Mylan, Impax Win Ruling in Doryx Generics Patent Case

Mylan Inc. said it began selling a generic version of the antibiotic Doryx today after a judge ruled it didn’t infringe a patent held by Warner Chilcott Plc.

Mylan, based in Canonsburg, Pennsylvania, won a ruling in federal court in Newark, New Jersey, where U.S. District Judge William Martini lifted his Feb. 8 order barring the company from offering a generic version of Doryx in 150-milligram delayed-release tablets. The drug had $264 million in sales for 2011, according to figures of research firm IMS Health Inc. cited in a Mylan statement.

The judge also ruled that Impax Laboratories Inc. didn’t infringe the Warner Chilcott patent. Both Mylan and Hayward, California-based Impax applied to the U.S. Food and Drug Administration to market generic versions of Doryx. Mylan won FDA approval and put sales on hold until today’s ruling.

Warner Chilcott, based in Dublin, sued in an effort to block generic competition until its patent expires in 2022. After a seven-day trial in February involving three lawsuits, Martini ruled that Warner Chilcott failed to prove infringement. He also said that Mylan and Impax failed to prove the patent was obvious and invalid.

“The company is reviewing the court’s decision, and intends to appeal the non-infringement determinations,” Warner Chilcott said in a statement.

Because of the ruling, Warner Chilcott will record an impairment charge of $90 million to $108 million, which will “materially reduce” the company’s net income for 2012, the statement said. Warner Chilcott will issue a new financial forecast when it releases its first-quarter results on May 4.

The cases are Warner Chilcott v. Impax, 08-cv-6304; Warner Chilcott v. Mylan, 09-cv-2073; Warner Chilcott v. Impax, 09-cv-1233; U.S. District Court, District of New Jersey (Newark).