Francisco A. Laguna & Priya Lamba
Despite the challenges it still faces, India has made considerable progress in a short period of time when it comes to the protection of its biodiversity and traditional knowledge. As a member of the Convention on Biological Diversity (CBD), India identified the following as some of its main goals in its National Policy and Macrolevel Action Strategy on Biodiversity (1999): securing the participation of State Governments, local communities and people, NGOs, industry and other interested parties; realizing the value of biodiversity through research and development; and ensuring that India gets the benefits as being the country of origin of biological resources, and that its indigenous communities and people get the benefits as being the conservers of biodiversity, creators and holders of traditional knowledge systems, innovations, and practices. This week’s blog will focus on the legislative and proactive steps India has taken in recent years.
India passed the Plant Varieties Protection and Farmers’ Rights Act (PVPFR) 2001, followed by the PVPFR Rules 2003. These two pieces of legislation ensure the protection of plant breeders’ rights over new varieties they develop and give farmers the entitlement to register new varieties and also to save, breed, use, exchange, share or sell the plant varieties that farmers have developed, improved and maintained over many generations. India also ratified the Patent Second Amendment Act 2002 and Patent Third Amendment Act 2005, amending its Patents Act 1970. These amendments prohibit the granting of patents for plants, animals, and traditional knowledge. Furthermore, India’s patent laws now require “mandatory disclosure of source and geographical origin of the biological material in the specification when used in an invention.” Should a party fail to disclose this information, or participate in wrongful-disclosure, then the amendments permit opposition to, or revocation of, the patent.
In 2002, India enacted the Biological Diversity Act of 2002 (Act). Per the Article 15 provision of the CBD, the Act regulates access to biological resources and associated traditional knowledge to ensure equitable sharing of benefits arising out of their use. The Act mandated the implementation of its provisions through the National Biodiversity Authority (NBA), an autonomous body advising the Central Government of India on conservation matters, sustainable use of biological resources, and fair and equitable sharing of benefits arising out of the use of such resources. Analogously, State Biodiversity Boards (SBBs) advise State Governments on the same issues, but subject to guidelines issued by the Central Government. At the local level, there are Biodiversity Management Committees (BMCs) that promote conservation, sustainable use, and documentation of biodiversity. In December 2012, the First National Biodiversity Congress 2012 (Congress) was held in Kerala, India. It was organized by the Ministry of Environment and Forest, the NBA, and SBBs to address several biodiversity issues, including the management of traditional knowledge and access and benefit sharing of genetic resources. Both, the site for the NBA and the Congress are good resources for current biodiversity laws and news, and also for providing links to other informative sites.
Collaboration between many groups, including the Council of Scientific and Industrial Research (the group that challenged the U.S. patent for haldi), has led to the development of the Traditional Knowledge Digital Library (TKDL), a valuable resource. The TKDL is a database that documents existing traditional knowledge and makes it available in the public domain. The information is available to patent examiners at International Patent Offices in their languages and formats. Thus, patent examiners worldwide now have the ability to check patent applications against the TKDL before issuing a patent that could be later-challenged, even revoked, on the grounds of bio-piracy (discussed in last week’s blog). The TKDL has been so successful, that India partnered with the World Intellectual Property Organization to host an international conference to address the misappropriation of traditional knowledge and how the TKDL could be emulated by other, interested countries.
It is evident that India is on the right path when it comes to protecting its national interest in its biodiversity and traditional knowledge, while granting access on a case-by-case basis. The issue of benefit sharing is tantamount, and India must now adopt a balanced approach to safeguard its genetic resources while promoting much needed growth in the biotechnology sector.
The momentum of the movement has been strong in recent years, but only time will tell if the efforts that have recently been started will be executed to their full potential. There is already some worry that the Indian government is already slacking in its efforts. In November 2012, the Environment Support Group (ESG) filed a petition highlighting the failures in the current legal and institutional regimes that result in bio-piracy, loss of India’s biodiversity and associated traditional knowledge, and also threaten “not only sovereign control over biological resources but also the livelihoods of indigenous and natural resources dependent peoples.” The High Court of Karnataka agreed to hear the case the fourth week of January 2013.
TransLegal assists clients with issues related to the Convention on Biological Diversity and benefit sharing under the Nagoya Protocol. Contact us to discuss these issues for India or other countries.