Journal of Intellectual Property Rights

Vol 15, January 2010, pp 55-65

Patenting Life the American, European and Indian Way

Ameen Jauhar† and Swati Narnaulia
West Bengal National University of Juridical Sciences, Salt Lake City, Kolkata 98, West Bengal

Received 27 September 2009, revised 19 December 2009

The patent regime heralds an expansion of its protective umbrella to the emerging sphere of biotechnology, full
repercussions of it are only just coming to fore. With revolutionary and rapid growth of industry, new legal and ethical
questions have burgeoned which require a meticulous and concerned deliberation. This article discusses evolution of
patenting life in the United States, Europe, and India. Additionally, implications of each country’s impact on international
patent regime in the light of TRIPS Agreement are also studied. The article also explores feasibility of offering similar
statutory protection to living organisms manufactured with significant human intervention in India, which thus far has only
witnessed a minimal onslaught of patent applications for ‘utility patents’.

Keywords: Bio-patents (life patents), TRIPS, product of nature, natural process, EPC, Biotechnology Directive

Generally, a patent is a negative right which affords varying extent in different countries. However,
the opportunity of exclusive commercial exploitation because traditional standards of non-obviousness and
to the patentee. However, a patent does not actually novelty apply to patenting of living matter as well,
include permission to use or market the invention, patenting of new life is based on the differences of
marketing approvals are granted separately.1 A patent new life with the characters and uses of known
hence furnishes a monopoly for a stipulated period of substances. Whether or not mere isolation of a
time2 and is a legal means of limiting competition. microorganism or gene from its natural surroundings
The limitation period for the monopoly is designed to is sufficient to obtain a patent also differs from
provide incentive to the inventor while adequately country to country. For instance, in the United States,
balancing the rights of the individual against those of ’isolated and purified’ compounds are considered
the society.3 Though it is imperative to be mindful of patentable subject matter when the application meets
the fact that patents4 are contested as a method of the statutory criteria for patentability. Yet a patent on
creating incentive for innovation and securing a gene covers the isolated and purified gene but does
necessary investment in production, marketing and not cover the gene as it occurs in nature. However, in
R&D. Inspite of such opposition, patent laws being a the European Union ‘biological material, which is
part of the traditional IPR regime have strong national isolated from its natural environment or produced by
roots and are subject to other domestic legislation. means of a technical process, may be the subject of an
Novelty and industrial application form the basic invention even if it previously occurred in nature.’5
criteria for determining patentability of subject matter. However, despite specific country’s standard for
Novelty marks the distinction between a discovery granting a patent on living matter, it clearly is a
and an invention. For decades this distinction has delicate, and often controversial, issue.
manifested itself in the form of ‘product of nature In addition to the legal debate, several practical
doctrine’ in the US and other similar rhetoric public health concerns have also been raised
elsewhere. It has contributed heavily to the exclusion concerning whether patents should be granted on bio-
of living matter from patentability. medical research. Many commentators point out that
Patents granted on living matter (i.e. micro- the patents on human gene sequences will
organisms), genetically modified plant and animal compromise medical treatments and medical research6
species, genes, cell lines, etc., are commonly referred as well as overburden the courts.
to as ‘bio-patents.’ Living matter is patentable to To address growing concerns over consequences of
—————— patenting of human genes, in September 1999, the
†Email Corresponding author: [email protected] then British Prime Minister, Tony Blair, entered into
56 J INTELLEC PROP RIGHTS, JANUARY 2010

an Anglo-American agreement with the then US ‘inventive’ status and private ownership or monopoly
President, Bill Clinton, to protect the 100,000 genes over life, per se emerged. There exists a debate over
of the human genome through the Human Genome whether new advances in technology mandate a new
Project, which is an international, collaborative, patent regime. In many ways, the arguments in favour
research program aimed to completely map and of an entirely new system resemble those voiced 30 to
understand all human gene, together referred to as the 40 years ago when polymer chemistry was an
‘human genome.’ It offered some relief to many who emerging technology.10 The debate goes beyond
feared monopolization of the human genetic whether existing patent regime should extend to living
information, patenting of human genes, cell lines and matter or not. As Chief Justice Burger explained, the
tissues, for the substances deposited in the issue was ‘not between living and inanimate things,
depositories would not be eligible for patents on but between products of nature—whether living or
account of having already been in public knowledge. not—and human-made inventions.’11 The ethical
In spite of such efforts, concerns over patentability concerns are continually voiced even today but are far
of living matter have acquired an increasingly global less vociferous. With bio-technology fast emerging as
dimension with full compliance by the developing a profitable sector its influence in biomedical and bio-
countries to WTO’s TRIPS Agreement. pharmacological sectors cannot be underestimated.
An increase in the number of bio-patents can safely be
The article is divided into three parts. Part I
predicted. It is hence imperative that a conclusion to
discusses the American and European patent regimes.
the debate be found sooner than later.
Part II discusses widely accepted fundamental legal
and moral challenges to this new form of patent Even though patents on living organisms were not
regime. Part III provides an insight into the Indian expressly excluded from the purview of patentable
history with the TRIPS Agreement and numerous matter, such a paradigm gained endorsement from
amendments made to the patent laws, before and the US Supreme Court in the epoch marking decision
after signing of the same. It also brings forth the in Diamond v Chakrabarty.12 In this case, the US
authors’ paradigm to India’s position with respect to Supreme Court held in a majority decision of 5:4, that
bio-patents. Congress, while drafting the enactment in question
(i.e. The US Patent Act) intended to ‘include anything
The American and European Patent Regimes and made by man under the sun.’ In reaching its decision,
Patentability of Bio-Patents the Supreme Court provided the requisite legal
protection to living organisms as long as they fulfilled
The American Jurisprudence on Life Patents patentability criteria under 35 U.S.C.°§ 101.
The Constitution of the United States empowers In Chakrabarty, the appellant (a microbiologist)
Congress to ‘secure for limited times to authors and challenged the USPTO’s decision refusing to grant a
inventors exclusive rights to their writings and patent on his mutated bacterium from the genus
inventions’7 for the promotion of innovation. The Pseudomonas containing therein at least two stable
United States Patent and Trademark Office (USPTO), energy-generating plasmids. This human-engineered
was established as a federal administrative unit to organism could help breakdown oil particles and
implement and regulate the US patent system.8 Under control oil spills; a novel attribute on which the
US legislation,9 there are four requirements for appellant based his arguments for the formation of a
granting a patent : the invention must be novel, must process for generating organism and for some unique
not statutorily be barred from acquiring patent rights, characteristics of the bacterium per se. The USPTO
must have utility, and must be non-obviousness. conceded that extraordinary characteristics exhibited
There is no imposition of any statutory bar on the made the organism non natural and hence could not
patentability of the subject matter, other than these be ousted as a ‘product of nature’. The USPTO
aforementioned four prerequisites. though agreeing to the plea of the applicant that such
The American law regarding patentability of ‘life organism was not naturally occurring in nature and
patents’ is ‘all inclusive’. Traditionally the system could not be barred patent rights as a ‘product of
of patents has been used for mechanical instruments, nature’.13 The sole ground for dismissing the patent
and the like. With the inclusion of biological material application was that the subject matter concerned was
to patentable subject matter disputes over their a ‘living organism’.14
 JAUHAR & NARNAULIA: PATENTING LIFE THE AMERICAN, EUROPEAN & INDIAN WAY 57

