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Appeals Claim Construction Generic Drugs

Cooley LLP

Janssen v. Teva: Federal Circuit Upholds Claims to Pharmaceutical Dosing Regimen, Clarifies Presumption of Obviousness for...

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On July 8, the US Court of Appeals for the Federal Circuit issued a precedential opinion in Janssen Pharmaceuticals, Inc. et al. v. Teva Pharmaceuticals USA, Inc. affirming the district court’s finding that patent claims to a...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases: Janssen Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc.

Janssen Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc., Appeal Nos. 2025-1228, -1252 (Fed. Cir. July 8, 2025) Our Case of the Week focuses on obviousness. More particularly, the decision included a lengthy...more

Knobbe Martens

Hard to Stomach: Things You Say to Prosecute a Patent Can and Will Be Used Against You

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AZURITY PHARMACEUTICALS, INC. v. ALKEM LABORATORIES LTD. Before Murphy, Moore, and Chen. Appeal from the United States District Court for the District of Delaware. Arguments and amendments made during prosecution of a parent...more

MoFo Life Sciences

In Patent Prosecution, You Have the Right to Remain Silent. Anything You Say Can and Will Be Used Against You in the Court of Law

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While a Miranda warning isn’t given prior to starting substantive examination, perhaps it should be. In Azurity Pharmaceuticals, Inc. v. Alkem Laboratories, Ltd., a precedential decision issued on April 8, 2025, the Federal...more

Alston & Bird

Patent Case Summaries | Week Ending April 11, 2025

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Azurity Pharmaceuticals, Inc. v. Alkem Laboratories Ltd., No. 2023-1977 (Fed. Cir. (D. Del.) Apr. 8, 2025). Opinion by Murphy (sitting by designation), joined by Moore and Chen. Azurity owns a patent directed to non-sterile...more

McDermott Will & Schulte

Prosecution Disclaimer Alive and Well, Especially in Closed Claim

The US Court of Appeals for the Federal Circuit affirmed a district court’s noninfringement determination, finding that the presence of a disclaimed compound in the accused product precluded infringement. Azurity Pharm., Inc....more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases: Azurity Pharmaceuticals, Inc. v. Alkem Laboratories Ltd.

Azurity Pharmaceuticals, Inc. v. Alkem Laboratories Ltd., Appeal No. 2023-1977 (Fed. Cir. Apr. 8, 2025) In our Case of the Week, the Federal Circuit affirmed that defendant Alkem’s proposed generic antibiotic did not...more

Irwin IP LLP

Federal Circuit Finds Loophole Allowing Patents To Cover Later Developed Technologies

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In re Entresto, 125 F.4th 1090 (Fed. Cir. 2025) - After Novartis’ patent on the blockbuster blood pressure medication Entresto was found invalid at the district court for covering technology that was developed after the...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases: Actavis Labs. FL, Inc. v. United States

Actavis Labs. FL, Inc. v. United States, Appeal No. 2023-1320 (Fed. Cir. Mar. 21, 2025) Our Case of the Week, in the words of its author, Circuit Judge Stark, “is not actually a patent case. It is, instead, a tax case.” In...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - November 2020 #2

Valeant Pharmaceuticals North America LLC v. Mylan Pharmaceuticals Inc., Appeal No. 2019-2402 (Fed. Cir. Nov. 5, 2020) - In our Case of the Week, the Federal Circuit addressed a lingering question about venue following the...more

Knobbe Martens

The Definition of “Half-Liquid” Is Only Half Baked

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IBSA INSTITUT BIOCHIMIQUE, S.A. V. TEVA PHARMACEUTICALS USA, INC. Before Prost, Reyna, and Hughes. Appeal from the District Court of Delaware - Summary: A term may be indefinite when the proposed construction is not...more

McDermott Will & Schulte

Definiteness, Drug Labels and Diclofenac, Oh My

McDermott Will & Schulte on

The US Court of Appeals for the Federal Circuit affirmed a district court’s invalidity and infringement judgments for patents directed to a topical nonsteroidal anti-inflammatory drug, finding that a patent claim reciting a...more

McDermott Will & Schulte

When Is “Wherein” Clause Limiting? When It’s Material to Patentability

The US Court of Appeals for the Federal Circuit affirmed a district court’s finding, based largely on the prosecution history, that disputed “wherein” clauses were limiting and therefore the grant of a preliminary injunction...more

McDermott Will & Schulte

Clear Disavowal in Specification Can’t Be Remedied by Non-Material Change in Claims

Addressing an appeal from four related actions concerning Orange Book patents covering Suboxone® sublingual film, the US Court of Appeals for the Federal Circuit affirmed the district court’s judgments that certain generic...more

Knobbe Martens

Federal Circuit Review - May 2018

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Priority Claims Cannot Be Incorporated by Reference - In Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Limited, Appeal Nos. 2016-2707 and 2016-2708, the Federal Circuit held that when a patent for a...more

Knobbe Martens

Sumitomo Dainippon Pharma Co. v. Emcure Pharmaceuticals

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Before Moore, Mayer, and Stoll. Appeal from the United States District Court for the District of New Jersey. Summary: Plain claim language will not be narrowed based on a patent’s specification unless the patentee clearly...more

Knobbe Martens

Federal Circuit Review - March 2018

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Distribution Agreements Can Constitute Offers for Sale Under Section 102(b) - In The Medicines Company v. Hospira, Inc., Appeal Nos. 2014-1469, 2014-1504, the Federal Circuit held that a distribution agreement qualified as...more

Holland & Knight LLP

Reverse-Payment Plaintiffs Mine Patent Litigation Record to Survive Summary Judgment

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We pointed out in a recent article that, based on recent decisions by the Courts of Appeals for the First and Third Circuits, private antitrust plaintiffs seeking damages from so-called “reverse-payment” settlement agreements...more

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