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Federal Circuit says biosimilar applicants can decline patent dance

Michael Loney, New York


The Federal Circuit in Amgen v Sandoz was split two ways, holding biosimilar applicants can opt out of the patent dance provisions but must wait for approval before giving 180 days notice of marketing. Applicants and patent owners now face tricky strategic questions

In a decision seen as favouring biosimilar applicants over so-called reference product sponsors (RPSs), the Federal Circuit has dismissed Amgen’s state law claims against Sandoz related to the first approved biosimilar product. This has cleared the way for Sandoz to...


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