Feeling Funk-y: Human Gene Patents in AMP v. Myriad

Abstract

In a stunning reversal of the long-standing practice of the U.S. Patent & Trademark Office permitting the patenting of human DNA, the Supreme Court unanimously held on June 13, 2013, in Association for Molecular Pathology v. Myriad Genetics, Inc., that an isolated segment of human DNA, such as a gene, is not eligible for patent protection under 35 USC x101. The decision suggests that more human intervention beyond mere cleaving of this naturally occurring molecule from its natural environment is required. The Court did not prevent patent protection on all genetic materials, however, as it also held that a type of nonnaturally occurring molecule known as complementary DNA was patent eligible. The Court’s analysis of these DNA-based claims was guided by two precedents, Funk Brothers Seed Co. v. Kalo Inoculant Co. and Diamond v. Chakrabarty, which addressed the patent eligibility of biological organisms. In this article, we examine these two precedents, how the Supreme Court applied them in its decision in Myriad, and some potential implications of the Myriad decision.