As we previously reported, REGENXBIO’s litigation against Sarepta, alleging infringement of U.S. Patent No. 11,680,274 (the “’274 patent”) by Sarepta’s gene therapy product, was stayed pending resolution of Sarepta’s IPR...more
Genentech, Hoffmann-La Roche, and Biogen have settled their BPCIA litigation against Dr. Reddy’s Laboratories (“DRL”) and Fresenius Kabi...more
Last week, Celltrion USA announced it had submitted a BLA for CT-P39, a biosimilar to XOLAIR (omalizumab). Phase 3 studies demonstrated that in patients with chronic spontaneous urticaria, CT-P39 and reference product...more
Sarepta and Catalent File Answers in REGENXBIO v. Sarepta Litigation -
As we previously reported, REGENXBIO Inc. and the Trustees of the University of Pennsylvania filed suit in Delaware against Sarepta Therapeutics,...more
Trial in Regeneron’s BPCIA case against Biocon regarding Biocon’s proposed aflibercept biosimilar concluded on June 15, 2023 in the Northern District of West Virginia. As we previously reported, the case was expedited, with...more
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...more
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
Innovent Biologics, Inc. announced the results of the Phase III ORIENT-31 study evaluating sintilimab in combination with BYVASDA (bevacizumab biosimilar) for the treatment of non-squamous non-small cell lung cancer. ...more