ROLE OF PATENT IN THE AREA OF BIOTECNOLOGY
The system of patent is subjected to continuous changes in its philosophy and in
its purview. The invention of new technologies is always a subject for the system
of patent with the emergence of the two pioneer technologies of the modern world
namely information technology and biotechnology. The fact that philosophy of patent
law is dynamic and prone to continuous changes has had its impact on patenting the
invention of new technologies. The modern world is very much influenced by these
technologies. For the improvement of research and development many inventions with
great ability and function have been claimed for patent. In todays world biotechnology
has become a whole new industry and patent protection for this is of immense commercial
importance. Patents are exclusive rights granted to inventions that satisfy the
criteria of patentability in the form of novelty, non obviousness and potential
for industrial application.
Bio technology is a new term evolved in the 20 the century. It is the scientific
manipulation of living organism for human benefit and its best known form is genetic
engineering, industrial agriculture, plant breeding, animal breeding are the backgrounds
of biotechnology. In simple biotechnology brings together technology with the science
of the living cells. This paper is focused on the role of patents in the area of
Biotecnology, an important tool to protect Biotechnological inventions
TRIPS AND PATENT IN BIOTECNOLOGY:
Trips that came into force in 1995, provides the minimum standard of patent
protection that requires mandatory compliance by all the member countries.Art.27
(3) (b) of TRIPS states that members may also exclude from patentability: plants
and animals other than micro-organisms, and essentially biological process for the
production of plants and animals other than micro-organisms, and essentially biological
process for the production of plants and animals other than non-biological and micro-biological
process.However,members shall provide for the protection of plant varieties either
by patent or by an effective sui-generis system or by any combination thereof.
PATENTABLE SUBJECT MATTER IN BIO-TECNOLOGY:
The patent protection is obtainable for most of the bio-technological innovations.
The protection thus provided serves as an incentive for the further development
and technical innovations. Accepting the traditional approach the new premise of
patent law state that natural life is the creation of god but the non natural life
is the creation of human being. So the new idea of patent law is that creation of
god or the creation of the nature could not be patented, where as creations of man
which involves the applications of human intelligence to natural things could be
PATENTAING OF MICRO-ORGANISM:
Art 27 of the TRIPS Agreement forms the basis for the
provisions on the patentability of micro-organism. Nevertheless, micro-organisms
also have to satisfy the novelty, utility and non-obviousness criteria to be patentable.
However, TRIPS agreement does not provide a precise definition of the term micro-organism.
The term is generally understood to include viruses, bacteria, yeast and other forms
of fungi Protozoa and unicellular algae and non differentiated animal or plant cells.
Even though micro-organisms can be patented as per TRIPS agreement; one is often
faced with a dilemma whether at all micro-organism constitute a patentable subject
matter since they are real life forms.
The law which opened the gates for inventions in the field of biotechnology,
particularly in micro organism, was a land marked judgement of the US Supreme Court
in 19809 in diamond v.chakaravarty.The dispute was with regard to a modified micro
organism developed by the Anada Chakravarty which has the ability of breaking down
the crude oil. This property introduced into the naturally occurring bacterium to
produce a genetically modified organism. The commissioner of patent in the US field
held that the subject matter of the invention was a living organism and was hence
not patentable. The US Supreme Court judge, however, decided in favour of the patentee
and stated that everything under sun is patentable. The landmark judgement paved
the way for the grant of a number of such biotechnology related patents.
In India the position of patentability of the micro-organism is parallel
to that of the UK and Europe. The Calcutta high court gave a path breaking judgement
in the case of dimminico A.G v.controller of patents and designs which has been
hailed in the Indian counter to Diamond V.Chakravarty of the U.S.A.The case related
to the patentability of a process for preparation of bursitis vaccine useful for
the protecting poultry against the infectious bursities.The ground for rejection
of the patent by the controller was that the examiner found that the claim did not
fall within sec.2(1)(j) of Indian patent Act,1970 and therefore is not an invention.
The court held that merely because the end product of process contains a living
organism does not preclude the process from being an invention and consequently
patentable.Further, the court found that the patent claimed was useful as it protected
poultry against contagious disease and the end product resulted in a new article.
PATENTIBULITY OF ANIMALS AND PLANTS:
The TRIPS agreement provides that the member states may exclude plants and
animals from patentability. This option has been adopted by a number of countries
such as the United Kingdom, Europe and India. The issue of the patentability of
animals arises mainly because the patentability of animals is considered to be moral
issue rather than a legal one. In India the plant varieties may be protected under
the protection of Plant Varieties and Farmers
Rights act. This act will come into force soon for the protection of plant
variety as it is a requirement under the TRIPS agreement. Inventions which concern
plants and animals may be patentable if the technical feasibility of the invention
is not confined t o a particular plant or animal variety. The onco-mouse case showed
that the exclusion is confined to varieties of animal alone. The EPO applied examinee
of animals which subdivides a species into subspecies and varieties. Varieties constitute
the lowest sub-division .although the invention was to be applied to mice, any non-human
mammal was claimed .As this did not confine the claims to a variety, the patent
Another aspect which is important to consider under biotechnology is patentability
of genes and DNA sequences. Genetic inventions encompasses medical. Agricultural
environmental and industrial application patenting of genes would be essential since
it would provide an incentive for the manufacture of new and important therapeutic
drugs and its application in different areas of biotechnology. The trend of granting
patent on non-natural loving being took an interesting turn which claims patent
on human genetic material. In john Moors case, patent was granted to cell lines
of human beings useful in producing cancer fighting protein, followed by patent
on human genetic materials like D NA and RNA in amezen Ins vs. Chuga Pharmaceuticals.
