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Biosimilars Patent Litigation

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

Goodwin

Amgen Files BPCIA Complaint Against Fresenius Kabi Regarding Denosumab

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On October 4, 2024, Amgen filed a BPCIA complaint in the District Court for the Northern District of Illinois Eastern Division against Fresenius Kabi related to Fresenius Kabi’s proposed biosimilar of Amgen’s PROLIA and...more

Venable LLP

Amgen Files Fourth BPCIA Lawsuit Against Proposed Prolia® / Xgeva® Biosimilar - Fresenius Kabi’s FKS518

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On October 4, 2024, Amgen filed Case No. 1:24-cv-09555 (N.D. Ill.) against Fresenius Kabi, alleging FKS518 (denosumab), its proposed Prolia® / Xgeva® (denosumab) biosimilar, would infringe 33 of Amgen’s patents....more

Venable LLP

Spotlight On: Biosimilar Litigations - October 2024

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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

Smart & Biggar

PM(NOC) Regulations: seven-year anniversary of major amendments

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September 21, 2024, marked the seventh anniversary of the significant amendments to the Patented Medicines (Notice of Compliance) Regulations (Regulations). This article provides an update on activities in the seventh year...more

Goodwin

Preliminary Injunction Denied Against Amgen in Aflibercept BPCIA Litigation

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In a sealed order that issued on September 24, 2024, the District Court for the Northern District of West Virginia denied a preliminary injunction against Amgen in the aflibercept BPCIA litigation. ...more

Venable LLP

Preliminary Injunction Against Amgen’s EYLEA® Biosimilar Pavblu™ Denied

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On September 23, 2024, Regeneron’s motion for a preliminary injunction against the commercial launch of Amgen’s EYLEA® (aflibercept) biosimilar Pavblu™ (aflibercept-ayyh) was denied in Case No. 1:24-cv-00039 (N.D.W. Va.) /...more

Goodwin

Alexion and Samsung Settle Eculizumab BPCIA Case

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​​​​​​​On August 30, 2024, Alexion Pharmaceuticals, Inc. and Alexion Pharma International Operations Ltd. (collectively, “Alexion”) and Samsung Bioepis Co. Ltd. (“Samsung Bioepis”) settled their BPCIA dispute related to...more

Venable LLP

Spotlight On: Biosimilar Litigations - September 2024

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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

Alexion and Samsung Bioepis Settle Soliris® Biosimilar Patent Proceedings for Epysqli®

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On August 30, 2024, Alexion and Samsung Bioepis filed voluntary dismissals in all of their pending patent proceedings related to Soliris® (eculizumab) biosimilar Epysqli® (eculizumab-aagh), including Case No. 1:24-cv-00005...more

Goodwin

Regeneron Files BPCIA Complaint Against Sandoz Regarding Aflibercept Biosimilar

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On August 26, 2024, Regeneron filed a BPCIA complaint in the District Court for the District of New Jersey against Sandoz Inc. related to Sandoz’s ENVEEZU (aflibercept-abzv)....more

Venable LLP

Regeneron Files BPCIA Complaint Against Sandoz’s EYLEA® Biosimilar Enzeevu™ Following FDA Approval

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Regeneron filed an eighth BPCIA litigation (Case No. 2:24-cv-08760 (D.N.J.)) related to an EYLEA® (aflibercept) biosimilar, against Sandoz’s Enzeevu™ (aflibercept-abzv).  The Complaint alleges infringement of 46 of...more

Venable LLP

Venable’s BiologicsHQ Monthly Injection - July 2024

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Please see full Newsletter below for more information....more

Morgan Lewis

Blockbuster Biologics - Review Issue 24

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Welcome to the latest issue of Blockbuster Biologics Review, which covers the status and developments of post-grant challenges and patent litigations implicating blockbuster biologics and legislative proposals related to...more

Venable LLP

Amgen Files BPCIA Lawsuit Against Samsung Bioepis Prolia® / Xgeva® Proposed Biosimilar SB16

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On August 12, 2024, Amgen filed Case No. 1:24-cv-08417 (D.N.J.) against Samsung Bioepis, alleging SB16 (denosumab), its proposed Prolia® / Xgeva® (denosumab) biosimilar, would infringe 34 of Amgen’s patents....more

MoFo Life Sciences

Senate Unanimously Passes Bill To Limit Patent Infringement Challenges By Drug Manufacturers

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The Affordable Prescriptions for Patients Act (APPA) of 2023 unanimously passed the Senate on July 11, 2024. The APPA was first introduced to the House on January 30, 2023 by Representative John Cornyn (R-Tx), with the aim of...more

Goodwin

Amgen Files BPCIA Complaint Against Samsung Bioepsis Regarding Denosumab

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On August 12, 2024, Amgen filed a BPCIA complaint in the District Court for the District of New Jersey against Samsung Bioepis and Samsung Biologics related to Samsung Bioepis’s proposed biosimilar of Amgen’s PROLIA and...more

Foley & Lardner LLP

Cancer Drugs: Antibody-Drug Conjugate Litigation

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Antibody-drug conjugates (ADCs) are typically composed of a monoclonal antibody attached to a cytotoxic drug via a chemical linker. The antibody is able to identify biomarkers on and attach to cancer cells, allowing targeted...more

Venable LLP

Spotlight On: Actemra® (tocilizumab) / Tofidence™ (tocilizumab-bavi) / Tyenne® (tocilizumab-aazg) - August 2024

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Tocilizumab Challenged Claim Types in IPRs: Claims are counted in each IPR, so claims from the same patent challenged in multiple IPRs are counted more than once. Within each IPR, claims are counted only once, whether they...more

Venable LLP

Spotlight On: Biosimilar Litigations - August 2024

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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

Jones Day

U.S. Senate Unanimously Passes Bill Limiting Number of Patents Asserted Against Biosimilar Applicants

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The Situation: Senate Bill 150 ("S.B. 150")—the Affordable Prescriptions for Patients Act of 2023—unanimously passed the Senate and would amend 35 U.S.C. § 272(e) to limit, under certain circumstances, the number of patents...more

Venable LLP

Venable’s BiologicsHQ Monthly Injection - June 2024

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Venable’s BiologicsHQ Monthly Injection – June 2024...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

Venable LLP

PTAB Issues Final Written Decision Invalidating Regeneron’s EYLEA® Patent (IPR2023-00442)

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On June 14, 2024, the PTAB issued a Final Written Decision (FWD) in Samsung Bioepis’s IPR2023-00442 (“the -00442 IPR) determining that the challenged claims of Regeneron’s U.S. Patent No. 10,130,681 (the ’681 patent) that...more

Axinn, Veltrop & Harkrider LLP

More Skinny-Label Drama or Just Your "Run-Of-The-Mill" Induced Infringement Case?

The Federal Circuit's recently issued decision in the Amarin/Hikma case continues the drama around skinny labeling for generic and biosimilar products, but the panel certainly went out of its way to couch its analysis as an...more

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