Tagged as: Mylan

PTAB Institutes Mylan’s Two EYLEA (aflibercept) IPRs

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 product—IPR2022-01225 (challenging U.S. Patent No. 10,130,681), IPR2022-01226 (challenging U.S. Patent No. 10,888,601), and IPR2023-00099 (challenging U.S. Patent No. 10,857,205). This week, the PTAB granted institution on two…

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

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.  As previously reported, Regeneron narrowed the twenty-four patents originally asserted against Mylan to six following the Northern…

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

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.  As required by the court’s scheduling order, on October 28, Regeneron identified six patents for the first phase of the litigation. …

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

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 alleges that Mylan has improperly “designated the entire 1,000,000+ pages of its biosimilar application and regulatory file as ‘Outside Counsel’s…

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

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 Mylan’s favor in both IPRs, holding all challenged claims of both patents invalid as anticipated by the same…

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Mylan Files IPR on Regeneron Aflibercept Patent

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, the claims “are drawn to monthly dosing [of aflibercept] to treat an angiogenic eye disorder.”  The Petition sets forth three anticipation grounds and…

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

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, Regeneron identified six patents for the first phase of the litigation.  Regeneron also agreed that “it will…

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

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 requesting an expedited status conference and to schedule a trial for no later than June 2023.  Briefing on Regeneron’s…

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