54. The representative of India said that the year 2010 had been proclaimed as the International Year of Biodiversity. This held a special significance for India which was one of the 12 mega biodiverse countries of the world. With only 2.4 per cent of the land area, India already accounted for seven to eight per cent of the recorded species of the world. This number was based on the survey of 65 to 70 per cent of the total geographical area of the country. Over 47,000 species of plants and 81,000 species of animals had been recorded by the Botanical Survey of India and the Zoological Survey of India respectively. It was anticipated that some of the remaining areas, such as the Himalayan region, Andaman and Nicobar Islands, might be far richer in biological diversity than most of the areas already surveyed. India was also one of the twelve primary centres of origin of cultivated plants. India was equally rich in traditional and indigenous knowledge, both coded and informal.
55. Pursuant to the ratification of the CBD, India had developed a comprehensive legislation on biodiversity, enacted Biological Diversity Act in 2002 and notified Biological Diversity Rules in 2004. This Act gave effect to the provisions of the CBD, including those related to access and benefit sharing and prior informed consent. In 2003, the National Biodiversity Authority had been set up. All matters relating to requests for access by foreign individuals, institutions or companies, and all matters relating to transfer of results of research to any foreigner were dealt with by the National Biodiversity Authority. India also had a vast resource of traditional knowledge that was well documented in many languages including Sanskrit, Hindi, Urdu, Arabic and Tamil. Before the Government had implemented the Traditional Knowledge Digital Library (TKDL), it had been challenging for patent examiners across the world to access this knowledge and assess claims of novelty in a patent application based on traditional Indian systems of Medicine. With the TKDL initiative, language and format barriers had been overcome and information was now scientifically structured in five international languages with the help of the information technology and a unique classification system called the Traditional Knowledge Resource Classification.
56. India had signed the TKDL Access Agreement with the European Union, the United States, the United Kingdom and Germany. Since July 2009, India had identified 36 patent applications at the European Patent Office which concerned Indian systems of medicine in which third party evidence had been filed. In two cases, the European Patent Office set aside its intention to grant patents after receiving the TKDL evidence. In the other 11 cases including an application by an Indian company, applicants themselves had decided to withdraw their four to five year old applications when they had been confronted with the TKDL evidence. While through the TKDL, India had created a defensive mechanism against erroneous patents, the TKDL remained only one of the multiple tools required to address the much larger issue of misappropriation of genetic resources and associated traditional knowledge and could be a useful complement to a mandatory disclosure requirement in patent applications.
57. He said that India looked forward to the 10th CBD Conference of Parties (COP) scheduled to meet in Nagoya, Japan in October 2010. He said that negotiations on the Protocol to Access and Benefit Sharing of Genetic Resources and Associated Traditional Knowledge were the most important negotiating process in progress in the CBD. Without an effective International Protocol on Access and Benefit Sharing, aimed at stopping biopiracy and providing legal certainty, the underlying causes that led to the loss of biodiversity and the implementation deficit regarding the fair and equitable sharing of the benefits arising out of the utilization of genetic resources would not be fully addressed.
58. He said that this effort would remain incomplete without a mutually supportive relationship between the TRIPS Agreement and the CBD. The most appropriate way forward was contained in the disclosure proposal in document IP/C/W/474 and subsequently, the key parameters contained in the modalities text on three TRIPS issues in document TN/C/W/52. He said that the TRIPS Agreement continued to ignore numerous intellectual property right related obligations in the CBD. This contradiction not only obstructed the proper implementation of the CBD but also caused an imbalance in the TRIPS Agreement. The incomplete disclosure requirement as contained in Article 29 of the TRIPS Agreement needed to be rectified. This aspiration had been voiced by a vast majority of the WTO membership, including developed and developing countries. About 110 Members had proposed key parameters contained in document TN/C/W/52 as a sound basis for the way forward on the substantive and procedural treatment of the issues of TRIPS CBD, GI extension and GI register.
59. He was appreciative of the consultations held by the Director General since March 2009 in accordance with the mandate contained in paragraph 39 of the Hong Kong Ministerial Declaration. The consultations had provided an opportunity for focused discussions among Members involved in the exercise to improve the understanding of technical and legal issues. He recalled that, at the open ended meeting of 12 March 2010, the Director General had acknowledged that Members had agreed on the shared objectives including combating misappropriation, complying with the conditions of prior informed consent and equitable benefit sharing, and avoiding erroneous patents. He was concerned that the momentum of such meetings had slackened of late. During the year of 2010, only one meeting had taken place. He urged the Director General to intensify his consultations on the issues of TRIPS/CBD and GI extension in accordance with paragraph 39 of the Hong Kong Ministerial Declaration. He also requested the Director General to draw up a road map for his consultations on the TRIPS issues alongside the Special Session process on the issue of GI register. He reiterated that an outcome on the TRIPS issues would be an integral part of the Doha development package.
