Today the U.S. Court of Appeals for the Federal Circuit (CAFC) issued its highly anticipated opinion in the Myriad Genetics case. The court reaffirmed its ruling last year that isolated human genes are eligible for patent protection, a victory for biotechnology companies and their investors.
In a 2 to 1 split decision, the court held that Myriad’s genetic screening patents, directed to two genes known as BRCA1 and BRCA2 that can indicate whether a woman has an increased risk of developing breast or ovarian cancer, constitute patentable subject matter under Section 101 of the U.S. Patent Code. The CAFC reversed the lower district court’s decision in two key respects: the composition claims at issue covering isolated DNAs, and the method claim for screening potential cancer therapeutics via in vitrochanges, are eligible for patent protection. The CAFC also affirmed in part the district court’s decision in that the method claims directed to comparing or analyzing gene sequences are not subject matter eligible.
The same three member panel of the CAFC had decided this case last year, largely on the same grounds. The decision was appealed to the U.S. Supreme Court, which granted certiorari but remanded the case to the CAFC in light of another case it had just decided on patentable subject matter – Mayo v. Prometheus (see MedTech Brief of March 20, 2012). In today’s opinion, the CAFC distinguished the Myriad case from Mayo by noting that the Prometheus patent claims at issue in Mayo were method claims, and should not have an impact on the patent eligibility of the DNA composition of matter claims at issue in Myriad. Judge Lourie stated that “permitting patents on isolated genes does not preempt a law of nature,” and that the process of extracting and isolating a gene from the human body makes the gene chemically distinct from the DNA that exists naturally.
The Association for Molecular Pathology, the main plaintiff-appellee in this case who want to make their own screening tests available to patients, may request that the case be reheard en banc by all twelve judges on the CAFC, and/or again appeal the decision to the U.S. Supreme Court.
Link to the court’s opinion: http://www.cafc.uscourts.gov/images/stories/opinions-orders/10-1406.pdf