“PATENTING OF LIFEFORMS”: A CONTENTIOUS ISSUE

Name of the Student: AARATHI KAKARLAPUDI

Roll No: 2018LLB123

Semester: V

Name of the Program: 5 year (B.A., LL.B.)

Name of the Faculty Member: Prof. Dr. P. SREE SUDHA

Date of Submission: 31st December, 2020

DAMODARAM SANJIVAYYA NATIONAL LAW UNIVERSITY

NYAYAPRASTHA, SABBAVARAM, VISAKHAPATNAM – 531035,
ANDHRA PRADESH

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 ACKNOWLEDGEMENT

I would sincerely like to put forward my heartfelt appreciation to Prof. Dr. P. Sree Sudha
for giving me a golden opportunity to take up this project on “Patenting of Life Forms: A
Contentious Issue”. I have tried my best to collect information and cases about the project in
various possible ways to depict clear picture about the given project topic. I would also like
to thank you for your great support and help in doing the project.

Name: Aarathi Kakarlapudi

Place: - Visakhapatnam Roll No. 2018123

Semester 5

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 ABSTRACT

A life form as it occurs in nature is not patentable because there is no inventive step. A
captured life form is also not patentable, because the concept of caging is not novel (though a
new and ingenious design of cage might be). A modified life form is patentable, but only as
far as the actual modification is concerned. This view is intermediate between current patent
practice, which has allowed excessively broad claims on the strength of a limited
modification (cotton, for example), and the vitalist position that nothing to do with life should
be patentable. Neither of these extremes makes sense. To think about this wide gap of
opinion, it helps to project forward to the time when new life forms will be synthesised from
scratch. Such life forms will surely be inventions, and therefore patentable. Before that point
it will be commonplace to modify life forms so extensively that their origins are unclear. The
expansion of intellectual property law during the last 30 years has been breathtaking. There
are clear beneficiaries, but the value for society as a whole is less certain. Indeed, many
consider that exploration and innovation are threatened by the continued advance of IP, and
that a culture of exclusive-rights patenting is an important contributor to the global health
gap. We should not move towards harmonisation without examining these issues with care.

A debate has also been raging in the WTO, which is reviewing Article 27.3(b) of the TRIPs
treaty, which deals with patenting of life forms. It allows countries not to patent plants and
animals but makes the patenting of micro-organisms and microbiological processes
compulsory, thus opening the road to the patenting of life. African countries are not satisfied
with Article 27.3(b) of TRIPs. The requirement for protecting micro-organisms, non-
biological and microbiological processes and plant varieties is unethical in allowing patents
over life forms, unfair in terms of bio piracy, and harms food security for local communities
as well as biodiversity.

‘The patent system was designed to protect mechanical inventions, and makes the
distinction between mere discoveries and inventions. It is clear that biological materials
are naturally occurring and can only be discoveries, and not inventions. Patents confer
monopolies over patented subject matter. In the cases of seeds and plant varieties,
patents on such biological materials will have serious implications for agriculture and
food security in the developing countries. The monopoly over biological resources and
knowledge essential for agriculture, medicinal and other uses may be misappropriated
and vest in individuals and corporations.’ Policies that lead to the devastation of the earth
or drastic reductions in genetic diversity should be opposed, and if this requires limitations on
the applications of biotechnology, so be it. But avenues of scientific research must not be
closed off in fear of what we will find out. Technology is neither inherently good nor
inherently bad-it just is, until it is applied in a specific context. Patents on new technology
should be granted, reserving the right to regulate specific applications. This is the only
sensible course.

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 TABLE OF CONTENTS

S. NO. NAME OF THE TOPIC PG NO.

1. INTRODUCTION 5
2. RESEARCH QUESTION 5
3. SCOPE AND OBJECTIVE OF THE SUDY 6
4. LITERATURE REVIEW 6
5. RESEARCH METHODOLOGY 7
6. SIGNIFICANCE OF THE STUDY & CHAPTERIZATION 7
7. PATENTS ACT, 1970 & TRIPS AGREEMENT 8
8. THE LIFEFORM PATENTING: THE ETHICAL DEBATE 10
8.1. Patents in Micro-organisms & its Conceptual issues 11
8.2. Negative impacts of Patenting of Transgenic animals 13
8.3. Patentability of Stem Cells 14
9. OVERSEAS LAWS ON PATENTING OF LIFEFORMS 16
9.1. Patentability of Life forms in Europe 16
9.2. Australian Law on Patenting of Life forms 18
9.3. Patentability of Life forms in India 19
10. PATENTABILITY OF LIVING MATTER: 22
DIAMOND v. CHAKRABARTY
10.1. Post-Chakrabarty developments in the United States 23
10.2. Post Chakrabarty Case Laws 23
11. PROS & CONS OF LIFEFORM PATENTING 27
12. WHETHER IT IS POSSIBLE TO GRANT PATENTING OF 30
LIFEFORMS IN FUTURE
13. CONCLUSION 31
14. BIBLIOGRAPHY 32

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 INTRODUCTION

A life form as it occurs in nature is not patentable because there is no inventive step. A
captured life form is also not patentable, because the concept of caging is not novel (though a
new and ingenious design of cage might be). Creations of the human brain are called intellect
and if they have commercial value they can be classified as property. Intellectual Property
thus refers to inventions, industrial designs for article, literary and artistic work, symbols, etc.
The word patent has been derived from the Latin word patent-em meaning open. The self-
contradiction demands an explanation. The widest possible dissemination of new knowledge
makes the greatest economic efficiency. But if everybody is free to access new knowledge,
the inventors have little incentive to commit resources to produce it. Intellectual Property
Rights (IPRs) temporarily transform knowledge from a public good into a private good so
that owners of intellectual property can recoup their expenditure in creating new knowledge.
On 16 April 1994, India signed the General Agreement on Trade and Tariff (GATT) along
with 116 other nations. The agreement also established the World Trade Organisation WTO)
which succeeded GATT .Under WTO, no country has the option to choose what part that it
likes and abstain from others. The Trade Related Aspects of Intellectual Property Rights
(TRIPS) Agreement of WTO imposes a number of rules on member countries.

The TRIPS agreement ensures that patent protection is available for all the fields of
technology including agriculture, energy and healthcare. Also, members can exclude certain
inventions from patentability if the exploitation of the invention would be affecting the
morality of general public. TRIPS further focussed on patentable subject matter in relation to
biological material. The patenting of life raises a whole range of issues - not only technical
and legal but also ethical, moral, social and religious. Scientific advances in genetic
manipulation have been so rapid and startling that their consequences have generated wide
ranging apprehensions. It is almost as if man has acquired the capacity to ‘play God’ through
his knowledge and control over life at the cellular level. Patent law is the primary vehicle
which enables scientists to secure exclusive rights to the commercial benefits of their genetic
research. Patent laws grant a limited property right to the patent holder, and exclude others
from using the patented item for a specific period of time, usually for a 17-20 year period

RESEARCH QUESTION

1. Whether higher life forms are patentable or not?

2. Whether the rising biotechnology is a bane or boon when related to life forms?

3. Whether the question of jurisdiction can be resolved when the question of lifeforms arises?

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 SCOPE OF THE STUDY

The scope of the study is limited to patenting of life forms and discussing about the
involvement of TRIPS Agreement and Patents Act, 1970. Along with these the study also
involves the conceptual and ethical issues of patenting life forms.

OBJECTIVE OF THE STUDY

Patenting life forms bring with them overbearing issues of religious and ethical values. In
today's competitive and globalized world, biotechnology revolution is affecting industry and
growth in a big way. So the main objective of this study would be to know why is patenting
of life forms a contentious issue and how far does this take us in the world of IPR.

LITERATURE REVIEW

PATENT POLITICS: LIFEFORMS IN THE US & EUROPE by Shobita Parthasarathy –

This book takes us through a particularly fierce and prolonged set of controversies over
patents on life forms linked to important advances in biology and agriculture and potentially
life-saving medicines. Comparing battles over patents on animals, human embryonic stem
cells, human genes, and plants in the United States and Europe, she shows how political
culture, ideology, and history shape patent system politics.

PATENTING OF LIFEFORMS by Rajeev Kumar Singh – This book deals with regard to the
immorality of life patents; several moral objections have been raised time to time by several
factions of people and stakeholders against the grant of patents on life forms. This book,
focuses on the ethical and moral considerations attached with patenting of life, especially
higher life and the ways that could be useful in settling the present controversies.

