* Sales from patent more than $4 billion annually for Merck
* Patent expires in 2017
* No immediate word if Mylan will appeal decision
WASHINGTON, Feb 7 The patent on Merck & Co's
cholesterol fighters Zetia and Vytorin, two of the
drugmaker's biggest products, is valid, a U.S. appeals court
ruled on Thursday.
Vytorin combines Zocor, a member of the statin family
developed by Merck, with a newer Merck cholesterol treatment
called Zetia. Sales of Vytorin are $1.75 billion while sales of
Zetia used by itself are another $2.6 billion a year.
The U.S. Court of Appeals for the Federal Circuit did not
discuss the ruling at length and simply affirmed a decision by a
lower court in New Jersey.
The U.S. District Court for the District of New Jersey had
ruled in April that the patent on Merck's Zetia and on Vytorin
was valid and issued an injunction blocking approval of a
generic version by Mylan Inc until the patent expires.
The patent expires in April 2017, Merck said.
"We invest heavily in the R&D that is needed to discover
innovative medicines like Vytorin and Zetia, and we will
vigorously defend our intellectual property rights," Merck
spokesman Ron Rogers said in an statement.
Mylan did not immediately respond to requests for comment.
Zocor, which is available as a generic, cuts the liver's
production of "bad" LDL cholesterol while Zetia blocks
absorption of LDL in the intestines. Vytorin, which combines
both in a pill, was approved by U.S. regulators in 2004.
Although Vytorin is a big seller, demand for it has been
hurt by uncertainty whether the combination of drugs lowers risk
of heart attack and stroke any more than using Zocor alone.
A long-term study, involving thousands of patients, is now
under way to answer that question.
The case is Merck Sharp & Dohme Corp. V. Mylan
Pharmaceuticals. The number at the U.S. Court of Appeals for the
Federal Circuit is 2012-1434. The number in the U.S. District
Court for the District of New Jersey is 10-3085.