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Patents Regeneron Patent Litigation

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Federal Circuit Affirms Preliminary Injunction Decisions for EYLEA® Biosimilars

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On March 5, 2025, the Federal Circuit affirmed the grant of a preliminary injunction against the launch of Celltrion’s proposed EYLEA® (aflibercept) biosimilar CT-P42 in CAFC Case Nos. 24-2058 and 24-2147 (appealing from...more

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FDA Accepts EYLEA® Biosimilar Application for Alvotech / Teva’s AVT06

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On February 18, 2025, Alvotech and Teva announced the FDA acceptance of an aBLA for AVT06 (aflibercept), a proposed biosimilar of Regeneron’s EYLEA® (aflibercept). This aBLA joins Celltrion’s CT-P42 (aflibercept) awaiting...more

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Federal Circuit Affirms Preliminary Injunctions in EYLEA® Biosimilar Litigations Against Samsung Bioepis and Formycon

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On January 29, 2025, the CAFC issued opinions affirming the preliminary injunctions issued against biosimilars of Regeneron’s EYLEA® (aflibercept): Samsung Bioepis’s Opuviz™ (aflibercept-yszy) (CAFC Case Nos. 24-1965,...more

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Celltrion Files IPR on Regeneron’s EYLEA® Patent

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On January 15, 2025, Celltrion filed IPR2025-00456 against Regeneron’s U.S. Patent No. 11,084,865 (“the ’865 patent”), challenging claims 1-17, 19-42, 44-50 as anticipated and claims 1-50 as obvious....more

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Are Reference Product Sponsors Asserting More Patents in BPCIA Litigation?

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On October 24, 2014, Amgen initiated the first litigation under the Biologics Price Competition and Innovation Act (“BPCIA”), asserting infringement of two patents. Over the last two calendar years, Amgen, Biogen, Genentech,...more

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Biosimilar Updates: EYLEA® IPR Filings, Herceptin® Biosimilar Hercessi™ Launch, Stelara® Biosimilar Yesintek™ Approval

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On November 20, 2024, Samsung Bioepis filed IPR2025-00176 against Regeneron’s U.S. Patent No. 11,084,865 (“the ’865 patent”), challenging as obvious 48 claims (claims 1-12, 14-17, 19-20, 22-36, 39-42, 44-45, and 47-55)...more

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Amgen Launches Pavblu™ as the First EYLEA® Biosimilar in the U.S.

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Amgen announced during its Q3 2024 Earnings Call that it had launched Pavblu™ (aflibercept-ayyh) as the first biosimilar of Regeneron’s EYLEA® (aflibercept) to be marketed in the U.S....more

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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

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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

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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

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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

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Recent PTAB Developments for Regeneron’s Aflibercept-Dosing Patents

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There have been several recent developments in the PTAB with respect to Regeneron’s aflibercept-dosing patents. On July 8, Regeneron voluntarily dismissed its appeals to the Federal Circuit (Case Nos. 2023-1395 and...more

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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

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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

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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

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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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Federal Circuit Dismisses Appeals in Regeneron v. Mylan (Aflibercept) BPCIA Litigation

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​​​​​​​As we previously reported, trial in Regeneron Pharmaceutical, Inc.’s BPCIA case against Mylan Pharmaceuticals Inc. and Biocon Biologics, Inc. (collectively, “the Biocon Defendants”) regarding the Biocon Defendants’...more

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EYLEA® Proposed Biosimilar M710 BPCIA Appeals Dismissed for Lack of Jurisdiction

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On April 12, 2024, the Federal Circuit dismissed CAFC Appeal No. 24-1402 and Cross-Appeal No. 24-1405 for lack of jurisdiction following its February 22, 2024 order directing Regeneron and Mylan / Biocon to show cause why the...more

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MDL Panel Grants Transfer of Aflibercept BPCIA Case

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As we previously reported, on January 11, 2024, Regeneron Pharmaceuticals, Inc. (“Regeneron”) moved to establish a multi-district litigation (“MDL”) for its aflibercept BPCIA litigation, and to transfer its case against...more

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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

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Post-Trial Updates on Regeneron v. Mylan (Aflibercept) BPCIA Litigation

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Appeals from and redacted memorandum and opinion in support of judgment in Regeneron v. Mylan (aflibercept) BPCIA case filed - As we previously reported, trial in Regeneron Pharmaceutical, Inc.’s BPCIA case against Mylan...more

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Updates on Aflibercept BPCIA Litigation - February 2024

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On Friday, January 20, 2024, Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed an ex parte application for a scheduling order setting the schedule for preliminary injunction proceedings or, in the alternative, an emergency...more

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Regeneron’s Disputes with Celltrion, Samsung Bioepis, and Formcycon on Service and Personal Jurisdiction in Aflibercept BPCIA...

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As we have previously reported, in November 2023 Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed complaints against Celltrion,  Samsung Bioepis and Formycon (collectively, “the Defendants”) in the U.S. District Court for...more

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Updates on Aflibercept BPCIA Litigation

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Emergency Motion for Entry of a PI Schedule Against Celltrion, Formcyon, and Samsung Bioepis - On December 28, Regeneron filed emergency motions for entry of a PI schedule in its aflibercept BPCIA cases against Celltrion,...more

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Regeneron Sues Samsung Bioepis for Proposed Biosimilar of EYLEA in West Virginia District Court

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​​​​​​​Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed a Complaint on November 22 against Samsung Bioepis Co., Ltd. (“Bioepis”) in the U.S. District Court for the Northern District of West Virginia, alleging infringement...more

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