INTRODUCTION:

A patent is an intellectual property which grants monopolyrights to a person who has invented
a new and useful article or an improvement of an existing article or a new process of making
an article. Historically, patent was given for improvements in the process of making beer and
improvement in the manufacture of yeast to Louis Pasteur in France, Italy, US in 1873. And
the patenting of life forms emerged as an important issue only after 1970's when there was a
boom in biotechnology by the emergence of Recombinant DNA Technology, Tissue culturing,
Hybridoma Technology etc. By using these technologies, it is possible for the researchers and
industries to exploit the biological resources and to produce in large-scale commercially viable
products in the field of pharmaceuticals, agriculture etc.

When compared to the traditional patenting in machinery, in biotechnology patenting the

subject-matter is living cells, plants, animals, gene, human cells, hybrid plants, transgenic
animals etc. Because of the commercial potential that lie from the use of biotechnology the
question of patenting of life forms emerged as a crucial issue. Through this paper, the attempt
is to highlight the issues regarding patentability of life forms comparing the standards followed
in US, UK and India in the context of TRIPS Agreement.

ISSUES IN PATENTING LIFE FORMS:

Patenting of new inventions require proof of novelty, inventive step or non-obviousness and
disclosure of invention. But in biotechnology inventions the basic subject-matter is something
already existing in nature. It is a well-accepted principle that in patent law naturally available
subject-matter is excluded from patenting because it contributes nothing new. So, in biotech
invention, the productivity of this material was considered as natural, converting them into
private property has been considered unethical and against public interest. In addition to this it
also raises moral and ethical issues like playing God by human beings and degrading Gods
creation to mere material objects by making it private property using the advanced techniques.
Also test of obviousness/inventive faculty in patent law created difficulties in granting biotech
patent for biotech inventions. Another problem involved is the practical requirement of written
description of invention and the production of samples. However, developments in
biotechnology resulted in finding solution for these issues.

LEGAL ISSUES:
Legal problem to patenting of life form is centered around, whether or not under existing
criteria of patentability, life forms may be patented. In US, until 1980s legal interpretation has
denied the eligibility of all life form for patent rights because it considered such inventions as
mere discovery of unknown things in nature.This was reflected in the decision in Funk Bros v.
Kalo Inoculant Co. In this case, the claim was for a patent for mixed culture of Rhizobia
capable of inoculating seeds of a plants belonging to several cross-inoculation groups. Here,
the Court held that "he who discover a hither of unknown phenomenon of nature has no claim
to a monopoly of it which the law recognizes. If there is to be invention from such a discovery
it must come from the application of law of nature to a new and useful end. Even though it may
have been the product of skill, it certainly was not product of invention.

But in 1980, US Supreme Court in Diamond v. Chakrabarty granted patent to genetically

modified bacteria useful for oil spill clean-up. The rationale for this decision centered on
ingenuity required to modify the bacteria. According to the Court by choosing liberal
interpretation for the term "manufacture" and "composition of the matter" modified by the
comprehensive "any" the Congress contemplated that the patent law should be given wide
scope to "include anything under the sun that is made by man". Here, the Court held that
patentee has produced a new bacterium with markedly different characteristics from any found
in nature and one having the potential for significant utility. The Court ruled that the discovery
in this case is not nature's hand- work but his own falling under Section 101, 35USC.

Thus, Diamond v. Chakrabarty opened a flood gates to various applications claiming patent
protection over plants and higher life forms. In 1985, by the Judgment In Re Hibbered full
patent rights were extended to plants, and also for animals in ex parte Allen". The decision is
purely based on test of degree of human intervention in making a product and the need to
protect it as per the constitutional mandate (distinguishing naturally occurring and non-
naturally occurring).

However, it created a major difficulty to draw a line between discovery and invention
especially when DNA technique has been developed to isolate genetic materials. Following the
Chakrabarty's decision the US patent office even granted patent for Oncomouse for studying
cancer drug. The only criterion was human intervention and they never considered the issue of
morality or public Order.

