In the first appellate challenge to a new regulatory path for creating generic versions of biologic medicines derived from living organisms, advocates for Sandoz Inc. and Amgen Inc. on Wednesday faced tough questions from a three-judge panel at the U.S. Court of Appeals for the Federal Circuit.
Sandoz wants to make a copycat version of Amgen’s arthritis and psoriasis drug Enbrel, which had sales last year of $4.1 billion, but is unsure whether doing so will infringe Amgen’s patents.
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