Traditional medicine - medicine based on the use of natural products and the knowledge held in indigenous and local communities - is of great importance in the health-care systems of many developing countries. It has been estimated that around 7,500 plant species are utilized in indigenous medicine, many of which (such as indigo) have multiple uses61. There are two major obstacles to affording patent protection to traditional medicine. First, the novelty requirement will generally impede the patentability of such products. Second, policy choices made to increase access to medicines - including a limitative approach towards the patentability of naturally occurring products and uses of existing products, as well as strict patentability requirements (see section 4, below) - may lead to the exclusion of protection for most traditional medicinal products.
61 See, e.g., Shankar, 1996, p. 170.
Moreover, national patent protection of traditional medicine will not address “biopiracy” concerns. Since the granting of patents is dependent on each national law, the non-patentability in one country does not mean that traditional knowledge could not be patented in another country without the authorization of the communities that developed or possessed that knowledge. In these cases it may be necessary to request the nullification of the patent, if wrongly granted, in the foreign country62.
62 An example of this was the action initiated by the government of India in relation to a patent on turmeric granted in the U.S., which was finally revoked.
Many proposals have been made to protect traditional knowledge (including of medicinal use) through a sui generis regime. This is the case, for instance, of proposals relating to “tribal” , “communal” or “community intellectual rights”63, and “traditional resource rights”, among others64. The establishment of such a regime would not conflict with the TRIPs Agreement, to the extent that the scope of intellectual property protection would be enlarged rather than restricted. Moreover, if a special regime were established, it would be outside the scope of the TRIPs Agreement, which only applies to the categories of intellectual property rights specified in its article 2.
63 See, e.g., Berhan and Egziabher, 1996, p. 38.
64 See, e.g., Posey and Dutfield, 1996.
Other approaches, outside of the intellectual property sphere, may also serve to promote the use of traditional knowledge for preventive and curative health care, or to block unauthorized appropriation by foreign countries. Act No. 8423 (1997) of the Philippines, for example, aims “to accelerate the development of traditional and alternative health care” by improving the manufacture, quality control and marketing of traditional health care materials (Section 3.d)65. Peru passed a law in July 1999 which bans the non value-added export of some botanical species with known healing properties, which had become the target of massive extraction by foreign laboratories. The law covers the two best-known medicinal plants in Peru’s indigenous pharmacopoeia: ‘cat’s claw’ and ‘maca’; and legislators are considering expanding the norm to cover other products (‘yacun’ and ‘para-para’).
65 There is no intention to discuss the different suggestions for the protection of traditional knowledge, or to propose the adoption of any of them. The purpose is only to indicate the need to consider this issue at the national level.