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Settlement Agreements Patent Litigation

Venable LLP

Fresenius Kabi and Celltrion Launch Prolia® / Xgeva® (denosumab) Biosimilars Conexxence™ / Bomyntra™ and Stoboclo® / Osenvelt®

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On July 1, 2025, Fresenius Kabi announced the U.S. launch of Conexxence™ / Bomyntra™ (denosumab-bnht), biosimilars of Amgen’s Prolia® / Xgeva® (denosumab), pursuant to a settlement agreement between the parties ending BPCIA...more

Akin Gump Strauss Hauer & Feld LLP

District Court Declines to Order Production of Test Results Referenced in Complaint and Initial Disclosures

The Northern District of Ohio denied a motion to compel the plaintiff to produce test results referenced in its initial disclosures and complaint. The court found that because the “test results are not facts but rather are...more

Bradley Arant Boult Cummings LLP

Another Bite at the Apple to Avoid $300 Million in Damages

Recently, the Federal Circuit vacated both the infringement and damages judgments against Apple in a patent case that involves standard-essential patents (SEPs) related to Long-Term Evolution (LTE) technology brought in the...more

Venable LLP

Sandoz Launches Jubbonti® / Wyost® (denosumab-bbdz) as First Prolia® / Xgeva® Interchangeable Biosimilars

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On June 2, 2025, Sandoz announced the launch of Jubbonti® / Wyost® (denosumab-bbdz), the first Prolia® / Xgeva® (denosumab) interchangeable biosimilars to launch in the U.S....more

Irwin IP LLP

Unreliable Expert Testimony Shall Not Pass 

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On May 21, 2025, the Federal Circuit en banc banished the notion that the reliability of an expert’s methodology under Federal Rule of Evidence 702 (“Rule 702”) is a question of weight, not admissibility. The en banc Court...more

Mintz - Intellectual Property Viewpoints

SEP Licensing Wins Continue—Multinational Litigation Strategy Drives Licensing Win for Ericsson

Ericsson finally sees resolution of its standard essential patent (“SEP”) campaign against Lenovo and Motorola, filed globally in multiple jurisdictions, importantly at the U.S. International Trade Commission (“ITC”). In a...more

Robins Kaplan LLP

ANDA Litigation Settlements

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Reported settlements in federal district court cases - 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...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

Goodwin

Regeneron, Mylan, and Biocon Settle in Aflibercept BPCIA Litigation

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On April 22, 2025, the U.S. District Court for the Northern District of West Virginia entered a Stipulation and Order Vacating Permanent Injunction and Dismissing All Claims and Counterclaims with Prejudice in In re:...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

Patterson Belknap Webb & Tyler LLP

To Threat or Not to Threat, That is the DJ Question: Judge Rakoff Dismisses DJ Action and Finds the Court Does Not Have...

On April 1, 2025, United States District Judge Jed S. Rakoff granted Defendants Marut Enterprises LLC and Brett Marut’s (collectively, “Defendants”) motion to dismiss and entered final judgment against Foto Electric Supply...more

Venable LLP

Soliris® (eculizumab) Interchangeable Biosimilar Launches: Bkemv™ and Epysqli®

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On April 7, 2025, Samsung Bioepis and Teva announced the launch of Epysqli® (eculizumab-aagh), a provisionally interchangeable biosimilar of Alexion / AstraZeneca’s Soliris® (eculizumab), at a 30% discount to Soliris®’s...more

Mintz - Arbitration, Mediation, ADR...

Arbitration of SEP Disputes—A Growing Trend?

