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Preliminary Injunctions Pharmaceutical Industry

Jenner & Block

A Secured Reversal of Preliminary Injunction in High-Stakes Pharmaceutical Battle

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In a significant victory for pharmaceutical competition and access to generic drugs, Jenner & Block secured a key litigation win on behalf of client MSN Pharmaceuticals. A federal judge denied a pharmaceutical company’s...more

Knobbe Martens

A Patent Does Not Guarantee the Patent Owner Will Be First to Market

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INCYTE CORPORATION V. SUN PHARMACEUTICAL INDUSTRIES, LTD. - Before Moore, Prost and Hughes. Appeal from the United States District Court for the District of New Jersey. A district court erred in issuing a preliminary...more

Goodwin

Recent PTAB Developments for Regeneron’s Aflibercept Formulation Patent

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Earlier this month, a Patent Trial and Appeal Board (“PTAB”) panel denied institution of two petitions that were filed separately by Samsung Bioepis (IPR2025-00176) and Formycon (IPR2025-00233) for inter partes review (“IPR”)...more

McDermott Will & Emery

This Week in 340B: June 3 – 9, 2025

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Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

McDonnell Boehnen Hulbert & Berghoff LLP

Treprostinil Saga Continues

United Therapeutics Corp. (UTC) and Liquidia Technologies Inc. have been battling for close to a decade over their respective inhaled formulations of treprostinil (UTC's Tyvaso®, Liquidia's Yutrepia™) for treatment of...more

Sheppard Mullin Richter & Hampton LLP

Biopharmaceutical Patent Litigation: Regeneron’s Defense Against Biosimilar Launches

This case involves an appeal from Regeneron Pharmaceuticals, Inc.’s (Regeneron) efforts to prevent defendants from marketing biosimilar versions of EYLEA®, a drug used to treat eye diseases, by asserting patent infringement....more

McDermott Will & Emery

This Week in 340B: May 13 – 19, 2025

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Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Alston & Bird

Patent Case Summaries | Week Ending May 9, 2025

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Ingenico Inc., et al. v. IOENGINE, LLC, No. 2023-1367 (Fed. Cir. (D. Del.) May 7, 2025). Opinion by Hughes, joined by Dyk and Prost. Ingenico filed a declaratory judgment action against IOENGINE relating to two patents owned...more

Goodwin

District of New Jersey Denies Preliminary Injunction in Ustekinumab Breach of Contract Case

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On April 28, the U.S. District Court for the District of New Jersey denied Janssen Biotech, Inc. (“Janssen”) and Johnson & Johnson’s motion for a preliminary injunction seeking to enjoin Samsung Bioepis Co. Ltd. (“Samsung”)...more

Venable LLP

Regeneron and Biocon Settle Litigation over EYLEA® Biosimilar Yesafili™

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On April 15, 2025, Biocon announced it reached a settlement agreement with Regeneron, dismissing CAFC Appeal No. 24-2002 and Case No. 1:22-cv-00061 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.) and allowing the...more

Hogan Lovells

Court of Appeal hands down reasons for awarding AZ an interim injunction in the UK against Glenmark’s generic dapagliflozin for...

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Just under two weeks ago, we reported the Court of Appeal had awarded AstraZeneca (AZ) a preliminary injunction in the UK against Glenmark’s generic dapagliflozin (dapa) product for type II diabetes, until the hearing...more

Hogan Lovells

UK Court of Appeal grants AstraZeneca an interim injunction against Glenmark’s generic dapagliflozin for type II diabetes

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In a reversal of fortune, yesterday (9 April) the UK Court of Appeal awarded AstraZeneca (AZ) an interim injunction keeping Glenmark’s dapagliflozin (dapa) off the UK market until the form of order hearing in the parallel...more

Troutman Pepper Locke

Trade Dress Disputes Continue To Be a Bitter Pill in Pharma

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A recent federal court decision highlights the delicate balance between U.S. Food and Drug Administration (FDA) guidance and trade dress protections for drugs administered in a tablet or capsule form. Last month, a district...more

A&O Shearman

AstraZeneca refused interim injunction on SPC for blockbuster diabetes treatment against Glenmark but swiftly obtains permission...