PATENTING LIFE: NEW DEVELOPMENTS IN BIOTECHNOLOGY - This book talks

about U. S. patent law as it relates to the patentability of micro-organisms, cells, plants, and
animals; as well as specific areas of concern, including deposit requirements and international
considerations. It includes a range of options for congressional action related to the patenting
of animals, intellectual property protection for plants, and enablement of patents involving
biological material.

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 RESEARCH METHODOLOGY

1. NATURE OF STUDY: The study is purely doctrinal in nature. It is a mixture of

descriptive, analytical and explanatory.

2. MODE OF CITATION: Bluebook 19th Edition.

3. SOURCES: PRIMARY – Intellectual Property Laws, Bare Act

SECONDARY – Books, Journals, Articles, etc

SIGNIFICANCE OF THE STUDY

The issue of patenting life or animate organisms and living cells, tissues et al, is more
challenging than the simple task of enacting legislation and statutes. The issue has, at its
heart, a conflict of interests, ideas, notions and paradigms. The challenges ensuing from it
evolve into more of a debate of scruples rather than anything else. There has been a systemic
lobbying and subsequent successful shift towards greater IP protection for biotech inventions,
including protection of living organisms. The process has quickened in the past decade with
the developing countries becoming fully TRIPS compliant.

CHAPTERIZATION

I – Introduction

II – Patents Act, 1970 & TRIPS Agreement

III – The Life Form Patenting: The Ethical Debate

IV – Overseas Laws on Patenting of Living Forms

V – Patentability of Living matter: Diamond v. Chakrabarty

VI – Pros & Cons of Life form Patenting

VII – Conclusion

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 PATENTS ACT, 1970 & TRIPS AGREEMENT

On 16 April 1994, India signed the General Agreement on Trade and Tariff (GATT) along
with 116 other nations. The agreement also established the World Trade Organisation WTO)
which succeeded GATT .Under WTO, no country has the option to choose what part that it
likes and abstain from others. The Trade Related Aspects of Intellectual Property Rights
(TRIPS) Agreement of WTO imposes a number of rules on member countries.

The TRIPS agreement ensures that patent protection is available for all the fields of
technology including agriculture, energy and healthcare. Also, members can exclude certain
inventions from patentability if the exploitation of the invention would be affecting the
morality of general public. TRIPS further focussed on patentable subject matter in relation to
biological material. For example:

 Plants, animals, essential biological process of production of plants and animals may
be excluded from patenting.
 Microorganisms per se and non-biological and microbiological processes are
patentable.

The Patent System in India is governed by the Patents Act, 1970 as amended by the Patents
(Amendment) Act, 2005 and the Patents Rules, 2003, as amended by the Patents
(Amendment) Rules 2006 effective from 5 May 2006. The same is in accordance with the
provisions of the TRIPS Agreement. The recent conferment of 'product patent' along with the
'process patent' is an example of such compatibility. The TRIPS Agreement was formulated
to bring basic level harmonisation in IPRs laws all over the world. The provisions of TRIPS
Agreement are the most extensive and rigorous in nature. They protect all the forms of IPRs
collectively.

In India before 2002, amendment the understanding is that there is no patent protection for
invention relating to life forms. But in Dimminaco A.G v. Controller of patent and design, the
Calcutta High Court held that a process for preparation of vaccine containing live virus is
patentable since the term manufacture covers even living organism. So according to the Court
even if the end product contains a live virus the process involved in bringing out the end
product becomes an invention. It may be noted that there is no decision reported till date
directly on the application of the inventive step standards to inventions relating to biotech
patents in India. In the light of Article 27 of TRIPS the Section 3 of Patent Act, 1970 has
been amended. The definition of invention, new invention, and inventive step reflects
restrictive approach to the legal protection of living materials. In the absence of definition
for plant, animal, micro organism essentially biological process, non-biological process and
plant variety its interpretation by the patent office becomes crucial. Since the term micro-
organism can have a variety of definition which may not be exhaustive to include genetic
material, it is argued that it is safer to place reliance upon the guiding provision in TRIPS
agreement.

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The TRIPS Agreement requires Member countries to make patents available for any
inventions, whether products or processes, in all fields of technology without discrimination,
subject to the normal tests of novelty, inventiveness and industrial applicability. It is also
required that patents be available and patent rights enjoyable without discrimination as to the
place of invention and whether products are imported or locally produced. There are three
permissible exceptions to the basic rule on patentability. One is for inventions contrary to
public order or morality; this explicitly includes inventions dangerous to human, animal or
plant life or health or seriously prejudicial to the environment. The use of this exception is
subject to the condition that the commercial exploitation of the invention must also be
prevented and this prevention must be necessary for the protection of order public or
morality1. The second exception is that Members may exclude from patentability diagnostic,
therapeutic and surgical methods for the treatment of humans or animals. The third is that
Members may exclude plants and animals other than micro-organisms and essentially
biological processes for the production of plants or animals other than non-biological and
microbiological processes. However, any country excluding plant varieties from patent
protection must provide an effective sui generis system of protection. Moreover, the whole
provision is subject to review four years after entry into force of the Agreement. This
includes life forms, which is highly controversial. Under Article 27.3(b) of the TRIPs, WTO
member states must provide patent protection over micro-organisms and microbiological
processes, such as those used in biotechnology. Countries are free to exclude plants and
animals from their patent laws. However, all nations must provide intellectual property titles
over plant varieties, either through patents or through an 'effective sui generis system'. The
Agreement allows Member countries not to patent higher organisms, whether plants or
animals, and "essentially biological processes for the production of plants and animals".
However, Members must generally provide patent protection for micro-organisms and for
"non-biological and micro-biological processes". Countries have to protect plant varieties by
patents, by an effective sui generis system or by any combination thereof.

Micro-organisms: Under Article 27.3(b), micro-organisms are mandatorily patentable.

Micro-organisms are commonly defined as any microscopic organism, including bacteria,
viruses, unicellular algae and protozoans, and microscopic fungi. They are considered to be a
category of life different from the kingdoms of plants and animals. Non-biological and micro-
biological processes include the transformation of cells or tissue with recombinant DNA or
the process of genetic engineering.

Plant and Animals: In Article 27.3(b), Members are provided the option to exclude plants
and animals from being protected by IPR. However, there is a single exception. Members are
obliged to provide protection for one particular classification, i.e. plant varieties, either by
patents as laid down by the TRIPS Agreement, by an effective sui generis system, or by any
combination thereof. Cells and tissues from higher plants and animals are the subject of
microbiology, but they are not micro-organisms. Under the concept of “essentially
biological” processes, classical plant breeding methods would be excluded from patentability
but genetic engineering methods would be patentable.
1
WIPO, Background Reading Material on Intellectual Property, Geneva, 1988, p.375

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 THE LIFEFORM PATENTING: THE ETHICAL DEBATE

Creation and patenting of synthetically produced life form as can be evidenced from the case
laws discussed above has tremendous potential to offer in the form of technological
development, like creating cheaper bio fuels, a reduction in environmental pollution induced
degradation, a solution to several medical problems etc.

However, with this also rises the possibility of heretofore un-thought of consequences like
creation of pathogens, further environmental degradation by interference in the genetic line of
species like rats etc. In this context, another ethical moral dilemma arises, especially in the
context of higher life forms, as organisms no matter how it is produced whether naturally or
with the help of bio-technology, retains the capacity for thinking and suffering. With the
newly acquired understanding of life at the most fundamental levels, it is important that we
do not regress into previous Pascalian modes of regarding nonhuman organisms as simply
machines to be owned, used up, and discarded and patent legislations should therefore reflect
a moral obligation not to incentivize the undue suffering of patented organisms. In the Indian
context this is reflected through the framing of Section 3 which excludes from patentability
clause (b) that denies patents on “invention(s) the primary or intended usage of which could
be contrary to public order or morality”.

Further patenting and owning genetic materials is often considered by many (including many
religious sects) to be tantamount to human slavery; which is then runs counter to the very
notions of human dignity, a basic non-derogable guarantee affirmed through numerous
documents like the United Nations Universal Declaration of Human Rights (UDHR) 1948.
This was an argument which had especially gained currency with the opposition of the
Relaxin patent claim. In the John Moore case, the patient challenged the patent on his cell
line arguing that since the patented cells were from his body, therefore they were his property
and argued that owning and patenting a part of a human body through patent is a gross
violation of human dignity and it struck at the moral roots of humanity. The Supreme Court
rejected Moore’s argument in a very controversial decision and held that there could not be
any property rights over one’s body. One of the determining factors in this decision as is
reflected in most patent application grants or refusals was an evaluation of the potential
benefits from the use of the patent versus ethical moral concerns. 

