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Patent Infringement Orange Book Today's Popular Updates

Fish & Richardson

Recent Decisions and FTC Challenges Dictate Caution When Listing Patents in the Orange Book

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In October 2023, Teva Pharmaceuticals filed a patent infringement lawsuit against Amneal Pharmaceuticals alleging that their generic version of Teva’s ProAir® HFA inhaler infringed upon the asserted claims of U.S. Patent Nos....more

Fish & Richardson

The Most Interesting Appellate Cases of 2024

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Appellate courts issued a variety of notable intellectual property (IP) cases in 2024, including cases touching on Orange Book listings, extraterritoriality, willful infringement, design patent obviousness, and public...more

Jones Day

FTC Weighs In on Orange Book Listing of Drug-Device Patents

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On March 22, 2024, the Federal Trade Commission ("FTC") filed an amicus brief in Teva Branded Pharmaceutical Products R&D, et al. v. Amneal Pharmaceuticals of New York, LLC, et al., 2:23-cv-20964, U.S. District Court for the...more

Fish & Richardson

District of Delaware Finds Non-Orange Book-Listed Patents Subject to the Same Pleading Standard as Listed Patents in ANDA...

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As part of the Hatch-Waxman Act, given the lack of information on the allegedly infringing product, courts have found that patentees can satisfy the pleading requirements of Twombly/Iqbal without having access to the accused...more

Hogan Lovells

Labeling carve-out does not shield generic drug makers from induced infringement claims, CAFC rules

Hogan Lovells on

The U.S. Court of Appeals for the Federal Circuit (CAFC) recently decided (2-1) in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc. that a labeling carve-out by a generic drug sponsor did not preclude a finding of...more

Patterson Belknap Webb & Tyler LLP

Claims Against Sanofi for Improper Orange Book Listings and Sham Litigation Dismissed

On January 10, 2018, in In re Lantus Direct Purchaser Antitrust Litig., the District Court for the District of Massachusetts dismissed the antitrust case against Sanofi-Aventis U.S. LLC (“Sanofi”), the manufacturer of Lantus...more

Morrison & Foerster LLP

The European Court of Justice on Enforcement of FRAND Patents: Huawei v. ZTE

The European Court of Justice (ECJ) rendered its highly anticipated ruling in Huawei v. ZTE on the enforcement of standard essential patents (SEPs) which are subject to a FRAND commitment. SEPs play a significant role in the...more

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