After this case, European patent office also started granting patents on human genetic
material. So it through many case laws that DNA, RNA and human cells could be patented.
At the same time it was also made clear that human beings though genetically engineering
or none naturally produced could not be patented.
PATENTING OF BIOTECNOLOGICAL PROCESS
Non natural or genetically modified living beings are the results of non
natural and genetically modified biological processes. Addition of human intelligent
to the natural processes renders it non natural. Since patents are available to
the products as well as processes, so the task ahead for the inventor of the biological
processes was to convince the patent office that biotechnological processes are
non natural and there is a role of human agency which differentiate a human process
and natural process. In Hybertech Inc Vs Monoclonal Antibodies Inc, a patent was
claimed for process of utilising protein to fight against the diseases. The inventors
convinced the court that the method is non natural process. Since it utilise proteins
produced inside the body on human prescription and obtained patent.
The current trend in the patent however states that the non natural life,
living beings and non natural living processes are patentable. Biotechnological
processes and micro biological processes are non natural processes which involve
addition of human intelligence to the natural process in producing none natural
and genetically modified living beings. The inventions of biotechnology ranges from
non natural micro organisms like bacteria plasmid, non natural plant, non natural
animal and non natural human genetic material which are undoubtedly patentable.
Besides, biotechnological process could also be patented in the upsurge of the new
period in patent law.
WHY MORALITY IS AN ISSUE IN PATENT IN BIOTECNOLOGY?
The debut concerning the legal, social and moral problems concerned with modern
biotechnology give rise to a very different attitude not only among
the internal participants of the patent system namely only scientists lawyers
but also the general public.
Another moral argument against the biotechnology is that animal testing for genetic
engineering purposes is wrong because pain and suffering is inflicted upon animals
for ends that appear frivolous in contrast. On the purely moral basis science should
be research driven.
The most complex issues arise when considering genetic modification of human beings
viewed from the public perspective the threat posed by contemporary biotechnology
is the possibility that will alter human nature in an irrevocable manner, some questions
Do we as a human own our genetic material or does it belong to society as a whole?
The common heritage argument i.e., material passed in abundance by vast numbers
of people cannot be the subject of a private monopoly.
Is intervention into the human genome an attack on human dignity?
Proponents of genetic engineering argue that intervention into human genome is necessary,
ultimately leading to an increase human biodiversity, while opponents, on the other
hand claim such a step is making the sacred into the profane. Only the society can
ultimately decide the degree of importance to be attached to the benefits, the hazards
and their impact.
However moral arguments enter the patent area directly through the gateway of the
Art. 53 of European Parent Convention, 1973. Art 53, inter alia, that patent shall
not be granted for inventions the publication and exploitation of which would be
contrary to public order and morality. Through this gate way have come arguments,
which previously, were not considered real issues in patent law. Biotechnology has
changed all that, patent law is now one of the central areas in which moral issues
Cloning raise several ethical issues and problems in the society. On the
representation of several organisations, press, judiciary of the American Government
banned the experiments on human cloning. This can be understood in another aspect.
In 1970 when test tube baby took birth, the same kind of criticism were flooded.
Soon such criticisms are calmed down. Like this, in tomorrow, human cloning may
be helpful to human beings for the enhancement of the health and prosperity.
Arguments against biotechnology per se suggest that it is the creation of
such inventions which is problematic. The core objection is that biotechnology and
more specifically genetic engineering, is wrong in itself, even if the net benefits
outweigh the harm caused. Genetic engineering is considered to be intrinsically
wrong for the following reasons
It is an attempt at playing God.
Genes represent the common heritage of mankind and should be passed from generation
to generation without technical intervention by man.
Genes occur naturally in organisms and should not suffer interference
Any science, including genetic engineering, will morally amount to a mixed
blessing, having both advantages and disadvantages. However on balance patent law
is primarily an instrument of economic policy. It provides incentive to invest and
innovate. Also the development of society depends on the development of science
and technology. The development in the entire sphere depends on the encouragement
and support provided through rewards for the efforts and labour in the production
of new inventions. As far as regulating the biotechnological invention is concerned
denying patentability on the basis of the morality is misguided as such a solution
does not match the nature of the problem. On the other hand for the improvement
of the law, science and economics a strong patent system is a core aspect of commercial
development. Economic and moral policies are not of equal validity. If a technology
is excluded from patentability, there is no incentive to invest in research. In
such a situation the public may be deprived of knowledge, and any advantage of the
technology might have to offer. Patent law is component in regulating the creation