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Mylan Pharmaceuticals Regeneron

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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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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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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

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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

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Regeneron v. Mylan - Update on Aflibercept BPCIA Litigation - June 2023

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As we have previously reported, Regeneron’s BPCIA case against Mylan regarding Mylan’s proposed aflibercept biosimilar is proceeding on an expedited schedule, with a two-week trial scheduled to begin on June 12, 2023, in the...more

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Amgen Intervenes in Regeneron v. Mylan BPCIA Aflibercept Litigation to Seek Public Access to Sealed Documents

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As we have previously reported, Regeneron’s BPCIA case against Mylan regarding Mylan’s proposed aflibercept biosimilar is proceeding in the U.S. District Court for the Northern District of West Virginia, with a two-week trial...more

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Regeneron v. Mylan BPCIA Aflibercept Litigation Update: Claim Construction Order and Stipulation to Narrow the Case for June 2023...

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As we have previously reported, Regeneron’s BPCIA case against Mylan regarding Mylan’s proposed aflibercept biosimilar is proceeding on an expedited schedule, with a two-week trial scheduled to begin on June 12, 2023. On...more

Goodwin

Regeneron v. Mylan - Update on Aflibercept BPCIA Litigation

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As we previously reported, Regeneron’s BPCIA case against Mylan regarding Mylan’s proposed aflibercept biosimilar is proceeding on an expedited schedule, with a two-week trial scheduled to begin on June 12, 2023, less than a...more

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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

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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

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BPCIA Aflibercept Litigation: Regeneron Files 12(c) Motion to Dismiss Mylan’s Counterclaim for Inequitable Conduct

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On Friday, December 16, 2022, Regeneron moved to dismiss Mylan’s inequitable conduct defense and counterclaim against two of the six patents asserted in the parties’ BPCIA suit concerning Mylan’s proposed biosimilar to EYLEA....more

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BPCIA Aflibercept Litigation: Mylan Seeks Leave to Add a Declaratory Judgment Counterclaim of No Lost Profits or Injunctive...

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As we previously reported, the Northern District of West Virginia ordered an expedited trial in Regeneron’s aflibercept BPCIA case against Mylan. Regeneron had asserted 24 patents in its complaint....more

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Regeneron Files Expedited Motion Challenging Mylan’s Designation of Entire aBLA Production as Outside Counsel’s Eyes Only

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On Tuesday, December 6, Regeneron filed an expedited motion to compel Mylan’s compliance with the protective order in the parties’ BPCIA litigation concerning Mylan’s proposed aflibercept biosimilar of EYLEA. Regeneron...more

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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

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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

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Regeneron Identifies Six Patents for Expedited Trial in BPCIA Aflibercept Case Against Mylan

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​​​​​​​As we reported last week, the Northern District of West Virginia court has ordered an expedited trial in Regeneron’s aflibercept BPCIA case against Mylan. As required by the court’s scheduling order, on October 28,...more

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Expedited Trial Ordered in Regeneron Aflibercept BPCIA Case Against Mylan

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The court has issued a scheduling order in Regeneron’s aflibercept BPCIA case against Mylan. The court scheduled a 2-week trial in June 2023, less than a year from Regeneron’s filing of its complaint in August 2022....more

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Regeneron Seeks Expedited Trial in BPCIA Case Against Mylan Regarding Aflibercept Biosimilar

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​​​​​​​As we previously reported, Regeneron filed a BPCIA complaint against Mylan on August 3, 2022, regarding Mylan’s proposed aflibercept biosimilar. Just two days after filing its Complaint, Regeneron filed a motion...more

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Regeneron Files First BPCIA Complaint Regarding Biosimilar Eylea against Mylan in West Virginia District Court

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Regeneron filed a complaint yesterday against Mylan in the U.S. District Court for the Northern District of West Virginia, alleging infringement of twenty-four patents under the BPCIA based on Mylan’s submission of an aBLA...more

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EYLEA (Aflibercept) Biosimilar Development Updates

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Regeneron’s EYLEA (aflibercept) was approved by the U.S. FDA on November 18, 2011, and is indicated for the treatment of patients with Neovascular (Wet) Age-related Macular Degeneration (AMD), Macular Edema following Retinal...more

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Litigation Updates on Pegfilgrastim and Dupilumab

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Pegfilgrastim litigation - We had previously covered Judge Stark’s grant of Coherus’s motion to dismiss Amgen’s complaint alleging infringement of the ‘707 patent in Amgen v. Coherus. Today, Judge Stark entered judgment...more

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