Category Biodiversity/Genetic Resources/Biotech

WIPO Director Gurry Highlights Value Of Indigenous Knowledge

Indigenous Peoples' knowledge and creativity is a valuable source of inspiration for all, but might benefit from being better protected, the head of the UN World Intellectual Property Organization said this month. WIPO is currently negotiating an international instrument or instruments to better protect genetic resources, traditional knowledge and traditional cultural expressions (folklore).

Decision Time On Biologics Exclusivity: Eight Years Is No Compromise

Burcu Kilic and Courtney Pine write: As the Trans-Pacific Partnership (TPP) negotiations approach their endgame, biologics exclusivity is still considered “one of the most difficult outstanding issues in the negotiation.”[2] Pharmaceutical companies seek longer data and marketing exclusivities to further delay market entry of cost-saving biosimilar drugs. Data exclusivity prevents follow-on pharmaceutical developers from relying on originators’ test data submitted for marketing approval while seeking such approval for its own product. The World Trade Organization’s (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) requires some protection against unfair competition for this sort of data, but it does not require countries to adopt rules conveying exclusive rights over it in the same way as it does regarding patents.[3] Currently, the US provides 12 years of exclusivity for new biological products under the Biologics Price Competition and Innovation Act (BPCIA).[4] The provision providing 12 years exclusivity was buried inside the 20,000-page healthcare law, The Patient Protection and Affordable Care Act. A robust debate over what would be an appropriate exclusivity period, if any, was overshadowed by other controversial aspects of the bill commonly referred to as Obamacare.

WIPO: Databases To Protect GRs, TK, Useful But Some Controversy

In the quest to find solutions to protect traditional knowledge and genetic resources from misappropriation, some countries have resorted to private databases to be used by patent examiners. Indigenous peoples are wary of the process primarily because they are not sure their knowledge will remain safe in those databases. Speakers at a World Intellectual Property Organization this week discussed the pros and cons of such defensive protection.