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Patents Injunctive Relief Biosimilars

Rothwell, Figg, Ernst & Manbeck, P.C.

District Circuit Denies Novartis’s Request for Injunctive Relief Against MSN’s Generic Version of Entresto®

The District Court for the District of Delaware recently rejected Novartis’s effort to block MSN Pharmaceuticals from launching a generic version of Entresto® (sacubitril/valsartan), its top-selling heart failure medication....more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

2021 PTAB Year in Review: Analysis & Trends

[co-author: Jamie Dohopolski] Love it or hate it, ignore the USPTO Patent Trial and Appeal Board (PTAB) at your peril. The introduction of the PTAB as part of the America Invents Act over ten years ago has forever changed...more

McDonnell Boehnen Hulbert & Berghoff LLP

Amgen v. Sandoz Update -- Supreme Court Seeks Views of United States

In other Supreme Court news from Monday, June 20, 2016, the Court invited the Solicitor General to file briefs in the Sandoz v. Amgen (No. 15-1039) and Amgen v. Sandoz (No. 15-1195) appeals to express the views of the United...more

Patterson Belknap Webb & Tyler LLP

Apotex Accuses Amgen of Sham BPCIA Litigation

Amgen recently sued Apotex under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) over Apotex’s proposed biosimilar of Amgen’s Neulasta (pegfilgrastim), a long-lasting version of Neupogen. This is the first...more

McDonnell Boehnen Hulbert & Berghoff LLP

Amgen v. Sandoz – Did the Federal Circuit Just Doom the New Biosimilar Approval Pathway?

Congress passed the Biologics Price Competition and Innovation Act (“BPCIA”) in 2009 in an effort to bring biosimilar drug products to market. The goal was for the BPCIA to mimic for biologic drugs the Hatch-Waxman statute...more

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