News & Analysis as of

Generic Drugs Food and Drug Administration (FDA) Induced Infringement

American Conference Institute (ACI)

[Event] 18th Annual Paragraph IV Disputes - April 19th - 20th, New York, NY

Hosted by ACI, 18th Annual Paragraph IV Disputes Conference returns to New York City for another exciting year with curated programming that not only addresses the hot topics, but also puts them within the context of pre-suit...more

Robins Kaplan LLP

Salix Pharms., Ltd. v. Norwich Pharms., Inc. Xifaxan® (Rifaximin)

Robins Kaplan LLP on

Case Name: Salix Pharms., Ltd. v. Norwich Pharms., Inc., C.A. No. 20-cv-430-RGA, 2022 WL 3225381 (D. Del. Aug. 10, 2022) (Andrews, J.) Drug Product and Patent(s)-in-Suit: Xifaxan® (rifaximin); U.S. Patents Nos. 7,612,199...more

McDermott Will & Emery

Federal Circuit Divided on Whether Skinny Labeling Compliance Precludes Inducement or Supports Equitable Estoppel

McDermott Will & Emery on

The US Court of Appeals for the Federal Circuit denied a generic drug manufacturer’s petition for en banc review of a panel opinion finding induced infringement liability despite the manufacturer’s adherence to skinny...more

Hogan Lovells

Federal Circuit affirms GSK labeling carve-out ruling in favor of innovator

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Earlier this month, in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., a panel of the U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed (2-1) upon rehearing its October 2020 decision that a labeling...more

Proskauer - Life Sciences

GSK v. Teva: Federal Circuit Issues New Opinion Analyzing Induced Infringement

On August 5, 2021, the Federal Circuit withdrew its October 2020 opinion in GSK v. Teva, summarized in this post on induced infringement of method-of-treatment claims, and issued an opinion that reiterated the prior holding...more

Locke Lord LLP

Federal Circuit Hints at Reversed Course on “Skinny Labels”

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On October 2, 2020, the Federal Circuit issued a precedential opinion vacating a district court’s judgment as a matter of law and reinstating a jury verdict finding of induced infringement of a patented use that had been...more

Schwabe, Williamson & Wyatt PC

Fresh From the Bench: Latest Federal Circuit Court Cases

In an ANDA applicant’s appeal from a bench trial judgment of validity and infringement, the Court affirmed the district court’s judgment on all counts. The case presented unusual procedural circumstances in a Hatch-Waxman...more

Robins Kaplan LLP

Takeda Pharms. U.S.A., Inc. v. West-ward Pharm. Corp.

Robins Kaplan LLP on

Case Name: Takeda Pharms. U.S.A., Inc. v. West-ward Pharm. Corp., Civ. No. 14-1268-SLR, 2016 U.S. Dist. LEXIS 65317 (D. Del. May 18, 2016) (Robinson, J.) - Drug Product and Patent(s)-in-Suit: Colcrys® (colchicine); U.S....more

McDermott Will & Emery

Supplier to ANDA Filer Is Not Liable for Induced Infringement Until After ANDA Approval - Shire LLC v. Amneal Pharms., LLC

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Addressing the scope of the safe harbor provision of § 271(e)(1), the U.S. Court of Appeals for the Federal Circuit reversed the district court, holding that supplying an active pharmaceutical ingredient (API) to the filer of...more

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