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Pharmaceutical Patents Healthcare Patent Infringement

Jones Day

Bill Seeks to Restrict 30-Month Stay in Hatch-Waxman Litigation to One Patent

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Senate Bill S. 4878 seeks to force innovator pharmaceutical companies to select a single Orange Book listed patent for the 30-month stay. ...more

Carlton Fields

Court Finds MSN Does Not Infringe Novartis’s Patent and Clears the Way for Generic Entresto

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In In re Entresto (Sacubitril/Valsartan) Patent Litigation, Judge Richard G. Andrews of the U.S. District Court for the District of Delaware granted MSN Pharmaceuticals Inc. a victory on noninfringement of U.S. Patent No....more

Venable LLP

Amgen Files Three New Prolia® / Xgeva® BPCIA Litigations Against Hikma, Shanghai Henlius Biotech, and Biocon’s Proposed...

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On June 25, 2025, Amgen filed its sixth and seventh BPCIA lawsuits against proposed biosimilars of Prolia® / Xgeva® (denosumab), Case No. 1:25-cv-12152 (D.N.J.) against Hikma and Gedeon Richter’s RGB-14 and Case No....more

Foley & Lardner LLP

GLP-1 Receptor Agonists: Drug Litigation Overview and Trends

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The recent uptick and rise in popularity of GLP-1 drugs for addressing weight loss and obesity has led to an increase in U.S. litigation involving this class of drugs. Over the past few years, litigation has focused on a wide...more

Smart & Biggar

SCC to revisit “method of medical treatment” patent claims

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This spring, the Supreme Court of Canada (SCC) will consider the scope of patentable subject-matter as it relates to “methods of medical treatment”....more

Robins Kaplan LLP

ANDA Litigation Settlements - Winter 2024

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This chart summarizes the case name, drug, patents-in-suit, and publicly available terms for reported settlements in federal district court cases that are filed pursuant to the Hatch-Waxman Act....more

Robins Kaplan LLP

Silvergate Pharms., Inc. v. Bionpharma Inc.

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Epaned® (enalapril maleate) - Case Name: Silvergate Pharms., Inc. v. Bionpharma Inc., Civ. Nos. 18-cv-1962, 19-cv-1067, 2024 WL 4417104 (D. Del. Oct. 4, 2024) (Goldberg, J.)  Drug Product and Patent(s)-in-Suit: Epaned®...more

Robins Kaplan LLP

Melinta Therapeutics, LLC v. Nexus Pharms., Inc.

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Minocin® (minocycline) - Case Name: Melinta Therapeutics, LLC v. Nexus Pharms., Inc., Civ. No. 21-2636, 2024 WL 4799896 (N.D. Ill. Nov. 15, 2024) (Kness, J.)  Drug Product and Patent(s)-in-Suit: Minocin® (minocycline);...more

Robins Kaplan LLP

Janssen Pharms., Inc. v. Teva Pharms. USA, Inc.

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Invega Sustenna® (paliperidone palmitate) - Case Name: Janssen Pharms., Inc. v. Teva Pharms. USA, Inc., Civ. Nos. 18-734, 19-16484, 2024 WL 5135666 (D.N.J. Dec. 17, 2024) (Cecchi, J.)  Drug Product and Patent(s)-in-Suit:...more

Robins Kaplan LLP

Novartis Pharms. Corp. v. MSN Pharms., Inc.

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Entresto® (valsartan/sacubitril) - Case Name: Novartis Pharms. Corp. v. MSN Pharms., Inc., Nos. 2024-2211, 2024-2212, 2024 WL 4969281 (Fed. Cir. Dec. 4, 2024) (Circuit Judges Lourie, Prost, and Reyna presiding; Opinion by...more

Robins Kaplan LLP

Galderma Labs., L.P. v. Lupin Inc.

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Oracea® (doxycycline USP) - Case Name: Galderma Labs., L.P. v. Lupin Inc., No. 2024-1664, 2024 WL 4998071 (Fed. Cir. Dec. 6, 2024) (Circuit Judges Moore, Linn, and Prost presiding; Opinion by Moore, C.J.) (Appeal from D....more

Robins Kaplan LLP

Teva Branded Pharm. Products R&D, Inc. v. Amneal Pharms. of NY, LLC

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ProAir® HFA (albuterol sulfate) - Case Name: Teva Branded Pharm. Products R&D, Inc. v. Amneal Pharms. of NY, LLC, No. 2024-1936, 2024 WL 5176737 (Fed. Cir. Dec. 20, 2024) (Circuit Judges Prost, Taranto, and Hughes...more

DLA Piper

Case-Narrowing Decisions are a One-Way Street: Reviewing Exeltis USA v. Lupin Ltd.