The benefits accruing from biotechnology and genetic research which is incentivised through
grant of relevant patents is all but obvious. It would not help with the continues shortage of
human organs by stem cell research assisting in the development of genetically compatible
organs, it would also minimise chances of xeno-transplantation or the transplantation,
implantation or infusion into a human recipient of cells, tissues or organs from a non-human
source which is often rejected by the host’s immune system; genetic research would also help
developing treatments for diseases and in discovering new pharmaceuticals for a wider range
of diseases.

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The dilemma from the ethical standpoint gets further aggravated by the use of inherently
vague biological concepts, such as human and lower and higher life forms which make it
difficult to determine in a non-arbitrary, consistent, and predictable way whether a life form
patent claim deserves to be granted. For instance, even in the face of intense opposition in
Canada, the United States, and Europe, isolated human elements, including nucleotide
sequences, are generally eligible for patenting, while at the same time, however, one cannot
patent a human being in any of these jurisdictions. This dichotomy leads to an uncertainty in
intermediary cases, such as determining the amount of human DNA that is required to make a
part-human organ grown un-patentable.

Another issue which arises in this context, are the consequences of countries and their trading
partners making an unilateral moral choice to not patent certain life forms; because then
given the large volume of trade that has come to characterise the world today such
restrictions would not only allow free riding but also operate as a strong disincentive for
inventions across the borders in a different jurisdiction all together. However, having said
that, it is also important to note, that morality by its very nature is unlikely to be uniform
across the globe and in the near future at least such dichotomy will continue to subsist owing
to a lack of consensus.

Patents in Micro-organisms:
Can microorganisms, for instance, be patented? Prior to 1980 the answer to this question was:
‘NO’. Microorganisms were clearly products of nature and as such were not considered
patentable. However, the era of manoeuvring DNA between organisms changed that.

The Mashelkar committee report has clearly stated that microorganisms are patentable
subject matter in India. Inventions pertaining to Microorganisms and other Biological
material were subjected to product patent in India, unlike many developed countries. But with
effect from 20.05.2003 India has started granting patents in respect of invention related to
microorganisms, though India was not obliged to introduce laws for patenting
microorganisms per se before 31st Dec, 2004. Microorganisms patenting per se being
considered to be a product patent, the period of protection was 5 years from the date of grant
or, 7 years from the date of filing of application for patent. Now grant of patents for
microbiological inventions is for a period of 20 years from the date of filing. The most vital
and important distinction between the legal practices of the India and developed countries is
that India (developing countries) does not allow patenting of microorganisms that already
exist in nature as the same is considered to be a discovery as per the provisions of the section
3(d) and therefore not patentable. But genetically modified versions of the same
microorganisms that result in enhancement of its known efficacies are patentable. The grants
of Patent in respect of Microorganisms depend upon the regulations concerning the
requirements for the deposition of Microorganisms under the Budapest Treaty of which India
has become a member, and accessibility of that microorganism from the depositories.

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As per proviso (ii) to section 10(d) the Microorganism if not being described fully and
particularly and is not available to public, the said Microorganism is to be deposited before
the International Depositary Authority under the Budapest Treaty.

Conceptual Issues:
India has allowed patenting of microorganisms but the Patent Act does not provide a
definition of the term Microorganisms. This has led to many debates regarding patentability
of microbes. In the absence of clear definition of microorganism and microbiological process
in the TRIPS agreement, the country needs to draw a distinctive line between the product of
human intervention leading to novelty and those freely occurring in nature.

Dimminaco Case: Although the Indian Patent Act, 1970 does not permit patenting of
microorganisms, per se, this particular case at Calcutta High Court is a case to understand the
intricacies of patenting. Dimminaco Case clarified the position relating to patentability of
biotechnology inventions, particularly in a case where a process of manufacture of vaccine
involving a living end product was involved. The main issue in contention between the
parties was whether the phrase 'method of manufacture' used in section 2(1) (j) could be said
to include a live organism. The court, in its positive affirmation, has held that the dictionary
meaning of 'manufacture' did not exclude from its purview the process of preparing a
vendible commodity that contains a living organism. The application of microorganisms in
food is a million dollar industry today. Since genetically modified microorganisms (a criteria
that lends the human intervention angle to satisfy one of the criteria to make the organism
patentable) is not permitted to be used in the food industry, the only source for improving the
textural and sensory properties of food is by isolation of new strains of bacteria that deliver
these properties.

One need not mention the time, effort and money involved in this exercise. In the Dairy
industry, lactic cultures are used for the preparation of fermented products and cheese whose
consumption rates are increasing at a rate of 10% annually. Suppressing the growth of these
fermented products is the growth of functional foods containing probiotic cultures. These are
bacteria that when consumed in sufficient quantities confer some beneficial attributes to the
host. The probiotic strains used in these products have been isolated after decades of research
work followed by clinical trials to prove their probiotic attributes. Most of these strains are
patented in the European Union and the United States (where isolation of a new strain of
bacteria is patentable). As a result, these companies are marketing these products containing
these microorganisms. However, the same protection for these bacteria is not available in
India. Some of the probiotic products launched in India are by companies which use strains
that are catalogued by leading international culture suppliers or by foreign companies that
have these strains. One may also run the risk of being accused by other nations of being
insensitive to the issues of promoting multilateral trade and hence of being subjected to
sanctions which may prove to be more economically ruinous in the long run.

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Negative impacts of patenting of transgenic animals:
The major concern that arises out of patenting of transgenic animals are that transferring
genes from one species to another transgresses the natural barriers between them and affects
the integrity of species. Species belonging to the same group, though they may slightly vary
from one region to the other based on the environmental conditions, they primarily have the
same gene pool.

Ethical Issues:

A number of ethical issues stem from the patenting of animals. Most of them deal with the
consequences that could arise subsequent to patenting of animals while the other arguments
focus on the religious, philosophical and spiritual grounds. The arguments which go against
the patenting of animals are difficult to prove as many of them are factual assertions which
are still to occur or to be proven. The DNA is considered to be intimately related to the
species identity and hence no part of it should be controlled for commercial interest. In case
of human beings, human DNA is unique and hence possesses intrinsic value of a sacred kind.
It can also be put as 'Human DNA bears the image of God' and to tamper with them and own
them for commercial and economic interests would hurt the sentiments of the many. The
view that plants, animals and microorganisms comprising life on earth are part of the natural
world into which we are born and hence the conversion of these species, their molecules, or
parts into corporate property through patent monopolies is counter to the interest of the
people of the country and world, has been taken by many.

Patents on human life:

A most alarming aspect of patenting life is the patenting of human genes, cell lines and
tissues. Corporate patent attorneys have lobbied the Patent office that these products of nature
are patentable once they have been isolated to produce a form not found outside of a
laboratory. For example, in 1976 a leukemia patient named John Moore had surgery at the
University of California to remove his cancerous spleen. The University was later granted a
patent for a cell line called Mo, removed from the spleen, which could be used for producing
valuable proteins. The long term commercial value of the cell line was estimated at over one
billion dollars. Mr. Moore demanded the return of the cells and control over his body parts,
but the California Supreme Court decided that he was not entitled to any rights to his own
cells after they had been removed from his body.

Morality and Patents- Is there a connection?

Patents on living organisms are morally objectionable to many. Patenting organisms and their
DNA promotes the concept that life is a commodity and the view that living beings are gene
machines to be exploited for profit. If it is possible to consider a modified animal an
invention, are patents and marketing of human reproductive cells far behind?

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Patents derive from concepts of individual innovation and ownership, which may be foreign
to cultures which emphasize the sharing of community resources and the free exchange of
seeds and knowledge.

What they say who are in favour:

That without patents society won't benefit from revelations about the molecular roots disease.
Moreover the arguments that patenting DNA promotes the view that life is a commodity,
cannot be accepted because it is not that the main aim of the DNA patenting to earn profit or
to use it for someone personal interest, on the contrary the overall aim of the patent system is
to promote the public interest and to provide a fair reward to inventors. The patents system is
said to be justified because it provides an important incentive for the development or new
products and technologies related to healthcare. One of the most coveted arguments which
are vociferously put forward against the patenting of life forms is that the First World
patenting of Third World genetic resources represents theft of community of biological
resources. Patents held by the industrialized world on biological resources from the
developing world will serve as a tool for the North to accumulate more wealth from the
already impoverished south.

