Patently Obvious: Why the District Court's Ruling in Association for Molecular Pathology v. USPTO is Incomplete

Kristin Wall, American University Washington College of Law

Abstract

In March of 2010, the United States Court of Appeals for the Southern District of New York invalidated Myriad Genetics’ patents on the BRCA1/2 genes, which predict susceptibility to breast and ovarian cancer. Prior to this decision, the USPTO and the legal system at large accepted patents relating to human genes as patentable subject matter. In opposition to this standard, the District Court found that human DNA sequences are inherently products of nature and thus fail under 35 U.S.C. § 101.

The Court should not have stopped there, however. The Intellectual Property Clause of the U.S. Constitution creates a standard for patentability based on inventiveness. Merely pinpointing the location of a particular gene sequence based on public information, as Myriad and other companies have done, does not meet this standard. Furthermore, isolating particular gene sequences is obvious under 35 U.S.C. § 103, and as such renders all gene sequences unpatentable.

The social and economic implications of invalidating existing gene patents and preventing future patenting are many; while the financial incentive afforded those holding exclusive ownership rights may decrease, free exchange of ideas and the public’s ability to receive diverse services will proliferate.