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…
Yesterday, Samsung Bioepis announced that the FDA has accepted for review the company’s BLA under the 351(k) pathway for SB3, a biosimilar candidate referencing Genentech’s Herceptin® (trastuzumab). The press release states that this is Samsung Bioepis’ first submission for FDA-approval of an oncology biosimilar candidate. According to the press release,…
Stay tuned for an in depth analysis of the arguments.
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,…
The parties in Amgen v. Sandoz (N.D. Cal.) (filgrastim and pegfilgrastim) have submitted a joint case management statement regarding the two pending cases between the parties: Case No. 3:14-cv-04741-RS (accused product: Zarxio® (filgrsatim-sndz), which Sandoz launched in September, 2015) and Case No. 3:16-cv-02581-RS (accused product: pegfilgrastim (biosimilar to Amgen’s Neulasta®). The parties…
A few BPCIA litigation updates to wrap up the week for our readers, looking ahead to next week: The Federal Circuit issued its formal mandate in Amgen v. Apotex yesterday. With the issuance of the formal mandate, the Federal Circuit has officially ordered that its July opinion in the case must now be…
Apotex has filed its reply brief in Amgen v. Apotex, which is currently on appeal before the Federal Circuit. The brief is available here. As we covered previously, the district court granted Amgen a preliminary injunction to prevent Apotex from marketing its biosimilar pegfilgrastim product until 180 days after Apotex provides a…