Bio-Piracy—Developing Nations

India and Brazil are leading a contingent of developing countries at the World Trade Organization in a proposal “to oblige patent applicants to disclose the origin of inventions using biological resources or traditional knowledge.”^[1] Those countries, along with Tanzania, Thailand, Peru, and Pakistan, have proposed an amendment to the WTO’s intellectual property agreement “that would make such a disclosure a condition of receiving the patent”; if the disclosure is not made, “existing patents would be revoked or made unenforceable.”^[2]

The amendment would place a duty on patent applicants to disclose not only the country from which the resource was obtained, but also the country of origin of the resource.^[3] There would also be a requirement to affirmatively show that the applicants are in compliance with national “prior informed consent” laws.^[4] The same would have to be shown “for access to the resource and on equitable benefit- sharing from its commercial development.”^[5] The UN Convention on Biological Diversity already requires such a showing for its signatories, but it “leaves it to member countries to decide whether and how to put these concepts into national law. The US, as a non-signatory, is not bound by the convention.”^[6]

The amendment is geared toward combating “bio-piracy,” which is the “exploitation of … genetic resources for drug development without a fair return to the host communities.”^[7] The US opposes the proposed amendment, which may be more of a gambit by poorer nations to receive concessions from richer nations during other negotiations in the Doha global trade round.^[8] Joining the US in opposition are Japan, Australia, South Korea, New Zealand, and Canada, while the EU is taking a more neutral approach, “favouring disclosure but opposing the invalidation of patents if disclosure requirements are breached.”^[9]

Under the Agreement on Trade Related Aspects of Intellectual Property Rights [hereinafter TRIPS],^[10] member nations must give effect to the provisions of the Agreement, but not in a more extensive way than is required under the Agreement.^[11] This means that the US, for example, would be under an obligation to make sure that every patent applicant in the United States complies with the provisions of Part II, Section 5 of TRIPs, meaning that the US would have to implement domestic law that would address the proposed amendments, if they are indeed passed.^[12] Typically, enforcement involves civil remedies,^[13] but there is a requirement that there be criminal penalties for trademark and copyright piracy, as well as the option for “other cases of infringement of intellectual property rights, in particular where they are committed wilfully and on a commercial scale.”^[14]

---

[1] Frances Williams, Developing Countries Set for Clash with US Over Patents, Fin. Times, Jun. 7, 2006, at 7.
[2] Id.
[3] Id.
[4] Id.
[5] Id.
[6] Id.
[7] Id.
[8] Id.
[9] Id.
[10] Marrakesh Declaration of 15 April 1994, Apr. 12-25, 1994, Annex 1C.
[11] Id. Art. 1, para. 1.
[12] See id. Art. 41, para. 1 (member nations must ensure that enforcement procedures are available under domestic law so as to permit effective action against any act of infringement of IP rights covered by TRIPS).
[13] Id. Arts. 42-49.
[14] Id. Art. 61.