Biosimilars Get Their Day in Court

Paul A. Calvo, Ph.D. was quoted in this The National Law Journal article discussing the decision by The U.S. Court of Appeals for the Federal Circuit to review the regulatory path for creating generic versions of biologic drugs. On Wednesday, September 10th The Federal Circuit will hear a suit by Sandoz Inc., which wants to make a generic version of Amgen Inc.’s arthritis drug Enbrel.

Mr. Calvo predicts that Sandoz will face an uphill battle at the Federal Circuit because Congress set out such a detailed framework for biosimilar approval. But the Federal Circuit is not the only avenue for Sandoz according to Mr. Calvo who said “”there’s nothing barring them from seeking an inter partes review.”” According to Mr. Calvo only one thing is certain “”the patents are going to be litigated. That’s as certain as the sun coming up tomorrow.””

To view the full article, please visit The National Law Journal’s website.