Protection and Promotion of Traditional Medicine - Implications for Public Health in Developing Countries
(2002; 131 pages) View the PDF document
Table of Contents
View the documentThe South Centre
View the documentPREFACE
View the documentINTRODUCTION
Open this folder and view contentsI. INTELLECTUAL PROPERTY AND TRM
Open this folder and view contentsII. RATIONALE FOR PROTECTION
Open this folder and view contentsIII. APPLYING EXISTING IPRS
View the documentA. Defining Public Domain
View the documentB. Title
Close this folderC. Applying Patent Laws
View the documentC.1. Subject matter
View the documentC.2 Patentability requirements
View the documentC.3. Novelty
View the documentC.4. Inventive step
View the documentD. Utility Models
View the documentE. Designing a sui generis Regime
View the documentF. Enforcement
View the documentG. Misappropriation Regime
View the documentH. Investment Incentives
View the documentI. Benefit Sharing
View the documentJ. Customary law
View the documentV. IPRs AND PUBLIC HEALTH
View the documentVI. CONCLUSIONS
View the documentREFERENCES

C.3. Novelty

The way in which the novelty requirement is defined, particularly with regard to non-written disclosure, has important implications for the possible misappropriation of TRM. As mentioned, the exclusion of non-written disclosures made outside the U.S. as a ground for the loss of novelty, as provided for under US law, allows for the patenting of knowledge that would be deemed part of the prior art in most other countries in the world. An amendment to such law aligning it with the standards applied elsewhere, would make a great contribution to reducing tensions in this area.

There have been initiatives to develop proper written documentation of traditional knowledge. They essentially aim at reducing the room for the patentability of codified TRM. These initiatives document knowledge, making it available to patent examiners throughout the world, so that “prior art” is readily identifiable.

These documentation efforts have been facilitated in the last years by the application of digital technology:

“In the recent past, there have been several cases of bio-piracy of traditional knowledge (TK) from India. For preventing such instances in the future there is a need for developing digital databases of prior art related to herbs already in the public domain. Following patents on brinjal, etc., in India, an exercise has been initiated to prepare easily navigable computerized database of documented TK relating to use of medicinal and other plants (which is already under public domain) known as TK Digital Library (TKDL). Such digital databases would enable Patent Offices all over the world to search and examine any prevalent use/prior art. And thereby prevent grant of such patens and bio-piracy” (Government of India, 2000).

The documentation of traditional knowledge, in the view of the Indian government, fosters not only the prevention of “bio-piracy”. It may also provide a basis for the sharing of benefits arising from the use of such knowledge, though documentation per se will not ensure benefit sharing with the holders of such knowledge (Government of India, 2000). A clear effect of such libraries is that both local/indigenous communities and third parties will be prevented from obtaining patents over documented knowledge.

The issue of traditional knowledge digital libraries (TKDL) has also been addressed by WIPO with the aim of not only detailing in writing traditional knowledge already in the public domain, but of improving the WIPO International Patent Classification (IPC) so that the data is easily accessible to patent examiners. Ideally, as these TKDL come into being, they will be incorporated in the minimum search documentation list of the Patent Cooperation Treaty (PCT), therefore ensuring that the data in these libraries will be considered during the processing of patent applications filed under the PCT system. It has also been suggested that search and examination guidelines in patent examining authorities be updated to ensure that TKDLs are consulted.141

141 See the Report on the Traditional Knowledge Workshop, 24 January 2002, Commision on Intellectual Property Rights, available at

Concerns have been expressed about the extent to which documentation programs may expedite “bio-piracy”, rather than preventing it, by facilitating the work of those who wish to appropriate the benefits of the knowledge which is being documented. Since this may occur, the development of TKDL does not exclude the need for regulations to prevent misappropriation. A related issue - which is beyond the remit of this study - is the protection conferred to the data bases containing that information.142

142 Article 10.2 of the TRIPS Agreement establishes that “compilations of data or other material, whether in machine readable or other form, which by reason of the selection or arrangement of their contents constitute intellectual creations shall be protected as such. Such protection, which shall not extend to the data or material itself, shall be without prejudice to any copyright subsisting in the data or material itself”. Specific legislation introducing a sui generis type of protection (including an “extraction right”) has been adopted in Europe, but in most countries original data bases are protected under the general rules of copyright law.

If the policy goal were to facilitate the patentability of TRM, rather than to limit it, a possible option would be to establish an extended grace period for inventions pertaining to this field whenever claimed by the communities or individuals that legitimately developed or hold them (Bhatti, 2000, p. 10). This would certainly expand the scope of patentability in cases where it would have been excluded by loss of novelty.143

143 In some countries (such as the United States, Argentina, Mexico) any publication made by the inventor within one year prior to the date of application for a patent does not destroy novelty. This grace period is particularly useful for the protection of research results obtained in universities and other public institutions, where researchers are usually under pressure to promptly publish their findings.

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