Supreme Court Decision on Gene Patents: Supreme Court Holds Naturally Occurring, Isolated DNA Is Not Patentable, While Synthetic DNA Is Patentable

Sullivan & Cromwell LLP - June 14, 2013

In a decision having implications for the healthcare, biotechnology, and pharmaceutical industries, on June 13, 2013, the U.S. Supreme Court held that a naturally occurring DNA sequence is not patentable simply because it has been isolated from surrounding genetic material. Assoc. for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. ___ (2013). The Court observed that Myriad’s claims to naturally occurring, isolated DNA sequences are primarily claims to the “information contained in the genetic sequence,” and found such sequences to be unpatentable “products of nature” notwithstanding minor changes in chemical composition as a result of the isolation process. While acknowledging the importance of discovering the location and sequence of useful genes, the Court explained that “groundbreaking, innovative, or even brilliant discovery” does not render a product of nature patentable.

The Court also held, however, that synthetic “complementary” DNA (cDNA) – which contains only the protein-coding nucleotides of a DNA sequence and omits the non-protein coding sections – is not naturally occurring and constitutes a “new and useful . . . composition of matter” that is patent eligible as long as the claimed cDNA sequence does not occur naturally.