After years of litigating against each other in several jurisdictions around the world, Ericsson and Lenovo announced last week that they had entered into a global cross-licensing agreement involving 4G and 5G wireless...more

Venable LLP

Stelara® Biosimilars Launch and Licensing Dispute Begins

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Three Stelara® (ustekinumab) biosimilars launched in the U.S. in the past week, Alvotech / Teva’s Selarsdi™ (ustekinumab-aekn) on February 21, 2025, and Sandoz / Samsung Bioepis’s Pyzchiva® (ustekinumab-ttwe) and Biocon’s...more

Snell & Wilmer

Federal Circuit Clarifies Legal Doctrines in Trade Dress and Litigation Privilege: Key Takeaways from Toyo v. Atturo

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The Federal Circuit recently issued a nonprecedential decision in Toyo Tire Corp. v. Atturo Tire Corp., concerning Toyo’s alleged trade dress in its tires, and Atturo’s counterclaims premised on Toyo’s settlement negotiations...more

Axinn, Veltrop & Harkrider LLP

Puma and the Pitfalls of the “Narrow” Exclusive License

8 Puma Biotechnology is the latest victim of standing requirements in patent cases that continue to wreak havoc on plaintiffs’ ability to recover a full measure of damages. In Puma Biotechnology, Inc. v. AstraZeneca...more

Goodwin

Biocon Settles with Janssen, Securing U.S. Market Entry Date for Ustekinumab Biosimilar

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​​​​​​​On February 29, Biocon Biologics Ltd announced that it signed a settlement and license agreement with Janssen Biotech Inc. and Johnson & Johnson (“J&J”) regarding Bmab 1200, Biocon’s proposed biosimilar to STELARA....more

Goodwin

Biocon Settles with Bayer and Regeneron, Securing Canada Market Entry Date for Aflibercept Biosimilar

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On March 4, Biocon Biologics Ltd. announced it has signed a settlement agreement with Bayer Inc. and Regeneron Pharmaceuticals, Inc. regarding YESAFILI, Biocon’s proposed biosimilar to EYLEA (aflibercept)....more

Goodwin

Alvotech Announces More Settlements and Expected Launch Dates Regarding Biosimilar to STELARA (ustekinumab), AVT04

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On February 15, Alvotech announced that it reached more settlement agreements with Johnson & Johnson for ATV04, Alvotech’s biosimilar to STELARA (ustekinumab). The settlements cover Canada, the European Economic Area, and...more

Weintraub Tobin

Court Denies Attempts to Compel Disclosure of Litigation Funding Documents

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In GoTV Streaming, LLC v. Netflix, Inc., 2-22-cv-07556 (CDCA May. 24, 2023) (Shashi H. Kewalramani), the Central District of California denied Defendant Netflix’s attempts to compel Plaintiff GoTV Streaming to provide...more

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

2022 Design Patents Year in Review: Analysis & Trends

Last year, in our inaugural issue of “The Year in Review,” we reported that since the landmark jury verdict in the IP litigation between Apple and Samsung in 2012, which awarded more than $1B to Apple for infringement of...more

Smart & Biggar

Competition Bureau closes two investigations into pharmaceutical patent litigation settlements

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On May 20, 2022, the Competition Bureau announced that it closed two investigations into pharmaceutical patent litigation settlement agreements as evidence gathered during the two investigations suggested the agreements did...more

Knobbe Martens

Federal Circuit Review - February 2022

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Ordered To Agree: Binding Settlement Agreement Provision Found Despite Absence of Singular, Executed Agreement - In Plasmacam, Inc. v. Cncelectronics, LLC Appeal No. 21-1689, the Federal Circuit held that an agreement on...more

Goodwin

Alvotech and AbbVie Settle Patent Dispute

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Alvotech Holdings S.A. (“Alvotech”) has announced that they have settled all pending disputes between AbbVie and Alvotech related to AVT02 (100mg/mL), Alvotech’s high-concentration, citrate-free biosimilar candidate for...more

McDermott Will & Emery

Precision Is Paramount: Court Enforces Terms of Email Agreement in Settlement

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The US Court of Appeals for the Federal Circuit reversed a district court order enforcing one party’s version of a settlement agreement, finding that version unsupported by the record. The Court found that the other party’s...more

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