Tagged as: Aflibercept

Celltrion Files IPR Petition on Aflibercept Patent

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 challenged claims of the ’992 patent “encompass a formulation comprising the VEGF inhibitor protein, aflibercept, which Regeneron markets…

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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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Coherus Agrees to Acquire a Biosimilar EYLEA Candidate from Klinge Biopharma

On Jan 9, Coherus BioSciences, Inc. (“Coherus”) announced that it has agreed to acquire the exclusive commercialization rights to FYB203, a biosimilar referencing EYLEA (aflibercept) from Klinge Biopharma GmbH (“Klinge Biopharma”) in the US. The parties expect to complete the transaction in Q1 2023.  Coherus plans to file an abbreviated…

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Year in Review: Top Deals in 2022

According to PwC, “2022 has been a challenging year for M&A in the pharmaceutical and life sciences sector, with both deal value and volume at multiyear lows thanks to overall macro headwinds coupled with broad-based market dislocation.”  PwC expects “M&A to more closely resemble prior years with a total deal…

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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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Biocon Biologics Confirms Completion of Multi-Billion Dollar Acquisition of Viatris’ Global Biosimilars Business

As we previously reported, Biocon Biologics Ltd. (a subsidiary of Biocon Ltd.) announced its intent to acquire the global biosimilars business of its long-term partner Viatris, Inc. This week, Biocon confirmed completion of its acquisition in a part-cash/part-equity transaction. Under the terms of this USD $3.335 billion deal, Biocon paid…

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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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