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US Judge Upholds Validity Of Merck's Vytorin Patent

04/27/2012 | 06:29pm US/Eastern

--Judge rules U.S. patent for Vytorin and Zetia is valid and enforceable

--Mylan had challenged patent in bid to sell generic Vytorin and Zetia

--Merck patent due to expire in April 2017

(Adds statement from Merck, additional details.)

   By Peter Loftus 

A federal judge has upheld the validity of a U.S. patent covering Merck & Co.'s (>> Merck & Co., Inc.) cholesterol-lowering drugs Vytorin and Zetia, which could stave off competing generic copies for several years.

In an opinion released Friday, U.S. District Judge Jose Linares in federal court in Newark, N.J., said the patent for was valid and enforceable. The patent covers ezetimibe, an active ingredient in both Zetia and Vytorin.

Merck, based in Whitehouse Station, N.J., said the U.S. patent for Vytorin and Zetia is due to expire in April 2017.

"The court appropriately ruled that the patent for Zetia and Vytorin in the U.S. is valid and enforceable," Bruce N. Kuhlik, executive vice president and general counsel of Merck, said in a press release.

Mylan Inc. (MYL) had applied for U.S. Food and Drug Administration approval to sell generic versions of Vytorin and Zetia before the patent expired, arguing that the patent was invalid and unenforceable.

Merck filed a patent-infringement lawsuit against Mylan in late 2009, seeking to block Mylan's plan to sell generic Vytorin, and in 2010 sued to block Mylan from selling generic Zetia. A trial was held in December 2011, leading to Judge Linares's opinion Friday.

Merck said the court also issued an injunction blocking the approval of Mylan's generic versions until the expiration of the patent.

A Mylan spokeswoman couldn't immediately be reached for comment.

Earlier Friday, Merck reported first-quarter Vytorin sales of $444 million and Zetia sales of $614 million.

Merck previously reached a settlement of patent litigation for Zetia with generics manufacturer Glenmark Pharmaceuticals. The pact will allow Glenmark to sell generic Zetia in December 2016, subject to final regulatory approval.

-By Peter Loftus, Dow Jones Newswires; 215-982-5581; peter.loftus@dowjones.com

Stocks mentioned in the article : Merck & Co., Inc.
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