Ass’n for Molecular Pathology v. Myriad Genetics, Inc.
By Alex Shank – Edited by David LeRay
Ass’n for Molecular Pathology v. Myriad Genetics, Inc., No. 12-398 (U.S. Apr. 15, 2013)
Transcript of Oral Argument
On Monday, April 15, the Supreme Court heard oral arguments to determine the validity of a patent encompassing the use of the BRCA1 and BRCA2 genes. Mutations in these genes correlate strongly with the development of breast and ovarian cancers. As the patent owner, Myriad Genetics, Inc. (“Myriad”) possesses and exercises the exclusive right to sell diagnostic testing kits based on these genes.
The ACLU first challenged the constitutionality of the Myriad patent in the District Court of the Southern District of New York (“SDNY”), claiming that the patent violated the First Amendment. The SDNY invalidated the patent on other grounds, holding that the genes were “products of nature” and thus not patentable subject matter. On appeal, the Court of Appeals for the Federal Circuit (“CAFC”) affirmed that “comparing” gene sequences was unpatentable as an “abstract mental step” but reversed the SDNY by holding that Myriad’s “screening” claims were patentable. After deciding Mayo Collaborative Servs. v. Prometheus Labs., Inc., the Supreme Court vacated the CAFC’s earlier decision and remanded the case to be decided in light of Mayo. The CAFC reaffirmed that isolated genes were patentable as “markedly different” from genes in the human body and reaffirmed its earlier position on the various method patents. The ACLU appealed to the Supreme Court.
SCOTUSblog comments on the Supreme Court’s skepticism regarding the validity of the Myriad patents. The New York Times offers a summary of the oral argument and background on the case. Nature newsblog and Patently-O predict how the Supreme Court may narrow the scope of its holding to a particular class of genetic material. JOLT Digest previously commented on the implications of a ban on gene patents. (more…)