WASHINGTON, April 16 Pharmaceutical company
Actavis Inc said on Tuesday that it would once again
sell a generic version of Bayer AG's Yaz after an
appeals court ruled that Bayer's patent for the oral
contraceptive was invalid.
The U.S. Court of Appeals for the Federal Circuit ruled on
Tuesday that a U.S. District Court in Nevada erred last March in
finding the patent to be valid. It reversed the ruling.
Actavis had launched its generic competitor in January 2012,
but took it off pharmacists' shelves after the ruling in Nevada.
The generic companies involved in the ruling -- Watson
Pharmaceuticals, which now goes by the name Actavis Inc; Sandoz
Inc, which is the generic drug unit of Novartis ; and
Lupin Ltd -- had argued that the patent was invalid
and had told the U.S. Food and Drug Administration that they
planned to sell generic versions of the contraceptive.
Sandoz will continue to ship its generic version of Yaz,
which it began selling in 2011, a company spokeswoman said.
Lupin declined to comment on the decision.
The challenged patent expires on June 30, 2014, the ruling
"We disagree with the court's ruling and are evaluating our
options," Bayer spokeswoman Astrid Kranz said in an email.
Global sales of Bayer's Yasmin and Yaz birth control pills,
which total more than $1 billion annually, have been on the wane
because of potential side effects and competition from cheaper
Yaz is a reformulated version of Yasmin and remains one of
the top-selling contraceptives in the United States. Actavis
said that U.S. sales of Yaz, both branded and generic, were
about $347 million annually.
Bayer's Yasmin brand has been controversial. In 2012, Bayer
agreed to pay a combined $400 million to settle almost one third
of about 6,000 legal claims in the United States that Yasmin
caused blood clots.
In April 2012, the FDA added information to the labels on
Bayer's Yaz and Yasmin, as well as others, to show they may
raise the risk of blood clots.
All common birth control pills increase the chances of
potentially fatal blood clots, but the FDA said the danger may
be greater for more recent pills that contain the synthetic
The cases at the Federal Circuit are: Bayer Healthcare
Pharmaceuticals, Inc. v. Watson Pharmaceuticals Inc. and Sandoz
Inc. (Case Nos. are 2012-1397, -1398, -1400) and Bayer Schering
Pharma AG v. Watson Pharma and Lupin, Ltd. (Case No. 2012-1424.)