News & Analysis as of

Pharmaceutical Patents Patents Injunctive Relief

McDermott Will & Emery

Hatch-Waxman or Not, Clinical Trials Aren’t Subject to Injunction

McDermott Will & Emery on

Analyzing the permissible scope of an injunction under the Hatch-Waxman Act, the US Court of Appeals for the Federal Circuit reversed the district court’s prohibitions on an open-label extension (OLE) of a then-running...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases: Pharmaceutical Patent Protections

This week, we take a closer look at two precedential cases concerning pharmaceutical patent protections as applied to drugs in development. In Incyte Corp. v. Sun Pharm., Judge Hughes entered a dissent pushing back on the...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

Knobbe Martens

Federal Circuit Review - May 2018

Knobbe Martens on

Priority Claims Cannot Be Incorporated by Reference - In Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Limited, Appeal Nos. 2016-2707 and 2016-2708, the Federal Circuit held that when a patent for a...more

Knobbe Martens

Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Limited

Knobbe Martens on

Federal Circuit Summaries - Before Prost, Lourie and Hughes. Appeal from the United States District Court for the District of Delaware. Summary: When another patent for a drug issues after an ANDA is filed, there can...more

Hogan Lovells

Hogan Lovells Moscow Life Sciences team secures major win in a precedent patent case for Novartis against a generic producer in...

Hogan Lovells on

Led by partner Natalia Gulyaeva, the Hogan Lovells Moscow team represented Novartis in a precedent case for pharma business proving that one can obtain an injunction using patent rights against a generic in Russia before the...more

Smart & Biggar

Canadian IP law and practice in 2016: reviewing the highlights

Smart & Biggar on

As the calendar turns the page from 2016 to 2017, we take the opportunity to review Canadian IP law and practice highlights from the past year....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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