The Supreme Court of the United States, while Four criteria are highlighted in the EPC for
examining these different arguments, agreed that an determining patentability of any subject matter. The
engineered organism constituted a novel invention and EPC directs that for successful patent protection, the
was not a ‘product of nature’.15. It also stated that the matter concerned should be patentable; should display
Congress could have plausibly foreseen the rapid novelty and include an inventive step; and must prove
expansion of science and technology and stated that the industrial usage. These four criteria were reaffirmed
patent umbrella can be expanded to any and every thing in the Directive of 1998. In fact, for the purposes of
that ‘man had made under the sun.’16 The Supreme ensuring compatibility between the EPC and bio-
Court agreed that a challenge posed on two previous patents, the Directive categorically under Article 3.2
legislations which regulated certain forms of plants from specifies that biological material, after considerable
being patented should not prevent the appellant from human processing and intervention, cannot be
successfully patenting his novel organism.15 precluded from the ambit of patent protection simply
The Supreme Court, while expanding the because its initial existence was inherent in nature.22
functional framework of § 101, held that if a product A novel feature of the EPC is incorporation of a
were novel and portrayed characteristics which were ‘public order and morality’ clause under Section
hitherto unknown to mankind,17 it would suffice the 53(a). The said provision bars according of
clause’s requirement. The Supreme Court did not patent protection to any invention which is against
concur with the then prevailing imperative nature of public order and morality. This position is in
the ‘product of nature’ doctrine. This doctrine had contradistinction to the American patent law which
been propounded by the Supreme Court in the case of is bereft of any such ‘morality’ clause. The
Funk Bros Seed Co v Kalo Inoculant Co18 and was complementary provision to this clause under Section
relied upon by the USPTO to deny patent protection 53(b) bars patent rights for any variety of plants or
and inventor’s rights to a majority of patent animals or natural processes.
applications, filed in respect with living organisms. The decision in Harvard/Onco mouse23 represents
However, post this landmark judgment the Supreme adoption of these attributes by the European Patent
Court has, in a series of decisions, averted from the Office (EPO). In this case, inventor successfully
age old doctrine and declared that life form patented the Onco mouse, a transgenic organism,
constitutes patentable matter until the time it is which was mutated and altered by sufficient human
significantly altered via human intervention.19 and technical intervention to improvise it into a novel
To summarize, the legal position in the US on organism. The Onco mouse was receptive to breast
life patents has undergone a transitional phase. cancer and therefore, could successfully facilitate an
Currently, the interpretation of statutory and early diagnosis. The EPO deliberated over Harvard’s
regulatory principles on life patents has a liberal application for securing a patent for the ‘Onco
implication. For utility patents, it is necessary to mouse’. However, this was dismissed by the EPO as it
disclose with the patent application the proposed or considered the subject matter ‘a variety of animals’
unique function of the novel invention. Without and thus barred from patent protection under Section
disclosure, patent application stands to be rejected and 53(a). On appeal, numerous parties enjoined briefs to
the application process terminated. However, the the motion before the appellate body which did not
disclosure is necessary only with respect to one uphold EPO’s decision of declaring Onco mouse as
particular usage technique and not all plausible an animal variety. It did however, recommend the
manners for securing a patent protection. patent office to consider the briefs of the enjoined
The European Jurisprudence on Life Patents parties and determine if the invention in question was
The European patent system displays a disciplined in violation of public order or morality. The EPO
yet inclusive regime of according patent rights to ultimately, in 1994, ruled in favour of applicants
biotechnology and its numerous progenies. The granting them the disputed patent. Du Pont, the main
guideline prescriptions for the European nations sponsor of the research and creation of the organism,
regarding municipal patent laws are incorporated in was also granted the patent rights.
two primary documents–the European Patent The Harvard/Onco mouse case clearly displays
Convention20 (EPC) and the Biotechnology Directive willingness in Europe to grant patents to adequately
of 199821 (the Directive). humanly engineered biological products. Again in
58 J INTELLEC PROP RIGHTS, JANUARY 2010