Microorganisms, plants, animals and even the genes of indigenous people have been patented
for the production of pharmaceuticals and other products. Requiring developing nations to
pay royalties to the wealthy industrial nations for products derived from their own natural
resources and innovation in robbery. Moreover the developing world has never received
compensation or recognition for these intellectual and technological contributions. Patenting
life forms will exacerbate this inequality. This bio-colonialism will continue the pattern of a
few transnational corporations profiting at the expense of genetic resources of the third world
countries

Patentability of Stem Cells:

The Indian Patents Act (1970) says that an application should also qualify criteria given
under section 3, for it to be considered as an invention. Stem cell technology falls under the
purview of 3(b) of the Act, according to which 'an invention, the primary or intended use or
commercial exploitation of which could be contrary public order or morality or which cause
serious prejudice to human, animal or plant life or health or to the environment, are not
inventions'. Whether the stem cell technology should be considered non-ethical or against
moral values, vis-à-vis the various benefits it offers to those who do not have any other cure,
is a debatable topic, which keeps recurring between the researchers and the policy makers. As
far as India and most of the other countries are concerned, they have voted for technology
only in case ethical ways are used to derive embryonic stem cells. These ethical ways, as
reported by the researchers, like using human embryos, produced by in-vitro fertilization,
aborted foetuses, and asexually produced human embryos for deriving such cells, are not
against public order or morality in any way2.

2
https://www.bananaip.com/ip-news-center/stem-cell-patent-debate-never-dies/

14
India is lucky in a way that the government is supporting researchers in this area for the good
of the nation. In addition, nothing has been mentioned in Patents Act (1970) which makes
stem cell and related research not patentable. Therefore, stem cell technology is considered
patentable, and a good number of patent applications are made every year and several are
granted3 to bring in optimistic competition among the researchers.

Over the years, the Indian Patent Office’s perspective on the issue of patentability of
inventions involving embryonic stem cells, appears to have changed. This change in stance is
apparent from the changes in the Manual of Patent Office Practice and Procedure. The 2005
draft of said guidelines treated the use of human or animal embryos for any purpose against
public order and morality and prohibited the same from patentability. This restriction
however, was removed from the subsequent draft of the guidelines and has not reappeared
ever since. Inspite of this change in the guidelines, the Patent Office till date raises the public
order and morality objection under section 3(b) of the Patents Act, on stem cell related
inventions (both methods and stem cell products). The concern most frequently expressed is
the possibility of destruction of human embryos. The prosecution history of several cases
shows that an objection on public order and morality has been raised even if the claims do not
call out embryonic stem cells but the specification mentions the possibility of use of
embryonic stem cells. The objection is frequently overcome by excluding any reference to
embryonic stem cells from the claims and by disclaiming the use of embryonic stem cells in
the operation of the invention.

However, the approach of treating stem cell research against public order and morality
appears to be in contrast to public policy in India. The National Guidelines for Stem Cell
Research (published by ICMR and DBT under the Ministry of Science and Technology)
prescribe conditions subject to which research on stem cells should be conducted. The
conditions include verification that the blastocysts used are spare embryos. The guidelines
also permit establishment of new human embryonic stem cell lines from spare embryos
subject to the approval of certain committees. Clearly, these government guidelines permit
safe and responsible stem cell research, including research on embryonic stem cells.

Moreover, it is a well-known fact that not every invention involving embryonic stem cells
would necessitate destruction of human embryos and a lot of research is based on embryonic
stem cell lines. Therefore, the indiscriminate imposition of objections under Section 3(b)
requires change.

3
https://stemcell.ny.gov/faqs/what-difference-between-totipotent-pluripotent-and-multipotent

15
 OVERSEAS LAWS ON PATENTING OF LIFEFORMS

Patentability of Life forms in Europe:

In regards to the European Patent system, the laws are little different. Article 52 (1) states that
“European patents shall be granted for any inventions which are susceptible of industrial
application, which are new and which involve an inventive step”. Hence in Europe all
inventions that are novel, not obvious and having industrial utility are patentable with certain
exceptions and exclusions which are specified. Inventions which would be contrary to the
“public order” or “morality” are not patentable. Plant or animal varieties or essentially
biological processes for the production of plants or animals are not patentable. Methods for
treatment of human or animal body by surgery or therapy and diagnostic methods are not
patentable. Discoveries, scientific theories, mathematical methods, aesthetic creations,
presentation of information, programs for computers, schemes, rules and methods for
performing mental acts, playing games or doing business all these are not considered as
inventions and hence cannot be patentable. According to Article 53 EPC 2000, the following
inventions are not eligible for European patents: inventions the commercial exploitation of
which would be contrary to “public order” or morality; plant or animal varieties; essentially
biological processes for the production of plants or animals; methods for the treatment of the
human or animal body by surgery or therapy; and diagnostic methods practiced on the human
or animal body. It can be seen that the excluded subject matters are substantially consistent
with those set forth in TRIPS.

In 1998, the European Union codified its patenting mechanism for transgenic plant and
animal varieties by passing the EC Directive 98/44/EC on patenting of biotechnological
inventions. On 16th June, 1999 the Administrative Council inserted a new Chapter VI
entitled ‘Biotechnological inventions’ in Part II of the EPC Implementing Regulations. The
new provisions entered into force on 1 September 1999 and implemented the requirements of
the EU Biotechnology Directive in European patent law.

The EPO has introduced four new rules, Rules 23b to 23e. Rule 23b sets out general matters
and defines the meaning of biotechnological inventions, biological material, plant variety,
and microbiological process. Rule 23c states patentable biotechnological inventions,
including material isolated from their environment, even if known in nature. This particularly
applies to genes that are isolated from their natural environment by means of technical
processes and made available for industrial production. Rule 23d sets out what is not
patentable. This includes processes for cloning human beings, processes for modifying the
genetic identity of human beings, using human embryos for commercial purposes and
modifying the genetic identity of animals such as may cause them suffering without
substantial medical benefit. The list is to be seen as giving concrete form to the concepts of
‘public order’ and ‘morality’. Rule 23e indicates what is and is not patentable with respect to
the human body. The human body and its elements cannot be patented. However, elements of
the body, when isolated from the body, may be patented.

16
Thus, European rules and regulations are stricter when compared to U.S rules and
regulations.

Plant or Animal varieties – Although plant or animal varieties are not patentable, however,
if the technical feasibility of an invention concerning a plant or animal is not confined to a
particular plant or animal variety, such an invention shall be patentable. Therefore, a claim
wherein specific plant varieties are not individually claimed is not excluded from
patentability even though it may embrace plant varieties. In this regard example may be cited
of NovartisII4 where in the Enlarged Board of Appeal held that the genetically created
herbicide resistance would not create a plant variety as this resistance could also be
transferred to other varieties. Thus, the technical feasibility of the invention was not only
confined to one plant variety. Therefore, the invention would not be excluded from
patentability, regardless of the fact that the claim might also embrace a plant variety.
Furthermore, the board clarified that although a patent cannot be obtained for a plant variety,
it may well be obtained for a method to produce such variety. This would apply even in the
light that products produced by a protected process are also covered by patent protection
according to Art. 64. However, if an invention consists only in genetically modifying a
particular plant variety, and if a new plant variety is bred, it will still be excluded from
patentability even if the genetic modification is the result not of an essentially biological
process but of a biotechnological process. Also, the decision of Harvard Onco-mouse 5
confirmed that a transgenic non-human mammalian animal does not fall within the scope of
animal varieties under Article 53 EPC.

The first European patent on a transgenic animal was granted in 1992 for a transgenic mouse
that was susceptible to carcinogens due to an introduced oncogene. The case did not only
break records with regard to its extraordinary consumption of time and human resources, it
also contains important clarifications as to the patentability of animals. Bearing in mind that
for animals – unlike plant varieties – no other industrial property right was available, the
Board of Appeal held that Art. 53 (b) has to be narrowly construed and only applied to certain
categories of animals but not to animals as such. Furthermore, the Board considered Art. 53
(a) EPC and concluded that it was necessary to carefully weighing up the suffering of the
animal and the risk to the environment on the one hand and the invention’s usefulness to
mankind on the other. Another slightly different balancing test has been adopted by the
Directive and later introduced in the implementation rules of the EPC in order to specify the
morality clause of the EPC and the national patent laws. According to rule 23 (d) EPC
processes for modifying the genetic identity of animals which are likely to cause them
suffering without any substantial medical benefit to man or animal, and also animals resulting
from such process, are excluded from patentability. Thus, genetic modification of test
animals for other than medical purposes, e.g. for the development of new cosmetics, are
excluded from patentability if the modification causes suffering to the animal. The exclusion
does not only comprise the animal but also the method of modification, thereby avoiding
patenting of the animal through the backdoor of method claims.

