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Gene patent ruling highlights tension between SCOTUS, Fed Circuit

8/17/2012 COMMENTS (0)

Last month, after the Federal Circuit Court of Appeals heard oral arguments on how the U.S. Supreme Court's March 2012 ruling in Mayo v. Prometheus Laboratories should affect the appeals court's reconsideration of the patentability of human genes, gene patent opponent Daniel Ravicher of the Public Patent Foundation went back to his office and told colleagues that the Federal Circuit majority was going to reach exactly the same conclusion it did in its first ruling on the Myriad breast cancer gene patents. "My first comment," he told me Friday, "was that they're simply going to open the same Word file and add a paragraph saying 'We see the Mayo issue and it doesn't change anything.'"

Ravicher was pretty much on the money. In Thursday's fractured 106-page ruling, Federal Circuit judges Alan Lourie and Kimberly Moore rather glancingly acknowledged the Supreme Court's Mayo ruling, which tightened the standard for patent eligibility. But the appellate panel reached exactly the same conclusions it did in its original consideration of the Myriad case last August -- and in almost exactly the same language. Writing for the court, Lourie held that Myriad's isolated breast cancer genes are eligible for patents because they are a man-made invention, distinct from what is found in nature, by virtue of being cleaved from the genome and thus chemically distinguishable. The panel also once again upheld Myriad method patent claims on testing that involves "transformed" cells but said patent claims that just call for comparing DNA sequences are ineligible.

The majority opinion agreed with Myriad's lawyers at Jones Day that Mayo "does not control the patent eligibility" of Myriad's isolated genes because Mayo addressed a method patent, not a composition patent. Even so, said Myriad counsel Gregory Castanias, the majority's analysis concluded that Mayo merely reinforces the standard for composition patents the Supreme Court set in 1980 in Diamond v. Chakrabarty, which said man-made transformations of naturally occurring materials are eligible for patents. "The court said Mayo's significance is that you still have to have a man-made invention to get a patent," Castanias told me. "The [Federal Circuit] already did the work Mayo required the court to do" in its first ruling in the case, he said, which is why the opinion is so similar this time around.

That's not Ravicher's take. According to the Public Patent lawyer, Lourie and Moore chose to ignore the Supreme Court, even though the justices sent the case back specifically to be re-evaluated. "It's not new for some members of the Federal Circuit ... to think they know best," Ravicher said. "There seems to be a ping-pong or tennis match between some judges on the Federal Circuit and the Supreme Court." (I've previously written about strong hints from the Supreme Court that it wants the Federal Circuit to think harder about what's patentable.)

As evidence of the Federal Circuit's go-your-own-way approach to patent eligibility, Ravicher pointed to the appeals court's divided ruling last month in CLS Bank v. Alice Corporation, in which the dissenter, Federal Circuit Judge Sharon Prost, accused the majority, judges Richard Linn and Kathleen O'Malley, of disregarding Supreme Court precedent -- including Mayo -- to find that a computerized trading platform is eligible for a patent. "The majority resists the Supreme Court's unanimous directive to apply the patentable subject matter test with more vigor," Prost wrote. "Worse yet, it creates an entirely new framework that in effect allows courts to avoid evaluating patent eligibility ... whenever they so desire," she continued. "The majority has failed to follow the Supreme Court's instructions -- not just in its holding, but more importantly in its approach."

Ravicher said Moore's concurrence in the Myriad reconsideration, in particular, contravened the Supreme Court's ruling in Mayo. Though Moore rejected Myriad's argument that Mayo doesn't apply to composition patents, she agreed that the isolated breast cancer gene is still patent-eligible as a man-made invention. And in language that's very useful to biotechs that want to continue patenting human genes, Moore also cited the U.S. Patent and Trademark Office's longstanding policy of granting such patents. "The settled expectations of the biotechnology industry -- not to mention the thousands of issued patents -- cannot be taken lightly and deserve deference," she wrote. But according to Ravicher, the Supreme Court expressly ruled out such deference to industry in Mayo, and, indeed, cautioned against issuing patents that inhibit research and innovation."

The Public Patent lawyer, who was co-counsel with the American Civil Liberties Union in the Myriad case, said gene patent opponents still have several options, aside from taking the Federal Circuit's advice and going to Congress to change the law. They can seek a rehearing before the same panel (a dubious prospect), seek en banc consideration from the Federal Circuit or do what they did after last year's rebuff at the Federal Circuit and file a petition for certiorari at the Supreme Court. Ravicher noted that the patent at issue in the Mayo case traveled exactly the same path through the courts as the breast cancer gene patent before it was deemed ineligible by the Supreme Court ruling. It was upheld by the Federal Circuit, then reconfirmed by the appeals court after the Supreme Court remanded the case for reconsideration in light of a high court ruling on method patent eligibility. Ravicher is hoping the breast cancer gene patent, like the medical testing patent in the Mayo case, is ultimately found to be unpatentable.

"As God is my witness, this isn't over yet," he said.

(Reporting by Alison Frankel)

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