One of the great judicial dialogues of the last few years has
been the back-and-forth between the U.S. Supreme Court and the
Federal Circuit Court of Appeals over what's patentable. The
roots of the debate predate the creation of the Federal Circuit
in 1982, but valuable software and biotech patents have lent
urgency to the issue -- and divergent views by the Supreme Court
and the Federal Circuit on patentability standards have led to a
series of rulings in which the justices contradict the appeals court but the Federal Circuit refuses to take the hint and
continues to go its own way. The conflict has created so much
uncertainty that over the summer two petitions for en banc
review, including one in a case remanded by the Supreme Court,
begged the Federal Circuit to resolve its own internal split on
how much deference to give the Supreme Court.
The Federal Circuit was at its most defiant last August,
when Judges Alan Lourie and Kimberly Moore once again ruled that
an isolated piece of human genetic code can be patented. The
case, which involves Myriad's patents on a gene mutation that
denotes a tendency to develop breast and ovarian cancer, had
been sent back to the appeals court by the Supreme Court for
re-evaluation in light of the justices' reminder in Mayo v.
Prometheus Laboratories that naturally occurring phenomena are
not patentable. But Lourie and Moore gave short shrift to the
Supreme Court's Mayo ruling. Lourie's opinion for the majority
and Moore's concurrence basically repeated their previous
findings on Myriad's gene patents, with an extra paragraph or
two about why Mayo isn't applicable or is outweighed by the
longstanding U.S. Patent and Trademark Office policy on granting
patents on isolated genes. (Judge Curtis Bryson dissented with
last summer's Myriad decision, just as he did the first time the
case was decided.) After the Federal Circuit's decision, Daniel
Ravicher of the Public Patent Foundation, who is co-counsel to
the gene patent opponents, told me that the ruling was the
latest shot in the ongoing patentability tennis match between
the appeals court and the justices.
The Supreme Court has now grabbed the ball in what should be
the last game of the match. On Friday, the court granted a
petition for certiorari filed by Public Patent and the American
Civil Liberties Union, which asked the justice to answer,
directly and with clarity, whether human genes or isolated
pieces of genetic code can be patented as the product of
man-made invention or are unpatentable because they are found in
nature. "Despite Myriad's claim that the law applied by
the(Federal) Circuit is settled, it is clear that the circuit
created new legal standards in upholding these patents, while
simultaneously rejecting those articulated in this court's
Section 101 (patentability) precedents," the ACLU and Public
Patent wrote in their response brief in support of cert.
If the Federal Circuit's opinion is allowed to stand, they
said, the Supreme Court would be endorsing the patentability of
any natural composition removed from nature and put to another
use. According to gene patent opponents, that's explicitly
contrary to the court's 1948 ruling in Funk Brothers Seed v. Kalo and, by extension, in last year's Mayo decision.
Myriad's lawyers at Jones Day countered in their brief opposing cert that the breast cancer screening company's patents
aren't on human genes but on pieces of genetic code isolated by
scientists and chemically distinct, by virtue of that isolation,
from what's found in nature. The PTO has been patenting such
man-made genes for decades, Myriad argued, and the 40,000 gene
patents the PTO has already issued have enormously benefited
science and healthcare. Myriad urged the Supreme Court to let
the Federal Circuit's two considerations of the breast cancer
gene case be the final word.
By granting cert, at least four justices have indicated that
they have something to add to the discussion. Ravicher of Public
Patent told me Monday that gene patent opponents shouldn't yet
celebrate, though. "We're far from over," he said. "This was a
great thing to happen, but there's a long way to go." At least,
he said, there's now a chance for some finality in an area where
intercourt bickering isn't helping anyone. "Smart people
sometimes have the downside of not listening to one another," he
said of the back-and-forth between the Federal Circuit and the
Supreme Court. "Both feel disrespected by the other. That
creates tension. The law shouldn't be this way."
Myriad lead counsel Greg Castanias said it appears that the
Supreme Court wants to eliminate uncertainty but added that he
believes the court's own precedent on what constitutes a
man-made invention (in 1980's Diamond v. Chakrabarty) and on
deference to PTO policy (in the 2001 decision in J.E.M Ag Supply v. Pioneer Hi-Bred) will persuade the justices to uphold
Myriad's patents. "This is another opportunity for the Federal
Circuit and the Supreme Court to explore their relationship," he
said.
(Reporting by Alison Frankel)
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