4
T1054/96,Plants/NOVARTIS
5
Article 5.1, Biotech Directive; Rule 29.1 EPC

17
Australian Law on Patenting Life forms:
Unlike the Patents Act 1977 (UK), the Patents Act 1952 as amended does not contain any
specific exclusion relating to living organisms. The position in Australia therefore would at
first glance be comparable to that in the U.S., where arguments addressed solely to the issue
of statutory interpretation as in Chakrabarty could lead to a conclusion that living organisms
can be patented in this country, the fact of their being alive having no legal significance. As
previously noted, the Patents Act 1952 refers to 'any manner of new manufacture the subject
of Letters Patent and grant of privilege within s.6 of the Statute of Monopolies'.

However in National Research Development Corporation v. Commissioner of Patents 6 the

High Court disapproved of any attempt to conclusively define the nature of manufacture,
saying in a joint judgment: The truth is that any attempt to state the ambit of s.6 of the Statute
of Monopolies by precisely defining 'manufacture' is bound to fail. The purpose of s.6, it
must be remembered, was to allow the use of the prerogative to encourage national
development in a field which already, in 1623, was seen to be excitingly unpredictable. To
attempt to place upon the idea the fetters of an exact verbal formula could never have been
sound. It would be unsound to the point of folly to attempt to do so now, when science has
made such advances that the concrete applications of the notion which were familiar in 1623
can be seen to provide only the more obvious, not to say the more primitive, illustrations of
the broad sweep of the concept. Matters of policy would need to be addressed in order to
determine whether living organisms are a 'proper subject' for patentability. Until a Court or
Parliament rules otherwise it will be possible to patent living organisms in Australia due to
the practice adopted by the Commissioner of Patents. This practice is expressed in the
following terms: The criteria to be met before an application concerned with living organisms
will be accepted are precisely the same as those for any other application, i.e. no distinction is
to be made solely on the basis that a claimed product or process is, or contains or uses, a
living organism. High life forms will not be treated any differently from lower forms such as
micro-organisms. The only criterion having particular significance in relation to living
organisms is the requirement of s.40 of the Patents Act concerning a full description of the
best method of performing the invention. In this regard it should be noted that disclosure of a
method of performing the invention, i.e. producing the new organism, which by repetition
will again produce the organism, is required7.

Thus, so long as a living organism is new, involves an inventive step, is useful (not in the
sense of commercial viability but in the sense that the result can be achieved by others) and
proper specifications for it are supplied the Commissioner will issue a patent for it. The issue
of patentability of a living organism had earlier required the attention of the Assistant
Commissioner in Rank Hovis McDougall Ltd's Application, 23 where claims were allowed
for specific variants of a new strain of micro-organism known as “tusarium graniearum”
useful in producing edible protein. The basic organism itself occurred m nature and was thus
not novel, however the variants could be produced only by human intervention.

6
(1959) 102 C.L.R. 252.
7
(1980) 50 A.O.J.P. 1162

18
The Assistant Commissioner took the view that the fact that they were alive was no bar to
their being patented: In respect of the invention claimed by claim, what has 'the inventor
done? What contribution has he made? He has discovered a naturally occurring micro-
organism and, by altering its conditions of growth, he has changed its morphological
characteristics. If that is all that he has done, he has made no useful contribution to the art. On
the other hand, I think the situation is quite different if, in producing the variant by some man
controlled microbiological process, he has produced a new micro-organism which has
improved or altered useful properties. To suggest that a patent should be not granted for such
an invention would in my opinion hardly accord with the views clearly expressed in the
decision in National Research Development Corp v. Commissioner of Patents. An objection
that a claim to a new micro-organism, being something living, is not a manner of
manufacture is based, in my opinion, on too restricted a view of the meaning of manufacture
in section 6 of the Statute of Monopolies. It may well be some time before the Courts in
Australia are called upon to determine the issue of patentability of living organisms, since the
Commissioner's practice means that no application will be rejected on the ground only that
the subject is alive and thus no dissatisfied applicant will take that issue to judicial
determination. Some cases involving disputes over specifications may provide important
opportunities for expression of obiter dicta on the matter; however final adjudication will
probably need to await a claim for infringement of a patent already granted wherein the
defendant will object to its validity in the first place. In the meantime it may be that
Parliament will intervene in an attempt to resolve the matter at least in the case of 'higher' life
forms.

Patentability of Life forms in India:

In India, not everything under the Sun is patentable in contrary to US Patent system. Section
3 of the Patent Act, 1970 provides a list of inventions which cannot be patented in India. So
for any invention to be patented; it must first fulfil the basic requirements of patentability,
i.e., it should be Nobel, useful and have industrial applicability and should not fall under the
purview of Section 3. As per Section 3(c) of the Act, the products such as microorganisms,
nucleic acid sequences, proteins, enzymes, compounds, etc., which are directly isolated from
nature are not patentable subject matter. It is mandated that microorganisms which are
naturally occurring are not patentable. It is implied also that only modified microorganisms
are patentable subject matter under the Act. Claims relating to basic biological processes of
growing plants, germination of seeds, of development stages of plants and animals are not
patentable.

Section 3(d) of the Act provides that any minor modifications in the already existing
substance in the prior art are not patentable unless the improved property or efficacy of the
modified substance is established. With respect to biotechnology patent applications, section
3(d) is applicable to those inventions relating to a three-dimensional or crystal structure of a
polypeptide unless it is proved that such polypeptide differs significantly in properties with
regards to therapeutic efficacy.Apart from setting the basic minimum standard for
patentability, TRIPs obliges member states to patent micro-organisms (Article-27 (3) (b)).

19
However, the term microorganism lacks a precise scientific definition because of which there
are inherent anomalies in patenting these life forms. Though the TRIPs agreement mandates
patent protection for micro-organisms, it does not define micro-organisms; thus there is no
standard definition for member nations to follow. TRIPs facilitate the provision for the
member country to adopt a sui generis (adoption of national laws and regulation) system to
protect the GEMs and invented biological material. It is not clear whether, the term would
include only genetically modified organisms or naturally occurring substances also.

The Calcutta High Court decision in Dimminaco AG v. Controller of Patents and Designs,
20028 relating to patentability of biotechnological process with living end product is another
milestone decision in Indian context. Dimminaco A.G., a Swiss company applied for
patenting the process for preparation of a live vaccine for Bursitis, an infectious poultry
disease and the invention involved a live (attenuated) vaccine to combat the disease. The
Controller of Patents refused to allow the application on the ground that the vaccine involved
processing of certain microbial substances; this was only a natural process devoid of any
manufacturing activities and hence not patentable. This was in consonance with the
prevailing practice that grants patents only to non-living and tangible inventions, 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 a vaccine with a living organism is not an article,
substance, or manufacture. 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. Justice Ashok Kumar Ganguly observed “if the end is the
commercial and vendible entity; and for that presence of living virus or micro-organism in
the end product cannot be a bar to its patentability”. The Calcutta High Court held that, the
Indian statute on patents does not put any restraints on patentability of micro-organisms
developed in a controlled environment in the laboratories. The Court also held that the
process for creating a vaccine leads to a vendible product even if the end product contains
live material. The court said that if the invention results in the production of some vendible
items or improves or restores formal conditions of vendible item.

Therefore since 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 in line with the position in US, most of the European countries as well as Japan, since
most processes in the biotechnology field 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 flourishing biotechnology industry.

8
2002 IPLR

20
PLANT VARIETY PROTECTION AND FARMER’S RIGHT ACT, 2001 - India has
ratified the TRIPS agreement and to give effect to this agreement, The Protection of Plant
Varieties and Farmers Rights Act, 2001 (PPV&FRA) was enacted. The main aim of this Act
is to establish an effective system for the protection of plant varieties and, the rights of the
breeders and to encourage the development of new varieties of plants. Any variety that fulfils
within the distinct, uniform and stable criteria and that is "new" (in the market) is eligible for
this kind of protection, and there is no need to demonstrate an inventive step or industrial
application, as required under a patent regime.

