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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