Patenting of Life Forms: Evolution and Development

Project: Intellectual Property Rights

Submitted to:
Ms. Tulika Shree

Submitted by:
Neeraj Ekka
ROLL NO. 78
4th year, VIIth Semester

HIDAYATULLAH NATIONAL LAW UNIVERSITY

ACKNOWLEDGEMENT
It gives me the greatest of pleasure to thank Ms. Tulika Shree for her invaluable help and
guidance without which it would not have been possible to make the project.
Her insight into the topic and continuous motivation has been a source of great inspiration for
me.
I would also like to thank my parents and my friends who supported me throughout the making
of my project and helped me as and when they could.
Neeraj Ekka
Sem. - VII

CONTENTS
Introduction......................................................................................................................................3
Creation of New Life Question........................................................................................................3
Patenting Life Forms: US Perspective.............................................................................................4
Diamond v. Chakrabarty Case.........................................................................................................5
Further Development of Life Form Patents.....................................................................................6
The Indian Perspective....................................................................................................................7
The Future of Patenting Life Forms..............................................................................................12
Bibliography..................................................................................................................................15

Introduction
The patenting of life forms is a relatively new phenomenon, but its incidence has grown at a
tremendous rate in recent years, especially since the establishment of the Trade Related
Intellectual Property Rights (TRIPS) Agreement of the World Trade Organization (WTO) in
1995. Most countries had prohibited patenting of biological resources, but the TRIPS treaty
makes it mandatory for WTO member states to allow patenting of at least certain life forms
(microorganisms) and certain living processes (microbiological processes). It also mandates the
intellectual property protection of plant varieties either by patents or an effective sui generis
system. The floodgates having been opened to patenting of biological resources has led to
serious consequences. Many critics of patenting of life forms have argued that it is inappropriate
to use the patent system to reward scientific work in the field of biological resources and
processes, as living organisms are qualitatively different from non-living materials.1

Creation of New Life Question

There is a conceptual issue involved in the phrase, creation of new life forms, and the
conceptual issue lies in how and where to draw a line between creation of a new life form and
modification or manipulation of an old one. As Dismukes has put it, to call intervention in
the normal processes by which strains of bacteria exchange genetic information Human
handiwork wildly exaggerates human power and displays the same hubris and ignorance of
biology that have had such devastating impact on the ecology of our planet. 2 Such arrogance
perhaps leads to the notion that our understanding of the fundamental mechanisms of life is
approaching completeness and that we are in a position to create nature after our own desires.
The conceptual link between creation of new life forms and an exclusive patent right is
through those forms being the result of someones own efforts. But of course the new life forms
1 Richard T. Hull, Ph.D., The Creation and Patenting of New Life Forms: A New Assault on Academic
Freedom?, Given as a University Honors Lecture Governors Quadrangle, SUNY at Buffalo March 20,
1988
2 Ibid

that are being produced by means of the technology of recombinant DNA differ from
manufactured objects; even if we grant that a new bacterium is the product of some persons or
laboratorys effort, its subsequent generations of offspring are not the products of human effort,
but of natural bacterial reproduction. My Datsun, despite all my efforts to coax and coddle it, will
never produce another Datsun. The capacity of self-reproduction is a hallmark of the distinction
between living and nonliving; the notion of patenting a life form threatens to muddle our
capacity to keep clear on such elements of thought. L.B. Cebik has objected that, in granting the
patentability of new forms of life, the Supreme Court is not undermining the concept of life. It
holds that it is merely necessary to determine whether an entity, living or inanimate, qualifies as
an invention by determining whether there has been sufficient manipulation, directly or indirectly
(e.g., via machinery or designed chemical processes), by human beings to qualify the resultant
entity as human made. But of course such a judgment will be valuational and philosophical.
Short of putting together from non-organic elements a cluster of functioning genes and a cell
body to house them, such research will always borrow from the natural technology of living
systems, always be working within the natural confines of organisms not of human invention.
Any judgment that a modified organism is human made has got to involve a deliberate turn away
from the facts of nature.3

Patenting Life Forms: US Perspective

What is patentable in the United States according to statute dates back to the patent law of 1793,
which declared, in language written by Thomas Jefferson, that patents could be obtained for "any
new and useful art, machine, manufacture, or composition of matter, or any new or useful
improvement thereof." Jefferson's phrasing remained -- and remains -- at the core of the U.S.
patent code, except for the eighteenth-century word "art," which was replaced in a 1952
Congressional overhaul of patent law by the word "process."4