Section 3(j) renders ‘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’ not patentable. Thus, in the
light of above mentioned Sections, simply isolating a gene from a living thing amounts to
‘discovery’ and not ‘invention’ and hence not patentable. That is to say, under the current
Patent regime naturally occurring DNA sequences cannot be patented as such. They can only
be patented when after isolating the sequence they are purified and chemically modified
resulting into a sequence that is new, inventive and has industrial application. Nevertheless,
artificially developed genetically engineered microorganisms, vaccines and recombinant
DNA are all considered to be patentable. Thus, when a genetically engineered gene, DNA, or
amino acid sequence is novel and holds an inventive step thereby ensuring its industrial
application, the patents can be claimed. It should be noted that rDNA, plasmids and process
of forming the same are allowed to be patentable if substantive inventive steps are employed.
One such example of gene patents in India, as seen in Indian Patent No. 243373
(279/MUM/2004) assigned to Sichuan Biotechnology Research Centre, discloses artificial
gene sequence for encoding recombinant super compound interferon with enhanced activity.
Further, unidentified functions of gene/DNA sequences and without any industrial
application cannot be construed to be patentable.

In relation to India, under the present TRIPS framework, irrespective of the fact that it is a
MNC or an Indian company, the edge exists for only those companies which are innovative
in their product profiles and who are continuously innovating and introducing new products.
Patenting of tropical bio-diversity should be emphasized so as to prevent patenting of Neem,
Turmeric, Basmati and other components of indigenous system of medicine by outsiders.
This will help ensure IPR protection to herbal and botanicals to MNC exploitation and also
revenue earnings for Indian companies dealing in them. Many Indian pharmaceutical
companies have already geared up for facing the reality of product patent.

21
 PATENTABILITY OF LIVING MATTER:
“DIAMOND v. CHAKRABARTY”

Prior to 1980 the PTO and the federal court system engaged in a seemingly determined effort
to abjure the patentability of living matter. Despite the anomalous patent, such as that issued
to Louis Pasteur in 1873 for his purified culture of yeast, the courts invariably rejected
patents that involved living subject matter. Their most effective weapon was the "products of
nature" doctrine, the success of which is illustrated in Funk Brothers. Where that doctrine
failed, the PTO and private plaintiffs reasoned that the two plant protection acts of 1930 and
1970 demonstrated a Congressional intent that the only living organisms to be afforded patent
protections were those qualifying under one of the acts. It would inevitably require the
Supreme Court of the United States to embrace this issue and champion the biotech industry.
In 1980 the U.S. Supreme Court issued an opinion in what is unequivocally heralded as the
landmark case in biotechnologically related patent law, Diamond v. Chakrabarty9. The case
was brought forth by a microbiologist challenging a ruling by the PTO denying his
application to patent a genetically engineered strain of bacteria capable of breaking down
multiple components of crude oil.

Chakrabarty's invention was a process for introducing specific plasmids capable of breaking
down four different oil components into a host Pseudomonas bacteria. The unaltered,
naturally occurring Pseudomonas had no capacity for degrading the oil. However, the
modified Pseudomonas was to have significant value for the treatment of oil spills. PTO
examiners denied Chakrabarty's application based on the dual analysis that: (1) micro-
organisms are non-patentable "products of nature," and (2) as living things, they are per se
non-patentable subject matter. The "products of nature" argument was subsequently rejected
by the Patent Office Board of Appeals upon recognition that Pseudomonas possessing the
special characteristics of Chakrabarty's bacterium are not naturally occurring. The Board,
however, affirmed the PTO ruling on the second argument, explaining that Congress's special
provisions under the Plant Patent Act of 1930 constituted conclusive evidence that section
101 was not intended to cover living things. The Supreme Court granted review on the issue
of "whether respondent's [Chakrabarty's] micro-organism constitutes a 'manufacture' or
'composition of matter' within the meaning of [35 U.S.C. § 101].

Step one of the Court's analysis required defining the concepts "manufacture" and
"compositions of matter. The term "manufacture" was defined according to its dictionary
definition, to mean "the production of articles for use from raw or prepared materials by
giving to these materials new forms, qualities, properties, or combination, whether by
handlabor or by machinery.

9
Diamond v. Chakrabarty, 447 U.S. 303 (1980).

22
A composition of matter was cited in prior case law as including "all compositions of two or
more substances and all composite articles, whether they be the results of chemical union, or
of mechanical mixture, or whether they be gasses, fluids, powders or solids 10. Step two
involved the reading of these terms in their statutory context11. The Court proclaimed that the
combination of such expansive terms as "manufacture" and "composition of matter" modified
by the all inclusive "any" was indicative of Congress's intention that the patent laws be read
broadly. The Court also referred to Committee Reports from the 1952 recodification of the
patent laws, which stated Congress's intent that the statutory subject matter include "anything
under the sun that is made by man" 12. In conclusion, the Court held that the language of
section 101 fairly embraced Chakrabarty's invention of the Pseudomonas organism, thus
dispelling the notion that living matter is not patentable13.

With this decision the Supreme Court opened a new world of opportunity to U.S. industry.
Many companies hesitated to see if Congress would accept the Supreme Court's invitation to
enact regulations to cover the freshly exposed area of patents on living matter. As the
resulting legislative paralysis became apparent, an excited rush into genetic research ensued.
Chakrabarty's broad interpretation of patentable subject matter provided U.S. companies with
the promise of patents to protect their investments. As the result, U.S. industry greatly
expanded its commitment to genetic engineering, establishing an early position of world
dominance, which it has yet to yield.

Post-Chakrabarty Developments in the United States:

The Chakrabarty opinion employed expansive language that broadened the narrow reach of
the patent laws to encompass living organisms as patentable subject matter allowable under
35 U.S.C. § 101. Yet, despite the sweeping construction of this precedent-setting opinion, the
future patentability of living matter remained uncertain. It has required a dozen years of
judicial and legislative activity following Chakrabarty to re-affirm that the comprehensive
language, "anything under the sun that is made by man," means in essence what it says. To
date the only express limit on the patentability of life is to preclude any patent "claim directed
to or including within its scope a human being,"' a narrow exclusion attributed to the
thirteenth amendment's prohibition of slavery. The following section discusses the major
judicial, legislative, and PTO activity that has occurred since the Chakrabarty decision.

Post Chakrabarty Case Laws:

Dimminaco A.G v. Controller of Patent and Design 14: - In India before 2002,
amendment the understanding is that there is no patent protection for invention relating to life
forms. But in Dimminaco A.G v. Controller of patent and design, the Calcutta High Court
held that a process for preparation of vaccine containing live virus is patentable since the
term manufacture covers even living organism.
10
Chakrabarty, 447 U.S. at 308
11
35 U.S.C. § 101 (1988).
12
Diamond v. Chakrabarty, 447 U.S. at 309
13
Chakrabarty, 447 U.S. at 308-09.
14
(2002) I.P.L.R. 255 (Cal)

23
So according to the Court even if the end product contains a live virus the process involved in
bringing out the end product becomes an invention. It may be noted that there is no decision
reported till date directly on the application of the inventive step standards to inventions
relating to biotech patents in India.

The landmark judgment of the Calcutta High court in the case of Dimminaco A.G. v.
Controller of Patents & Designs on 15th January, 2001, prior to the 2002 amendment in the
patents act, 1970 established a benchmark in the field of micro-biological research. In this
case, an appeal was filed against the Assistant Controller of Patents & Designs, wherein, the
process for preparation of infectious Bursitis Vaccine was refused on the grounds that the
process of preparation of vaccine that contained a living virus cannot be considered
manufacture and that a vaccine comprising of a living virus cannot be considered a substance
or inanimate object. The court in this case reversed the decision of the Assistant controller
and held that, the process of preparing a vendible commodity containing a living substance is
not excluded from the purview of the word, ‘manufacture’ and that the controller erred in
denying patent protection to the vaccine just because it contained a live virus. Furthermore,
the end product was novel, capable of industrial application and was useful for protecting
poultry against contagious Bursitis infection, thus making the process an invention. The court
further allowed the appeal and directed the petitioner’s patent application to be reconsidered
within two months of the publication/delivery of the judgement.

