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30 March 2015Americas

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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More on this story

Americas
Amgen antibody patents ‘too broad’, says Fed Circuit
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.
Americas
FDA clears orphan drug backlog
14 September 2017   The Food and Drugs Administration has cleared the backlog of orphan drug designation requests, one month early.
Americas
Apotex ordered to provide 180 days’ biosimilar notice to Amgen
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.

More on this story

Americas
Amgen antibody patents ‘too broad’, says Fed Circuit
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.
Americas
FDA clears orphan drug backlog
14 September 2017   The Food and Drugs Administration has cleared the backlog of orphan drug designation requests, one month early.
Americas
Apotex ordered to provide 180 days’ biosimilar notice to Amgen
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.

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