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Patents Hatch-Waxman Appeals

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

McDermott Will & Emery

Prosecution Disclaimer Alive and Well, Especially in Closed Claim

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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

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

Hatch-Waxman Requires Patent Term Extension for Reissued Patents To Be Based on Original Patent

The Federal Circuit held in Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., 23-2254 that a reissued patent receives patent term extension (PTE) based on the issue date of the original patent, not the reissue patent,...more

Irwin IP LLP

Federal Circuit Finds Against Generics Where Hatch-Waxman's Full Five-Year Extension Fixes Delay For Pharmaceutical FDA-Review  

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Merck Sharp & Dohm B.V. v. Aurobindo Pharma USA, Inc. et al (Fed. Cir. March 13, 2025) - The Hatch-Waxman Act seeks to strike a balance in the pharmaceutical industry by incentivizing drugs makers to develop innovative...more

McDermott Will & Emery

What’s the (Re)issue? Patent Term Extensions for Reissue Patents

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Addressing the calculation of patent term extensions (PTEs) under the Hatch-Waxman Act, the US Court of Appeals for the Federal Circuit affirmed a district court decision that under the act the issue date of the original...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

McDonnell Boehnen Hulbert & Berghoff LLP

Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc. (Fed. Cir. 2025)

Early last year, Aurobindo, one of the Defendants* in ANDA litigation against Merck, advanced the proposition that in cases where a patent had been reissued patent term extension ("PTE") under 35 U.S.C. § 156 should be...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Federal Circuit: Reissue Patents Get PTE Based on the Original Patent’s Issue Date

On March 13, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed a five-year patent term extension (“PTE”) for Merck’s sugammadex patent, holding that the district court had correctly calculated PTE based on the...more

McDonnell Boehnen Hulbert & Berghoff LLP

Aurobindo v. Merck Sharp and Dohme -- Oral Argument

The Federal Circuit heard oral argument in Auribundo's appeal of the district court's decision in favor of plaintiff Merck, in a case captioned In re Sugammadex (alternatively, Aurobindo v. Merck Sharp and Dohme). The issue...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - December 2024 #3

CloudofChange, LLC v. NCR Corp., Appeal No. 2023-1111 (Fed. Cir. Dec. 18, 2024) In our Case of the Week, the Federal Circuit addressed the question of divided infringement in the context of system claims. In its...more

McDermott Will & Emery

The Devil Is in the Details: Bioequivalence, In Vitro Testing Not Enough to Establish Infringement

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Addressing for the first time the issue of whether bioequivalence data and in vitro testing can show that an abbreviated new drug application (ANDA) product with different immediate and delayed release portions infringed on a...more

A&O Shearman

New Jersey District Court Orders Delisting Of Teva Inhaler Patents From The Orange Book

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On June 10, 2024, Judge Stanley R. Chesler of the United States District Court for the District of New Jersey granted the Amneal defendants’ motion for partial judgment on their counterclaims in a Hatch-Waxman dispute, and...more

Sheppard Mullin Richter & Hampton LLP

Federal Circuit Upholds Rifaximin Patent Rulings, Affirms ANDA Approval Restrictions

In Salix Pharmaceuticals, Ltd. v. Norwich Pharmaceuticals, Inc. 2023-1952 (Fed. Cir. April 11, 2024), this case involves appellate review of a district court’s findings regarding patent obviousness and infringement in...more

A&O Shearman

Federal Circuit affirms district court finding of no induced or contributory infringement of generic depression drug

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In H. Lundbeck A-S v. Lupin Ltd., Case No. 2022-1194 (Fed. Circ. December 7, 2023), Plaintiffs, H. Lundbeck A/S (“Lundbeck”) and Takeda Pharmaceutical Company Ltd., Takeda Pharmaceuticals U.S.A., Inc., Takeda Pharmaceuticals...more

McDermott Will & Emery

If the Label Is Skinny Enough – No Inducement Under Hatch-Waxman

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The US Court of Appeals for the Federal Circuit made explicit what has long been considered implicit based on Warner-Lambert and its progeny, namely, that plaintiffs asserting an induced infringement theory to bar the entry...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - July 2023 #4

United Therapeutics Corporation v. Liquidia Technologies, Inc., Appeal Nos. 2022-2217, 2023-1021 (Fed. Cir. July 24, 2023) In the Federal Circuit’s only precedential patent case this week, the Court considered questions...more

McDermott Will & Emery

File Like an Eagle: ANDA pH Specification Rules Infringement Inquiry

The US Court of Appeals for the Federal Circuit affirmed a district court’s finding of noninfringement in a Hatch-Waxman case under 35 U.S.C. § 271(e)(2) and § 271(a)-(b). The Court found that the alleged infringer’s...more

McDermott Will & Emery

Heightened Written Description Standard for Negative Limitations?

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Addressing the issue of negative claim limitations, the US Court of Appeals for the Federal Circuit granted a petition for panel rehearing, vacated its prior decision (authored by now-retired Judge O’Malley) and reversed the...more

McDermott Will & Emery

Federal Circuit Clarifies Venue in Hatch-Waxman Case

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Addressing venue in the context of a Hatch-Waxman case, the US Court of Appeals for the Federal Circuit explained that sending a paragraph IV notice letter to a company in the district is insufficient to establish venue....more

McDermott Will & Emery

The Skinny Label That Wasn’t—Federal Circuit Reinstates Induced Infringement Verdict

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The US Court of Appeals for the Federal Circuit vacated the district court’s grant of judgment as a matter of law (JMOL) of non-infringement where substantial evidence supported the jury’s verdict of induced infringement by...more

Schwabe, Williamson & Wyatt PC

‎Latest Federal Court Cases - August 2021 #2

Our Case of the Week this week is a re-write of our Case of the Week on October 5, 2020. The case involves a drug that could be used for multiple therapeutic purposes. A patent covered use of the product for a specific...more

McDermott Will & Emery

The Future of Skinny Labeling in Patent Litigation Will be Reconsidered

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The US Court of Appeals for the Federal Circuit has now vacated its prior ruling finding induced infringement based on so-called skinny labeling on a pharmaceutical product. GlaxoSmithKline LLC v. Teva Pharmaceuticals USA...more

McDermott Will & Emery

Special Report - 2020 IP Law Year in Review: Patents

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In 2020, the US Supreme Court and Court of Appeals for the Federal Circuit continued to refine key aspects of intellectual property law on issues that will have an impact on litigation, patent prosecution and business...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

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