News & Analysis as of

Preliminary Injunctions Pharmaceutical Patents Appeals

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

Venable LLP

Regeneron and Biocon Settle Litigation over EYLEA® Biosimilar Yesafili™

Venable LLP on

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...

A&O Shearman on

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

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

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

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

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

A&O Shearman

Federal Circuit Upholds Preliminary Injunction Barring Sale Of Cancer Test

A&O Shearman on

On July 12, 2024, the U.S. Court of Appeals for the Federal Circuit (“Federal Circuit”) affirmed a decision by the U.S. District Court for the Middle District of North Carolina granting a preliminary injunction that barred...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

A&O Shearman

The UPC Court of Appeal in action: Insights from the first hearing before the UPC Court of Appeal

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Today marked a ‘historic moment’ for the UPC, as Klaus Gabrinsky, the President of the UPC Court of Appeal, noted in his opening remarks: the first UPC Court of Appeal hearing, on 18 December 2023 in Luxembourg. The case...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

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

Federal Circuit Appeals from the PTAB and ITC: Summaries of Key 2021 Decisions

[co-author: Jamie Dohopolski] Last year, the continued global COVID-19 pandemic forced American courts to largely continue the procedures set in place in 2020. The U.S. Court of Appeals for the Federal Circuit was no...more

McDonnell Boehnen Hulbert & Berghoff LLP

Takeda Pharmaceuticals U.S.A., Inc. v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2020)

ANDA litigation, pursuant to the Hatch-Waxman Act, has become more complicated over the years since enactment of the statute in 1984, with more patents being asserted and more parties participating over the opportunity to...more

McDermott Will & Emery

Unlikely to Succeed: Preliminary Injunction Denied Despite Stipulation to Irreparable Harm

McDermott Will & Emery on

In a dispute over the terms of a settlement agreement, the US Court of Appeals for the Federal Circuit found that a patent owner was not entitled to a preliminary injunction despite a stipulation that it would be irreparably...more

Knobbe Martens

Preliminary Injunction Denied Because of Failure to Draft Precise Terms That Capture the Intent of the Parties

Knobbe Martens on

TAKEDA PHARMACEUTICALS U.S.A., INC. V. MYLAN PHARMACEUTICALS INC. Before Prost, Newman, and Hughes. Appeal from the United States District Court for the District of Delaware - Summary: The scope of a contract term may...more

Goodwin

Federal Circuit Hears Oral Argument in Bevacizumab Preliminary Injunction Appeal

Goodwin on

Today, a panel of the Federal Circuit (Judges Moore, O’Malley, and Hughes) heard oral argument in Genentech v. Amgen. The case is on appeal from the District of Delaware, where the court denied Genentech’s motion for...more

Goodwin

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

Goodwin on

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

Knobbe Martens

Federal Circuit Review - August 2019

Knobbe Martens on

Mere Potential for Future Appeal Does Not Prevent Triggering Estoppel of Inter Partes Reexamination When Party Fails to Seek Relief in the First Instance - In Virnetx Inc. v. Apple Inc., Appeal Nos. 2017-1591, -1592,...more

McDermott Will & Emery

When Is “Wherein” Clause Limiting? When It’s Material to Patentability

McDermott Will & Emery on

The US Court of Appeals for the Federal Circuit affirmed a district court’s finding, based largely on the prosecution history, that disputed “wherein” clauses were limiting and therefore the grant of a preliminary injunction...more

Knobbe Martens

The Sometimes Limiting Effect of "Wherein" Clauses

Knobbe Martens on

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

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - September 2019

PATENT CASE OF THE WEEK - BioDelivery Sciences Int’l, Inc. v. Aquestive Therapeutics, Inc., Appeal Nos. 2019-1643, -1644, -1645 (Fed. Cir. Aug. 29, 2019) - Our case of the week this week focuses on Section 314(d)—the...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

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