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 April 19, the Court issued a claim construction order construing seven terms from the claims of the four…
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 year from Regeneron’s filing of its complaint in August 2022. The Court’s scheduling order, issued in October…
On March 10, 2023, the PTAB denied institution of IPR2022-1524, filed by Apotex Inc. regarding Regeneron’s Patent No. 11,253,572. As we previously reported, Apotex filed an IPR petition against the ’572 patent in September 2022, challenging claims that generally relate to methods for treating angiogenic eye disorders with a claimed dosing regimen…
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…
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…
As we ring in the new year, we look back at the top legal developments of 2022 that could influence the market for biologics and biosimilars. There were many interesting decisions and other developments in district court, at the Federal Circuit, and at the PTAB. Below is our recap of…
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…
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. …
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…
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…