1995, the Court granted a patent for a DNA sequence discovery in all patent law regimes, has never been
encoding a human protein, produced by pregnant protected under the patent umbrella.
women, which assisted with the pregnancy.24 It was The only point which can be definitively concluded
held that the subject matter in question was more than in such a debate is whether sufficient human
a mere discovery as it ‘had to be isolated from its intervention has occurred to create an organism
surroundings and a process had to be developed to distinct and independent in existence from the one
obtain it.’ This case restricted the applicability of the previously occurring. Under almost all patent
‘products of nature’ doctrine. regimes, affiliated directly or indirectly to the TRIPS
All this said, it is not to be misconstrued that the Agreement or deriving substance of their municipal
patent regime in Europe is ‘all inclusive’ like the law from it, bio-patents are permissible. The argument
American regime. The European regimes clearly bars of the subject matter being ‘products of nature’ has
inventions of varieties of plants and animals, naturally been dismissed as archaic and obsolete and therefore,
occurring processes, those opposed to public order untenable.27 However, circumspection needs to be
and morality and certain other subject matters exercised while traversing this realm of patent laws.
highlighted under Section 52(2) of the EPC. The An excessive award of ‘utility patents’ to living
European disposition, as far as bio-patents are organisms and allied structures can often spark off
concerned, has been liberal and derives a lot from the ethical qualms.
TRIPS Agreement. Under Article 27.1 of TRIPS, it is
a prerequisite that the subject matter of the patent The Issue of Informed Consent
application be defined as an invention and not a mere ‘Every human being of adult years and sound mind has the
discovery; following this the invention further has to right to determine what shall be done with his body.....’
sufficiently be ‘new, innovative and capable of Cardozo J., (1914)28
industrial application.’25 However, in spite of this The current argument examines the legal basis of
liberal inclination among the common European informed consent doctrine as means to respect patents
patent instruments, namely ,the EPC and the and persons who act as research subjects and it
Directive, the national IP laws of a majority of the considers the extent to which consent to patenting does,
European nations are still in aberration and pursue a and should play a role in contemporary patent law.
more rigorous and stringent approach to the grant of The idea of informed consent stems from the
life patents. This is primarily because of the fundamental ethical principle of autonomy, which
subservience of both the aforesaid documents to gives the patient right to knowledge of his own
municipal laws. medical condition, and requires the physician to
respect any decision made by the patient in regard to
Bio-Patents: The Ethical and Moral Dilemmas his own health care. In consistence with the autonomy
The issue of patenting life or animate organisms principle, the goal of informed consent is to fully
and living cells, tissues et al, is more challenging than educate the patient on his condition, thereby enabling
the simple task of enacting legislation and statutes. him to make the best decision for himself.
The issue has, at its heart, a conflict of interests, ideas,
However, encumbering onus of obtaining an
notions and paradigms. The challenges ensuing from
‘informed consent’ of a research subject requires a
it evolve into more of a debate of scruples rather than
meticulous disclosure of the intentions of the
anything else.26 A discussion of the moral and legal
researcher, especially those of commercial nature.29 A
debates follow, which are considered as critical moot
landmark judgment which expounds on the vitality of
points under the bio-patent regimes.
informed consent is the John Moore case23, delivered
The ‘Invention versus Discovery’ debate by the Californian Supreme Court. The case involved
A major argument has consistently irked anti-bio removal of spleen from the appellant on the premise
patent advocates; whether an organism or a living end of an imminent medical procedure. The spleen was
product manufactured by essentially using a naturally later used to manufacture an immortal spleen line
occurring product can be contended to be more than a which was subsequently patented. The Supreme
mere discovery, and go on to be granted patent Court, admonishing the defrauding action of the
protection as a ‘novel invention’. The question is a respondents, stated that the necessary information was
fundamentally vital issue to be determined as a mere not disclosed to the appellant thereby making his
 JAUHAR & NARNAULIA: PATENTING LIFE THE AMERICAN, EUROPEAN & INDIAN WAY 59

consent redundant. A vital matter that was patents. If the above stated ‘subject’s welfare’
conspicuously absent in the court’s deliberation was argument is forwarded with respect to human patents,
the validity of the patent granted to the respondents. the same can be contended on the presumption of a
It is also not ‘redundant’ to incorporate a regulatory competent consent. Therefore, insofar private
clause in the patent laws in addition to other individuals are concerned the argument fails as
regulatory mechanism. The aforementioned problem adequate amount of care and interest protection is
regarding the status of the patent in Moore’s case can guaranteed while informing the subject of the nature
justify this stipulation. An eminent jurist31 has also of commercial interests that the researcher intends to
suggested incorporation of a clause which necessitates pursue, thereby leaving the discretion of continuing
procurement of the consent of the research subject with the research with the subject.35
before filing of the application. Such a provision is
not supplanting or transgressing into the territory of The Questions of Ordre` Public and Morality
the regulatory mechanism. It actually complements The TRIPS Agreement under Article 27(2)
the same through its concomitant functioning rather maintains that member nations can exclude inventions
than being contradictory to it.32 from patentability for enforcing ordre public or
morality. Similar provisions can be located under the
The ‘Environmental Ethics’26 Question Biotech Directive and European Patent Convention.
The term environmental ethic has been defined as The complexity arises as none of the text
relationship between man and his surroundings which unequivocally stipulates what is the essence of such a
establishes a cardinal sense of respect for the land and provision. The TRIPS provision, for example,
not merely determines it as an exploitative resource. It prohibits only commercial exploitation of the
also aspires to forge a more compatible existence of invention on grounds of public order or morality. This
men and their fellow beings with the latter not only is a huge lacuna given the fact that the exception is
facing the brunt of an exploitation rage. handicapped in situations where certain unethical
The ‘Lockean’ derivative in the ‘fruits for labour’ inventions are not put to commercial usage.
argument33 is prima facie antithetical to the very It is argued whether the provisions suggest a bar on
principles of environmental ethics. While the former research in those areas or limiting the grant of patents
endeavors to accord adequate benefits to any man in the same. Thus there emerges a conflict providing
who creates a product, the latter is the flip side; it patent law a transcendental role infringing into the
stems from the proposition that since the end product territory of regulatory law. However, it is undesirable
derives a valuable input from the originally innately that patent law defends something when the very
occurring organism, hence, interests of this organism seminal research is considered unethical.
are paramount concern, ethically. It is critical to scrutinize these arguments and try to
The authors at this point, wish to take strong note diagnose their ramifications for the successful yet,
of the discrepancy and fallacy in this argument. As ethical implementation of any IPR regime. The
even in the stand taken by the US Supreme Court in questions aforementioned are not unnecessary
Diamond v Chakarabarty, human intervention leads academic averments but indeed, stipulate certain
to the creation of a novel organism, something legitimate apprehensions of an expanding patent
hitherto not unknown to mankind but one that was not regime. Simultaneously an overly cautious tone to any
there before. Even in Indian jurisprudence emphasis regulatory machinery will inevitably invite numerous
has been given to the crucial nature of inventive steps unwanted but licit challenges to the same. Therefore,
which alter the original substance into something a quintessential system, especially ones in nascent
considerably variable from its previous state.34 It is patent regimes like India, needs to derive a balance
the authors’ firm belief that a presumption of between the two with the provision of enough room to
ownership in favour of the subject of research, or the insert situational exceptions.
person from whom the research material is extracted,
over the end product which uses human ingenuity, is Life Patents: The Indian Perspective
fallacious even if the material is essentially his. The Indian Patents Act, 1970 governs patent
A second disagreement stems from an alleged protection in India. It has been gradually amended
neglect of the subject’s welfare. Such an argument is over 1999-2005 to suit India’s international
untenable at least for the purposes of human life obligations under TRIPS. The TRIPS seeks to remove
60 J INTELLEC PROP RIGHTS, JANUARY 2010

