The legal battle over patents on the breast cancer genes BRCA1 and BRCA2 held by Myriad Genetics of Salt Lake City took a new twist today with a ruling from a U.S. appeals court. The decision supports some of the company’s claims and denies others.
This argument over BRCA gene testing went all the way to the Supreme Court earlier this year, following an appeal by both sides—Myriad and a group of medical organizations coordinated by the American Civil Liberties Union and the Public Patent Foundation (PUBPAT), both of New York City. The Supreme Court sent it back down to the Court of Appeals for the Federal Circuit (CAFC) for a fresh analysis.
In today's opinion, CAFC rules that Myriad's patents on the genes themselves are valid "because each of the claimed molecules represents a nonnaturally occurring composition of matter." This reasoning assumes that the patents are based on "nonnatural" segments of DNA extracted from cells, not DNA as it occurs in the nucleus. The court also rules that a method of screening for potential cancer therapeutics by tracking their effects on cell growth rates is patentable, contrary to the view of a lower court. But CAFC finds invalid the company's claims on testing for cancer risk by comparing or analyzing DNA sequences because these methods are based on "abstract, mental steps" of logic that are not "transformative."
One of the three deciding judges, William Bryson, dissents in part from the majority opinion, arguing that Myriad's claims to the BRCA gene and gene fragments are not valid. He writes that he feared that if the majority opinion stands, it "will likely have broad consequences, such as preempting methods for whole-genome sequencing."
The decision is not likely to fully satisfy either of the battling parties, although some biotech companies may be relieved to learn that the court did not wipe out any gene patents.
Myriad has not responded to an e-mail query about what it planned to do next. Attorney Daniel Ravicher of PUBPAT, who has led the legal battle against the BRCA patents, responds that his group has not "made any final decisions about what we'll do. … But we are not satisfied with this result, and think the dissenting judge in the Court of Appeals decision today is correct that isolated human genes are not patentable."