Role of Patent in the area of Biotecnology.

ROLE OF PATENT IN THE AREA OF BIOTECNOLOGY

PARAMITA HATI

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 patentable.

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 was granted.

    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 arising are:

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 are raised.     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

CONCLUSION:

      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 of biotechnology.