BIODIVERSITY

Biodiversity describes the total variability present among and within the species of living organisms in their natural habitats. Biological diversity is the hallmark of life on earth. It is very backbone of sustainable development. The current Intellectual Property Rights (IPR) regime is encouraging commercialization of seed development, monoculture, and protection of new plant varieties, microorganisms, and genetically modified organisms.

Biological Diversity Act, 2002 of India has defined various terms. “Biological Diversity” means the variability among living organisms from all sources and the ecological complexes of which they are part and includes diversity within species or between species and of eco-systems. Intellectual Property Rights (IPR), as the term suggests, are meant to be rights to ideas and information, which are used in new inventions or processes. These rights enable the holder to exclude imitators from marketing such inventions or processes for specified period of time; in exchange the holder is required to disclose the formula or idea behind the product/process. The effect of IPR is therefore monopoly over commercial exploitation of the idea /information, for a limited period of time. The stated purpose of IPRs is to stimulate innovation, by offering higher monetary returns than the market otherwise might provide.

In order to comply with the TRIPs (Trade Related Intellectual Property Rights) and CBD (convention on Biological Diversity) India has passed Indian Patent (Second Amendment) Act, 2002 and the Biological Diversity Bill, 2002 respectively. According to this Amendment Act, 2002 the duration of the term of patent has been extended to 20 years for all product and process patents. Now microorganisms will be patentable subject in India.

Indian scenario

India is classified among the 12 mega-diversity centres of the world. India's record in agro-biodiversity is equally impressive. There are 167 crop species and 320 species of wild crop relatives and several species of domesticated animals. India is considered to be the centre of origin of a huge and varied heritage of biodiversity and ranks seventh in terms of contribution to world agriculture.

CONVENTION ON BIOLOGICAL DIVERSITY (CBD)

The CBD came into force way back in 1993 with an objective to prevent unfair exploitation of bio wealth and traditional knowledge of developing countries by the signatories.

The aims of CBD are:

  • Sovereign rights of members on their genetic resources,
  • Prior consent from the country of origin to facilitate foreign access,
  • Equitable sharing of benefits and transfer of technology within the members,
  • IPR regime should not negate the CBD’s objectives.

The FAO Global Plan of Action focuses on the fact that the primary mechanism to protect the rights of the providers of genetic resources is the rights of farmers. However, the CBD entails a wide range of beneficiaries. CBD offers minimum guidance in context of the nature and mixture of benefits, what constitutes a fair and equitable share and who all are the beneficiaries.

IPR AND THE CBD

The IPR regime plays a major role in protecting information. The information in the genetic resources has high commercial value. IPR is a private right. As an incentive to the inventor for innovation, the grant the holder the exclusive rights to prevent other from using a product or a process. The rights granted by patent enables the holder to limit who can use the resources, and therefore claim benefits of commercialization. The patent system contemplated by the TRIPS Agreement, for example, allows the holder of a product patent to prevent third parties from making, using, offering for sale, selling or importing the product.

Thus, IPR defines who can use the genetic resources and impact the distribution of benefits flowing from the use. IPR will affect who shares in the benefits arising from genetic resources, with implication in the conservation and use of biodiversity. As a result of the value associated with IPRs, there is increasing pressure by commercial interests to gain intellectual property rights over genetic resources. This pressure, and the resulting IPR systems, is raising challenges for policy-makers who seek to give effect to the objectives of the CBD.

IPR AND THE WTO AGREEMENT OF TRIPS AGREEMENT

The TRIPs Agreement includes many forms of IPR which impact biodiversity conservation including patents, and “sui generis systems” for plant variety protection. Patent protection and sui generis systems defines who gains access to information about genetic resources, how the benefits are shared (including with traditional communities), and what technologies are developed and transferred with implications for conservation and sustainable use of biological diversity.

