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…
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…
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 the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) recommended two biosimilar medicines for approval. First, the CHMP adopted a positive opinion for the marketing authorization of Kanjinti® (ABP 980), Amgen and Allergan’s proposed biosimilar to Herceptin® (trastuzumab). The CHMP opinion recommends…
As we previously reported, Amgen is seeking en banc review of the Federal Circuit panel decision vacating a permanent injunction that would have otherwise prohibited the sale of Sanofi and Regeneron’s Praluent® (alirocumab) product and remanding the appeal to the district court for a new trial on the defendants’ written…
We previously reported on Genentech’s complaint in the District of Delaware alleging that Amgen’s MVASI™ (bevacizumab-awwb) infringes over twenty Genentech patents and Amgen’s motion to transfer that complaint to the Central District of California. Today Amgen filed its reply (redacted) in support of transfer. In its reply, Amgen addresses Genentech’s…
As we previously reported, on October 6, 2017, Amgen and Genentech filed separate lawsuits regarding Amgen’s bevacizumab biosimilar (MVASI®), with Amgen filing for declaratory judgment in C.D. Cal. of non-infringement, invalidity, and unenforceability of 27 patents, and Genentech filing a complaint for infringement of 24 patents in Delaware and a…
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…
On January 3, 2017 in the Amgen v. Sanofi/Regeneron action, Judge Robinson denied Defendants’ motion for judgment in their favor as a matter of law (JMOL) and request for a new trial regarding written description and enablement of the asserted claims of the patents-in-suit. On March 16, 2016, after a trial,…