perceived barriers to ‘free-trade’ by establishing article, substance, nor is it manner of manufacture. It

minimum IPR standards across the world. It directs had claimed that since the vaccine involved
member countries to provide for product patents to all processing of certain microorgasm it was only a
technologies and on microorganisms. It also makes natural process. Even though there was no express or
non-compliance with the statutes of the WTO liable to implied bar in the Indian Patent Act 1970, patents
prosecution and severe punitive action including were traditionally granted only to non-living
sanctions or fines. Inspite of safeguards and other inventions that fulfilled the patentability criteria. The
flexibilities provided in the form of preferential appellant contended that there had been a violation of
treatment to the developing and least developed rule of law as preference was given to discretionary
countries, scope of patentability as outlined under administrative policy over the statutory definition of
TRIPS is considered far too wide by most developing what an invention entailed, which did not bar the
members.36 They argue that overly strong IPR with barring of a patent on the process of manufacturing a
extended scope and duration of protection are proving vaccine, containing a live virus.43
to be detrimental to the very object and purpose of The Court observed that the term ‘manufacture’
TRIPS Agreement.37 India has always maintained that had not been defined in the Act and consulted a
‘…patent rights should be exercised coherently with variety of dictionary meanings to conclude that the
the objectives of mutual advantage of patent-holders process for manufacturing such a vaccine is new
and users of patented medicines, in a manner process and such new process was patentable under
conducive to social and economic welfare and to the §544 read with §2(I)(i)45 of the Patent Act. The
balance of rights and obligations.’38 Hon’ble Court relied on the vendibility test46 to
When India became a party to the WTO in 1995, in determine the question of patentability of a process. It
spite of strong civil society opposition,39 TRIPS was concluded that since the claim process for patent leads
an indispensable part of the deal. The then national to a vendible product, it is certainly a substance after
policy makers hoped that the overall gains made from going through the process of manufacture. Reference
greater links with the global trading community was also made to M/s Bishwanath Prasad Radhey
would more than upset any possible dangers of Shyam v Hindustan Metal Industries station (AIR
accepting a stricter IP regime. 1982 SC 1444) to clarify the other patentability
Having contested to fully utilize its ten year requirements of newness and usefulness.
transition period India has introduced three major The Court adopted a careful stance though many
amendments to the Patents Act, 1970. The first among considered it a bold step, legalizing patentability of
these was the 1999 amendment which introduced living matter in India even before a legislative
exclusive marketing rights (EMRs)40 and established amendment expressly provided for the same. It is
mailbox applications for patents for pharmaceuticals important to note that the case was for a process
and agrochemicals from 1 January 1995.The next patent over the process of manufacture, as was
amendment came in 2002 which allowed for patents repeatedly stressed by the appellant. It only allowed
on microorganisms.41 Even prior to this amendment, for patenting of a process resulting in a product with
the judiciary had interpreted the patent regime under living matter not over the living matter itself. The
the unamended Patent Act to cover a patent on a case was also fundamentally different from that of
living organism much to the displeasure of the Indian gene patenting, which would have had other concerns
Patent Office. The Hon’ble High Court of Calcutta, in of impediments to research et al, the case was about a
the matter of Dimminaco A G v Controller of Patent process patent over a vaccine. Issues about all future
Designs & Ors (2002 IPLR 255 Cal. H.C.),42 was mutations of a gene being covered by one patent and
approached by a Swiss company which had been availability for further competitive research become
refused a process patent for preparation of a live more prominent in case of a product patent regime.
vaccine for Bursitis. The Patent Office had denied to Moreover, even though the case was decided in
grant a patent on the grounds that the so-called favour of the Appellant, the Court reserved its right to
invention, containing a living organism, was not decide such cases on a factual basis. It held that
patentable as under §2(1)(j). The Patent Office whether a claim for the grant of patent was an
contended that the process of making a vaccine with a invention or not, had to be decided only after detailed
living organism is neither a process resulting in an scrutiny of the facts of each case.
 JAUHAR & NARNAULIA: PATENTING LIFE THE AMERICAN, EUROPEAN & INDIAN WAY 61