MORAL AND ETHICAL ISSUES:

The Grant of patent on higher life form such as human cells, gene, mice etc. has provoked a
numerous ethical objection to the patenting of life. Many of them rooted in religion claiming
that patent reduces Gods creature to mere material objects, degrades God given dignity of life
forms by making it one’s own property. However, there should be some sort of control on
human being playing God using new technological development and acquiring patent in
technological invention. This issue was addressed by the European Court in Relaxin case. Here,
the claim was for patenting human gene encodes for Relaxin. It was held that patenting of a
single human gene has nothing to do with patenting human life. Even if every gene in human
genome were cloned it would be impossible to reconstitute a human being from the sum of its
gene. And such patent does not confer any right over any individual human being. The tissue
is taken with consent within the framework of gynecological operations. Many lifesaving
substances were isolated in this way and thus serve social purpose, by contributing to humanity,
lifesaving drugs and such inventions are industrially applicable technical solutions to a
technical problem. Hence, they are patentable. Thus, using DNA technique gene was cloned
making it possible subsequently, to produce synthetic Relaxin a hormone which relaxes the
uterus during the child birth. Until it was isolated, gene coded for Relaxin was unknown hence,
it was held that it is not mere discovery.
It was in PGS, Green Peace, the patentability of transgenic plant was challenged on the ground
of public Order and morality under the European Patent Law. The technical Board of Appeal
provided definitions for the first time for "Ordre public" and "morality," and observed that they
were to be applied individually as opposed to together. Order public was defined as "relating
to protection of public security and environment" and morality was described as 'relating to the
belief in European society as some behavior as right and acceptable where as other behaviors
as wrong, this belief being founded on conventionally accepted standard inherent in European
society and civilization. And the board rejected the relevance of opinion polls and surveys
presented by Green Peace.

In common Law no one can claim property rights in human body or parts of human body like
organs because of the social and ethical concerns prevailed in their society. The emerging
patent claims for genetic material compelled them to pass a Directive on Biotechnological
invention in 1998. The Directives contains provisions defining Biotechnological inventions,
Biological process etc. and what should not be patented-like cloning of human beings, use of
human embryos for industrial and commercial purposes, modifying the genetic identity of
humans etc. and only the processes that lead to their discovery and isolation can be patented.
Another specialty in the Directive is the European Union ethics panel where the patent office
can seek advice on the order public and morality issues involved in the patent claims. Since the
directive was passed, social activists have mounted many successful challenges in Europe
against biotech patents, including patents on stem cell lines and various genetically engineered
plants.

It may be noted that even from the decision in 2004, the EPO feels that new rules are more than
merely 'interpretative' in nature.Perhaps the pending decision in relation to stem cells may
provide fresh guidance on the application of Article 53(a) and the new Rules.

ENVIRONMENTAL ISSUES:
Some of the concerns about the new technology include its potential adverse effects on
biological diversity and potential risks to human health. GMO's do present risk to human health
and environment, has also raised considerable uncertainties, regarding environmental impacts.
Here, the precautionary principle should be respected when there is reasonable ground for
concern even without complete documentation. Country should be reluctant to allow
patentability, or even commercial use of GMO's until more knowledge is available regarding
the safety of GMO's'. However, in Onco-Mouse/Harvard case in respect of "possible risks to
the environment" the Court considered purpose of the invention. According to the Court the
purpose of the present invention is to provide animal test models which are to be used
exclusively in the laboratory under controlled condition by qualified staffs. No release is
intended in to the general environment. Therefore, the risk of uncontrolled release is practically
limited to intentional misuse or blatant ignorance on the part of the laboratory personal carrying
out the test. The mere fact that such uncontrollable acts are conceivable cannot be a major
determinant for deciding whether patent should be granted or not.

Thus, environmental standards are for legislature or executive to frame. Parliament may set
down health, safety and environmental standards to be fulfilled by any applicant desirous of
getting GMO's patented.
STANDARDS OF PATENTABILITY OF BIOTECHNOLOGICAL
INVENTIONS IN US AND UK:
When new technology emerges, it becomes more complicated to apply the same parameters of
patent standards. In the case of biotechnological inventions, the novelty and non-obviousness
requirements are applied differently when compared to inventions relating to machinery or
pharmaceuticals. This is evident from the analysis of following cases.

