Has Amgen Already Won Its BPCIA Dispute With Sandoz?

By Brian Coggio and Ron Vogel (August 2, 2017, 11:12 AM EDT) -- Based on the U.S. Supreme Court's decision in Sandoz Inc. v. Amgen Inc.,[1] many have concluded that a biosimilar applicant has the "option' to disclose its application and manufacturing information to the research sponsor, but need not do so. While Sandoz apparently had this choice, it may be argued that the court's decision will likely require Sandoz to disclose such information to Amgen. This is because the court held that the "requirement" that a biosimilar "must" provide the sponsor with the former's application and manufacturing information is not enforceable by an injunction under federal law, and nothing more. The action was remanded to the Federal Circuit to decide if Sandoz violated California unfair competition law by failing to disclose its confidential information and whether that statute provides for an injunction requiring such disclosure. This, of course, assumes that federal remedies (which are nonexistent) are not exclusive....

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