Tag Archives: Amgen

Supreme Court Voids Amgen’s Patents using “Undue Experimentation” Standard

In Appeal no. 21-257 (May 18, 2023), the Supreme Court affirmed the judgement of the Fed. Cir. by ruling that all of the claims of Amgen’s U.S. Patent nos. 8,829,165 and 8,859, 741 were invalid due to their failure to … Continue reading

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Biogen v. Serano – When is a Recombinant Polypeptide Novel?

When I posted about this Fed. Cir. decision (Biogen MA v. EMD Serano, Appeal no. 2019-1133 (Fed. Cir., Sept. 28, 2020) on October 12, 2020, I viewed it as a straightforward application of the maxim that an otherwise non-novel product … Continue reading

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Biogen v. EMD Serono – “A Nest of Limitations”

By now, other commentators have posted on this Fed. Cir. decision (Appeal no. 2019 -1133, Sept. 28, 2020)—and found it to be a routine reversal of a district court’s relying on “source limitations” to find claims to a recombinant IFN-B … Continue reading

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Novartis Wins Landmark Biosimilar Approval

Novartis Navigates The FDA-ACA Maze – Gets Approval For Generic Neuprogen. Amgen will soon find itself in a price war with Sandoz – a Novartis company – as it tries to maintain its share of the market for Neuprogen (filgraslim). … Continue reading

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