70. The representative of India said that the issue of incorporating the CBD provisions into the framework of the TRIPS Agreement demanded much greater involvement of WTO Members, especially after the signing of the Nagoya Protocol by 193 countries. The first Conference of Parties in the UN Decade on Biodiversity to be hosted by India in October 2012 would be the first milestone to assess the progress in the implementation of the Nagoya Protocol, and the work in the Council could significantly contribute to its success. The disclosure of origin had been successfully implemented in India and in many developing countries. It was indeed a workable solution which motivated developing countries to make submissions to the Council in order to have an international architecture that could protect their interests. The latest proposal contained in document TN/C/W/59 submitted in April 2011 was a major step forward from the proposal contained in document TN/C/W/52 and it incorporated the provisions of the Nagoya Protocol. The proposal was compatible with the TRIPS Agreement and did not diminish the rights of the patent holder as provided for in the TRIPS Agreement.
71. He said that the Indian Patent Law had incorporated the disclosure requirements within Section 10 specifying clear and complete disclosure requirements. While Section 10(4)(a) embodied the enablement and written description requirements, Section 10(4)(b) provided for the disclosure of the best mode of performing the invention. Further Section 25 of India's Patent Law provided for pre-grant and post-grant opposition that helped in avoidance or revocation of erroneous patents for failure of the patent applicant to meet the disclosure requirements. The prior approval of the National Biodiversity Authority was required for any invention based on research/information on biological resources. In addition, India's Traditional Knowledge Digital Library (TKDL) was an important contribution to prevent misappropriation of traditional knowledge at international patent offices. Today, the TKDL was capable of protecting about 2.5 lakh medicinal formulations similar to those of neem and turmeric. Access to the TKDL had been given to eight international patent offices as of now.
72. Challenging patents at international patent offices was a long drawn process and was very expensive. For example, Mexico had been able to get the patent on enola bean at the United States Patent and Trademark Office cancelled in July 2009 after more than 10 years of legal battle. Similarly, the Monsanto soybean patent was cancelled at the European Patent Office in July 2007 after 13 years of legal battle. India's limited initiative in the form of the TKDL could only prevent erroneous patents in the limited field of traditional Indian medicine. The TKDL enabled the cancellation/withdrawal of wrong patent applications at zero cost and in a time period of a few weeks. In sharp contrast, in the absence of the TKDL, it had taken 10 years (1995-2005) to get neem patent invalidated for antifungal properties at the European Patent Office. The TKDL's impact on biopiracy was already visible. The references to TKDL as prior art had led to significant outcomes towards achieving the goal of preventing misappropriation of Indian traditional knowledge. Beginning in July 2009, the TKDL team had submitted 571 prior art references, resulting so far in 88 patent applications of the pharmaceutical companies of the United States, the United Kingdom, Japan, Spain, Italy, China, etc. being set aside or withdrawn/cancelled or declared as dead patent applications. According to a recent study, there had been a sharp fall (44%) in patent applications filed at the EPO concerning Indian systems of medicines. While the disclosure obligation ensured that the applicant had provided accurate and adequate information on the source of the traditional knowledge, the TKDL enabled in identifying prior art and to ascertain the novelty in the claims. With the development of databases similar to the TKDL by other developing countries and their extensive use by the international patent offices, it was possible to avoid grant of erroneous patents in future in areas where the databases had been developed. Hence incorporating the disclosure provision was an appropriate measure that would bring in uniformity in the practice of patent offices in using such databases and coherence in ascertaining the validity of patent claims involving traditional knowledge and/or associated genetic resources.
73. In conclusion, he reiterated that the TRIPS-CBD issue was one of the outstanding implementation issues and the Council should take a serious note of the compliance issues under the Nagoya Protocol to deal with internalizing the relationship between access and benefit sharing and IP protection to become an important deliverable of the Round for developing countries. Exhaustive discussions alone on the TRIPS-CBD issue over the last ten years were not enough if Members sought a positive outcome on the issue. Members needed constructive engagement in the Council, which was sadly missing on part of some developed country Members. He noted with considerable concern that some Members could not agree to a presentation by the CBD Secretariat on the Nagoya Protocol in spite of the fact that 193 countries had already adopted the Nagoya Protocol. It was unfortunate that the same Members who opposed a presentation by the CBD Secretariat in the WTO had no problems with the CBD being present in the WIPO or WHO.
