News & Analysis as of

Preliminary Injunctions Patents Pharmaceutical Industry

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 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

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

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

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

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

Venable LLP

Preliminary Injunctions Issued Preventing Launch of EYLEA® Biosimilars

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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

Goodwin

Preliminary Injunction Issued Against Samsung Bioepis in Aflibercept BPCIA Litigation

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In a sealed order that issued last week, the Court has granted a preliminary injunction against Samsung Bioepis in the aflibercept BPCIA litigation brought by Regeneron. ...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.

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(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

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

WilmerHale

District Court Enjoins California's Unprecedented "Reverse Payment" Law

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On December 8, 2021, a federal district court granted a preliminary injunction temporarily enjoining enforcement of the California state law Preserving Access to Affordable Drugs, which attempts to sanction reverse-payment...more

Goodwin

Federal Circuit Hears Argument Regarding the Denial of Genentech’s Motion to Preliminarily Enjoin Amgen’s Sales of Trastuzumab

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We previously reported on Genentech’s appeal of the district court’s denial of Genentech’s motion for a preliminary injunction against Amgen’s launch of trastuzumab. Today, a Federal Circuit panel (Judges Prost, Wallach, and...more

Kramer Levin Naftalis & Frankel LLP

Biosimilars in 2020: What’s Ahead

The Biologics Price Competition and Innovation Act of 2009 (BPCIA) was passed as part of health reform signed into law by President Obama in March 2010. This year, the BPCIA turns 10. While the U.S. Biosimilars Pathway has...more

Goodwin

Legal Developments to Keep an Eye Out for in 2020

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Here are our picks of some legal developments to keep an eye out for in the new year: Federal Circuit Decisions on Bevacizumab and Trastuzumab Preliminary Injunctions: Appeals are pending on the District of Delaware’s...more

Knobbe Martens

The Sometimes Limiting Effect of "Wherein" Clauses

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ALLERGAN SALES, LLC v. SANDOZ, INC. Before Prost, Newman, and Wallach. Appeal from the United States District Court for the District of New Jersey. Summary: A “wherein” clause can be limiting if it is material to...more

Foley & Lardner LLP

Statements of Efficacy and Safety Material Claim Limitations

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In Allergan Sales, LLC v. Sandoz, Inc., (Fed. Cir. 2018-2207, Aug. 29, 2019), the Federal Circuit held that “wherein” clauses in a patent claim were limitations because the “wherein” elements were material to patentability....more

Goodwin

Sandoz Initiates Declaratory Judgment Action Against Amgen Concerning Manufacturing of Filgrastim and Pegfilgrastim Biosimilars

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On February 21, 2019, Sandoz initiated a lawsuit against Amgen in the Northern District of California seeking a declaration that its biosimilar filgrastim and pegfilgrastim products do not infringe the Amgen’s ’997 patent. ...more

Morrison & Foerster LLP

What Are the Top Hatch-Waxman and BPCIA Developments for November 2018?

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This month we highlight two reversals by the Federal Circuit and a summary judgment of indefiniteness from New Jersey. CASES - Federal Circuit - Grant of Preliminary Injunction Reversed - Indivior Inc. v. Dr....more

McDonnell Boehnen Hulbert & Berghoff LLP

Indivior Inc. v. Dr. Reddy's Laboratories, S.A. (Fed. Cir. 2018)

Having a court grant a preliminary injunction is frequently an important strategic victory for a patent plaintiff in an infringement suit. The injunction not only eliminates a revenue stream for the accused infringer but...more

Morrison & Foerster LLP

What Are the Top Hatch-Waxman and BPCIA Developments for August 2018?

This month we highlight a district court opinion from Judge Dyk, sitting by designation, denying a preliminary injunction in a brand-vs-brand litigation, and a lengthy district court opinion from Judge Bryson, sitting by...more

Goodwin

Judge Sets Preliminary Injunction Briefing Schedule in Genentech v. Sandoz

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We previously reported that on December 21, 2017, Genentech filed suit against Sandoz in the District of New Jersey based on Sandoz’s proposed rituximab biosimilar, Rixathon/GP2013. On April 24, 2018, Judge Renee Marie Bumb...more

Schwabe, Williamson & Wyatt PC

Fresh From the Bench: Latest Federal Circuit Court Cases

Berkheimer v. HP Inc., Appeal No. 2017-1437 (Fed. Cir. Feb. 8, 2018) - In Berkheimer v. HP Inc., the Federal Circuit reviewed the District Court’s summary judgment finding that certain claims of a patent were invalid as...more

K&L Gates LLP

The Federal Circuit Weighs in on the Doctrine of Equivalents for Chemical Inventions

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In Mylan Institutional LLC v. Aurobindo Pharma Ltd., the Federal Circuit affirmed the district court granting a preliminary injunction based on infringement of U.S. Patent No. 9,353,050 (the product patent), directed to an...more

Schwabe, Williamson & Wyatt PC

Fresh From the Bench: Precedential Patent Cases From the Federal Circuit

In Mylan v. Aurobindo the Circuit affirms the grant of a preliminary injunction based upon the infringement of one of the three patents in suit. However, the panel reverses the injunction as to the other two patents based on...more

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