Since the establishment of the Federal Circuit three decades ago, the Supreme Court has tended to distance itself from the development of patent law. As the Federal Circuit holds exclusive jurisdictions over appeals arising from disputes involving patents, circuit splits are unlikely to arise, and its judges are deeply familiar with the subject area. Thus it is not entirely surprising that as a general matter it is rare for the Supreme Court to review its judgments.
However, in recent years the Supreme Court has reviewed several high profile Federal Circuit high-profile decisions, perhaps most notably in the area of the scope of patentable subject matter under 35 U.S.C. § 101. In Bilski v. Kappos, the Court agreed that an investment strategy was unpatentable subject matter, but indicated ambivalence towards the Federal Circuit’s chosen analysis. This year, in Mayo Collaborative Services v. Prometheus Laboratories, Inc, the Court held that claims over a medical diagnostic test were unpatentable “products of nature,” reversing the Federal Circuit.
On November 30, 2012, the Supreme Court granted review in Assoc. for Molecular Pathology v. Myriad Genetics, a case involving the patentability of human genes. The case has had a long journey through the federal courts. In 2011, the Federal Circuit found that claims over “isolated” DNA molecules are patentable subject matter, as well as certain associated method claims. This judgment was vacated and remanded to the Federal Circuit for further consideration in light of Mayo. On remand, the Federal Circuit once again held these patents to be directed towards patentable subject matter. Now before the Supreme Court again, it is likely that the Court will be directly addressing the question of whether human genes are patentable.
Petitioner argues that the patents at issue are invalid because they claim subject matter directed to a law or product of nature. They claim that these patents, which cover “isolated” forms of the BRCA1 and BRCA2 genes linked hereditary breast and ovarian cancer, have prohibited clinical testing, scientific research, and patients’ access to their genetic information. The respondent, Myriad Genetics, claims that the patents cover subject matter that was human-made and does not occur in nature. Myriad stresses the “enormous amount of human judgment” involved in their research and development of this area, and the importance of patent protection to support their industry.
This case is likely to be closely followed by many. Patentable subject matter is an area that the Supreme Court has shown a close interest in recently, lending much uncertainty to the state of the doctrine. Patent lawyers and scholars will wait to see whether the Supreme Court clarifies this area of law. The decision is likely to have a major impact on the biotechnology industry, who for many years has successfully obtained patents such as the ones at issue here with relatively little questioning of their validity. The public will be watching as well, as the question of whether human genes are patentable is a topic likely to generate excitement and intrigue from many.