Amgen dealt blow as FDA rules 'patent dance' optional
The US Food and Drug Administration (FDA) has denied Amgen’s petition asking that the so-called patent dance between a biosimilar maker and the product’s innovator be a mandatory requirement.
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16 February 2021 The US Court of Appeals for the Federal Circuit has invalidated two Amgen antibody patents, finding that their functional claims were too broad.
15 December 2015 Parties are required to provide 180 days’ notice to a patent owner before marketing a biosimilar version of its drug, a US district court has ruled.