Tag Archives: Amgen

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

Posted on May 22, 2023 by Warren Woessner

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 →

Posted in Enablement | Tagged Amgen, Ariad, Enablement, s. 112 | Leave a comment

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

Posted on May 27, 2021 by Warren Woessner

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 →

Posted in Anticipation | Tagged Amgen, anticipation, Federal Circuit, novelty | Leave a comment

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

Posted on October 12, 2020 by Warren Woessner

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 →

Posted in Anticipation | Tagged Amgen, anticipation | Leave a comment

Novartis Wins Landmark Biosimilar Approval

Posted on March 9, 2015 by Warren Woessner

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 →