Merck & Co.’s patent for the cholesterol drugs Zetia and Vytorin is valid and enforceable, a federal judge ruled today in a case against Mylan Inc., which sought to sell generic versions of the drugs before the patent expires.
Mylan, the biggest U.S. maker of generic drugs, was sued in 2009 and 2010 over applications to sell the copies before the 2017 expiration date. The patent at issue is RE 42,461 which covers ezetimibe, an active ingredient in both Zetia and Vytorin, Whitehouse Station, New Jersey-based Merck said in an e-mailed stetement.
A federal judge in Newark, New Jersey, issued a court order today blocking approval of Mylan’s generics before expiration of the patent, Merck, the second-largest U.S. drugmaker, said. The injunction couldn’t be confirmed in court filings.
Michael Laffin, a spokesman for Canonsburg, Pennsylvania-based Mylan, didn’t immediately respond to an e-mail message after regular business hours seeking comment on the ruling.
The case is Schering v. Mylan, 09-6383, U.S. District Court, District of New Jersey (Newark).