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 of aflibercept to treat angiogenic eye disorders, including diabetic macular edema and age-related macular degeneration. As we…
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 April 3, 2023, Celltrion announced positive 24-week results from its global Phase III Clinical Trial of CT-P42 (aflibercept), a biosimilar referencing Regeneron’s EYLEA. The trial is a 52-week trial in 348 patients with diabetic macular edema (DME) across thirteen countries. The primary endpoint was the change in best corrected…
As we previously reported, Magistrate Judge Hall issued a Report and Recommendation (“R&R”) on February 10, 2023 denying Amgen’s motion to dismiss Regeneron’s antitrust claims in Regeneron Pharmaceuticals, Inc. v. Amgen Inc., 22-cv-697 pending in the district of Delaware. On February 24, 2023, Amgen filed its Objections to the Report…
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…
We previously reported on Regeneron’s antitrust suit against Amgen in the U.S. District Court for the District of Delaware. The case concerns Regeneron’s allegation that Amgen has violated antitrust law by engaging “in a persistent exclusionary campaign to deny patients the life-saving benefits of [] Regeneron’s cholesterol-reducing medication, Praluent® (alirocumab).” …
On February 8, 2023, Regeneron announced that the FDA approved its EYLEA® (aflibercept) injection for the treatment of retinopathy of prematurity (ROP) in preterm infants—the first pediatric approval for this indication. Regeneron reported that the approval is supported by data from FIREFLEYE and BUTTERFLEYE—two phase III clinical trials comparing 0.4…
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…