James Love and Claire Cassedy, Knowledge Ecology International (KEI)
The basic proposal for an international legal instrument relating to intellectual property, genetic resources and traditional knowledge associated with genetic resources prepared by the World Intellectual Property Organization (WIPO) Secretariat (GRATK/DC/3) sets out in its Article 3 a narrow obligation to disclose (1) the country of origin of the genetic resource, or if not known, its source, and (2) the Indigenous Peoples or local community that provided traditional knowledge associated with the genetic resource, or the source of such knowledge.
Article 6 of the basic proposal sets out the sanctions and remedies for failures to make such disclosures. Among the controversies in the current diplomatic conference is Article 6.3, which states that “no Contracting Party shall revoke or render unenforceable a patent solely on the basis of an applicant’s failure to disclose the information specified in Article 3,” unless there has been “fraudulent intent.” (Article 6.4)
One lesson to learn from the U.S. experience under the Bayh-Dole Act is that required disclosures that are against the interest of the patent holder are often ignored when the enforcement of the obligation is weak.
In the case of the proposed treaty requiring the disclosure of the source of genetic materials and traditional knowledge, Article 6 in the Basic Proposal could be strengthened by eliminating the prohibition on revoking patent protections in Article 6.3, and also by creating a mechanism for third parties to file evidence of failures to disclose, perhaps within the PCT, and for some type of auditing process to evaluate if patent offices are enforcing the disclosure obligations.
To read more about the sanctions for non-disclosure as set out in Article 6 of the basic proposal, the full research paper can be accessed here: https://digitalcommons.wcl.american.edu/research/127/