As we reported earlier this week, the Supreme Court held in SAS Institute Inc. v. Iancu that when the PTAB institutes an IPR, it must decide the patentability of all challenged claims. The U.S. Patent and Trademark Office yesterday issued guidance on the impact of SAS. The guidance explains that going forward: …
We previously reported that in the ongoing Genentech v. Amgen litigation regarding Amgen’s proposed bevacizumab biosimilar, Mvasi™, Amgen moved to dismiss Genentech’s declaratory judgement counts relating to when Amgen could begin commercial marketing of its product. In particular, Genentech had sought a judgment that Amgen could not market its product…
Today, in the Immunex v. Sandoz patent litigation under the BPCIA concerning Sandoz’s Erelzi™ (etanercept-szzs) biosimilar, New Jersey District Judge Claire C. Cecchi issued an order that trial will commence on September 11, 2018. (Trial had originally been slated to begin this month.) The Court also ordered the parties to…
AbbVie recently announced positive results for upadacitinib, a small molecule Janus Kinase (JAK) inhibitor, in a phase 3 clinical trial of patients with rheumatoid arthritis (RA). According to AbbVie, upadacitinib met all primary and secondary endpoints in the study, including superiority versus adalimumab, the anti-TNFα antibody that Abbvie markets as…
Last week, Japan-based Nichi-Iko Pharmaceutical Co. announced the completion of a biologics production facility in Osong, South Korea by its Korean affiliate Aprogen Biologics “[t]o provide a stable supply of premium quality biosimilars to market in the USA as well as Japan.” The facility will reportedly use a perfusion system…
This morning, the United States Supreme Court issued two key decisions concerning the fundamental authority of the United States Patent and Trademark Office (USPTO) to institute inter partes review (IPR) proceedings. First, in Oil State Energy Services, LLC v. Greene’s Energy Group, LLC, the Court held in a seven to two…
Today, Pfizer announced that it received a Complete Response Letter (CRL) from the FDA in response to Pfizer’s application for its proposed biosimilar of Herceptin® (trastuzumab). According to Pfizer’s press release, the CRL “highlighted the need for additional technical information,” but the “requested information does not relate to safety or…
Pegfilgrastim litigation We had previously covered Judge Stark’s grant of Coherus’s motion to dismiss Amgen’s complaint alleging infringement of the ‘707 patent in Amgen v. Coherus. Today, Judge Stark entered judgment against Amgen and dismissed the case. In the Amgen v. Mylan litigation earlier covered here, Mylan recently filed a…
Last week, Fujifilm Kyowa Kirin Biologics (FKB) and Mylan announced that they will partner with one another to commercialize in Europe FKB327, a biosimilar of adalimumab developed by FKB. As we previously reported, the European Medicines Agency (EMA) accepted FKB’s Marketing Authorization Application for review on May 18, 2017 and the companies expect to get a decision from EMA by the second half of this year. Under the agreement, FKB grants Mylan…
Pursuant to the five year reauthorization of FDA’s user fee programs for prescription drugs, generic drugs, and biosimilars, FDA recently released its five-year financial plans (2018-2022) for the programs. The plans “communicate the anticipated financial positions of the Biosimilar User Fee Amendments of 2017 (BsUFA II), the Generic Drug User…