National Research Development Corporation v. Commissioner of Patents 15: -

Court would not be content with a limited exercise in statutory interpretation. Matters of
policy would need to be addressed in order to determine whether living organisms are a
'proper subject' for patentability. This was not a question which needed to be considered in
the NRDC Case and indeed it has not yet been the subject of any judicial determination in
Australia. Until a Court or Parliament rules otherwise it will be possible to patent living
organisms in Australia due to the practice adopted by the Commissioner of Patents. This
practice is expressed in the following terms: The criteria to be met before an application
concerned with living organisms will be accepted are precisely the same as those for any
other application, i.e. no distinction is to be made solely on the basis that a claimed product or
process is, or contains or uses, a living organism. High life forms will not be treated any
differently from lower forms such as micro-organisms. The only criterion having particular
significance in relation to living organisms is the requirement of s.40 of the Patents Act
concerning a full description of the best method of performing the invention. In this regard it
should be noted that disclosure of a method of performing the invention, i.e. producing the
new organism, which by repetition will again produce the organism, is required 16. Thus, so
long as a living organism is new, involves an inventive step, is useful (not in the sense of
commercial viability but in the sense that the result can be achieved by others) and proper
specifications for it are supplied the Commissioner will issue a patent for it.

15
(1959) 102 C.L.R. 252.
16
(1980) 50 A.O.J.P. 1162

24
The issue of patentability of a living organism had earlier required the attention of the
Assistant Commissioner in Rank Hovis McDougall Ltd's Application 17, where claims were
allowed for specific variants of a new strain of micro-organism known as ‘tusarium
graniearum’ useful in producing edible protein. The basic organism itself occurred in nature
and was thus not novel; however the variants could be produced only by human intervention.
The Assistant Commissioner took the view that the fact that they were alive was no bar to
their being patented: In respect of the invention claimed by claim 2, what has 'the inventor
done? What contribution has he made? He has discovered a naturally occurring micro-
organism and, by altering its conditions of growth, he has changed its morphological
characteristics. If that is all that he has done, he has made no useful contribution to the art. On
the other hand, I think the situation is quite different if, in producing the variant by some man
controlled microbiological process, he has produced a new micro-organism which has
improved or altered useful properties. To suggest that a patent should be not granted for such
an invention would in my opinion hardly accord with the views clearly expressed in the
decision in National Research Development Corp v. Commissioner of Patents.

Commissioner of Patents v. President and Fellows of Harvard College 18:- Two

scientists from Harvard Medical School gained the first patent for a living animal by the
United States in April of 1988 for a “transgenic mammal, “commonly referred to as the
“Harvard mouse” or “Oncomouse”. A cancer-promoting gene is injected into fertilized mouse
eggs as close as possible to the one-cell stage. The eggs are then implanted into a female host
mouse and permitted to develop to term. After the offspring of the host mouse are delivered,
they are tested for the presence of the oncogene. Those that contain the oncogene are called
"founder" mice. Founder mice are mated with mice that have not been genetically altered.
Fifty per cent of the offspring will have all of their cells affected by the oncogene, making
them suitable for animal carcinogenic studies. Therefore, section 2 of the Canadian Patent
Act sets forth the criteria for patentability. In order to be patentable, the art, process,
manufacture or composition of matter must be considered an “invention.” Once considered
an invention under section 2, this invention must be considered “new” and “useful”. The
question which arises here is whether a higher life form can be considered an “invention”, as
defined under the Patent Act, and subsequently whether is patentable. The crux of the legal
dispute is what constitutes a "manufacture" or a "composition of matter.

The examiner rejected the product claims because they did not fall within the definition of
"invention" under section 2 of the Canadian Patent Act. In large part, this refusal was based
on a strict reading of statutory subject matter. The Act defines "invention" as "any new and
useful art, process, machine, manufacture or composition of matter, or any new and useful
improvement in any art, process, machine, manufacture or composition of matter". In his
rejection, the examiner noted that, had Parliament intended to include animals as patentable
subject matter, it would have expressly included animals in the definition of "invention".

Moreover, the examiner relied on the Manual of Patent Office Practice's express exclusion of
animals as statutory subject matter. In issuing his Final Action, the examiner also relied
17
(1976) 46 A.O.J.P. 3915.
18
2002 SCC 76, 219 D.L.R

25
heavily on case law from Pioneer Hi-Bred Ltd. v. Canada (Commissioner of
Patents)19 as evidence of the statutory bar on patenting animals. In Pioneer Hi-Bred, the
result of cross-breeding of soybeans was found to be unpatentable because obtaining a new
variety of soybean through cross-breeding and cultivated naturally did not represent an
invention within the meaning of section 2 of the Patent Act.

The Supreme Court of Canada found the Harvard-mouse unpatentable under the words of the
Patent Act. In particular, the Court looked at the meaning of the words “manufacture” and
“composition of matter”. As to the definition of a “composition of matter,” the court found
the Chakrabarty definition too broad, finding that the words did not encompass higher life
forms. The Supreme Court of Canada accepted the Harvard mouse case to determine
“whether Parliament intended the definition of invention to be interpreted broadly enough to
encompass higher life forms”. In order to make that conclusion, the Court specifically asked
“whether the words “manufacture” and “composition of matter,” in the context of the Patent
Act, are sufficiently broad to include higher life forms”. The Court reasoned that “just as
“machine and “manufacture” do not imply a living creature, the words “composition of
matter” are best read as not including higher life forms”. Consequently, the Supreme Court of
Canada decided that the Oncomouse was unpatentable as a higher life form. The Court
nonetheless noted that "Parliament did not leave the definition of invention open, but rather
chose to define it exhaustively". Thus, despite the objects of the Act, an invention must still
be within the terms of the Act to be patentable.

The Oncomouse has been held patentable, and is now patented in jurisdictions that cover
Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg,
The Netherlands, Portugal, Spain, Sweden, the United Kingdom and the United States. A
similar patent has been issued in Japan. New Zealand has issued a patent for a transgenic
mouse that has been genetically modified to be susceptible to HIV infection. Indeed, it seems
that no country with a patent system comparable to Canada's (or otherwise) has refused a
patent on the Oncomouse upon submission of an application within their jurisdiction.

PROS & CONS OF LIFEFORM PATENTING

19
(1987) F.C. 8 (Federal Court of Appeal).

26
Most people would probably oppose patentability of any human life form, but short of that
the difficulty is always where to draw the line. Section 1(3) of the Patents Act 1977 (U.K.)
provides one answer although difficulties may occur in defining 'animals' which interestingly
enough is not a term defined in the U.K. Act. The authors now propose to examine some of
the policy arguments on each side of the patentability for living organisms’ case in order to
ask, but perhaps not answer, whether the U.K. approach of confining patents to micro-
organisms is the correct one.

The following principal arguments may be presented in favour of patentability of

living organisms:

 Firstly, useful advances have already been made in such diverse fields as medicine
and pollution control through use of biotechnology and mankind has benefited as a
result. Examples abound and can be found in areas such as production of interferon (a
possible cancer suppressant) and genetic engineering of bacteria to deal with oil spills
such as in Chakrabarty. The potential exists to further benefit mankind through
genetic engineering which may reduce disease and also hunger, by making super-
productive crops and farm animals. One of the most outspoken proponents of genetic
engineering is Professor Bernard Davis, professor of bacterial physiology at Harvard
Medical School, who says the technology has been yielding increasing benefits in
medicine, agriculture and industry for six years. In Australia, Professor Carl Wood
told a recent Symposium20 that reproductive biology could offer a simpler and more
effective way to improve human behaviour, for example to reduce the killing instinct
or to improve metabolic processes so that people can survive on less food. Recent
research in the United States has been directed at genetically altering animals to make
them susceptible to human diseases so that new drugs may be tested on them. In terms
of the necessity for patents it is argued that genetic engineering and biotechnology are
unlikely to achieve their full promise without intellectual and financial input from the
private sector which will not be forthcoming without some financial protection and
reward at the end, such as patent monopolies. According to Professor Wagner of the
University of Ohio Animal Biotechnology Centre, genetic engineering opens the
prospect for large profits to be made by companies in the private sector but these
companies will need encouragement for developmental costs in the form of patents on
the end products of the research they fund. This argument was rejected by the
majority in Chakrabarty.

 Secondly, patentability places biotechnological inventions in the public domain and

precludes the secrecy which would attend an unprotected research environment. In
this argument it is implicit that secrecy is to be avoided because society generally
should be in a position to control biotechnological pursuits upon ethical grounds
which cannot be trusted to self-regulation among the scientific community. As it is

20
R.M.I.T. Centenary Conference on Future Directions in Technology, Education and Society; 12 May 1987.

27
 society which will have to bear the cost of biotechnological failures which produce
harmful results, it is argued, then society has a right to know what is happening so that
where necessary appropriate controls may be put in place.

 Thirdly, patentability vests discoveries in the public domain and via compulsory
licenses allow society to benefit from all discoveries, not just those which are seen to
be economically viable at a given time.