3 Shelley A. Rowland & James W. Piper, Patents and Biotechnology: Issues Around the Patenting of Life
Forms
4 Ibid

The code said nothing about patenting life, but a key precedent discouraging it was established in
1889, when, in a landmark ruling, the U.S. Commissioner of Patents rejected an application for a
patent to cover a fiber identified in the needles of a pine tree. He noted that ascertaining the
composition of the trees in the forest was "not a patentable invention, recognized by statute, any
more than to find a new gem or jewel in the earth would entitle the discoverer to patent all gems
which should be subsequently found." The commissioner added that it would be "unreasonable
and impossible" to allow patents upon the trees of the forest and the plants of the earth. The
commissioners ruling formed the basis for what came to be known as the "product-of -nature"
doctrine -- that while processes devised to extract what is found in nature can be patented,
objects discovered there cannot. They are not inventions, nor can they as a class be made
anyones exclusive property.5
There was no other extension of patent law to vital entities for forty years, but in 1970 Congress
established a system -- through the Plant Variety Protection Act (PVPA) for granting
intellectual property rights in sexually reproducing plants. The protection was weaker than what
patents provided; it was nevertheless a step forward for plant breeders. More important, during
that period it became possible to identify living organisms with a high degree of specificity
through such markers as blood types and, in the 1970s, their DNA.
The landmark breakthrough in the field of patenting life forms was through the case of Diamond
vs. Chakraborthy. Ananda Chakrabarty, a biochemist at the General Electric Company, having
genetically modified the bacterium to consume oil slicks, filed for a patent on the living, altered
bacterium. In 1987, the United States Commissioner of Patents announced that "the Patent and
Trademark Office now considers non-naturally occurring nonhuman multi cellular living
organisms, including animals, to be patentable subject matter. The Commissioner was simply
following the Supreme Court's lead. In allowing the patenting of a genetically altered oil-eating
bacterium seven years earlier, the Court claimed Congress intended patentable subject matter
to "include anything under the sun that is made by man.6
5 Ameen Jauhar and Swati Narnaulia, Patenting Life the American, European and Indian Way Journal of
Intellectual Property Rights Vol 15, January 2010, pp 55-65
6 Ibid

Diamond v. Chakrabarty Case7

Patents on living organisms were not expressly excluded from the purview of patentable matter,
such a paradigm gained endorsement from the US Supreme Court in the epoch marking decision
in Diamond v Chakrabarty. In this case, the US Supreme Court held in a majority decision of
5:4, that Congress, while drafting the enactment in question (i.e. The US Patent Act) intended to
include anything made by man under the sun. In reaching its decision, the Supreme Court
provided the requisite legal protection to living organisms as long as they fulfilled patentability
criteria under 35 U.S.C. 101. In Chakrabarty, the appellant (a microbiologist) challenged the
USPTOs decision refusing to grant a patent on his mutated bacterium from the genus
Pseudomonas containing therein at least two stable energy-generating plasmids. This humanengineered organism could help breakdown oil particles and control oil spills; a novel attribute
on which the appellant based his arguments for the formation of a process for generating
organism and for some unique characteristics of the bacterium per se. The USPTO conceded that
extraordinary characteristics exhibited made the organism non natural and hence could not be
ousted as a product of nature.
The USPTO though agreeing to the plea of the applicant that such organism was not naturally
occurring in nature and could not be barred patent rights as a product of nature. The sole
ground for dismissing the patent application was that the subject matter concerned was a living
organism. The Supreme Court of the United States, while examining these different arguments,
agreed that an engineered organism constituted a novel invention and was not a product of
nature. It also stated that the Congress could have plausibly foreseen the rapid expansion of
science and technology and stated that the patent umbrella can be expanded to any and every
thing that man had made under the sun. The Supreme Court agreed that a challenge posed on
two previous legislations which regulated certain forms of plants from being patented should not
prevent the appellant from successfully patenting his novel organism. The Supreme Court, while
expanding the functional framework of 101, held that if a product were novel and portrayed

7 35 U.S.C. 101

characteristics which were hitherto unknown to mankind, it would suffice the clauses
requirement.8

