News & Analysis as of

Injunctions Patent Litigation Pharmaceutical Patents

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

Jazz Pharma. v. Avadel CNS Pharma: Federal Circuit Applies a Fact-Specific Approach to the Patent Infringement Safe Harbor

In a precedential ruling, the U.S. Court of Appeals for the Federal Circuit in Jazz Pharma. v. Avadel CNS Pharma., 2025 WL 1298920, — F.4th — (Fed. Cir. May 6, 2025), addressed the scope of the 35 U.S.C. § 271(e)(1) “safe...more

A&O Shearman

AstraZeneca refused interim injunction on SPC for blockbuster diabetes treatment against Glenmark but swiftly obtains permission...

A&O Shearman on

On March 28, 2025, Michael Tappin KC, sitting as a deputy judge of the High Court, refused to grant AstraZeneca (“AZ”) an interim injunction to restrain Glenmark from launching in the U.K. a generic version of its type 2...more

Smart & Biggar

Federal Court declines to grant injunction for infringement of HUMIRA formulation patent

Smart & Biggar on

On December 4, 2023, the Federal Court issued its public judgment and reasons in two patent infringement actions pursuant to s. 6(1) of the Patented Medicines (Notice of Compliance) Regulations (“Regulations”) and two patent...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - February 2023 #4

Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC, Appeal No. 2023-1186 (Fed. Cir. Feb. 24, 2023) In this week’s Case of the Week, the Federal Circuit affirmed a permanent injunction requiring appellant Jazz...more

Smart & Biggar

Federal Court upholds validity of Janssen’s paliperidone palmitate patent

Smart & Biggar on

On May 5, 2020, Manson J. of the Federal Court issued the second decision on the merits under the amended Patented Medicines (Notice of Compliance Regulations). The Court upheld the validity of Janssen’s patent for...more

Hogan Lovells

Patent law in Europe: What pharmaceutical companies need to know

Hogan Lovells on

Increasing competition within Europe’s pharmaceutical space makes knowing the market and understanding available patent protections more critical than ever for both well established and new market players. Andreas von Falck...more

WilmerHale

Federal Circuit Patent Updates - February 2018

WilmerHale on

Nalco Company v. Chem-Mod, LLC (No. 2017-1036, 2/27/18) (Moore, Schall, O'Malley) - O'Malley, J. Reversing district court's dismissal of patent claims for failure to state a claim. The district court's dismissal of direct...more

McDonnell Boehnen Hulbert & Berghoff LLP

Sandoz' NEUPOGEN® Biosimilar Now on the Market

Sandoz is having a good year. The company succeeded in having their NEUPOGEN® (filgrastrim) biosimilar product, Zarxio™, approved by the FDA in March, a mere ten months after filing its biosimilar application last July. The...more

Polsinelli

First Biosimilar Drug Now Available; Ongoing Legal Dispute Remains

Polsinelli on

The first biosimilar is now available in the United States. Sandoz announced the availability of Zarxio™ (filgrastim-sndz) earlier today, after the Federal Circuit denied Amgen Inc.'s attempt to stall the launch. The launch...more

McDonnell Boehnen Hulbert & Berghoff LLP

Federal Circuit Lifts Injunction Against Sandoz

Sandoz successfully (at least for now) has overcome conventional wisdom, the plain language of the Biologics Price Competition and Innovation Act (BPCIA) (or, at least those provisions regarding patent litigation) and Amgen...more

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