Viatris generic hypertension drug does not violate J&J patents, US court says

J&J sued over Viatris generic of cardiovascular drug Veletri Viatris defeats infringement allegations after appeals court revived case By Blake Brittain March 15 (Reuters) - Generic drugmaker Viatris (VTRS.O) has convinced a federal judge in West Virginia that its proposed generic version of a Johnson & Johnson (JNJ.N) unit’s cardiovascular drug Veletri would not infringe J&J’s patents, according to a decision made public on Friday. U.S. District Judge John Bailey agreed with Viatris’ Mylan Pharmaceuticals that its generic of Veletri would not include a patented element of the name-brand drug made by J&J subsidiary Actelion Pharmaceuticals, clearing a hurdle for the release of Viatris’ proposed drug. The ruling follows a U.S. appeals court’s decision to revive the case last year after finding that Bailey may have misinterpreted key parts of J&J’s patents. Representatives for J&J and Viatris did not immediately respond to requests for comment on the decision. Actelion’s hypertension drug Veletri was approved by the U.S. Food and Drug Administration in 2010. J&J acquired Switzerland-based Actelion in 2017 for $30 billion. J&J filed the lawsuit in 2020 after Viatris applied to make a generic version of Veletri. The companies agreed to a final judgment for J&J in 2022 after Bailey found that the solution of the active ingredient in Viatris’ generic, like J&J’s patented solution, had a pH of 13 or higher. The U.S. Court of Appeals for the Federal Circuit reinstated the case last year after finding that Bailey should have considered outside evidence to determine whether “13” meant a range between 12.5 and 13.4, like J&J proposed, or 13 more precisely, as Viatris argued. On remand, Bailey agreed with Viatris that its generic would not have a pH of 13 or higher and did not infringe J&J’s patents. Bailey also said that J&J’s proposed interpretation of its patents would render them invalid. The case is Actelion Pharmaceuticals Ltd v. Mylan Pharmaceuticals Inc, U.S. District Court for the Northern District of West Virginia, No. 1:20-cv-00110. For J&J: Jason Sheasby and Lisa Glasser of Irell & Manella For Viatris: Deepro Mukerjee, Lance Soderstrom and Jitty Malik of Katten Muchin Rosenman Read more: Viatris US court win reopens path to generic of J&J hypertension drug