Applying Mayo to Myriad: Latest Decision Brings No New News (Plus: Why the Final Myriad Decision Might Not Matter for Personalized Medicine)
The latest chapter in the Myriad gene patent litigation was written yesterday, with the Federal Circuit issuing its much anticipated opinion (pdf) after rehearing the case following the Supreme Court’s unanimous decision earlier this year in Prometheus v. Mayo.
Or perhaps we should say that the latest chapter was “rewritten” as, in a move that surprised approximately nobody, and as we predicted earlier this spring, the Federal Circuit reached precisely the same result in its opinion today as it did last July when it issued its first substantive ruling in the Myriad litigation. Below, we examine how the Federal Circuit applied Mayo to Myriad, what the next step in the Myriad litigation is likely to be (spoiler alert: it’s another appeal) and why we think the final opinion in this case, whenever it arrives and whatever it says, might not matter all that much.
Applying Mayo to Myriad. As mentioned, the only major change since the last time the Federal Circuit ruled in Myriad, and the reason for the re-hearing, was the Supreme Court’s decision earlier this spring in Mayo.
However, Mayo was about method patents and the boundary between a patent-eligible method and a law of nature. It was not about product patents or the product of nature doctrine. Since the Federal Circuit had already invalidated all but one of Myriad’s method patents even before the Supreme Court tightened the criteria for method patents in Mayo, it was hard to see much of substance changing the second time around.
This past March Judge Robert Sweet handed down an unexpected summary judgment ruling in the Myriad gene patent litigation (see: Pigs Fly: Federal Court Invalidates Myriad’s Patent Claims). Myriad quickly appealed Sweet’s district court decision to the Court of Appeals for the Federal Circuit (CAFC).
After several months of courtroom quiet, the briefs began rolling in to the CAFC last week. Most, including Myriad’s own appellant brief (pdf), presented the argument we would expect. Myriad and its supporters frame Judge Sweet’s ruling as an erroneous application of settled patent law and policy that, if upheld, “would have far-reaching negative consequences” (pdf) for the continued development of biotechnology.
And then there is the United States government. In an amicus brief filed on Friday (pdf) the Department of Justice (DOJ), on behalf of the United States, dropped a minor bombshell. Contradicting the longstanding policy of the United States Patent and Trademark Office (PTO), the government’s brief argues that isolated human genes, without further modification, are a product of nature and do not constitute patent-eligible subject matter under § 101 of the Patent Act.