Ass’n for Molecular Pathology v. Myriad Genetics, Inc.

Whether human genes are patentable.

Medical practitioners commonly use genetic testing to determine whether mutations that indicate an increased risk for hereditary breast and ovarian cancer are present in a patient’s genes. Respondent owns patents on an isolated form of the two genes most commonly used in this analysis. The patents preclude use of the genes in conventional genetic testing techniques.

Petitioners filed a complaint against the Patent and Trademark Office (PTO) and Respondents challenging claims from seven different patents. The district court dismissed the PTO from the proceedings and granted Petitioner’s motion for summary judgment, explaining that the isolated genes were precluded from qualifying as patentable subject matter. Respondent appealed to the Court of Appeals for the Federal Circuit, which reversed the decision. A divided court held that because the isolated DNA was structurally different from naturally occurring DNA it was not precluded from patent eligibility. The Supreme Court granted certiorari, vacated the Federal Circuit’s decision and remanded the case for further proceedings in light of its decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012). On remand the Federal Circuit again upheld the validity of the patents on isolated genes. Petitioners appealed to the Supreme Court, which granted certiorari to determine whether isolated genes constitute patentable subject matter.

On appeal, Petitioners note the importance of determining whether human genes and the information they convey constitute patentable subject matter. They argue that neither the Patent Act, nor the U.S. Constitution encompass the possibility of isolated genes qualifying as patentable subject matter. The thrust of their argument is that the isolation techniques result in random DNA fragments that are identical to those that exist naturally in the body and therefore do not meet the requirement that patentable subject matter be “human made.”