The Myriad Breast Cancer Patent Case Continues

Posted by Pete Shanks August 1, 2011
Biopolitical Times

The Court of Appeals for the Federal Circuit on Friday handed down its decision — which is not expected to be the last word — on the much-watched Myriad gene patent case. Despite broad mobilization by patients, researchers and public interest groups in highlighting the serious harms posed by gene patents, the 2–1 decision falls largely in favor of Myriad Genetics. It upholds seven of Myriad's patents on the BRCA1 and BRCA2 genes, mutations of which are highly associated with heritable forms of breast and ovarian cancer.

The ruling reverses a 2009 landmark ruling by District Court Judge Robert Sweet that genes, even "isolated and purified" ones, are unpatentable products of nature. The reversal represents a significant setback to the position — supported by CGS, the American Civil Liberties Union, the Obama Administration, and many others — that genes cannot and should not be owned.

But it's a split decision. As Daniel B. Ravicher, executive director of the co-plaintiff Public Patent Foundation, said, "They can't agree among themselves." The judges did all agree that the plaintiffs had standing, and that some of Myriad's methods cannot be patented, but they split 2–1 on the issue of whether isolated DNA is patentable, and indeed the two in the majority had somewhat different rationales for allowing patents. The ruling is available as a pdf, and the most detailed analysis seems to be that by Genomics Law Report, under the headline:

Pigs Return to Earth: Federal Circuit Reinstates Most — But Not All — of Myriad's Patents

The next steps are not yet certain, but since the decision disappoints both sides, at least partly, both have the right to appeal. One possible next step is to request a hearing en banc, which means that all ten active judges of the Federal Court of Appeal would hear it together; another, after that or in place of it, is an appeal to the Supreme Court. So far, ACLU attorney Sandra Park has simply said:

"That ruling will continue to have the effect of preventing our clients, including geneticists, from doing the testing and research they want to do. We'll certainly be consulting with our clients about next steps both with this court and the Supreme Court."

Most reports include speculation about this. Science Insider, for example, concludes its piece:

Robert Cook-Deegan, director of the Center for Genome Ethics, Law & Policy at Duke University in Durham, North Carolina, called today's ruling "a very interesting decision" that's likely to lead to further legal action: "I wouldn't be surprised if both sides appealed to the Supreme Court."

Dr. Cook-Deegan is not exactly out on a tiny limb … or if he is, it's awful crowded. This is clearly a major issue of public importance, and even though this ruling is a setback, it's by no means definitive. As John Conley and Dan Vorhaus of Genomics Law Report note, "it was a 2–1 decision, so the anti-gene patent position is neither crazy nor hopeless." Moreover, the Supreme Court has already taken up the somewhat related Prometheus case. It would not be surprising if they were to consider Myriad at the same time. Or, of course, there is another branch of the Federal government.

Previously on Biopolitical Times: