Pfizer Canada Defeats Neupogen Patent Claims On Obviousness

Company Now Holds NOC For Nivestym Filgrastim Biosimilar

With a biosimilar to Amgen’s Neupogen already on the market in the US, Pfizer has challenged key claims of Amgen’s Canadian drug substance patent, in an attempt to clear a path to market for its Nivestym biosimilar.

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Pfizer Canada has now been issued with an NOC for Nivestym, following setbacks • Source: Shutterstock

Pfizer Canada has confirmed that it has been issued with a Canadian marketing authorization, or Notice of Compliance, for its Nivestym (filgrastim) biosimilar after a Canadian federal court sided with the firm in patent-litigation proceedings with Amgen, owner of the Neupogen original.

Following a trial, five key claims of Amgen’s Canadian filgrastim drug substance patent 1,341,537 were ruled invalid by federal court...

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