Further Development of Life Form Patents

"Utility patents" for plants came next, and by the end of the decade Harvard University received
the first patent on animal life. Its patent was for a mouse genetically altered to be susceptible to
breast cancer. As the project's major sponsor, Du Pont possesses commercial rights and the
chemical company is selling the patented research specimen for fifty dollars apiece. The Patent
and Trademark Office has recently issued three additional patents on types of animals, all for
mice to be used in biomedical research. Although human organisms have not been patented,
human material routinely is patented. One particularly controversial example is the University of
California at Los Angeles's patent of a cell line produced from a spleen removed from a
Leukemia patient named John Moore. Although the commercial potential of the pharmaceuticals
that this cell line can produce is several billion dollars, the California Supreme Court has ruled
that Moore has no ownership interests in these cells after they have been removed from his body.
Post this landmark judgment the Supreme Court has, in a series of decisions, averted from the
age old doctrine and declared that life form constitutes patentable matter until the time it is
significantly altered via human intervention.9

The Indian Perspective

The Indian Patents Act, 1970 governs patent protection in India. It has been gradually amended
over 1999-2005 to suit Indias international obligations under TRIPS. The TRIPS seeks to
remove perceived barriers to free-trade by establishing minimum IPR standards across the
world. It directs member countries to provide for product patents to all technologies and on
8 LOUISM. GUENIN, Patents, Ethics, Human Life forms, available at
http://guenin.med.harvard.edu/Documents/Ethics%20of%20Patents%20on%20Human%20Life
%20Forms.pdf
9 M. Chakrabarty, Patenting Life Forms: Yesterday, Today, and Tomorrow.

microorganisms. It also makes non-compliance with the statutes of the WTO liable to
prosecution and severe punitive action including sanctions or fines. In spite of safeguards and
other flexibilities provided in the form of preferential treatment to the developing and least
developed countries, scope of patentability as outlined under TRIPS is considered far too wide
by most developing members. They argue that overly strong IPR with extended scope and
duration of protection are proving to be detrimental to the very object and purpose of TRIPS
Agreement. India has always maintained that patent rights should be exercised coherently
with the objectives of mutual advantage of patent-holders and users of patented medicines, in a
manner conducive to social and economic welfare and to the balance of rights and obligations.'10
When India became a party to the WTO in 1995, in spite of strong civil society opposition,
TRIPS was an indispensable part of the deal. The then national policy makers hoped that the
overall gains made from greater links with the global trading community would more than upset
any possible dangers of accepting a stricter IP regime. Having contested to fully utilize its ten
year transition period India has introduced three major amendments to the Patents Act, 1970. The
first among these was the 1999 amendment which introduced exclusive marketing rights (EMRs)
and established mailbox applications for patents for pharmaceuticals and agrochemicals from 1
January 1995.The next amendment came in 2002 which allowed for patents on
microorganisms.11
Even prior to this amendment, the judiciary had interpreted the patent regime under the
unamended Patent Act to cover a patent on a living organism much to the displeasure of the
Indian Patent Office. The Honble High Court of Calcutta, in the matter of Dimminaco A G v.
Controller of Patent Designs & Ors12, was approached by a Swiss company which had been
refused a process patent for preparation of a live vaccine for Bursitis. The Patent Office had
denied to grant a patent on the grounds that the so-called invention, containing a living organism,
was not patentable as under 2(1) (j). The Patent Office contended that the process of making a
10 Ibid
11 Patenting of Higher life forms and related issues, Report to the Government of Canada Biotechnology
Ministerial Coordinating Committee
12 2002 IPLR 255 Cal. H.C.

