News & Analysis as of

Patent Infringement Clinical Trials

Knobbe Martens

Federal Circuit Review | May 2025

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In Jazz Pharmaceuticals, Inc. v. Avadel Cns Pharmaceuticals, LLC, Appeal No. 24-2274, the Federal Circuit held that injunctions prohibiting the initiation of new clinical trials for paper NDA drugs before patent expiration...more

Fish & Richardson

Federal Circuit Reverses Injunction That Barred Clinical Trials in Jazz v. Avadel

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The Federal Circuit recently considered the scope of a permanent injunction that prohibited a drug manufacturer from conducting certain clinical and regulatory activities in Jazz Pharmaceuticals, Inc. v. Avadel CNS...more

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

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

Foley & Lardner LLP

Cancer Drugs: Antibody-Drug Conjugate Litigation

Foley & Lardner LLP on

Antibody-drug conjugates (ADCs) are typically composed of a monoclonal antibody attached to a cytotoxic drug via a chemical linker. The antibody is able to identify biomarkers on and attach to cancer cells, allowing targeted...more

WilmerHale

Federal Circuit Addresses Scope of Medical Device and Drug Infringement Safe Harbor

WilmerHale on

On March 25, 2024, the Federal Circuit issued an opinion in Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., addressing whether the act of importing two heart valve systems for a medical conference was within the...more

Foley & Lardner LLP

Federal Circuit Applies Safe Harbor to Imported Medical Device Samples

Foley & Lardner LLP on

The “safe harbor” of 35 USC § 271(e)(1) shields certain acts from liability for patent infringement if they are conducted “solely for uses reasonably related” to obtaining U.S. Food and Drug Administration (FDA) approval to...more

TransPerfect Legal

Smart Strategies For Legal Leaders: Insuring Life Sciences

TransPerfect Legal on

On May 10, 2023, I attended the Association for Corporate Counsel (ACC) live CLE event "2023 Life Sciences Conference: Future-Ready Resilience: Preparing to Face Challenges in the Uncertain Future." Eric Long, executive vice...more

Fish & Richardson

Federal Circuit to Consider the Relevance of an Alleged Infringer’s “Intent” in a Hatch-Waxman Safe Harbor Analysis

Fish & Richardson on

The Federal Circuit will consider the relevance of an alleged infringer’s intent in a safe harbor analysis in the appeal of Edwards Lifesciences Corp. v. Meril Life Scis. Pvt.1 The District Court granted summary judgment that...more

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

MarkIt to Market® - September 2022: Watching the Pot™

IP for Psychedelics: Lessons From Biopharma - Following hot on the heels of the cannabis industry is the readily emerging psychedelic industry. Indeed, earlier this month, the Psychedelic Bar Association held its first...more

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

MarkIt to Market® - September 2022

Thank you for reading the September 2022 issue of Sterne Kessler's MarkIt to Market® newsletter. This month, we discuss the how the growing psychedelic industry can learn from the cannabis and biopharma industries regarding...more

Smart & Biggar

Federal Court rejects Apotex’s invalidity allegations on claims for use of abiraterone acetate in combination with prednisone

Smart & Biggar on

On October 29, 2019, the Federal Court issued its final decision under the pre-amended Patented Medicines (Notice of Compliance) Regulations: Janssen Inc v Apotex Inc, 2019 FC 1355. Justice Phelan granted Janssen’s...more

Robins Kaplan LLP

Teva Pharms. USA, Inc. v. Sandoz Inc.

Robins Kaplan LLP on

Case Name: Teva Pharms. USA, Inc. v. Sandoz Inc. (In re Copaxone Consol. Cases), 906 F.3d 1013, Fed. Cir. No. 2017-1575, 2018 U.S. App. LEXIS 28751 (Fed. Cir. Oct. 12, 2018) (Circuit Judges Reyna, Bryson, and Stoll; Opinion...more

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

Worldwide Bolar-type Provisions*

Please see full chart for Bolar Excemption rules in foreign countries regarding Clinical Trials, New Drugs, Biosimilars and Foreign Jurisdiction issues. ...more

Foley & Lardner LLP

Clinical Trials as Prior Art: PTAB Denies Bass IPR Petition With Only a "Hope" of Efficacy

Foley & Lardner LLP on

In the most recent loss for Kyle Bass’ hedge fund in IPR proceedings, the Board denied institution of an IPR based on a petition filed by Coalition for Affordable Drugs V LLC (CFAD) against Biogen MA Inc. IPR2015-01136, Paper...more

Polsinelli

New Judicial Interpretations on Scope of Hatch-Waxman Safe Harbor

Polsinelli on

The Federal Circuit recently provided additional clarity about the scope of the Hatch-Waxman safe harbor. In Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc., the appellate court sharpened the line between...more

McDonnell Boehnen Hulbert & Berghoff LLP

News from Abroad: Research Exemptions and Active Ingredient Manufacture

After a series of papers, reports and consultations on the scope of the research exemptions to patent infringement stretching over 10 years, section 60 of the Patents Act 1977 was finally amended on 1 October 2014 by the...more

Cadwalader, Wickersham & Taft LLP

Federal Circuit Clarifies Standards for a Clinical Trial to Be Public Use

In 2007, Dey L.P., Dey Inc., and their parent company Mylan, Inc. (collectively, "Dey") sued Sunovion Pharmaceutical, Inc. ("Sunovion"; formerly known as Sepracor, Inc.) for infringement of five of Dey's patents....more

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