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Patent Litigation Preliminary Injunctions Pharmaceutical Patents

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

A&O Shearman

How to commence main proceedings before the UPC: deadlines and court fees

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Patent holders must start Unified Patent Court (UPC) proceedings on the merits within a certain period if they do not want to risk the revocation of provisional measures. The UPC has now clarified that filing the statement of...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

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

Goodwin

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

Goodwin on

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

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

Goodwin

Federal Circuit Affirms Injunction Against Samsung and Formycon in Aflibercept BPCIA Litigation

Goodwin on

On January 29, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed the District Court for the Northern District of West Virginia’s entries of preliminary injunction preventing Samsung Bioepis Co., Ltd....more

Venable LLP

Federal Circuit Affirms Preliminary Injunctions in EYLEA® Biosimilar Litigations Against Samsung Bioepis and Formycon

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On January 29, 2025, the CAFC issued opinions affirming the preliminary injunctions issued against biosimilars of Regeneron’s EYLEA® (aflibercept): Samsung Bioepis’s Opuviz™ (aflibercept-yszy) (CAFC Case Nos. 24-1965,...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases: Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc.

Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc., Appeal Nos. 2024-1965, -1966, -2082, -2083 (Fed. Cir. Jan. 29, 2025) Our Case of the Week is a 31-page decision that touches on a variety of issues, including...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

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

Personal Jurisdiction Over Foreign Companies that File an ANDA or aBLA in the U.S.

On January 29, 2025, the Federal Circuit issued paired decisions addressing Samsung Bioepis’s (“SB”) and Formycon AG’s (“Formycon”) appeals of preliminary injunctions entered in ongoing aflibercept biosimilar litigations with...more

Venable LLP

Amgen Plans At-Risk Launch of EYLEA® Biosimilar Pavblu™ After Federal Circuit Lifts Temporary Injunction

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On October 22, 2024, the Federal Circuit (CAFC Case No. 24-2351) denied Regeneron’s request for an injunction pending appeal for Amgen’s EYLEA® (aflibercept) biosimilar Pavblu™ (aflibercept-ayyh), concluding that “Regeneron...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

Sheppard Mullin Richter & Hampton LLP

Understanding Preliminary Injunction: A Review of a Recent Federal Circuit Decision

This Federal Circuit opinion addresses a district court’s decision granting plaintiff’s motion for a preliminary injunction. Background - Plaintiff Natera, Inc. (“Natera”) and defendant NeoGenomics Laboratories, Inc....more

Bradley Arant Boult Cummings LLP

Preliminary Injunction Halts Sales of Tumor-Informed Cancer Screening Test

Late last week in Natera, Inc. v. NeoGenomics Laboratories, Inc. (24-1324), the Federal Circuit affirmed a preliminary injunction ruling from the lower court that mostly prohibits NeoGenomics from selling its oncology test...more

Venable LLP

Preliminary Injunctions Issued Preventing Launch of EYLEA® Biosimilars

Venable LLP on

In June 2024, the Court granted preliminary injunctions against the commercial launch of three EYLEA® (aflibercept) biosimilars, Samsung Bioepis’s Opuviz™ (aflibercept-yszy) (Case Nos. 1:23-cv-00094 (N.D.W. Va.),...more

American Conference Institute (ACI)

[Event] Pharma & Biotech Patent Litigation Conference in Europe - May 29th - 30th, Amsterdam, Netherlands

Hosted by C5 Group, the 17th Annual Forum on Pharma & Biotech Patent Litigation in Europe returns for another exciting year with curated programming that will provide up-to-the-minute information and strategic insights on...more

Knobbe Martens

Middle District of North Carolina Grants Preliminary Injunction in Natera, Inc. v. NeoGenomics Laboratories, Inc.

Knobbe Martens on

(December 27, 2023) Natera Inc. succeeded in obtaining a preliminary injunction against NeoGenomics Laboratories, Inc.’s medical assay test. Natera’s ongoing federal lawsuit alleges that NeoGenomics’ product “RaDaR,” a tumor...more

Fish & Richardson

Middle District of North Carolina Finds Public Interest Favors Granting Preliminary Injunction

Fish & Richardson on

On December 27, 2023, Chief Judge Catherine Eagles of the U.S. District Court for the Middle District of North Carolina granted a motion for preliminary injunction by Natera Inc. enjoining NeoGenomics Laboratories Inc. from...more

American Conference Institute (ACI)

[Event] 21st Annual Life Sciences IP Summit - September 27th - 28th, Munich, Germany

Hosted by C5 Group, the 21st Annual Life Sciences IP Summit returns for another exciting year with curated programming with speakers from the pharma, biotech and medical device industries that will provide practical insights...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court - February 2022 #2

Adapt Pharma Operations Limited v. Teva Pharmaceuticals USA, Inc., Appeal No. 2020-2106 (Fed. Cir. Feb. 10, 2022) - In our Case of the Week, the Court of Appeals for the Federal Circuit, in both the majority opinion and...more

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