PATENT PROTECTION The TRIPS Agreement requires Members to offer patent protection for inventions in all areas of technology, whether products or processes, that are new, involve an inventive step, and are capable of industrial application (Article 27.1). This requirement, which is cast in broad terms, is subject to some important exceptions, which may be relevant to the successful implementation of the objectives of the CBD. First, Members may exclude inventions from patentability where it is necessary to "protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment" (Article 27.2). Second, while Members are required to grant patents over micro-organisms as well as nonbiological and essentially biological processes for the production of plants and animals, they are not required to grant

patents over plants or animals (Article 27.3(b)). Third, Members may provide limited exceptions to the exclusive rights conferred by patents, subject to certain qualifications (Article 30). Finally, Members may permit use of the patented invention by third parties without the authorisation of the patent owner in certain circumstances (Article 31). So far, the scope and utility of these provisions in ensuring compatibility with CBD objectives remains unclear at the WTO.

SUI GENERIS SYSTEMS OF PLANT VARIETY PROTECTION

The exception to patentability in Article 27.3(b) also gives rise to the requirement to offer sui generis protection over plant varieties. Article 27.3(b) provides that Members must provide protection for plant varieties, either in the form of patents or an "effective sui generis system". A sui generis system is a system for the protection of plant varieties that is chosen by the Member, and can be designed to accommodate the particular needs of that Member. Members can also choose a combination of patents and sui generis protection.

The interpretation and application of these provisions on plant variety protection will have significant implications for the implementation of the CBD. How the rights to information are allocated under the TRIPS Agreement will impact on how benefits from the use of genetic resources are shared. Sui generis protection may, provide a tool for implementing the CBD’s objectives, including access and benefit sharing, and technology transfer. Inappropriately defined, sui generis protection may frustrate the CBD objectives, particularly access and benefit sharing, the preservation of the practices of indigenous and local communities, and technology transfer.

KEY ISSUES

The relationship between IPR and the TRIPs Agreement and CBD gives rise to the following issues:

  • Access to and the Fair and Equitable Sharing of Benefits arising from the Utilisation of Genetic Resources
    Access and benefit sharing under the CBD may be affected by the IPR systems required by the TRIPS Agreement. IPRs are often granted to individuals of one country over genetic resources obtained from another country. Consequently, if the objectives of the CBD are to be achieved, IPR holders should have gained access to genetic resources with prior informed consent, on mutually agreed terms, and with provisions to guarantee fair and equitable sharing of benefits. This, however, is not always the case. IPRs required or permitted by the TRIPS Agreement may in certain circumstances undermine efforts to ensure equitable benefit sharing – in both countries that use genetic resources, and that provide access to genetic resources.
  • Preservation of and Respect for the Knowledge, Innovations, and Practices of Indigenous and Local Communities
    The existing IPR systems such as patents may increase the risk of misappropriation of traditional knowledge. There is also concern that existing IPRs fail to provide positive incentives for local and indigenous communities to preserve and, if they wish, to capitalise on their traditional knowledge. It is clear that existing IPR systems such as patents are largely inappropriate to protect traditional knowledge: they are often expensive and difficult to access, and are unable to safeguard traditional knowledge that is often communally held and passed through the generations. Other forms of IPRs, such as geographical indications, copyright and trademarks may be used by some communities, but their effectiveness and breadth of coverage is limited.
  • Transfer of Technology First, IPRs, including patents and sui generis systems for the protection of plant varieties, may have a significant impact on the types of technology developed and whether they are appropriate for “the conservation and sustainable use of biological diversity or make use of genetic resources and do not cause significant damage to the environment”. In this context, technologies contemplated by the CBD include both those resulting directly from the use of genetic resources (e.g. biotechnology), and a broader category of technology “relevant to” conservation and sustainable use of biodiversity (e.g. agriculture and land use technologies).
    Second, IPRs may also have a significant effect on access to and transfer of technology to developing countries on “fair and most favourable terms” as required by the CBD. The TRIPS Agreement also includes obligations regarding the transfer of technology, including its objectives in Article 7 (which define technology transfer as a fundamental objective of the TRIPS Agreement) and Article 66.2 (which require incentives to be established to encourage technology transfer to the least developed countries). As noted, however, little has been done to implement these provisions, and concern has been raised about the requirements of Article 27.3(b) regarding IPR protection over plants, microorganisms and micro-biological processes, and the consequent control of the components of biological diversity.
  • Conservation and Sustainable Use of Biological Diversity The IPRs established pursuant to the TRIPS Agreement may have other effects on the conservation and sustainable use of biological diversity. These impacts on biodiversity conservation are often indirect, and are difficult to measure with precision.