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Inter Partes Review (IPR) Proceeding Regeneron

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

Venable LLP

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

Venable LLP

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

Goodwin

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

Goodwin

Year in Review: Top Legal Developments of 2023

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​​​​​​​As we settle into 2024, we reflect on the significant legal developments of 2023 that hold potential impact on the biologics and biosimilars market. The following is a recap of some of the top five legal decisions and...more

Goodwin

Samsung Bioepis Files IPR Petition Challenging Regeneron Aflibercept Patent

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​​​​​​​On August 18, Samsung Bioepis Co., Ltd. (“Samsung Bioepis”), filed a petition for Inter Partes Review, IPR2023-01312, challenging the validity of claims 1-18 of U.S. Patent No. 10,464,992, assigned to Regeneron...more

Goodwin

Update: Post-Trial Briefing in Regeneron v. Mylan Aflibercept BPCIA Case Now Complete

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​​​​​​​We previously reported on the opening post-trial briefs in Regeneron’s BPCIA case against Mylan and Biocon (who was added as a defendant after the original defendant, Mylan, transferred its rights to the aflibercept...more

Goodwin

Aflibercept IPR Updates - July 2023

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​​​​​​​On July 19 and 20, 2023, the PTAB granted institution of IPR2023-00442, filed by Samsung Bioepis regarding Regeneron’s Patent No. 10,130,681 which is directed to treating angiogenic eye disorders with alibercept, and...more

Goodwin

Samsung Files IPR Petition on Regeneron’s Aflibercept Patent

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​​​​​​​Last week, Samsung Bioepis filed an IPR petition challenging claims of U.S. Patent No. 11,253,572 (“the ’572 patent”), owned by Regeneron Pharmaceuticals. According to the petition, the claims are directed to the use...more

Goodwin

Celltrion and Samsung File IPR Petitions on Aflibercept Patents

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​​​​​​​Celltrion and Samsung recently filed IPR petitions challenging claims of Regeneron patents directed to treating angiogenic eye disorders with aflibercept. Specifically, Celltrion and Samsung have each filed petitions...more

Goodwin

Celltrion Files IPR Petition on Aflibercept Patent

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Last week, Celltrion filed an IPR petition, PTAB IPR2023-00462, seeking cancellation of claims 1-18 of U.S. Patent No. 10,464,992 (“the ’992 patent”), assigned to Regeneron Pharmaceuticals, Inc. According to the Petition, the...more

Goodwin

PTAB Institutes Mylan’s Two EYLEA (aflibercept) IPRs

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As we previously reported, Mylan recently filed three IPR petitions challenging claims of Regeneron patents directed to treating angiogenic eye disorders with aflibercept, the active ingredient in Regeneron’s Eylea...more

Goodwin

PTAB Issues Final Written Decisions Finding Claims of Regeneron’s Aflibercept Patents Invalid

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On November 9, 2022, the PTAB issued final written decisions in IPR2021-00880 and IPR2021-00881, filed by Mylan on two Regeneron patents related to aflibercept—U.S. Patent Nos. 9,254,338 and 9,669,069. The PTAB ruled in...more

Goodwin

Mylan Files IPR on Regeneron Aflibercept Patent

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​​​​​​​Mylan Pharmaceuticals Inc. recently filed an IPR petition, PTAB-IPR2023-00099, seeking cancellation of claims 1-3 of U.S. Patent No. 10,857,205, assigned to Regeneron Pharmaceuticals, Inc. According to the petition,...more

Rothwell, Figg, Ernst & Manbeck, P.C.

PTAB Agrees to Review Novartis’ Patent for an Ophthalmic Injection Syringe

On October 26, 2021, the Patent Trial and Appeal Board (PTAB) granted Regeneron’s petition to institute an inter partes review (IPR) of Novartis’s patent U.S. Pat. No. 9,220,631 (“the ’631 patent”), which covers a pre-filled...more

Goodwin

Immunex Files Complaint Against Sanofi and Regeneron

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On April 5, Immunex (a wholly-owned subsidiary of Amgen) filed a complaint against Sanofi and Regeneron related to Sanofi and Regeneron’s Dupixent® (dupilumab) product, which received FDA approval last week. Immunex’s...more

Goodwin

FDA Approves Sanofi and Regeneron’s Dupixent (dupilumab)

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Sanofi and Regeneron announced yesterday that their Dupixent® (dupilumab) product has received FDA approval for the treatment of adults with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled...more

Goodwin

Sanofi and Regeneron Take Aim on Amgen IL-4 Receptor Patent

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This week Sanofi-Aventis and Regeneron Pharmaceuticals took aim at Amgen’s U.S. Patent No. 8,679,487 on two fronts, filing a declaratory judgment action in district court and a petition for inter partes review in the U.S....more

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