The U.S. Supreme Court (SCOTUS) heard arguments on Monday specifically addressing whether “human genes are patentable.” Ass’n for Molecular Pathology v. Myriad Genetics, Inc., No. 12-398 (U.S., argued April 15, 2013). The Federal Circuit Court of Appeals decision from which the appeal was taken affirmed its earlier ruling, in the wake of Mayo Collaborative Services v. Prometheus, Inc., 132 S. Ct. 1289 (2012), that isolated DNA molecules were patent eligible and that most of Myriad’s “method claims” for comparing molecules to determine whether a patient’s genes have mutations that could cause breast and ovarian cancer were not patent eligible. Further details about the Federal Circuit’s ruling appear in Issue 41 of this Bulletin. An opinion is expected by the end of June 2013.
While Justice Antonin Scalia questioned whether a company would “incur massive investment if it cannot patent,” Justices Sonia Sotomayor, Stephen Breyer and Anthony Kennedy all questioned counsel about the narrow, middle ground suggested by the Obama administration, which has called for the court to void parts of the patents while allowing other aspects to be upheld. The U.S. Solicitor General argued that Myriad is not entitled to a patent on “isolated DNA,” but may be entitled to patent synthetic DNA molecules, which require skilled human manipulation to produce.
With the potential for the Court’s decision to have a wide impact on science, medicine, biotechnology, and basic research, the industry is watching the case closely, and several dozen amicus briefs were filed in the case. Some believe that it could pose obstacles to personalized medicine and whole-genome sequencing if the Court upholds the validity of individual gene patents. Other Court watchers suggest that any ruling may have limited effects because much of the human genome has been sequenced and put into the public domain, and many of the patents that have been awarded to date involve selective isolation of specific DNA stretches. See USA Today, April 10, 2013; Nature, April 11, 2013; The New York Times, April 14, 2013; Bloomberg, April 15, 2013.