46. The representative of Brazil said that the main goal of the group of countries which had proposed the disclosure requirements was to collaborate closely with the Director-General to enable the fulfilment of the mandate set out by Ministers in Hong Kong and in Doha. In Hong Kong, Ministers had decided to review progress and to take "any appropriate action" no later than 31 July 2006 on the relationship between the TRIPS Agreement and the CBD. The Hong Kong Ministerial Declaration recognized the progress achieved in the debate on the disclosure of origin, prior informed consent and benefit sharing in patent applications. Significant critical mass had been attained on the issue of the TRIPS Agreement and the CBD as demonstrated by the number of documents circulated on this issue in recent years as well as by the number and depth of the questions raised therein.
47. He said that the current patent system was unable to prevent biopiracy and misappropriation of genetic resources and traditional knowledge. The group of countries had given numerous examples of erroneously granted patents whose commercial exploitation ran counter to the objectives of the CBD, as well as of unenforceability of national-level access, prior informed consent and benefit-sharing regimes. He gave two examples of patents which were based on Brazilian biological resources: patents granted over substances extracted from the Kambo frog (Phillomedusa bicolor) of the Brazilian Amazon forest, and a patented drug against hypertension that was based on a substance extracted from the Jararaca snake, also found in the Brazilian rainforest. Authorities in Brazil estimated that about US$ 40 billion was lost per year on account of biopiracy.
48. He said that the inclusion of a disclosure provision in the TRIPS Agreement would improve the patent system and would be a critical tool for biodiversity-rich countries in tracking patent applications that were based on biological resources and associated traditional knowledge, enabling challenges to erroneous patents in a less burdensome manner. In the absence of the disclosure requirements, the aggrieved countries only had the option of challenging the patent based on their efforts to collect evidence of prior art or access without prior informed consent or benefit sharing. This did not suggest that action outside the WTO might not complement action within. He further said that developing countries had neither the capacity nor the financial resources to go through the thousands of patents using biological material and associated traditional knowledge and to take the costly steps in multiple jurisdictions to revoke the patents. By addressing this problem at its root, the disclosure requirement would discourage applicants seeking erroneous patents and contribute to preventing the reward of a patent for knowledge or information misappropriated from another country. National legislations alone were inadequate to prevent the misappropriation of genetic resources and associated traditional knowledge unless accompanied by an internationally agreed disclosure provision in the TRIPS Agreement.
49. Furthermore, he said that the introduction of a disclosure provision into the TRIPS Agreement would bring many advantages. It would be an additional reason why patent applicants would be encouraged to comply with national laws on access and benefit sharing. The onus on the patent applicant was limited to providing information and evidence known to him, making the administrative and cost burdens on him minimal. The burden on patent offices would be even less. It would increase the capacity of patent offices in examining patent applications that dealt with biological resources and associated traditional knowledge. It would serve as a critical tool for biodiversity-rich countries in tracking down applications. Biodiversity was found in abundance in developing countries, while the technological capability for its exploitation was largely concentrated in industrialized developed countries. The disclosure requirements would help to establish a level playing field, whereby all would benefit from the exploitation and sustainable use of biodiversity and associated traditional knowledge. There would be implications for the WIPO Patent Co-operation Treaty and Patent Law Treaty. However, changes elsewhere without the proposed change to the TRIPS Agreement would not be sufficient to address either the mandate or the problem as a disclosure obligation for WTO Members could not be established through non-WTO instruments.
50. In conclusion, he said that in complying with Members' mandates given under paragraphs 12 and 19 of the Doha Ministerial Declaration and taking into account the development dimension as instructed by Ministers, Members must move on to a new stage by negotiating how a provision could be introduced into the TRIPS Agreement. His delegation looked forward to having a text-based negotiation by April 2006.
