The Mayo Clinic and its lawyers at Mayer Brown weren't the only
ones to welcome the U.S. Supreme Court's ruling Tuesday that
Prometheus Laboratories cannot patent a medical test that relies
on correlations between drug dosages and treatment. Lawyers at
the American Civil Liberties Union see the high court's
unanimous decision as a good omen for their own case challenging
the patentability of human genes.
The plaintiffs in both cases have relied on the same
argument: that the patents in dispute are naturally occurring
phenomena that do not qualify for patent protection. The Supreme
Court bought that argument wholeheartedly in Mayo's case.
"We conclude that the patent claims at issue here
effectively claim the underlying laws of nature themselves.
Those claims are consequently invalid," wrote Justice Stephen
Breyer. Just as Einstein could not have patented E=mc2 and
Newton could not have laid claim to the law of gravity, Breyer
wrote, so Prometheus cannot patent a test kit that correlates a
patient's blood chemistry with the best drug dosages for
treatment. The decision overturned a ruling by the U.S. Court of
Appeals for the Federal Circuit upholding Prometheus's patents.
"We were really pleased with the Prometheus decision," said
Sandra Park, an ACLU attorney fighting on behalf of a host of
researchers and breast cancer patients to invalidate Myriad
Genetics' right to patent isolated breast cancer genes. "The
decision bodes well for the ultimate outcome of the Myriad
case," she said.
Last summer, a three-judge panel of the Federal Circuit
Court of Appeals issued a fractured decision upholding Myriad's
right to patent isolated human genes -- BRCA1 and BRCA2 -- that
are linked to most inherited forms of breast and ovarian
cancers. (All three judges wrote separate opinions; two of them
backed Myriad.) The ACLU has filed a petition asking the Supreme
Court to review the Federal Circuit's decision, but the court
has not yet decided whether to grant cert. That decision is
expected in coming weeks, Park said.
In the meantime, ACLU attorneys are examining the Prometheus
decision for any clues about the high court's thinking. Park
said many of the Supreme Court's points in the Prometheus
decision are directly relevant to the Myriad case, in which the
ACLU has argued that patents on genes prevent clinicians and
researchers from improving their testing methods and conducting
That point was featured front and center in the Prometheus
decision on Tuesday: "The court has repeatedly emphasized ...
that patent law not inhibit further discovery by improperly
tying up the future use of laws of nature," Breyer wrote. The
Supreme Court also rejected arguments by Prometheus' counsel at
Latham & Watkins that because blood is removed from the patient
and analyzed, it is transformed from a naturally-occurring
phenomenon. A similar concept buttressed the Federal Circuit
majority in the Myriad case, which found that when DNA is
removed from a human cell, the ends of the gene are chemically
changed, making it patentable. The ACLU claims that those ends
are constantly being broken and reformed in the human body, and
are therefore still a natural phenomenon and not patentable.
The Prometheus decision also seemed to respond directly to
the Federal Circuit majority's reasoning in the Myriad case that
courts cannot disrupt companies' IP rights in human genes, given
the U.S. Patent and Trademark Office's longstanding policy of
granting such rights. The Supreme Court in Prometheus concluded
that it is not up to the court to weigh different groups'
interests. Just as patent protection gives companies monetary
incentives to create, invent and discover new technology, it
also obstructs the flow of information that would otherwise spur
innovation, the court noted.
"We need not determine here whether, from a policy
perspective, increased protection for discoveries of diagnostic
laws of nature is desirable," Justice Breyer wrote.
Myriad disputed the ACLU's take on the Prometheus ruling,
drawing a distinction between the method claims in that case and
the composition-of-matter claims in the gene patent suit.
"There's no relationship from this ruling that can be applied to
the Myriad case," a company spokeswoman said. A March 21 report
drafted by Myriad adviser Cowen and Company, detailing a call
with patent consultants, described the Prometheus ruling as
"surprisingly narrow." The memo did note that the Supreme Court
ruling could place isolated gene claims at increased risk, but
said the justices may want to avoid the "extremely broad"
implications of that finding.
Gregory Castanias and Brian Poissant of Jones Day, who
represented Myriad at the Federal Circuit, did not respond to
requests for comment.
(Reporting by Terry Baynes)
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