In accordance with the generally accepted concept of novelty, developing countries could incorporate a novelty requirement that encompasses any written or oral disclosure, including through use anywhere in the world86. A rule of this type may help to avoid the patenting of knowledge or materials developed by and diffused within local or indigenous communities.
86 As mentioned before, nothing would prevent national legislation from providing for a less stringent concept of novelty in other areas of IPRs, for instance, in order to protect “minor” innovations under utility models, designs or similar forms of protection.
Given the non-discrimination principle contained in article 27.1 of the TRIPs Agreement, no specific rules on novelty for health-related inventions are recommended, but rather the application of well-defined general rules. A possible legislative text may contain the elements identified in the box.87
87 The provisions of the law should be supplemented by specific regulations and guidelines for patent offices.
a) An invention shall be deemed to be new when it does not form part of the state of the art. The state of the art shall comprise everything made available to the public in any country by means of a written or oral description, by use or in any other way.
b) The state of the art , as defined in paragraph 1, shall include knowledge developed by or in possession of a local or indigenous community.
c) The state of the art shall also comprise unpublished patent applications filed at the national Patent Office, where such applications are subsequently published.
The language proposed in paragraph a) of the model option, which is based on article 54 of the European Patent Convention, should prevent the patenting of local or indigenous knowledge. Paragraph b) would do this explicitly. Given the territorial nature of patent laws, such knowledge would not be patentable in the country/ies where the proposed concept of novelty is adopted, but it would not prevent patentability in other countries. In order to remedy this situation, an international standard should be adopted, for instance, as part of a possible review of the TRIPs Agreement.
Developing countries may want to accompany this exclusion with special laws that do protect such knowledge outside the patent system under a sui generis regime88, or that promote the conservation and use of such knowledge, particularly traditional medicinal knowledge.
88 See, e.g., Posey and Dutfield, 1996. See also the “African model legislation for the recognition and protection of the rights of local communities, farmers and breeders, and for the regulation of access to biological resources”, prepared by the Organization of African Unity (1999).
Paragraph c) considers that inventions described in other applications, which were published on or after the date of application for a patent, shall also constitute an anticipation for the purposes of novelty This is the solution adopted by the European Patent Convention (article 54.3).