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On March 28, 2025, Michael Tappin KC, sitting as a deputy judge of the High Court, refused to grant AstraZeneca (“AZ”) an interim injunction to restrain Glenmark from launching in the U.K. a generic version of its type 2...more

Knobbe Martens

District Court Finds the FDA Reasonably De-listed Eli Lilly’s Weight Loss Drug From Drug Shortage List

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Congress authorized the FDA to determine whether a drug is “in shortage in the United States.” The FDA’s determination of a drug shortage triggers mechanisms designed to alleviate the shortage. For example, a determination of...more

Venable LLP

Federal Circuit Affirms Preliminary Injunction Decisions for EYLEA® Biosimilars

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On March 5, 2025, the Federal Circuit affirmed the grant of a preliminary injunction against the launch of Celltrion’s proposed EYLEA® (aflibercept) biosimilar CT-P42 in CAFC Case Nos. 24-2058 and 24-2147 (appealing from...more

Goodwin

Federal Circuit Affirms Denial of Injunction Against Amgen in Aflibercept BPCIA Litigation

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On March 14, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed the District Court for the Northern District of West Virginia’s denial of a preliminary injunction against Amgen Inc. (“Amgen”) in the ongoing...more

McDonnell Boehnen Hulbert & Berghoff LLP

Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2025)

Completing a recent jurisprudential "hat trick,"* the Federal Circuit affirmed a District Court grant of a preliminary injunction against a biosimilar applicant for Regeneron's EYLEA biologic drug in Regeneron...more

Foley & Lardner LLP

Compounded GLP-1 Drugs: Texas Judge Denies PI Motion and Request for Stay of FDA’s Declaration that Tirzepatide Shortage is...

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On March 5, 2025, one U.S. District Court ruled unequivocally in the Food & Drug Administration’s (FDA) favor in the case, Outsourcing Facilities Ass’n, et. al. v. U.S. Food and Drug Admin., et. al., 4:24-cv-0953-P, slip op.,...more

Wilson Sonsini Goodrich & Rosati

FDA Can Keep Tirzepatide off the Drug Shortage List, Judge Says

On March 5, 2025, the U.S. District Court for the Northern District of Texas denied the Outsourcing Facilities Association’s motion for a preliminary injunction to prevent the U.S. Food and Drug Administration (FDA) from...more

Goodwin

Federal Circuit Affirms Injunction Against Celltrion in Aflibercept BPCIA Litigation

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On March 5, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed the District Court for the Northern District of West Virginia’s entry of a preliminary injunction preventing Celltrion, Inc. (“Celltrion”) from...more

Polsinelli

Personal Jurisdiction Considerations for International Biosimilars Companies

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The Federal Circuit recently issued decisions in a pair of appeals that provide guidance about when international filers of abbreviated Biologics License Applications (aBLAs) are subject to jurisdiction in the United States....more

McDonnell Boehnen Hulbert & Berghoff LLP

Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2025)

Note: This post addresses two Federal Circuit decisions issued on January 29, 2025.  Both appeals involved Plaintiff-Appellee Regeneron Pharmaceuticals, Inc., with the first appeal involving Defendant-Appellant Formycon AG...more

A&O Shearman

Federal Circuit Affirms Finding Of Personal Jurisdiction And Preliminary Injunction Against Biosimilar Applicants

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On January 29, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed the grant of a preliminary injunction by the Northern District of West Virginia in favor of Regeneron Pharmaceuticals, Inc. against Samsung...more

McDermott Will & Emery

Eye-Catching: Biosimilars Injunction Prevails

Addressing a preliminary injunction in patent litigation related to the Biologics Price Competition and Innovation Act (BPCIA), the US Court of Appeals for the Federal Circuit upheld the district court’s grant of a...more

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