) Understanding the WTO: Basics,
what is the World Trade Organization? 5 March,
http://www.wto.org/english/thewto_e/whatis_e/
tif_e/fact1_e.htm , accessed 26 March 2010 .
16 . WTO ( 2010 ) Uruguay Round Agreement, General
Agreement on Tariffs and Trade 1994 , http://www
.wto.org/english/docs_e/legal_e/06-gatt_e.htm ,
accessed 5 March 2010 .
17 . WTO ( 2010 ) Uruguay Round Agreement: TRIPS,
part II – Standards concerning the availability, scope
and use of intellectual property rights . Sections 5 and
6,Article 27 Patentable Subject Matter, http://www
.wto.org/english/docs_e/legal_e/27-trips_04c_e.htm ,
accessed 12 April 2010 .
18 . Mittal , D . P . ( 1999 ) Indian Patent Law . New Delhi:
Taxmann Allied Services .
19 . EUROPA . ( 1950 ) European Union institutions and
other bodies, institutions of the EU, European
Commission , http://europa.eu/institutions/inst/
comm/index_en.htm , accessed 16 April 2010 .
20 . Nanda , V . P . (
1996 ) European Union law after
Maastricht: A practical guide for lawyers outside
the common market . In: R.H. Folsom and R.B.
Lake (eds.) The Union Has Two Primary Types of
Legislative Acts, Directives and Regulations . The
Hague, The Netherlands: Kluwer , p. 5 .
21 . Heritage , J . , Evans , E . G . V . and Killington , R . A .
( 2002 ) Introductory Microbiology . London: Cambridge
University Press .
22 . Madigan , M . T . , Martinko , J . M . and Parker , J .
( 1997 ) Brock Biology of Microorganisms . London:
Prentice Hall International (UK) .
23 . Smith , E . J . ( 1996 ) Biotechnology . Cambridge, UK:
Cambridge University Press .
24 . Westerlund , L . ( 2002 ) Biotech Patents Equivalency
and Exclusions under European and US Patent Law .
New York: Kluwer Law International .
Patenting of microorganisms
© 2010 Macmillan Publishers Ltd. 1462-8732 Journal of Commercial Biotechnology Vol. 16, 4, 337–347 347
33 . Indian Legislation . ( 2002 ) PATENTS (Amendment)
Act 2002 . Act No. 38 OF 2002, 25 June , http://
www.commonlii.org/in/legis/num_act/
pa2002189/ , accessed 13 March 2010 .
34 . Patent Act of India . ( 1970 ) Section 2(1) (j), http://
www.iprsonline.org , accessed 1 May 2010 .
35 . The Patents Act . ( 1970 ) [39 of 1970, dt. 19-9-1970]
[As amended by Patents (Amdt.) Act, 2005 (15 of
2005), dt. 4-4-2005], http://www.spicyip.com/
docs/statute-combined%20patents% 20act%
202005.pdf , accessed 19 April 2010 .
36 . Janice , M . M . ( 2000 ) An Introduction to Patent Law .
New York: Aspen Publishers .
37 . Michigan State University v. The Assistant
Controller of Patents and the Controller General of
Patents, Trademarks, Designs and Geographical
Indications, Patent Offi ce http://indiankanoon.org/
doc/918903/ , accessed 3 May 2010 .
38 . Prashant , R . D . ( 2010 ) Patenting of microorganisms
. indlaw.com, 15 May, http://students.indlaw.com/
display.aspx?4631
, accessed 22 April 2010 .
39 . Manpreet , K . ( 2010 ) Patentability of micro-
organisms . IPR-Indlaw.com, 15 May, http://ipr
.indlaw.com/search/articles/?c09721d8-3644-4ceb-b9d7-
303558cb0182 , accessed 26 March 2010 .
40 . The Patent Offi ce . ( 2008 ) Draft Manual of Patent
Practice and Procedure , 3rd edn. India: The Patent
Offi ce , http://www.patentoffi ce.nic.in/ipr/patent/
DraftPatent_Manual_2008.pdf , accessed 7 April
2010 .
25 . Kollek , R . ( 1995 ) Ambiguous genes . Biotechnology
and Development Monitor 23 : 24 .
26 . European Patent Convention (EPC 1973) . ( 2010 )
Convention on the grant of European patents
(European Patent Convention ) . 29 November,
http://www.epo.org/patents/law/legal-texts/html/
epc/1973/e/ma1.html , accessed 2 April 2010 .
27 . Philip , W . G . ( 2004 ) Patents for Chemical
Pharmaceuticals and Biotechnology Fundamentals of
Global Law, Practice and Strategy . London: Oxford
University Press .
28 . 35 USC 100-section of the U.S. Patent Act
(found in Title 35 of the United States Code
[35 USC § § 1 et seq.], http://www.bitlaw.com/
source/35usc/100.html , accessed 26 April
2010 .
29 . 35 U.S.C. § 1, Term of patent in the United States,
27 April, http://en.wikipedia.org/wiki/ Term_of_
patent_in_the_United_States , accessed 30 April 2010 .
30 . U.S. Constitution. Article I, § 8, Cl.8 U.S., http://
www.usconstitution.net/const.html , accessed 22
April 2010 .
31 . Diamond v. Chakrabarty, 447 U. S. 303 (1980),
http://supreme.justia.com/us/447/303/ case.html ,
accessed 5 April 2010 .
32 . United States Patent and Trademark Offi ce . ( 1999 )
35 U.S.C. 101 Inventions patentable. – Patent
Laws, http://www.uspto.gov/web/offi ces/pac/
mpep/documents/appxl_35_U_S_C_101.htm ,
accessed 22 April 2010 .
