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Patent Litigation Prosecution History Estoppel Pharmaceutical Patents

Knobbe Martens

Federal Circuit Review | July 2025

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In Janssen Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc., Appeal No. 25-1228, The Federal Circuit found that claims reciting a dosing regimen with unequal loading doses were not obvious and that a presumption of...more

Hudnell Law Group

Federal Circuit Rejects Formalistic Shield to Prosecution History Estoppel

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On July 18, 2025, the U.S. Court of Appeals for the Federal Circuit reversed a $106 million jury verdict in Colibri Heart Valve LLC v. Medtronic CoreValve, LLC, No. 2023-2153, finding that Colibri’s infringement claim under...more

Womble Bond Dickinson

Reminder: “Consisting essentially of” Is U.S. Patent Claim Language Needing Interpretation

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On June 30, 2025, the Federal Circuit issued a precedential opinion in Eye Therapies v. Slayback Pharma in which the court interpreted the transition phrase “consisting essentially of” to be a closed term excluding other...more

Proskauer - The Patent Playbook

Eyes Open to the Past: Federal Circuit Holds Prosecution History Is Claim Construction Evidence

The Federal Circuit’s decision in Eye Therapies, LLC v. Slayback Pharma, LLC provides further insight into the tools available for patent claim construction. The Federal Circuit had previously held that a patent’s...more

Akin Gump Strauss Hauer & Feld LLP

Federal Circuit: Statements Made During Prosecution of Parent Application Disavow Claim Scope in Subsequent Patents

The Federal Circuit affirmed a District of Delaware finding of non-infringement in an ANDA litigation due to the patentee’s clear and unmistakable disavowal of claim scope during prosecution. Specifically, the court held that...more

Robins Kaplan LLP

Allergan USA, Inc. v. Sun Pharm. Indus. Ltd.

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Case Name: Allergan USA, Inc. v. Sun Pharm. Indus. Ltd., No. CV 19-1727-RGA, 2022 WL 16921800 (D. Del. Nov. 14, 2022) (Andrews, J.) Drug Product and Patents-in-Suit: Viberzi® (eluxadoline); U.S. Patents Nos. 9,675,587 (“the...more

Robins Kaplan LLP

Almirall, LLC v. Torrent Pharms., Ltd.

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Case Name: Almirall, LLC v. Torrent Pharms., Ltd., Civ. No. 20-1373-LPS (D. Del. July 13, 2021) (Stark, J.) - Drug Product and Patent(s)-in-Suit: Aczone® Gel, 7.5% (Dapsone); U.S. Patent No. 9,517,219 (“the ’219 patent”)...more

McDonnell Boehnen Hulbert & Berghoff LLP

Eli Lilly & Co. v. Apotex, Inc. (Fed. Cir. 2020)

After more than two decades of being the red-headed stepchild of patent infringement before the Federal Circuit, infringement under the doctrine of equivalents has made a dramatic comeback in the past few years, the Court...more

McDonnell Boehnen Hulbert & Berghoff LLP

Supreme Court Denies Another Certiorari Petition on Doctrine of Equivalents

The Federal Circuit during 2019 and 2020 has issued a spate of decisions on the proper application of the Doctrine of Equivalents (see, e.g., UCB, Inc. v. Watson Laboratories Inc. and Galderma Laboratories, L.P. v. Amneal...more

Bradley Arant Boult Cummings LLP

The Dedication-Disclosure Rule: An Effective and Efficient Tool in the Defense Toolbox

The Federal Circuit has affirmed infringement under the doctrine of equivalents in a number of cases over the last few years. Briefly, the judicially created doctrine of equivalents is intended to expose those who adopt the...more

McDonnell Boehnen Hulbert & Berghoff LLP

Eagle Pharmaceuticals Inc. v. Slayback Pharma LLC (Fed. Cir. 2020)

Infringement under the doctrine of equivalents (as a basis of a successful cause of action having renewed vigor before the Federal Circuit recently (see, e.g., "Galderma Laboratories, L.P. v. Amneal Pharmaceuticals LLC") is...more

McDonnell Boehnen Hulbert & Berghoff LLP

DOE Infringers Petition for Certiorari over PHE "Tangential Relationship" Test

Recently, the Federal Circuit has taken up issues relating to infringement under the doctrine of equivalents (DOE) and a related doctrine, prosecution history estoppel (PHE), that limits the scope of equivalents that can be...more

Foley & Lardner LLP

Prosecution History Informs Claim Meaning Even Without Unmistakable Disclaimer

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Although non-precedential, the Federal Circuit decision in Aptalis Pharmatech, Inc. v. Apotex Inc. is worth a read to see how the court “tiptoes” the “fine line between reading a claim in light of the specification, and...more

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