vaccine with a living organism is neither a process resulting in an article, substance, nor is it
manner of manufacture. It had claimed that since the vaccine involved processing of certain
micro orgasm it was only a natural process. Even though there was no express or implied bar in
the Indian Patent Act 1970, patents were traditionally granted only to non-living inventions that
fulfilled the patentability criteria. The appellant contended that there had been a violation of rule
of law as preference was given to discretionary administrative policy over the statutory definition
of what an invention entailed, which did not bar the barring of a patent on the process of
manufacturing a vaccine, containing a live virus.13
The Court observed that the term manufacture had not been defined in the Act and consulted a
variety of dictionary meanings to conclude that the process for manufacturing such a vaccine is
new process and such new process was patentable under S.5 read with S.2(I)(i) of the Patent Act.
The Honble Court relied on the vendibility test to determine the question of patentability of a
process. It concluded that since the claim process for patent leads to a vendible product, it is
certainly a substance after going through the process of manufacture. 14
This decision of the Calcutta High Court is also seen as concurrent with the position in US and
most EU countries which allow patentability of biotech inventions. Subsequent to the decision,
the Act has been amended by the Patents Amendment Act 2002. The amendment has changed the
definition of invention. The earlier requirements under Section 2(j) which added to the primary
requirement of newness and usefulness like those of an invention being art, product or process,
method or manner of manufacture; machine, apparatus or other article; substance produced by
manufacture, including any useful improvements on the said has been omitted.
The definition has been simplified and the only requirements of patentability now are that a
product of process must be new, non-obvious and useful. The relevance of the decision
subsequently, though debatable does highlight the relative unwillingness of the judiciary to
refuse the patent merely on ethical grounds. However in the new scheme of things it is uncertain
whether addition of S.3 (j), which excludes from patentability essentially biological processes for
13 Daniel J. Kevles, A history of patenting life in the United States with comparative attention to Europe
and Canada, 2002
14 Ibid

production of plants and animals, or plants and animals in whole or in part other than
microorganisms, would derail the benefits for future applicant, if the subject of patent application
was adjudged to not be a microorganism by the virtue of being a non-microscopic organism.
It is therefore necessary to have a clear working definition for microorganism either as a
legislative explanatory amendment or judicial pronouncement. A review of the draft manual of
patent, practice and procedure by the national working group on patent laws also reveals that
there is a need to define the term microorganism. The deletion of 5 of the Act, pursuant to the
2005 amendment, which provided for only process patents on chemical processes, including
biochemical, biotechnological and microbiological processes as well as substances intended for
or capable of being used as food or medicine, it appears, if the Honble High Courts intention is
read right, that the doors have been opened for patenting products with living microorganisms
with both legislative as well as judicial sanction. The 2005 amendment substituted new S.3(d) for
the existing section which limited the scope of patentability by excluding the mere discovery of
a new form of a known substance which does not result in the enhancement of the known
efficacy of that substance.15
More recently, the constitutional validity of S.3 (d) was subsequently unsuccessfully challenged
by global pharmaceutical giant, Novartis in the Honble High Court of Madras. The overall
expansion of patentability criteria has resulted in an increased number of patent applications and,
consequently, an increase in the number of patents granted in the field of biotechnology. An
assessment of the annual reports of the Indian patent office (2007 Annual Report) reveals that
from 2000-01, where four applications were submitted and no patents were granted, the number
of applications has been steadily increasing. In 2003-04, 23 patent applications had been filed,
though no patents were granted. During 2004-2005, there was a Phenomenal increase in the
number of applications biotechnology patents were granted in that year alone. .
TRIPS leaves it to member countries to determine appropriate method of implementing its
provisions and define certain key provisions that determine the scope of patentability. Carlos
Correa argues that there is no obligation under the TRIPS Agreement to adopt an expansive
concept of invention, as is currently done by many developed countries. In particular, nothing
15 Ned Hettinger, Patenting Life: Biotechnology, Intellectual Property, and Environmental Ethics,
Boston College Environmental Affairs Law Review, Volume 22 Issue 2 Article 4

