News & Analysis as of

Biosimilars Intellectual Property Litigation Prescription Drugs

Goodwin

Amgen and Accord BioPharma Settle Denosumab BPCIA Case

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​​​​​​​On July 16, 2025, the District Court for the District of New Jersey entered a Consent Judgment and Injunction in view of a settlement agreement between Amgen, Inc. (“Amgen”) and Accord BioPharma, Inc. (“Accord”)...more

Venable LLP

Spotlight On: Biosimilar Litigations - July 2025

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Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more

Venable LLP

Spotlight On: Humira® (adalimumab) / Amjevita™ (adalimumab-atto) / Cyltezo® (adalimumab-adbm) / Hyrimoz™ (adalimumab-adaz) /...

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Adalimumab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

Venable LLP

Spotlight On: Neulasta® (pegfilgrastim) / Fulphila® (pegfilgrastim-jmdb) / Udenyca® (pegfilgrastim-cbqv) / Ziextenzo®...

Venable LLP on

Pegfilgrastim Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

Robins Kaplan LLP

New ANDA Cases

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Federal district court cases that are filed pursuant to the Hatch-Waxman Act - This chart summarizes the case name, presiding judge, drug, and patents-at-issue in all federal district court cases that are filed pursuant to...more

Venable LLP

Spotlight On: Lantus® / Lantus® SoloSTAR® (insulin glargine recombinant) / Basaglar® (insulin glargine) / Semglee® (insulin...

Venable LLP on

Insulin Glargine Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

Venable LLP

Permanent Injunction Issued Preventing Launch of EYLEA® Biosimilar Yesafili™

Venable LLP on

On June 11, 2024, the Court in Case No. 1:22-cv-00061 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.) issued a permanent injunction against the launch of Biocon and Mylan’s Yesafili™ (aflibercept-jbvf), a recently approved...more

American Conference Institute (ACI)

[Webinar] 3rd Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA - October 10th - 26th, 1:00 pm EST

Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials, a critical competency for legal and business professionals in the biopharmaceutical arena. Attend ACI’s Hatch-Waxman and BPCIA Proficiency Series...more

Goodwin

FDA Approves First Interchangeable Biosimilar Insulin Product - Update

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July 28, 2021 - the U.S. Food and Drug Administration (FDA) approved Viatris Inc.’s (formerly Mylan Pharmaceuticals Inc.) SEMGLEE (insulin glargine-yfgn), a biosimilar to LANTUS (insulin glargine). According to the press...more

Robins Kaplan LLP

[Remote Event] Health Care Antitrust Under President Biden - What Health Care Companies May Expect By Way Of Antitrust Policy And...

Robins Kaplan LLP on

After a turbulent year that roiled the economy, and the health care sector more than most, the Democrats emerged with control of both the White House and Congress for the first time since 2014. Business leaders and in-house...more

Herbert Smith Freehills Kramer

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

American Conference Institute (ACI)

[Event] Global Legal and Regulatory Summit On Biosimilars - December 3rd-4th, Munich, Germany

Legal, Regulatory and Commercial Perspectives on the International Biosimilars Marketplace - The Global Biosimilars market is expected to grow robustly. Market watchers anticipate that Europe in particular will experience...more

Patterson Belknap Webb & Tyler LLP

Following Biosimilar Trial, Jury Awards Amgen $70 Million for Pfizer’s Pre-Approval Infringement of Now-Expired EPO Patent

In one of the first Biologics Price Competition and Innovation Act (BPCIA) litigations to reach trial, a jury on Friday awarded Amgen $70 million in damages for Pfizer’s infringement of one of Amgen’s expired patents...more

Patterson Belknap Webb & Tyler LLP

CIMZIA Does Not Infringe Yeda’s Monoclonal Antibody Patent

In UCB, Inc. v. Yeda Research and Development Co., the Federal Circuit affirmed the determination by the District Court for the Eastern District of Virginia that UCB, Inc.’s Cimzia® (certolizumab pegol), a biologic medicine...more

McDonnell Boehnen Hulbert & Berghoff LLP

Celltrion Healthcare Co. v. Kennedy Trust for Rhematology Research (S.D.N.Y. 2014); Hospira Inc. v. Janssen Biotech Inc. (S.D.N.Y....

Earlier this month, Judge Paul Crotty, U.S. District Court Judge for the Southern District of New York handed down rulings in two separate cases related to the biosimilars law (the Biologics Price Competition and Innovation...more

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