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….
With the growing volume of biosimilar and pharma litigation in district courts and before the PTAB, the U.S. International Trade Commission may emerge as another forum for patent holders against imported biosimilars. Section 337 of the Tariff Act of 1930 allows patent holders with a domestic industry relating to the…
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…
On Monday, March 6, House Republicans unveiled their plan to repeal and replace the Affordable Care Act (“ACA”). Although the proposed legislation repeals or amends several provisions of the ACA, based on a preliminary review of the current key provisions, the Biologics Price Competition and Innovation Act (“BPCIA”) appears unaffected.
Coherus Biosciences has filed two petitions for inter partes review of Abbvie’s U.S. Patent 9,085,619. (IPR2017-01008 and IPR2017-01009). Coherus recently filed four other petitions for inter partes review of the ‘619 patent, as we’ve reported. Those cases are pending an institution decision. According to the petitions, the ‘619 patent is drawn…
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…