in the Agreement obliges Members to consider that substances existing in nature, biological or
not, are patentable, even if isolated and claimed in purified form.16
It is interesting to note that in Novartis AG, in Ritushka Negi and Anr v Adarsh Pharma and
Anr17, one of the contentions raised was how 3(d) was contradictory to Article 27 of TRIPS,
which obligates WTO member states to provide patent protection to all fields of technology
without discrimination, and therefore violates the obligations under the TRIPS Agreement. But
the court sought jurisdiction issue and did not deal with the matter. The Honble Courts
suggestion to approach the WTO dispute settlement mechanism was also not followed. But the
Court did reaffirm the provisions constitutional validity with Article 14.
Further stipulation under Article 8 accords adequate discretion to TRIPS signatories to deny
patents in observing and up keeping interests in ordre` public and morality. And India has
forever stressed, in a stance complimented by Paragraph 4 of the Doha Declaration, that any
interpretation of the provisions of the agreement should be consistent with Article 8. Another
safeguard in place is the presence of a global depository of genetic data as mandated under
Budapest Treaty and the Convention for Bio-Diversity. Microbial Type Culture Collection and
Gene Bank (MTCC) at the Institute of Microbial Technology (IMTECH), Chandigarh ensures
that all micro-biological data is deposited, and the region of its availability disclosed and kept
open to research and other such uses after the publication of patent application.18
The depositories under the human genome process perform a similar function, for once some
information is disclosed or made public it is no longer new and cannot be patented. To assess
whether after the 2005 amendment India had indeed become TRIPS compliant and if the
measures taken to ensure TRIPS compliance were in national interest the Mashelkar Committee
was set up in April 2005. One of the issues the Committee dealt with was whether it would be
consistent with TRIPS to exclude microorganisms from patenting. The Mashelkar committee
16 Martin Khor, IPRs and Biodiversity: Stop the Theft of Indigenous Knowledge,
www.twnside.org.sg/title/jb6.htm
17 2004(3)CTC95
18 Supra note 17

submitted a report in December 2006 which it later withdrew citing technical inaccuracy and
plagiarism as reasons.19
The revised version of the report restates to a large extent the Committees previous findings,
which had been criticized for not taking into account public health goals. The committee
concluded that it shall be in violation of TRIPS to exclude microorganisms completely from
patentability and that microorganisms involving human intervention and utility are patentable
subject matter under the TRIPS Agreement, provided they meet the prescribed patentability
criteria. The Committee has also been criticized for not having taken a policy perspective on the
issue. It furthers patents on bio-tech inventions on three grounds. The first one being increased
prospects of FDI and contract R&D by attracting foreign collaboration to the ever growing and
increasingly profitable bio-tech industry in a bio-diverse country like India.
India would have an advantage in attracting FDI and other such projected benefits only so long
as other nations do not provide similar relaxations. It is relevant to note that most countries with
advanced bio-tech fields like, USA, Republic of Korea, Japan, China and European Countries
already provide far wider patent protection on living matter than India. The second reason cited
by the committee was concern over biological matter of Indian origin being patented by foreign
players. This is a faulty argument as well. India is already a signatory to the Convention on Biodiversity (CBD), according to Article 15 of the CBD when a material is taken from a country
prior informed consent and material transfer agreements are required to be initiated to
acknowledge the country of origin. It must be Indias prerogative to uphold the CBD to prevent
bio-piracy instead of looking for alternatives which require India to adopt a system least suited to
its needs. The committee finally seeks to justify its suggestions by citing obligations under
TRIPS. It refuses to realize that there are flexibilities available within TRIPS like non-definition
of three criteria of patentability (novelty, non-obviousness, usefulness) which make it possible
for India to define restrictively the scope of patentable subject matter.20

19 Dr Johanna Gibson, Patenting Lives, Patenting Alternatives Commercializing Agricultural

Biotechnologies in the Developing World, Queen Mary Intellectual Property Research Institute
20 Ibid

The Future of Patenting Life Forms

Biotechnology is an old technology. The use of living organisms to make bread, wine, and cheese
is a longstanding human practice. People have "genetically-engineered" plants and animals,
including humans, by selective breeding for desirable characteristics for thousands of years.
The new biotechnologies promise a lot; in some cases they have already delivered. Medical
benefits of biotechnology include the development of new drugs and enhanced production of old
drugs that combat cancer, A.I.D.S., dwarfism, diabetes, hepatitis, and even aging. Geneticallyaltered pigs produce human hemoglobin that might be used to develop a human blood substitute.
Genetically-altered mice produce an extractable protein in their milk that dissolves blood clots.
Both creatures exemplify a trend toward turning animals into living drug factories. The new
biotechnologies also make it easier to identify genetically-caused diseases and permit the
replacement of defective genes. Ultimately, such technology will allow us to choose our
children's genetic makeup. In agriculture, bio-technicians have altered plants and animals for
improved nutritional value.21
Bio-technicians have produced potatoes with more starch and pigs with an increased protein-tofat ratio. Researchers

