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Patents Biosimilars Patent Litigation

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

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

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

Venable LLP

Spotlight On: Biosimilar Litigations - June 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

Goodwin

Update on Aflibercept BPCIA Litigation

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In a sealed order that issued on June 11, the Court granted a permanent injunction in favor of Regeneron against Mylan/Biocon in the pending aflibercept BPCIA litigation. ...more

Goodwin

Amgen Files BPCIA Complaint Against Celltrion Regarding Denosumab

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On May 28, Amgen filed a BPCIA complaint in the District Court for the District of New Jersey against Celltrion related to its denosumab biosimilar of Amgen’s PROLIA and XGEVA. This is the second BPCIA litigation regarding...more

Venable LLP

Regeneron Files Second BPCIA Complaint Against Celltrion’s Proposed EYLEA® Biosimilar CT-P42

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On May 17, 2024, Regeneron filed a second infringement litigation against Celltrion’s proposed EYLEA® (aflibercept) biosimilar CT-P42, Case No. 1:24-cv-00053 (N.D.W. Va.). The aBLA for CT-P42 was submitted to the FDA in June...more

Venable LLP

The First Biosimilar Disputes at the Unified Patent Court (UPC)

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As the era of biologics and biosimilar litigations heats up in the United States, Europe’s Unified Patent Court (UPC) is also taking center stage with the first two biosimilar disputes filed in March and April....more

Venable LLP

Amgen and Sandoz Settle Prolia® / Xgeva® Biosimilar Litigation

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Amgen and Sandoz reached a settlement in Case No. 1:23-cv-02406 (D.N.J.) on April 29 just hours before a New Jersey District Court Judge (Christine O’Hearn) was scheduled to announce her ruling on Amgen’s preliminary...more

Venable LLP

Spotlight On: Biosimilar Litigations

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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

Goodwin

Court Cancels Injunction Hearings In Aflibercept BPCIA Litigation; Regeneron May Seek Temporary Restraining Orders

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As we previously reported, the Judicial Panel on Multidistrict Litigation recently granted Regeneron Pharmaceutical’s (“Regeneron”) motion to establish a multi-district litigation (“MDL”) for its aflibercept BPCIA litigation....more

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