As we reported yesterday, Mylan announced that it has reached a settlement with Genentech, Inc. and F. Hoffman-La Roche Ltd. relating to trastuzumab, which extended to Mylan agreeing to withdraw its IPR challenge to U.S. Pat. No. 6,331,415 (the ‘415 patent). Mylan and Genentech have now filed a joint motion to…
On Friday, March 10, Amgen filed its consolidated opening and responsive brief to the Supreme Court in Sandoz v. Amgen. As we covered in a previous post, Sandoz filed its opening brief in the case last month, addressing the question of whether an effective notice of commercial marketing can be given before FDA licensure of…
Mylan announced today that it had reached a settlement with Genentech, Inc. and F. Hoffman-La Roche Ltd. that provides Mylan with global licenses to commercialize its biosimilar to Genentech’s Herceptin® (trastuzumab). As part of the settlement, Mylan agreed to withdraw its IPR challenges to U.S. Pat. Nos. 6,407,213 and 6,331,415….
We have been following the IPRs filed by Mylan against Genentech’s U.S. Patent No. 6,407,213, which relates to humanized antibody polypeptides and methods for their preparation and use. On Tuesday, March 7th, the parties filed motions in IPR2016-0193 and IPR2016-01694 asking the Board to terminate the IPRs due to settlement. No…
The court has issued a memorandum and order reflecting the guidance it provided during the Feb. 23 and 24, 2017 hearing concerning the standards for determining damages in the litigation. The guidance is here. Stay tuned to Big Molecule Watch for more updates.
On Friday March 3, 2016, in a decision in cases brought by Samsung Bioepsis UK Ltd. and Fujifilm Kyowa Kirin Biologics Co. Ltd., a U.K. court held invalid two European patents owned by Abbvie that purportedly cover Humira® (adalimumab). The patents relate to certain dosage regimens for the treatment of rheumatoid…
Connecticut-based Alexion Pharmaceuticals, Inc. announced today that the FDA has accepted its supplemental Biologics License Application (sBLA) for SOLIRIS® (eculizumab) as a potential treatment for patients with refractory generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. According to Alexion, the submission is supported by phase III data…
Yesterday, Coherus announced that CHS-1420, its proposed biosimilar of Humira® (adalimumab), met the primary endpoint in a clinical pharmacokinetic (PK) bioequivalence study that compared CHS-1420 to Humira. According to Coherus, the study showed clinical PK similarity on all prospectively defined PK endpoints. It was reported that both agents were well tolerated and that…
We previously reported that the Committee for Medicinal Products for Human Use (CHMP) had recommended that the European Medicine Agency (EMA) grant marketing approval for Truxima (CT-P10), Celltrion Healthcare’s biosimilar of Roche’s monoclonal antibody product MabThera (rituximab). Last week, the EMA authorized Truxima for all the approved therapeutic indications of…
As we previously reported, yesterday Judge Sleet, United States District Court for the District of Delaware, heard arguments on Amgen’s motion to dismiss in Genentech v. Sandoz. The court orally granted Amgen’s motion under the Federal Circuit’s holding in Amgen v. Sandoz. The court dismissed Genentech’s complaint in its entirety without prejudice and with leave to amend…