Endowed with extraordinary genetic diversity, the world’s tropical rainforests have produced the raw material for many highly profitable pharmaceuticals.  Yet, the nations in which the rainforests are located — many of which are among the poorest in the world — often realize little economic benefit.  “Bioprospectors” have traditionally had little difficulty operating outside the legal regulation of source nations.  And, once biological materials are transported to the developed world, they may be made the basis for legally enforceable patents there.  Then, adding insult to injury — or perhaps more accurately, injury to insult — the patents may impair the ability of source nations to use their own genetic resources.  To critics, this dynamic — often labeled “biopiracy” — calls to mind the long tradition of exploitative north-south relationships going back to colonial days. 

The Convention on Biological Diversity aims to strengthen the position of source nations by requiring bioprospectors to obtain prior informed consent before using materials from other nations.  However, the treaty has a weak enforcement mechanism, and the United States is not even a party to it.

Responding to the weaknesses of the CBD, 3L Laura Grebe has an interesting new proposal to incorporate the prior informed consent concept into U.S. patent law.  Her proposal is described and defended in a new paper on SSRN entitled “Requiring Genetic Source Disclosure in the United States.”  In essence, Laura would require patent applicants to disclose the origin of their genetic materials and whether they obtained prior informed consent from the source nations.  Among other things, she hopes that U.S. reforms along these lines would become a model for other nations.

The abstract to Laura’s paper appears after the jump. 

Bioprospecting and biopiracy are an increasing problem, particularly for developing nations. Large companies, usually from developed nations, gather biological samples to use in research, and often patent the results without sharing profits with the nations from which the biological samples were taken. The Convention on Biological Diversity (CBD) attempted to address these issues by stating that natural resources belong to the source nations, and entities wishing to use those resources should obtain prior informed consent before using them. The CBD, however, lacks an enforcement mechanism. Other nations and organizations have proposed amendments to the Agreement on Trade-Related Aspects of Intellectual Property Rights and the Patent Cooperation Treaty to bring these laws more in line with the spirit of the CBD, but there has been little progress made on these proposals. This article provides a proposed genetic source and prior informed consent disclosure that the U.S. can implement that will not significantly upset the current patent regime, bring the U.S. into closer harmony with the CBD, and make the U.S. a model for other nations to implement similar legislation.