This decision of the Calcutta High Court is also if the Hon’ble High Court’s intention is read right,
seen as concurrent with the position in US and most that the doors have been opened for patenting
EU countries which allow patentability of biotech products with living microorganisms with both
inventions. legislative as well as judicial sanction.
Subsequent to the decision, the Act has been The 2005 amendment substituted new §3(d) for
amended by the Patents Amendment Act 2002. the existing section which limited the scope of
The amendment has changed the definition of patentability by excluding ‘the mere discovery of a
‘invention’. The earlier requirements under Section new form of a known substance which does not result
2(j) which added to the primary requirement of in the enhancement of the known efficacy of that
newness and usefulness like those of an invention substance’.51 The constitutional validity of §3(d) was
being art, product or process, method or manner of subsequently unsuccessfully challenged by global
manufacture; machine, apparatus or other article; pharmaceutical giant, Novartis in the Hon’ble High
substance produced by manufacture, including any Court of Madras.
useful improvements on the said has been omitted.
The overall expansion of patentability criteria has
The definition has been simplified and the only
resulted in an increased number of patent applications
requirements of patentability now are that a product
and, consequently, an increase in the number of
of process must be new, non-obvious and useful.47
patents granted in the field of biotechnology. An
The relevance of the decision subsequently, though
assessment of the annual reports of the Indian patent
debatable does highlight the relative unwillingness of
office (2007 Annual Report)52 reveals that from
the judiciary to refuse the patent merely on ethical
2000-01, where four applications were submitted and
grounds. However in the new scheme of things it is
no patents were granted, the number of applications
uncertain whether addition of §3(j),48 which excludes
has been steadily increasing. In 2003-04, 23 patent
from patentability essentially biological processes
applications had been filed, though no patents
for production of plants and animals, or plants
were granted. During 2004-2005, there was a
and animals in whole or in part other than
phenomenal increase in the number of applications;
microorganisms, would derail the benefits for future
73 biotechnology patents were granted in that year
applicant, if the subject of patent application was
alone. The tally for 2007-08 (the last available report)
adjudged to not be a microorganism by the virtue of
stands at 1950 applications and 314 grants.
being a non-microscopic organism.49 It is therefore
necessary to have a clear working definition for Judging from India’s insistence upon substantial
‘microorganism’ either as a legislative explanatory review of Article 27.3, support for the African
amendment or judicial pronouncement. A review of group’s proposal53 on review of Article 27.354
the draft manual of patent, practice and procedure by presented in 1999 (which suggests that ‘patents on life
the national working group on patent laws50 also should be prohibited, including those on
reveals that there is a need to define the term microbiological processes’). Indian polity does not
microorganism. Moreover, the draft manual on seem too keen on allowing patents on life forms.
page 72, paragraph 4.10.1 of the draft manual In July 1999, India highlighted the need to focus on
indicates that any microorganism discovered from two complementary dimensions, one of which was
nature is not patentable while according to §3(j) of the fundamentally political question of whether patenting
amended act by implication all ‘microorganisms’ are life is acceptable in terms of ethics.55 India has also
patentable. If such discrepancies are not ironed out the adopted a more conservative European approach on
judiciary may strike down the guidelines in the draft patents by opting to utilize the morality clause in
manual as administrative instructions which cannot TRIPS. It is in stark opposition to the US approach,56
overrule the statue. which argues that patenting of life forms has
Further, with the deletion of §5 of the Act, pursuant tremendous advantages.
to the 2005 amendment, which provided for only There is no time frame stipulated in the TRIPS
process patents on chemical processes, including provisions for conclusion of the review process.
biochemical, biotechnological and microbiological Accordingly it has been delayed by the developed
processes as well as substances intended for or block effectively, little progress being made since the
capable of being used as food or medicine, it appears, review process started in December 1998.57
62 J INTELLEC PROP RIGHTS, JANUARY 2010

