Gene Patents at Home and Abroad: Should the WTO Take Action in Light of Myriad?

Abstract

In 2012 the U.S. Supreme Court granted certiorari to the Myriad case. In doing so, the Court created an opportunity to harmonize U.S. patent law with global patent law norms regarding patents for composition claims of isolated human gene segments. The domestic importance of this case is high: it is estimated that as of 2005, 40,000 patents in the U.S encompass approximately twenty percent of the human genome.While the decision of the Myriad case is uncertain, the current global operating environment for gene patents poses a veritable minefield for practitioners in relevant industries. This article will attempt to address three questions. First: Is there a practical difference between allowing a patent on isolated genes and disallowing a patent on the method used with the isolated genes to diagnose patients? Second: Should the World Trade Organization (WTO) consider adopting a uniform approach on this issue, or is it too controversial? Third: Does a U.S. Supreme Court decision to disallow Myriad Genetics’ isolated gene sequence patents violate Article 27 of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement)?In part IIA, this article will examine the current posture of the Myriad case. In part IIB, the article will examine the background of international laws regarding patent law as relevant to the issue of isolated human gene segments. In part IIC, the article will examine the international law regarding patent law and human gene patents. In part IID, the article will examine the relevant U.S. domestic precedent affecting the validity of Myriad’s composition claims.In part IIIA, the article will analyze the differences between allowing a patent on isolated genes and disallowing a patent on the method used with the isolated genes to diagnose patients. In part IIIB, this article will analyze the considerations facing the WTO in considering whether to adopt a uniform approach to human gene patents.The article concludes that there is a difference between allowing a patent composition claim for on an isolated gene patent while disallowing an associated method claim. The WTO should not consider incorporating the World Intellectual Property Organization (WIPO) Substantive Patent Law Treaty into WTO TRIPS. Rather, there are existing mechanisms in the WTO TRIPS agreement that may be amended to facilitate a uniform, global treatment of human gene patents.Finally, a U.S. Supreme Court decision that disallows Myriad Genetics’ isolated gene sequence patents likely would not violate the current WTO TRIPS Agreement Article 27 because of the principle of nationality present in WTO TRIPS and other international patent agreements.