April 30, 2012

Federal Circuit Schedules Rehearing of Gene Patent Challenge

Today, the Federal Circuit has released its schedule for the rehearing of the gene patent litigation, Association for Molecular Pathology v. U.S. Patent and Trademark Office (AMP v. USPTO), in which a coalition of physiicans, researchers and patients brought a declaratory judgment action against Myriad Genetics, Inc., alleging that its patent claims to the isolated BRCA1 and BRCA2 genes as well as its methods for genetic testing were not patentable subject matter under 35 U.S.C. 101. After the district court handed down its decision in 2010, invaliding both types of patent claims, Myriad appealed to the Federal Circuit (I filed an amicus brief, available here). The 2011 Federal Circuit decision affirmed the invalidation of the method claims, but ruled that the isolated DNA claims were patentable subject matter. An appeal then went to the Supreme Court, which now had two pending biotechnology patentable subject matter cases in its docket for the first time since Diamond v. Chakrabarty in 1980 (in which the Supreme Court upheld a patent on a genetically engineered bacterium). In the interim, the Supreme Court decided Prometheus v. Mayo (Mayo) which presented the issue of whether patent claims to a method of drug treatment which utilized a metabolic relationship to formulate drug dosages violated the long-standing prohibition against patenting laws of nature. In the opinion authored by Justice Breyer, the court decided that the method claims were not patentable subject matter: “To put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well-understood, routine conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately. The Court described the practical burden that invalid or overly broad patent claims place on the general enterprise of innovation: “that very exclusivity can impede the flow of information that might permit, indeed spur, invention, by, for example, raising the price of using the patented ideas once created, requiring potential users to conduct costly and time-consuming searches of existing patents and pending patent applications, and requiring the negotiation of complex licensing arrangements.” Instead of taking on the merits of AMP v. USPTO, the Court then granted certiorari, but vacated the judgment and remanded the case back to the Federal Circuit for reconsideration in light of its Mayo decision. Today's Order asks the parties and amici to address the following issue: “What is the applicability of the Supreme Court’s decision in Mayo to Myriad’s isolated DNA claims and to method claim 20 of the ’282 patent?” The rehearing in AMP v. USPTO will now center squarely on the disputed patent claims to the isolated genes, with the Supreme Court's reaffirmation of two key points from Mayo providing context: the distinctness of the patentable subject matter doctrine and the integrity of the well-established patenting limits. Additionally, these product (composition of matter) patent claims must now be analyzed using the perspective provided by the Court's analysis of the method claims in Mayo. The Federal Circuit has scheduled the new oral argument in AMP v. USPTO for July 20, 2012.

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