The following principal arguments may be presented against allowing patentability of

living organisms, at least under present arrangements:

 Firstly, if living organisms are to be patentable, that is a decision which should be

taken by the legislature rather than the Courts. There is sufficient doubt about the
matter for the Courts to refuse patentability unless Parliament makes the position
clear. Whilst this argument attracted the support of four members of the U.S. Supreme
Court in Chakrabarty it is submitted that it has little force in the Australian context.
As a general rule, an Australian Court should not in interpreting a statute exclude
from the operation of that statute things which were not known to Parliament at the
time it was enacted if those things now fall within the words of the statute in their
current meaning21. The opposite of this proposition, contemporanea expositio est
optima et fortissima in lege, was argued in Chakrabarty and rejected by the majority.
Its use is now confined to very old statutes. The correct question is: would the
legislature have intended the Act to encompass this subject-matter if it had been
known when the Act was passed? The answer in the context of patents for living
organisms can be found only in an examination of policy considerations, and here it
should again be pointed out that the High Court in the NRDC Case have placed
responsibility for finding the answer upon the shoulders of the judiciary. In a recent
book Professor Weeramantry argues that the Anglo-Australian legal system,
dominated by the adversarial notion of litigation, is not structured to be able to deal
with scientific advances22.

 Secondly, the risks involved in biotechnology are so great that such work is not to be
encouraged through patentability of the results. The matter it is argued has gone far
enough with patents for protection of processes. This is the 'parade of horribles'
approach referred to in Chakrabarty but avoided by the majority in their belief that
determination of policy was not their role. In answer to this, commentators such as
Professor Bernard Davis of Harvard Medical School state that the bulk of genetic
engineering experiments are not dangerous. They use harmless organisms and
produce harmless materials such as human insulin. According to Professor Davis, the
power of biotechnologists is limited by nature's own 4self-policing' process, so that
only very small bits of genetic material can be transferred (less than one part per
thousand) between species. He concedes however that the future may unlock the

21
Lake Macquarie S.C. v. Abedare C.C. (1969) 123 C.L.R. 327.
22
C.G. Weeramantry, The Slumbering Sentinels: Law and Human Rights in the Wake of Technology, (1983).

28
 secret of transferring larger amounts. Furthermore, it is often only long after a
discovery and perhaps the granting of a patent that detrimental effects of a discovery
originally thought to be only useful are themselves discovered. Denying patents will
not stop this, because it will not stop the research in the first place.

 Thirdly, it is morally wrong to grant proprietary rights over any life form because it is
morally wrong to engage in biotechnology and genetic engineering Biotechnology
companies would obtain ownership of a life form and such exploitation of nature
should not be permitted. Few perhaps would disagree in the case of 'higher' life, many
perhaps would disagree in the case of bacteria which could improve the conditions in
which higher life exists. Dr Ricketson points out that we generally draw a dividing
line between human life and all lesser life forms. If we can own and destroy an animal
at will, he asks; why not acknowledge the right to make a particular type of animal by
genetic engineering?23 As stated earlier in this article the difficulty is where to draw
the line. The 'human versus others' species test may be totally inapplicable to a
genetically engineered creature looking non-humanoid yet possessing unmistakable
human characteristics such as rationality and ability to choose. Few would doubt that
animals are intelligent; some would say they have rights which should be protected in
the same way as human rights. Nonetheless, it is submitted that it would be absurd to
deny patentability of micro-organisms on these grounds.

 Fourthly, current patent laws are ill-equipped to cope with the difficulties of
description of a 'patentable' living organism. This, it is submitted, is no answer to the
central question. If one agrees that living organisms should be capable of being
patented, the 'specification' requirements can always be tailored appropriately. An
attempt has already been made through the 1984 amendments to s.40, Patents Act.

23
S. Ricketson, The Law of Intellectual Property in Australia, (1984)

29
 WHETHER IT IS POSSIBLE TO GRANT PATENTS FOR
LIFEFORMS IN FUTURE

It might be possible to grant patents for life forms in future. Patentable subject-matter is a
dynamic concept and with the enormous power unleashed by the ever-growing trends in
Biotechnology, it is bound to get transformed in future. However, an equally important
determinant is the acceptability to the society. Modern biotechnologies have yielded
processes and products which have commercial significance. Protecting intellectual property
for these applications critical for commercial viability of innovator projects has been a
challenge. Patent protection for living organisms became possible subsequent to the award of
a patent for a modified bacterium not found in nature which was created through human
ingenuity. In 1987, the USPTO announced that it would consider patents for non-naturally
occurring, non-human multi cellular living organisms, including animals resulting in the
patenting of the Onco Mouse in 1988. Patenting DNA sequences has been possible as
sequences isolated from living organisms are considered compositions of matter and articles
of manufacture. However, there is an increasing emphasis on sequences which demonstrate a
“substantial, credible, and specific use” only being eligible for patenting.

Life form patenting thus, the consensus even if somewhat forces lies on an utilitarian
balancing of the benefits to society with the moral ethical concerns while at the same time
ensuring that even this balancing exercise stays within the realms of an accepted notion of
morality as well as the patentable criteria of the life forms being synthetically produced, non-
naturally occurring and as regards human genetic materials being completely isolated etc. It is
said to be constrained within the accepted notion of morality because notwithstanding all
justifications and benefits supporting it, human cloning is still not patentable in any the
world’s major jurisdictions indicating that there are certain non derogable fundamental
societal precepts which cannot be compromised upon no matter what the benefits from doing
so. So life patenting as of the present lies on an evolving if somewhat hazy dichotomous
consensus among growing tolerance for the intrusions of science. While there is growing
convergence on issues relating to patentability, there is still an occasional difference in
opinions of different patent office’s which renders the law unpredictable.

30
 CONCLUSION

Patents on life forms hinder research, indigenous economies, and genetic diversity. No
individual, institution or corporation should be able to claim ownership over species or
varieties of living organisms. In actuality, patents enable companies to create a monopoly on
a product, permitting artificially high pricing. As a result, products such as drugs are often
priced out of reach for many of those who need them. Patents in science promote secrecy and
hinder the exchange of information. By patenting products of research, the free flow of ideas
and information necessary for cooperative scientific efforts is reduced.

Scientific materials required for research will become more expensive and difficult to
purchase if one corporation owns the rights to the material. Patents exploit taxpayer-funded
research. The development of biotechnology rests on 50 years of federally funded biomedical
research. Corporations can make profits on their patented products by charging high prices to
the citizens whose tax dollars supported the research and development of the products.
Citizens are unfairly being asked to pay twice for medicines and other products. Patents
promote unsustainable and inequitable agricultural policies. A disastrous decline in genetic
diversity could be the result of patenting of crop species. The genetic diversity inherent in
living systems makes patent claims difficult to defend. The development of genetically
uniform organisms would make it easier for corporations to maintain their patent claims.
Biotech companies holding broad spectrum patents on food crops will lure farmers to grow
modified varieties with promises of greater yields and disease resistance. However, numerous
examples worldwide show the improved crops have failed to hold up to corporate promises,
and led to the loss of the rich diversity of traditional crop varieties. First World patenting of
Third World genetic resources represents theft of community resources.

Patents held by the industrialized world on resources from the developing world will serve as
a tool for the North to accumulate more wealth from the already economically impoverished
South. Microorganisms, plants, animals and even the genes of indigenous people have been
patented for the production of pharmaceuticals and other products. Requiring developing
nations to pay royalties to the wealthy industrial nations for products derived from their own
natural resources and innovation is robbery. Patenting life forms bring with them overbearing
issues of religious and ethical values. In today's competitive and globalized world,
biotechnology revolution is affecting industry and growth in a big way. It would, thus, be in
our national interest to document, protect and modify new microorganisms isolated from
various parts of our country and find their new and improved industrial uses. However, in the
clash between socialist and capitalist centric ideologies, the betterment of the society as the
prime objective should be borne in mind before our regulatory bodies arrive at a conclusion.

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 BIBLIOGRAPHY

ARTICLES/ JOURNALS: -
 Journal of Intellectual Property Rights, Volume 15, pp 55-65
 Fordham International Law Journal, Volume 16, Issue 4
 https://www.iatp.org/news/patents-on-life-forms-should-be-re-examined/

BOOKS: -
 Patenting Living Matter in the European Community, David G. Scalise
 Patenting New Life Forms: I.A. Wilson and K.R. Wilson

WEBSITES: -
 http://ssrn.com/patentabilityoflifeforms/
 http://www.worldtradelaw.net/uragreements/tripsagreement
 http://www.bitlaw.com/source/35usc

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