In Amgen v. Chugai pharmaceuticals, the issue was regarding two patents - one claiming the
gene or DNA sequence encoding a protein and another claiming the protein itself in a highly
purified form. Amgen patent was with respect to a purified and isolated DNA sequence
encoding human Erythropoietin and host cell transformed, by which potential treatment of
chronic anemia is possible. Here, Amgen got patent in 1987 October and for Chugai June 1987.
But Amgen was the first to conceive the DNA sequence of the protein simultaneous in the
production of purified EPO. But in the case of Chugai an inventive concept for its isolation
was there, but its DNA sequence was never known till the Amgen made it. The Court held that
probing and screening method employed by the Plaintiff is factor which distinguished the
invention from the prior art and held Amgen's invention as novel.

Thus, the test of obviousness in Graham's case was diluted. The reason being there was a degree
of the predictability in the art in this case. It is true that absolute predictability was not required
for obvious condition under Section 103 of Patent Act, 1952. Thus, uncertain predictability in
the case of biotech inventions can tamper non-obviousness standard traditionally followed.
This is reflected from the treatment of the Court in Chugai's contentions that other technique
could have been used to clone the EPO gene as mere speculations. "Obvious to try" was not
the proper standard for determining obviousness under Section 103 of US Patent Act, 1952.
An invention is obvious if both the suggestion and expectation of success is founded in the
prior art and not in applicants disclosure. If there is a reasonable expectation of success then
test of non-obviousness must satisfy. In the context of biotech invention inventive concept
means complete mental conceptions of purified and isolated DNA sequence encoding EPO and
a method of preparation. So the standard of skill attributed to a hypothetical person skilled in
art as in Graham's test becomes totally unrealistic in biotechnology. This high standard of skill
of hypothetical person for assessing inventive step adds to the difficulties for granting patent
in biotech inventions.

The approach followed by the UK Court is reflected in Biogen v. Medeva. The Plaintiff in this
case obtained a patent for DNA molecules coding for Hepatitis B Virus Antigen. At the date
of patent application, the said DNA had not been sequenced. Biogen was the first to express
the protein of Hepatitis B Virus Antigen in prokaryotic cell. So inventive step is the solution
that someone discovered to solve the problem not the goal itself or general method of achieving
it. Also, inventive idea could be doing a new thing which is the idea of using an existing thing
to do something new which others have not thought of or an inventive idea could be achieving
solution to a problem. Here, Court held that "even though Biogen had taken the initiative
something uncontemplated by others; it used available techniques and methods in research.
They had not developed a new inventive process or had not discovered anything about those
processes and it was only a business decision to carry out research to pursue an identifiable
goal by known means". Held, Biogen's patent is invalid.
It may be noted that both in Amgen and Biogen case issue is similar. But the Courts applied
the standards of inventive steps and non-obviousness differently. In both cases inventive
concepts was known to the scientific world but in Amgen case when using probing and
screening technology resulted in desired result not succeeded for the first time and the Court
held it as non-obvious. But in Biogen even though the prior art goal was known to scientific
world since the technique used is known it was held that 'it was obvious to person skilled in
art" following a higher standard than what was applied by the US Court in Amgen. Also, the
claimed invention in Biogen was too broad, not due to inability of the teaching to produce
desired results, but to the fact that the same results could be produced by different means and
one may not be allowed to monopolies every other way of doing obvious desirable goal.

This trend is followed in Kirin-Amgen Inc. v. Roche Diagnostics GmbH also. In this case, it
was held that "the law of patents is ultimately concerned with practicality," so a prior art
experiment which, when performed, reliably produced a result "more than 99 per cent of the
occasions on which it is conducted" would be regarded for the purposes of disclosure as
"inevitably" leading to the result in question. It follows that a claim which defines an invention
by reference to parameters, for example, of a process or a product, is anticipated by a disclosure,
which when put into practice would necessarily fall within the scope of the claim, even if the
disclosure does not refer to these parameters.

