[Ip-health] Federal Appeals Court Upholds BRCA1/2 Decision Against Myriad Genetics

Jamie Love james.love at keionline.org
Wed Dec 17 13:08:22 PST 2014

Myriad loses another.


Federal Appeals Court Upholds BRCA1/2 Decision Against Myriad Genetics

Dec 17, 2014 | a GenomeWeb staff reporter

NEW YORK(GenomeWeb News) – The US Court of Appeals for the Federal Circuit
today upheld an earlier decision denying Myriad Genetics' request for an
injunction against Ambry Genetics to prevent it from marketing a BRCA1 and
BRCA2 gene test.

The US District Court for the District of Utah denied Myriad's motion for a
preliminary injunction in March. In addition to Myriad, the plaintiffs in
the case are the University of Utah Research Foundation, the Trustees of
the University of Pennsylvania, Hospital for Sick Children Research and
Development Limited Partnership, and Endorecherche.

In its decision, the appeals court essentially ruled that three patents —
US Patents No. 5,753,441; No. 5,747,282; and No. 5,837,492 — which cover
Myriad's BRACAnalysis test, should not have been issued and "the district
court properly denied Myriad's motion for preliminary injunction."
Specifically, the court said today that certain claims contained in the
three patents covering primers and methods are patent ineligible.

"We are disappointed with the Court's ruling," Myriad said in a statement
emailed to GenomeWeb. "We currently [are] reviewing the decision and will
consider all our options."

Ambry CEO Charles Dunlop said in an email, "I knew intellectually that we
were right, and our basic arguments were correct. I have cancer, and I
could not believe – I found it offensive, actually – that somebody with
cancer would not have options for genetic testing.  Because we believed our
position was correct under the law, we decided move forward and defend
Ambry from Myriad’s claims."

Myriad and the other plaintiffs originally sued Ambry in July 213 alleging
the Aliso Viejo, Calif.-based firm's BRCA testing process for gauging
mutations in BRCA1/2 associated with breast and ovarian cancer risk
infringed a total of 10 patents owned or licensed by them. The lawsuit
followed a decision by the US Supreme Court a month earlier that human
genes cannot be patented but synthetic DNA, or cDNA, is patent eligible
because it does not occur naturally.

After the SCOTUS decision, a number of competitors launched their own
BRCA1/2 tests. Myriad and its fellow plaintiffs responded by suing them,
accusing them of patent infringement. Along with Ambry, other firms that
Myriad has sued include Laboratory Corporation ofAmerica, Quest
Diagnostics, GeneDx, InVitae, and Gene by Gene.

In February, Gene by Gene settled its dispute with Myriad.

James Love.  Knowledge Ecology International
KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
+41.76.413.6584, twitter.com/jamie_love

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