Assn. For Molecular Pathology v. Myriad Genetics, Inc.

Isolated sections of naturally occurring DNA, without more, are products of nature and are not eligible for patent protection.

Opinion (THOMAS): The Association for Molecular Pathology ("the Association") filed a lawsuit seeking a declaratory judgment that several patents held my Myriad Genetics ("Myriad") were invalid because they claimed unpatentable subject matter. The patents cover the location of two genes (BRCA1 and BRCA2) the mutation of which increase the risk an individual will develop breast or ovarian cancer. The patents also claimed synthetic DNA created from those genes (called complementary DNA or cDNA). The District Court granted summary judgment for the Association, determining that both the gene and cDNA claims were invalid because they claimed products of nature. The Federal Circuit reversed on both counts, concluding that breaking the covalent bonds, which was required to isolate the genes, created new molecules that were patentable. The Supreme Court granted certiorari. In a unanimous opinion, the Supreme Court held that despite the extensive efforts exerted by Myriad in determining the location of the genes, finding the location of genes already existing in naturally occurring DNA does not render the genes “new … composition[s] of matter” eligible for patent protection. Myriad's argument that by severing the chemical bonds in order to isolate the genes it created a new molecule, was unavailing because the patents covered the information in the genes themselves, rather than the chemical composition of the molecules. Although the Court determined that isolated sections of naturally occurring DNA are not patent eligible, it held that cDNA, which consists of DNA that has had its non-coding regions removed, is not naturally occurring and therefore is not a product of nature and is potentially eligible for patent protection. However, the Court expressed no opinion whether the cDNA claims in Myriad's patents were valid.