With all the increased application numbers, the micro-biological data is deposited, and the region of
Indian polity still robustly implements a more its availability disclosed and kept open to research
rigorous patent regime for protection of living and other such uses after the publication of patent
organisms than its American counterpart. There are application. The depositories under the human
still options open to India and other developing genome process perform a similar function, for once
countries reluctant to extend patentability provisions some information is disclosed or made public it is no
to living matter. Article 27.1 of TRIPS guards against longer new and cannot be patented.
discrimination but differentiation is still permitted.58 To assess whether after the 2005 amendment India
The non-discriminatory provision does not prevent had indeed become TRIPS compliant and if the
member countries from fixing the threshold of measures taken to ensure TRIPS compliance were in
patentability criteria which are applicable to all national interest the Mashelkar Committee was set
fields of technology and hence not discriminatory. up in April 2005. One of the issues the Committee
TRIPS leaves it to member countries to determine dealt with was whether it would be consistent with
appropriate method of implementing its provisions TRIPS to exclude microorganisms from patenting.
and define certain key provisions that determine the The Mashelkar committee submitted a report in
scope of patentability. Carlos Correa argues that there December 2006 which it later withdrew citing
is no obligation under the TRIPS Agreement to adopt technical inaccuracy and plagiarism as reasons.61 The
an expansive concept of ‘invention’, as is currently revised version of the report was submitted in March
done by many developed countries. In particular, 2009 which has only recently been released to the
nothing in the Agreement obliges Members to public. The revised version of the report restates to a
consider that substances existing in nature, biological large extent the Committee’s previous findings, which
or not, are patentable, even if isolated and claimed in had been criticized for not taking into account
purified form.59 public health goals. The committee concluded that it
It is interesting to note that in Novartis AG, shall be in violation of TRIPS to exclude
represented by its Power of Attorney Ms Ritushka microorganisms completely from patentability and
Negi and Anr v Adarsh Pharma and Anr that ‘microorganisms involving human intervention
(2004(3)CTC95) 60, one of the contentions raised was and utility are patentable subject matter under the
how §3(d) was contradictory to Article 27 of TRIPS, TRIPS Agreement, provided they meet the prescribed
which obligates WTO member states to provide patentability criteria.’62 The Committee has also
patent protection to all fields of technology without been criticized for not having taken a policy
discrimination, and therefore violates the obligations perspective on the issue. It furthers patents on
under the TRIPS Agreement. But the court sought bio-tech inventions on three grounds. The first one
jurisdiction issue and did not deal with the matter. being increased prospects of FDI and contract R&D
The Hon’ble Court’s suggestion to approach the by attracting foreign collaboration to the ever growing
WTO dispute settlement mechanism was also and increasingly profitable bio-tech industry in a bio-
not followed. But the Court did reaffirm the diverse country like India.
provisions constitutional validity with Article 14. The authors would like to point out that India
Further stipulation under Article 8 accords adequate would have an advantage in attracting FDI and other
discretion to TRIPS signatories to deny patents in such projected benefits only so long as other nations
observing and up keeping interests in ‘ordre` public do not provide similar relaxations. It is relevant to
and morality’. And India has forever stressed, in a note that most countries with advanced bio-tech fields
stance complimented by Paragraph 4 of the Doha like, USA, Republic of Korea, Japan, China and
Declaration, that any interpretation of the provisions European Countries already provide far wider patent
of the agreement should be consistent with Article 8. protection on living matter than India.
Another safeguard in place is the presence of a The second reason cited by the committee was
global depository of genetic data as mandated concern over biological matter of Indian origin being
under Budapest Treaty and the Convention for Bio- patented by foreign players. This is a faulty argument
Diversity. Microbial Type Culture Collection and as well. India is already a signatory to the Convention
Gene Bank (MTCC) at the Institute of Microbial on Bio-diversity (CBD), according to Article 15 of the
Technology (IMTECH), Chandigarh ensures that all CBD when a material is taken from a country prior
 JAUHAR & NARNAULIA: PATENTING LIFE THE AMERICAN, EUROPEAN & INDIAN WAY 63

informed consent and material transfer agreements are 5 EU: Directive 98/44/EC, Art. 3.2.
required to be initiated to acknowledge the country of 6 http://www.greenpeace.org/international/campaigns/genetic-
engineering/feeding-the-world-facts-vers/risks, August 1, 2009
origin. It must be India’s prerogative to uphold the (*Patenting allows industry to take control of and exploit
CBD to prevent bio-piracy instead of looking for organisms and genetic material as exclusive private property
alternatives which require India to adopt a system that can be sold to or withheld from farmers, breeders,
least suited to its needs. The committee finally seeks scientists and doctors; See Interview of Dr Tewolde
Egziabher, Head, Ethiopian environmental protection authority
to justify its suggestions by citing obligations under and the non-profit Institute for Sustainable Development by
TRIPS. It refuses to realize that there are flexibilities Michael Friedrich (Greenpeace) (20 June 2002).
available within TRIPS like non-definition of three 7 U.S. Constitution. Art. I, § 8, Cl. 8.
criteria of patentability (novelty, non-obviousness, 8 35 U.S.C. § 1.
usefulness) which make it possible for India to define 9 http://www.bitlaw.com/source/35usc/index.html. August 16,
2008 (*U.S. Patent Act (35 U.S.C.). The US Patent Act is
restrictively the scope of patentable subject matter. found in Title 35 of the US Code and contains the federal
statutes governing patent law in the United States).
Conclusion 10 Doll John J, The patenting of DNA, Science, 280 (5364)
There has been a systemic lobbying and subsequent (1998) 689 - 690.
successful shift towards greater IP protection for 11 DeMott John S & Thomas Evan, Test-Tube Life: Reg. US
Pat. Off., 30 June 1980, http://www.time.com/time/magazine
biotech inventions, including protection of living /article/0,9171,924274,00.html (1 August 2009).
organisms. The process has quickened in the past 12 447 US 303 (1980).
decade with the developing countries becoming fully 13 A product of nature, under both US and European laws is
TRIPS compliant. However, even with such unpatentable as it fails to satisfy the preliminary criterion of a
compliance the question of providing protection akin novel invention. The European paradigm as is reflected in the
Biotechnology Directive and the European Patent
to that available in the developed world hangs in the Convention (EPC) is discussed in the subsequent pages.
balance with concerns over potential trade and FDI 14 The USPTO expressing its inhibitions of liberally construing
benefits and ethical political positions etc. weighing the expression ‘new matters of composition’, stipulated that
on either side. It is in view of this conflicting position such proactive action would ‘open the flood gates to
patentability for all newly produced microorganisms as well
that the authors would posit here the need to balance as for all newly developed multi-cellular animals such as
out; the commercial interests of individuals’ vis-à-vis chickens and cattle.’
the interests of the rabble. It is the authors’ belief 15 Diamond v Chakrabarty, 447 U.S. 303, 310-318.
that the direct and most effective implementation of 16 The Court emphasized on the broader implementation that
TRIPS still leaves potential scope for introducing was envisioned under the Patent Act of 1793, authored by
Thomas Jefferson. It also cited the Congress Committee’s
flexibilities considering the indigenous conditions reports [Rep. No. 1979, 82d Cong., 2d Sess., 5 (1952); H. R.
prevalent in the Indian IP regime. Sensitivity towards Rep. No. 1923, 82d Cong., 2d Sess., 6 (1952)], on the re-
interests of public by heeding adequately to the codified Patent statute which imported the same broad
numerous ethical and public health issues raised is essence of Jefferson’s seminal statute.
17 Funk Bros case (333 US 127) (‘Product of Nature’ doctrine).
vital. However, any exhibition of unfound paranoia 18 In Funk Bros, plaintiff Kalo Inoculant Company brought a
must be diametrically denounced and abstained from; patent infringement action against the Funk Brothers Seed
so as to promote scientific knowledge and Company. The Supreme Court applied the ‘products of nature’
temperament, as is also a constitutional (fundamental) doctrine to reject Kalo's patent. Justice Douglas declared that
duty to which every citizen is bound. patents cannot issue for the discovery of the phenomena of
nature. The qualities of these bacteria are manifestations of laws
of nature, free to all men and reserved exclusively to none.
References 19 Ex Parte Allen, 2 U.S.P.Q. 2d 1425, 1426-27 (1987); The
1 For commercially exploiting a patented drug one needs to
apply for marketing approval to various national regulatory Amgen case [927 F.2d 1200, 1206 (Fed. Cir. 1991)]
authorities. These marketing approvals are granted upon (Patentability of Human Deoxyribonucleic Acid (DNA)
satisfaction of a variety of criteria and effectively be used to sequences).
negate monopolization of markets. 20 The EPC was signed in Munich as the Convention on the
2 http://www.worldtradelaw.net/uragreements/tripsagreement. Grant of European Patents, 5October 1973. Signatories to the
pdf (31July 2009). EPC included the then fifteen EU member states,
3 Panel Report, Canada-Patent Protection of Pharmaceutical Switzerland, Liechtenstein, Monaco, and Cyprus. The term
Products, WT/DS114/R (2000). used is suggestive of an absolute coverage of the said
4 Patents are often viewed as instrument of economic convention in all of Europe. However, two points to be
policy aimed at rewarding the inventor, Straus Joseph, considered are, firstly, the convention does not grant an
Biotechnology and Patents, 54 CHIMIA 293 (2000). all-European patent and any patent accorded is to be
64 J INTELLEC PROP RIGHTS, JANUARY 2010

