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:
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 Farmer’s 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 Moor’s 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.