GE Healthcare announced today that Dr. Reddy’s will install GE Healthcare’s FlexFactory in Dr. Reddy’s facility in Hyderabad, India. According to the press release, “FlexFactory will help Dr. Reddy’s increase its capacity to meet both the expected growth of its currently marketed biosimilars as well as support the launch of…
The PTAB has issued a Final Written Decision in IPR2016-00172, filed by Coherus, finding Abbvie’s U.S. Patent 8,889,135 unpatentable as obvious over the prior art. The ‘135 patent is directed to methods of treating rheumatoid arthritis with a human anti-tumor necrosis factor α (TNF) antibody. Patent Owner tried to defend the…
Researchers in Denmark recently published a report from an observational study of 802 Danish patients who switched from Remicade to the biosimilar infliximab product Remsima for the treatment of rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis. In May 2015, Denmark implemented a national guideline mandating non-medical switching of all patients…
Last week, Hospira filed a motion for summary judgment of non-infringement asserting that “all of Hospira’s accused erythropoietin drug substance batches are protected by the safe harbor provisions of 35 U.S.C. § 271(e)(1) and thus do not infringe U.S. Patent Nos. 5,756,349 and 5,856,298.” Hospira further stated that it does not infringe…
Otsuka announced today that it has agreed to pay Teva $50 million and later milestone payments for the exclusive rights to develop and commercialize Fremanezumab in Japan. Fremanezumab, which targets the calcitonin gene-related peptide, is a monthly subcutaneous injection that Teva has been developing globally for the treatment of migrane,…
Amgen has filed a BPCIA suit in the District of Delaware against Coherus Biosciences, Inc., alleging infringement of U.S. Patent No. 8,273,707—a patent “directed to a process for purifying proteins.” The complaint alleges that following FDA’s acceptance of Coherus’s abbreviated biologics application for a biosimilar version of Amgen’s Neulasta® (pegfilgrastim)…
Earlier this week, Celltrion filed two petitions for inter partes review of Genentech’s U.S. Patent No. 6,407,213. According to Celltrion’s petitions, the patent is directed to humanized antibodies. Mylan previously challenged the same patent in two IPR petitions, which terminated in settlement with Genentech. We will continue to monitor and report…
On Thursday, May 4, 2017, Baxalta, a wholly-owned subsidiary of Shire, filed a complaint (available here) against Genentech and Tokyo-based Chugai Pharmaceutical in the U.S. District Court for the District of Delaware. The complaint alleges infringement of Baxalta’s U.S. Patent No. 7,033,590, which Baxalta alleges covers the defendants’ emicizumab product (a/k/a…
Merck Sharpe & Dohme and Genentech have filed a Joint Motion to Terminate IPR2016-00710, relating to U.S. Patent No. 6,331,415. As we reported earlier, the ‘415 patent is known as one of the “Cabilly” patents, and is generally applicable to manufacturing recombinant antibodies. According to the motion, the parties have reached…
As we previously reported, in Janssen v. Celltrion, Janssen appealed the district court’s partial final judgment that Janssen’s ’471 patent, relating to monoclonal antibodies including infliximab, is invalid. As we also previously reported, Janssen filed its opening appeal brief on January 26, 2017. On March 7, 2017, Celltrion filed its response brief. On April 20,…