judge accusing his colleagues last year of
waging “guerrilla warfare” against the
Alice decision.
Nowhere was the appellate court’s
frustration more evident than in Athena
Diagnostics. In a 7-5 vote denying en banc
review, all 12 active members of the court
called on the Supreme Court or Congress
to revisit patent eligibility as it’s applied to
medical diagnostics.
Athena’s counsel of record, Wilmer
Cutler Pickering Hale and Dorr partner Seth Waxman, called it “an unprecedented cry for help” in his petition for
certiorari. “This Court should heed that
cry and provide much-needed guidance
on the proper application of the judi-cially-created exceptions to Section 101
of the Patent Act,” he wrote.
The Pharmaceutical Research and
Manufacturers of America, the Biotechnology Innovation Association and the
Intellectual Property Owners Association
were among the amici curiae supporting
certiorari.
Mayo was represented by Fish & Richardson, which argued that the court correctly decided this issue just seven years ago
in Mayo Collaborative Services v. Prometheus
Labs, the second in the Supreme Court’s
quartet of decisions. It endorsed “a bright-line prohibition” against patenting laws
of nature, argued Fish partner Jonathan
Singer, who was counsel of record to Mayo.
At issue in Athena was U.S. Patent
7,267,820 held by Oxford University and
the Max Planck Society and licensed to
Quest Diagnostics Inc. subsidiary Athena
Diagnostics Inc. The inventors discovered
that antibodies to a protein called muscle-specific tyrosine kinase (MuSK) are correlated with neurological disorders such
as myasthenia gravis. The Mayo Clinic
developed a competing test that Athena
accuses of infringing.
The court had asked for the solicitor
general’s views on Hikma and Berkheimer.
The SG recommended against taking
both but stressed that it was time for the
Supreme Court to revisit Section 101 in
an appropriate case.
“As the government’s brief dramatically illustrates, there is a raging debate
over the scope and wisdom of this Court’s
unanimous decision just seven years ago
in Mayo Collaborative Services v. Prometheus
Laboratories, Inc.,” Hikma’s attorneys at
Winston & Strawn and Wilson Sonsini
Goodrich & Rosati argued in a Dec. 20
response to the solicitor general’s brief.
Hikma addresses the patentability of
methods of treating disease, such as new
dosing regimes for existing drugs. The U.S.
Court of Appeals for the Federal Circuit
ruled 2-1 that Vanda’s patent on a method
of treating schizophrenia, by determining
a patient’s particular genotype and adjusting dosage of iloperidone accordingly, is
eligible for patenting. Vanda’s successful
opposition was led by counsel of record
Nicholas Groombridge, who is a partner at
Paul, Weiss, Rifkind, Wharton & Garrison.
HP v. Berkheimer involves a computer-implemented invention. The question is
whether the second step in the Supreme
Court’s patent eligibility framework—
determining whether a skilled artisan
would have considered claimed processes
routine and conventional at the time of
the patent—is a question of law or fact.
The Federal Circuit held the latter in
2018, making it more difficult for accused
infringers to get patent suits dismissed
early on the pleadings.
HP was represented by Morgan,
Lewis & Bockius and Gibson, Dunn &
Crutcher. Morgan Lewis Washington,
D.C., partner David Salmons was counsel
of record. The Electronic Frontier Foun-
dation, Computer & Communications
Industry Association, Engine Advocacy
and finance-industry supported Askelad-
den were among those urging the court to
grant cert. Jenner & Block partner Adam
Unikowsky led the successful opposition,
with help from Much Shelist and Skier-
mont Derby.
Villanova’s Risch said that, although
the court took no cases, it may have, in
a sense, been striking a compromise. By
leaving Berkheimer in place, patent owners gain some procedural protections.
The court leaves the substantive law in
place, perhaps because it continues to
believe medical diagnostic tests should
not be patent eligible, he said.
“This result makes sense to me in the
end,” says George Washington University
law professor Dmitry Karshtedt. “If I’m
on the Supreme Court and not steeped in
the turmoil with 101, these three opinions
are just examples of case-by-case development of the doctrine that was sent down
in Mayo [v. Prometheus] and Alice.”
ip insider
“The court leaves the substantive law in place, perhaps
because it continues to believe medical diagnostic tests
should not be patent eligible.” —Michael Risch
U.S. Supreme
Court building in
Washington, D.C.
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