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Exeltis USA, Inc. and other parties (Exeltis) recently prevailed against Lupin Ltd. and Lupin Pharmaceuticals, Inc. (Lupin) in a patent infringement suit brought in the District of Delaware. After a three-day bench trial, the...more

Robins Kaplan LLP

Allergan Holdings Unlimited Co. v. MSN Labs. Private Ltd. - Viberzi® (eluxadoline)

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Case Name: Allergan Holdings Unlimited Co. v. MSN Labs. Private Ltd., Civ. No. 23-794-RGA, 2024 WL 3444368 (D. Del. July 17, 2024) (Andrews, J.)....more

Robins Kaplan LLP

Otsuka Pharm. Co., Ltd. v. Lupin Ltd. - Jynarque® (tolvaptan)

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Case Name: Otsuka Pharm. Co., Ltd. v. Lupin Ltd., Civ. No. 21-900-RGA, 2024 WL 3618123 (D. Del. July 31, 2024) (Andrews, J.)....more

Robins Kaplan LLP

Pacira Pharms., Inc. v. eVenus Pharms. Labs., Inc. - Exparel® (bupivacaine)

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Case Name: Pacira Pharms., Inc. v. eVenus Pharms. Labs., Inc., Civ. No. 21-19829, 2024 WL 3812188 (D.N.J. Aug. 9, 2024) (Arleo, J.)....more

Robins Kaplan LLP

Novartis Pharms. Corp. v. MSN Pharms. Inc. - Entresto® (sacubitril/valsartan)

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Case Name: Novartis Pharms. Corp. v. MSN Pharms. Inc., Civ. No. 20-MD-2930-RGA, 2024 WL 3756787 (D. Del. Aug. 12, 2024)....more

Robins Kaplan LLP

Novartis Pharms. Corp. v. Hetero USA Inc. - Entresto® (sacubitril/valsartan)

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Case Name: Novartis Pharms. Corp. v. Hetero USA Inc., Civ. No. 20-md-2930-RGA, 2024 WL 3757086 (D. Del. Aug. 12, 2024)....more

Robins Kaplan LLP

Novartis Pharms. Corp. v. Becerra - Entresto® (sacubitril/valsartan)

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Case Name: Novartis Pharms. Corp. v. Becerra, No. 24-CV-02234 (DLF), 2024 WL 3823270 (D.D.C. Aug. 13, 2024) (Friedrich, J.)....more

Robins Kaplan LLP

Teva Branded Pharm. Products R&D, Inc. v. Deva Holding A.S. - ProAir® HFA (albuterol sulfate)

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Case Name: Teva Branded Pharm. Products R&D, Inc. v. Deva Holding A.S., Civ. No. 24-4404 (SRC), 2024 WL 3966314 (D.N.J. Aug. 28, 2024) (Chesler, J.)....more

A&O Shearman

District Court Denies Regeneron’s Motion For Preliminary Injunction To Block Amgen’s Eylea Biosimilar

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On September 23, 2024, Judge Kleeh of the Northern District of West Virginia denied Regeneron Pharmaceuticals, Inc.’s (“Regeneron”) motion for a preliminary injunction against Amgen Inc. (“Amgen”) related to Amgen’s filing of...more

Robins Kaplan LLP

Generically Speaking: A Hatch-Waxman Litigation Bulletin Second Quarter - New ANDA Cases

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This chart summarizes the case name, presiding judge, drug, and patents-at-issue in all federal district court cases that are filed pursuant to the Hatch-Waxman Act. It also includes the same information for proceedings...more

Robins Kaplan LLP

Generically Speaking: A Hatch-Waxman Litigation Bulletin Second Quarter - Generic Launches

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This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications....more

Robins Kaplan LLP

Generically Speaking: A Hatch-Waxman Litigation Bulletin Second Quarter - ANDA Litigation Settlements

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This chart summarizes the case name, drug, patents-in-suit, and publicly available terms for reported settlements in federal district court cases that are filed pursuant to the Hatch-Waxman Act....more

Robins Kaplan LLP

Generically Speaking - Summer 2024

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This chart tracks the date, drug, reference-listed company, and applicant of Abbreviated New Drug Applications and 505(b)(2) Applications receiving final approval by the FDA....more

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