corroborated under national patent laws. Secondly, the patent regime follows suit, congruence would suggest that it
convention though ratified and signed by numerous EU re-enforces the system. Where a research process progresses
members, is an independent entity. For an elaborate infractuous to the right to self determine, such process
discussion on the provisions of the EPC, see Gitter Donna M, culminating into a patent protected object would be
International conflicts over patenting human DNA sequences offensive. Therefore, a mandatory check in the patent law
in the United States and the European Union: An argument only complements the delimitations of the regulatory
for compulsory licensing and fair-use exemption, N.Y.U. Law mechanism.
Review, 76, 2001. 33 The argument derives its bedrock ingredients from the
21 The European Biotechnology Directive; directive 98/44/EC Lockean argument which concurs with the right to ownership
of the European Parliament and the Council on the legal of a man over any product crafted by him. The argument
protection of biotechnological inventions. The directive was boils down from the ‘I made it and it would not have existed
a consequence of the decision to uniformly structure the without my intervention’ paradigm. For a summary on the
patent laws of various nations. The Directive was Lockean theory of labor argument of property see Lawrence
incorporated in the EPC in 1999. Becker, Property Rights, Chapter 4, (1997) in Hettinger N,
22 This particular provision of the Directive seeks to derive its Patenting Life: Biotechnology, Intellectual property and
endeavored goals from Recital 18 in the text of the Biotech Environmental Ethics, Boston College. C. Environmental
Directive; the same exposing the inadequacy of European Affairs Law Review, 22, 1994-1995, 267.
municipal legislations for protecting and encouraging 34 Bishwanath Prasad Radhey Shyam v Hindustan Metal
biotechnological development. The provision under Article Industries, AIR 1982 SC 1444.
3.2 is reinforced by the stipulation under Article 1.1 which 35 Such a disclosure is necessary as was also held in Californian
cajoles European nations to amend their domestic enactments Supreme Court’s holding in Moore wherein they stated the
in conformity with the Directive. For example, UK amended
the national legislation (the Patents Act, 1977) in 2000. The imperative obligation of the researcher to disclose all of their
subsequent adoption of S-76A inculcates the Directive’s commercial interests, if any.
objective with respect to Biotechnology. 36 ‘When the Uruguay Round was launched, several developing
23 Harvard/Onco mouse, 1992 O.J. E.P.O. 588 (Examining countries resisted the entry of Intellectual Property Rights
Div.), reprinted in 1991 Eur. Pat. Off. Rep. 525, 525-27. (IPRs) into the agenda. But under pressure from the U.S.
24 Hormone Relaxin, 1995 O.J. E.P.O. 388 (Opp. Div.) (and its S.301 threats) they yielded, resulting in the
25 Article 27.1 provides, ‘patents shall be available for any agreement on Trade- Related Intellectual Property Rights
inventions, whether products or processes, in all fields of (TRIPS) as part of the WTO agreements.’ The industrialized
technology, provided that they are new, involve an inventive countries (and the industries of the North that were the
step and are capable of industrial application.’ driving force behind TRIPS) succeeded in setting rules that
26 Hettinger N, Patenting life: Biotechnology, intellectual were viewed by several economic experts of developing
property and environmental ethics, Boston College countries as having the potential to cause most damage to
Environmental Law Review, 22, 1994-1995, 267. development prospects’, Failure of TRIPS: A time for review,
27 The position of the American, European and Australian The Hindu, 21 April 2001.
courts is articulated through a chain of case laws. These have 37 The objective of TRIPS, mentioned in Article 7, states: ‘The
already been alluded to in the Part I. the case law and protection and enforcement of intellectual property rights
legislative inclination strongly denounces the denial of patent should contribute… to the mutual advantage of producers
protection on grounds of the object being ‘a product
and users of technological knowledge and in a manner
of nature’ or naturally occurring. As stipulated in the
Chakrabary case, a genetically altered organism is conducive to social and economic welfare…’
distinctively variant from it original form and therefore, 38 http://www.centad.org/focus_33.asp, 1 August 2009
novel and ingenuous in nature. (Gopakumar K M, Mashelkar Committee Report: A Critique).
28 Schloendroff v Society of New York Hospital, (1914) 105 39 V R Krishna Iyer, O Chinnappa Reddy, D A Desai &
N.E. 92, 93 (NY). Rajinder Sachar, Peoples’ Commission on GATT, Centre for
29 In fact one of the proposed amendments in the process of Study of Global Trade System and Development (1996).
drafting of the European Biotechnology Directive was to 40 India's domestic patent law describes the EMR as the
incorporate a clause making it imperative for the researcher exclusive right to sell and distribute the substance or article
to purport his commercial interests, if any, to the research concerned. TRIPS mandates a five-year EMR in the interim
subject so as to provide the latter ample opportunity to in exchange for letting the corresponding product patent
exercise his will over his physical autonomy. application lie in the mailbox to be opened only after 1
30 Moore v Regents of the University of California, 271 Cal. January 2005 and until it is thereafter decided. MR should be
Rptr. 146 (Cal 1990). allowed on satisfaction of two conditions: product patent and
31 Graeme Laurie, Patents, Patients and Consent: Exploring the marketing approval in a foreign country, and marketing
approval and product patent application in India.
Interface between Regulation and Innovation Regimes, in 41 Patents (Amendment) Act § 4(e) (25 June 2002).
The Regulatory Challenge of Biotechnology, 214 (Hans 42 The Indian Patent Office rejected the patent application of
Somsen ed., 2007). the appellants on grounds similar to those contended in
32 The aim of such a provision would be to ‘achieve Diamond v Chakrabarty (US Supreme Court). The Patent
congruence’ with the regulatory mechanism. Where the Office argued that the patent regime intended and had
regulatory mechanism has already mandated consent and the conventionally protected the rights of inventors of inanimate
 JAUHAR & NARNAULIA: PATENTING LIFE THE AMERICAN, EUROPEAN & INDIAN WAY 65

