| June 6
June 6 A federal appeals court hinted on Tuesday
it may let Sanofi AG and Regeneron Pharmaceuticals Inc
sell a cholesterol drug Amgen Inc has been
trying to block on patent infringement grounds, according to
lawyers and analysts who attended oral arguments in the case.
Paul Clement, a lawyer for Regeneron and Sanofi, urged the
U.S. Court of Appeals for the Federal Circuit to reverse a lower
court order that would ban sales of their jointly developed drug
Praluent for 12 years because it infringed patents owned by
Amgen Inc, which makes a competing drug, Repatha.
Clement asked the court to invalidate Amgen's patents
because they improperly claim a broad monopoly on an entire
category of antibodies, known as PCSK9 inhibitors, that lower
"bad" cholesterol levels.
Amgen's lawyer, Daryl Joseffer, argued the injunction was
the only fair outcome in the dispute after a jury upheld the
validity of Amgen's patents. He also said Amgen's patents
reflect true innovations that resulted from a $2 billion
investment in research and development.
Zachary Silbersher, a patent lawyer at Kroub, Silbersher &
Kolmykov who is not involved in the case, said the three judges'
questions frequently put Jossefer on the defensive and suggest
that they may be "leaning a little toward Regeneron."
Silbersher noted that much of the argument focused on
whether the trial judge unfairly handicapped Regeneron and
Sanofi by blocking them from presenting certain evidence during
the jury trial. That line of questioning suggests the Federal
Circuit could order a do-over trial in the case, he said.
Umer Raffat, an analyst at the investment banking advisory
firm Evercore ISI, agreed the case is "leaning more toward
Regeneron" but added that it was "impossible to call with high
PCSK9 inhibitors like Repatha and Praluent have been shown
to dramatically lower "bad" LDL cholesterol and are expected to
generate billions in sales. The U.S. Food and Drug
Administration approved both drugs in 2015.
Amgen sued Paris-based Sanofi and Tarrytown, New York-based
Regeneron in 2014. A federal jury in Delaware upheld the
validity of Amgen's patents in March 2016, prompting U.S.
District Judge Sue Robinson to hand down an injunction blocking
Praluent sales for 12 years.
The sales ban was stayed pending Regeneron and Sanofi's
(Reporting by Jan Wolfe; Editing by Dan Grebler)