IPR Issues in Biotechnology
Ms. Bindu Sharma

Introduction

Biotechnology is a popular term for the generic technology of the 21st century. Although it has been utilized for centuries in traditional production processes, modern biotechnology is only about 50 years old, and in the last decades it has witnessed tremendous developments. Since R & D in biotechnology is extremely time consuming and requires huge investment, granting Intellectual Property Rights (IPR) is an effective tool to protect biotechnology inventions. There are however, no internationally accepted guidelines for the management of IPR, and a wide range of opinions exists regarding the utility of IPR in the area of biotechnology.

Legislative framework

The legal protection remains very sensitive and complex in case of biotechnology in general and agricultural biotechnology in particular because of technical and ethical issues involved. Indian biotech industry at present is facing great challenges of the emerging Trade Related Aspects of Intellectual Property Rights (TRIPS) compliant patent system in India from January 1, 2005. Article 27.3 (b) of TRIPS excludes biological processes for the production of plants or animals as a patentable subject matter, but patents can be granted to the microorganisms, non-biological, and microbiological processes used in the production of plants and animals. This covers even the gene sequences, which may be for a particular character, or a promoter or genetic markers or similar ones. With the increase of transgenic research both in public and private research organizations, the issues of royalty payments, material transfer agreements (MTA), and legal obligations and bindings are to be clearly understood.

IPR protection of new life forms raises a number of difficult technical and ethical issues because of which the patentability of new biological forms and processes is still not accepted in many countries.

Indian Patent Act 1970 defines patentable invention as: a new product or process involving an inventive step and capable of industrial application

Since IPR protection is granted only for invention and not for discoveries, in case of biotechnology innovations, it is difficult to say whether the new life form in the form of gene, DNA, cell etc is a scientific discovery or a technological invention. Discovery is merely making available what already exists in nature. A substance freely occurring in nature, if merely found or discovered, is not patentable. However, if the substance found in nature has first to be isolated from its surroundings, and a process for obtaining it is developed, that process is considered invention and hence patentable.

The consideration of industrial application is yet another obstacle for securing patents for inventions in biotechnology. However, in India there are several ethical issues too related to patenting of life forms, the most important being extent of private ownership that could be extended to life forms. One of the major causes of uncertainties and controversies related with IPR protection of life forms is lack of an established practice in protecting not only such living materials, but any form of intellectual property. But, it is not so with regard to ownership of physical property that has a tangible market value. In the traditional cultural context, Indians have considerable problems fixing monetary value to anything that is not a tangible physical pretty that has market value. Hence, there is an urgent need for developing countries like India to define clear policies for IPR in case of scientific and technological innovations.

Several Civil Society Organizations (CSO) and Non-Governmental Organizations (NGO) argue that naturally occurring organisms are God’s gift, and therefore are common property of the mankind, and therefore cannot be appropriated by any person(s) or organizations or entities by just modifying it or tinkering with it. The idea of profit making by exploiting any common heritage of civilization or culture is abhorrent to lots of people and communities. In case of modern biotechnology, these objectors do not see much innovation being done, and therefore argue that any form of IPR must not be granted.

Article 27 (3)(b) of TRIPs agreement allows members to exclude from patent protection, plants and animals other than micro-organisms; and biological processes for the production of plants or animals other than microbiological processes. TRIPs provide option to member states protecting new plant variety by means of patent or sui generis system or both. India opted for sui generis protection and legislated “Plant Varieties Protection and Farmers Right Act-2000” that enables the farmer to save, use, sow, re-sow, exchange, or share the seeds of protected variety, besides offering protection on farmers' variety, extant variety and essentially derived variety.

Whereas plant variety protection could boost research in the area of plant biotechnology by both public and private bodies, it could also result in higher prices for seeds, thus naturally excluding the small and marginal farmers from accessing such new technologies.

Farmers and indigenous peoples in developing countries such as India are facing serious problems as plants that they developed and conserved are being 'appropriated” by private entities leading to biopiracy and exploitation of traditional knowledge claiming the exclusive right to produce and sell many 'modified' plants and animals. This is a great matter of concern today that knowledge, innovation and efforts of these communities are not acknowledged when the legal 'intellectual property rights' systems grant patents on genetic and biological materials and on living organisms to private corporations.

In 2000,CSIR found that almost 80 per cent of the 4,896 references to individual plant based medicinal patents in the United States Patents Office that year related to just seven medicinal plants of Indian origin. Three years later, there were almost 15,000 patents on such medicines spread over the United States, UK, and other registers of patent offices. In 2005 this number had grown to 35,000, which clearly demonstrates the interest of developed world in the knowledge of the developing countries. Whilst the corporations stand to make huge revenues from this process, the local communities are unrewarded and in fact face the threat in future of having to buy the products of these companies at high prices.

Hence such system of IPR only benefits the private industries or multi-national corporations of industrially developed countries at the expense of the developing countries. There is need to define guidelines and policies for the implementation of IPR in India so that the people like farmers get recognition for their efforts and contributions prevent bio-piracy. World Intellectual Property Organization (WIPO) is now developing guidelines to protect traditional and indigenous knowledge systems.

Position of FBAE

FBAE feels that Government of India must develop a clear and stringent national IPR policies as well as guidelines. Indian Patent Office for biotechnology patents must institute regulations to:

* Prevent misuse of national biodiversity and plant genetic material and make set procedures to oppose and revoke patents that have been granted in other countries

* Have clear line drawn between patentable subject matter with regard to biotechnology and traditional knowledge specially related to new life forms.

* Spread awareness among farmers about the legislative framework in the form of Plant variety & farmer’s rights that we have in country to safe guard their interests and various provisions such as:

- Benefit sharing systems when their innovations get commercialised
- Reward they can get from National Gene Fund for their role in conservation of biodiversity
- Procedure involved in protection of new plant variety
- Their rights when plant variety gets protection
- Consequence of infringing others right

* Make sure that farmers get their share of profit by means of appropriate benefit sharing arrangement when they play role in generating new plant variety or conservation of biodiversity

* FBAE strongly supports development of an IPR regime in India that rewards bio-innovations through an effective IPR system so as to promote private investment in biotechnology development and overall economic development.