Merck Wins Ruling to Block Mylan’s Copy of Zetia, Vytorin

Merck & Co. won a U.S. appeals court ruling that will prevent Mylan Inc. from selling a generic version of the Zetia and Vytorin cholesterol medicines before April 2017.

The U.S. Court of Appeals for the Federal Circuit in Washington denied an appeal by Mylan Inc. over the patent for the active ingredient in the drug, ezetimibe. The court posted notice of its decision to affirm a trial judge’s ruling on its website today, two days after it heard arguments.

Together, the drugs had about $2 billion in U.S. sales last year, with Zetia generating $1.33 billion and Vytorin bringing in $764 million, said Ron Rogers, a Merck spokesman. Sales of Vytorin, which combines Zetia with Merck’s Zocor cholesterol pill, have been falling because of questions about its effectiveness.

“The appellate court appropriately upheld the lower court’s ruling in April 2012 that found the patent for Zetia and Vytorin is valid and enforceable,” Rogers said. “We invest heavily in the research and development that is needed to discover innovative medicines like Vytorin and Zetia, and we will vigorously defend our intellectual property rights.”

According to Merck’s third-quarter report, the Whitehouse Station, New Jersey-based company also had sued Impax Laboratories Inc. and Actavis Inc. over their plans to sell generic versions of Vytorin. Those cases were put on hold pending the outcome of the Mylan case, Merck said in the filing.

Patent Concession

Vytorin sold $186 million in the fourth quarter of 2012, compared with $296 million in the same period in 2010 and $319 million in 2009. UnitedHealth Group Inc., the insurer, doubled patients’ co-payments for Vytorin in 2010 after an analysis of 30,000 patients found the drug didn’t work any better than a generic.

Mylan, based in Canonsburg, Pennsylvania, conceded that it infringed the patent, leaving only the issue of whether it was valid and enforceable. Officials with the company didn’t respond to e-mail queries seeking comment.

The case is Merck Sharp & Dohme Corp. v. Mylan Pharmaceuticals Inc., 12-1434, U.S. Court of Appeals for the Federal Circuit (Washington). The lower court case is Schering v. Mylan, 09cv6383, U.S. District Court, District of New Jersey (Newark).