are also

attempting to produce larger, faster growing, and

more

productive agricultural animals that require less feed. Bio-technicians are already altering
plants to withstand pests and disease, and they hope to be able to produce plants that fix their
own nitrogen and resist drought and cold. The first genetically-altered whole food-product has
recently appeared on supermarket shelves in the form of a tomato that spoils less quickly than
unaltered tomatoes.22
These developments raise hopes for an increase in the world's food supply and a decrease in the
use of chemicals in agriculture. Genetically-altered microbes that eat toxic wastes and
degrade synthetic compounds may be useful in waste treatment. Genetic technologies can
help preserve endangered species. Biotechnology even provides economic incentives for
21 Biotechnological inventions: patenting of genes and life forms, and the impact of patenting on
upstream science, John Sulston, WIPO
22 Ibid

preservation, as it makes possible commercial uses of genetic material that previously lacked
economic value. Biotechnologies could lessen human dependence on other forms of sentient life
by providing genetically altered, insentient life-forms as substitutes.
There are notable differences between contemporary biotechnologies and both past human
practice and what nature does by itself. Recent techniques for genetic manipulation are much
faster and far more precise than is traditional, whole-organism crossbreeding. Modern biotechnicians can produce organisms that possess specific desirable characteristics, while
traditional, whole-organism cross breeders produce organisms with a variety of new traits,
many of which are undesirable and difficult to breed out. While selective breeding
necessarily takes place within a species or closely-related species, the new biotechnologies
permit the combination of genetic material from significantly different species.23
The technology of animal and human reproduction, as well as the techniques of genetic
manipulation, is progressing so rapidly it creates situations that transcend our legal structure and
directly affect our social and moral fabrics. It is high time the legislature takes a serious look at
where the science is going, where it needs to go to make a positive contribution, and perhaps
define the boundaries of our venture into the unknown biological mysteries of nature. Of course,
no mandate will ever cover all future scientific directions or orient human ingenuity, and the
judiciary will play increasing roles in resolving conflicts involving human genetic reproduction,
genetically manipulated plants and foods, and environmental restoration. There is thus a great
need to continue dialogues between the judiciary, the legal community, the legislature, the
interested public, and the scientific community to provide guidance in scientific developments
that may have major impacts on society.
In any case, with regard to the institutional framework, TRIPS still leaves potential scope for
introducing flexibilities considering the indigenous conditions prevalent in the Indian IP regime.
Sensitivity towards interests of public by heeding adequately to the numerous ethical and public
health issues raised is vital. However, any exhibition of unfound paranoia must be diametrically

23 Danish Board of Technology (2005), Recommendations for a Patent System of the Future, available
athttp://www.tekno.dk/subpage.php3?article=1132&toppic=kategori11&language=uk&category=11

denounced and abstained from; so as to promote scientific knowledge and temperament, as is

also a constitutional (fundamental) duty to which every citizen is bound.

Bibliography

Richard T. Hull, Ph.D., The Creation and Patenting of New Life Forms: A New Assault
on Academic Freedom?, Given as a University Honors Lecture Governors Quadrangle,

SUNY at Buffalo March 20, 1988

Shelley A. Rowland & James W. Piper, Patents and Biotechnology: Issues Around the

Patenting of Life Forms

Ameen Jauhar and Swati Narnaulia, Patenting Life the American, European and Indian

Way Journal of Intellectual Property Rights Vol 15, January 2010, pp 55-65
LOUISM.
GUENIN,
Patents,
Ethics,
Human
Life

forms,

http://guenin.med.harvard.edu/Documents/Ethics%20of%20Patents%20on%20Human

%20Life%20Forms.pdf
M. Chakrabarty, Patenting Life Forms: Yesterday, Today, and Tomorrow.
Patenting of Higher life forms and related issues, Report to the Government of Canada
Biotechnology Ministerial Coordinating Committee

Daniel J. Kevles, A history of patenting life in the United States with comparative

attention to Europe and Canada, 2002

Ned Hettinger, Patenting Life: Biotechnology, Intellectual Property, and Environmental

Ethics, Boston College Environmental Affairs Law Review, Volume 22 Issue 2 Article 4
Martin Khor, IPRs and Biodiversity: Stop the Theft of Indigenous Knowledge,

www.twnside.org.sg/title/jb6.htm
Dr Johanna Gibson, Patenting Lives, Patenting Alternatives Commercializing
Agricultural Biotechnologies in the Developing World, Queen Mary Intellectual Property
Research Institute