The Privy Council following the above approach in Ancare New Zealand Ltd.’s Patent held
that scientific opinion is out of accord with what is done in the market. In this case, the patentee
argued that an inventive step lay in including the tapeworm agent because there was scientific
hostility against treating tapeworms in sheep. However, it was common practice for New
Zealand farmers to treat their lambs for tapeworm at the priority date. The Privy Council,
upholding Judgments of the New Zealand High Court and Court of Appeal to revoke the patent
for obviousness and not involving any inventive step over what was known or used before the
priority date of the claim in New Zealand, held that the fact that scientific opinion might have
thought that something was perfectly useless did not mean that practicing it, or having the idea
of making a preparation to do it, was an inventive step. Otherwise, anyone who adopted an
obvious method for doing something which was widely practiced but which the best scientific
opinion thought was pointless could obtain a patent.

Recently, in KSR Intl' Co. v. Teleflex Inc. the United States Supreme Court altered the way in
which patent claims are to be analyzed by Courts and patent examiners, creating a new multi-
factor approach to reach the ultimate determination as to whether an invention is non-obvious
and therefore, capable of being patented. According to the Court if some motivation or
suggestion existed to combine the prior art, then the new invention, is obvious and cannot be
patented. The Court further observed that "the diversity of inventive pursuits and of modern
technology counsels against confining the obviousness analysis by a formalistic conception of
the words teaching, suggestion and motivation or by overemphasizing the importance of
published articles and the explicit content of issued patents." The Court further observed that
"[W]hen there is a design need or market pressure to solve a problem and there are a finite
number of identified, predictable solutions, a person of ordinary skill in the art has good reason
to pursue the known options within his or her technical grasp. If this leads to the anticipated
success, it is likely the product is not of innovation but of ordinary skill and common
sense" The series of US judicial decisions from Graham to KSR and decisions of UK's Courts
from Wind surfing to Kirin Amgen. one can see fluctuations in the standards of patentability. It
is clear that the Court is applying the general concept of obviousness and inventive step in the
field of new technology which may not be envisaged when the statute was made. Thus, varying
standards is being read into non- obviousness. So, it is the want of definite criteria to assess
non-obviousness requirement in the case of biotech inventions which lead to much dilemma.

Thus, by comparing the standards followed in the US and UK in patenting biotechnology

inventions, it could be seen that in US the private interest is given more priority to accelerate
technological advancement in the guise of promotion of science and technology thus reducing
the space in public domain. But the recent decision of US Supreme Court in KSR Intl' Co. v.
Teleflex Inc. gives a clear indication of change in their attitude by setting higher standards of
patentability. It is also realized that granting patent protection to advances that would occur in
the ordinary course without real innovation retards progress and may, for patents combining
previously known elements, deprive prior inventions of their value or utility.

But in UK such flexibility could not be seen and their priority seems to be more towards the
public interest trying to keep balance between private monopoly and public interest thus
keeping up the underlying philosophy of intellectual property. Thus, one can see that Europe
is experiencing more turmoil in recent years over the patenting of genetically modified
organisms. The trend in United States also is likely to see a steady increase in challenges to
biotech patents as advocacy groups raise broad questions about the role of the public in science
and technology policy-making.

PATENTING OF LIFE FORMS- THE INDIAN STAND:

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," "inventive step" reflects restrictive approach to the
legal protection of living materials.In the absence of definition for "plant," "animal,"
"microorganism" "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.

Another concern is that if the "inventive step" is going to be interpret by considering only
technical advance or economic significance, then standard of patentability gets lowered and the
same should not be allowed. Because these factors have been used as secondary considerations
and they never served as a basis for establishing "inventive step."

The 2008, patent manual incorporates provisions which is used as a guidance by the patent
office to interpret various provisions in the Act. Standing Problem,
Distance, Surprising Effect, Long Felt Need, Failure of Others, Complexity of Work,
Commercial Success, Cheaper and more economical Product and simplicity of the proposed
technological solution are considered as indicators of inventive step in 2008 draft Manual of
Patent Practice and Procedure.

So, it is up to the patent office to decide whether to set higher standards or not. Due to the
absence of litigation in the field of biotechnology one has to wait and see the kind of standard
our judiciary is going to follow.

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