Sept 6, 2012, Cancer Discover--Myriad Genetics of Salt Lake City, UT, can check off another legal victory on its BRCA1 and BRCA2 patent claims.
On August 16, 2012, the U.S. Court of Appeals for the Federal Circuit in Washington, DC, upheld its earlier ruling that Myriad can keep its patents on the 2 genes, which fuel many inherited breast and ovarian cancers.
However, the ruling, issued by a 3-judge panel in a 2–1 decision, dealt only with whether the genes are eligible for patenting. To be patentable, inventions also have to be novel and nonobvious, but the plaintiffs in this case never challenged Myriad's claims with respect to those additional criteria, according to Konstantin Linnik, PhD, a prominent patent attorney and partner in the law firm Nutter, McClennen, and Fish in Boston, MA.
For years, Myriad has fought off legal challenges from plaintiffs who claim that genes can't be patented because they're products of nature. The company's response is that unlike branches snipped from a tree, the BRCA genes are isolated and manipulated using processes that require human ingenuity.
In the current case—Association for Molecular Pathology et al v. U.S. Patent and Trademark Office et al—the Federal Circuit agreed. The majority opinion, written by Judge Alan Lourie, stated “…isolated DNA is not purified DNA…it has been manipulated chemically so as to produce a molecule that is markedly distinct from that which exists in the body.”
Because isolated genes aren't the equivalent of purified DNA, they are therefore eligible for patenting, in the Federal Circuit's view. That's a crucial distinction given that last March, in Mayo Collaborative v. Prometheus Laboratories, thespan>, the U.S. Supreme Court ruled that correlations between drug dosage and metabolite levels in the body comprise a “law of nature” that can't be claimed as intellectual property. In light of that decision, the Supreme Court remanded the Myriad case, which it had scheduled to hear, back to the Federal Circuit.
By upholding its previous ruling, the Federal Circuit affirms that Prometheus does not apply to “composition” claims such as those having to do with DNA that's been isolated and then chemically manipulated, Linnik explains. “But it's possible the U.S. Supreme Court could overturn this decision,” he adds. “The Court already took the case once before so they likely will take it again if it's appealed.”
Plaintiffs have 90 days from the date of the ruling to appeal to the Supreme Court, or 45 days to appeal en banc to all the judges on the Federal Circuit Court. As of August 31, 2012, no appeals had been filed.
Assuming the Supreme Court agrees with the Federal Circuit, future gene cases will be determined on the basis of novelty and nonobviousness, or inventiveness. “The eligibility criteria will have already been settled,” Linnik says