objects and living organisms were per se ineligible for the 54 WT/GC/W/302; The African Group’s comprehensive
same protection. The Hon’ble Calcutta High Court proposals have received much support from
overturned this order of the Patent Office. other developing countries in the WTO, civil society groups,
43 The defendant argued that process for the preparation of the and NGOs.
said vaccine, which had a living entity in it, would not be 55 The developing countries which had little or no say
covered under the definition of manufacture. The controller in drafting most TRIPS provisions viewed the review
of patents contended that the final product had the micro- process scheduled every 4 years as a means to make their
organism in a dormant lyophilized state, hence not dead. demands heard. See, Review of Article 27.3(b), Paper
Lyophilization is the technique of removing water from a IP/C/W/369/Rev.1.
frozen biomaterial via application of a vacuum. 56 http://www.iprsonline.org/ictsd/docs/IPR_collection.pdf
44 Patent Act, 1970, § 5 says a product intended for use, or (1 August 2009).
capable of being used, as food or medicine or drug, or which
57 Article 27.3(b): Views of the United States of America,
is created by a chemical process is not patented. paper presented at the TRIPS Council, WTO, Geneva, 20
45 Defined invention under the un-amended Patent Act, 1970. October 1999, p. 7.
46 The vendibility test is a test to check if the process results in
the production of some vendible item, i.e.an item which can be 58 For a detailed chronological account of developments in the
transferred upon sale and purchase. The Court ultimately held long review process see Grain, for a full review of TRIPS
that the process for creating a vaccine leads to a vendible 27.3(b), 15 March 2000, http://www.grain.org/briefings_files
product, even if the end product contains live material. /tripsfeb00.pdf ( 1 August 2009); Cecilia Oh, Available
47 Subbaram N R, Protection of biotech inventions, The Hindu, options Article 27.3(b) of the TRIPS Agreement: Review
29 December 2003. options for the South, http://www.twnside.org.sg/title/oh1-
48 Patents (Amendment) Act § 4(e) (June 25, 2002); § 3 (j) was cn.htm ( 1 August 2009).
developed along the lines of Article 27(3) (b) it states that 59 Panel Report, European Communities and their Member
plants and animals in whole or any part thereof other than States, WT/DS 114/R (17 March 2000).
micro-organisms but including seeds, varieties and species
60 Carlos Correa, Intellectual property rights, the WTO and
and essentially biological processes for production or
developing countries: The TRIPS Agreement and policy
propagation of plants and animals are not patentable.
options, Third World Network, London / Penang 2000.
49 The Patents (Amendment) Act, 2005, §3.
50 Microorganisms are generally described as microscopic 61 Dr Raju K D, The debacle of Novartis patent case in India:
organisms. Strict interpretation of patentability criteria under Article 27
51 http://www.patentoffice.nic.in/ipr/patent/Patent_Manual_Fee of the TRIPS Agreement, Indian Journal of Intellectual
dback/NATIONAL_WORKING_GROUP_ON_PATENT_L Property Law, 1 (1) (2008).
AWS_NEW_DELHI.pdf , 1 August 2009. 62 Sharma Ravi and Hiddleston Sara, Mashelkar committee on
52 The Patents (Amendment) Act, 2005, www.patentoffice Patent Law withdraws report; seeks more time, The Hindu,
nic.in /ipr/patent/patent_2005.pdf. 22 February 2007, http://www.thehindu.com/2007/02/22/
53 http://ipindia.gov.in/cgpdtm/AnnualReport_English_2007- stories/2007022206751200.htm.
2008.pdf, 1 August 2009 (Indian Patent Office, Annual 63 Report of the Technical Expert Group on Patent Law Issues,
Report 2007-08). revised March 2009.