As we previously reported, on May 22, 2018 in Genentech v. Amgen, which concerns Amgen’s Mvasi® (bevacizumab-awwb) biosimilar, Genentech filed a motion to dismiss and to strike Amgen’s counterclaims and certain affirmative defenses. On June 19, 2018, after Amgen filed under seal an amended answer and counterclaim, Genentech filed updated…
We have recently reported on multiple discovery rulings in the ongoing AbbVie v. Boehringer Ingelheim litigation concerning Boehringer Ingelheims’s (“BI’s”) aBLA for Cyltezo™ (adalimumab-adbm), a biosimilar version of AbbVie’s Humira® (adalimumab) product. On June 14, 2018, Magistrate Judge Lloret issued two additional opinions regarding discovery in the case. In the first opinion, the Court granted-in-part…
We have covered the ongoing AbbVie v. Boehringer Ingelheim litigation concerning Boehringer Ingelheims’s (“BI’s”) aBLA for Cyltezo™ (adalimumab-adbm), a biosimilar version of AbbVie’s Humira® (adalimumab) product, including the grant of a recent motion to compel discovery regarding BI’s unclean hands defense. Magistrate Judge Lloret issued two additional orders regarding discovery in that case….
On May 29, 2018, a week-long bench trial began before Judge Andrews in Sanofi-Aventis U.S. LLC v. Merck Sharpe & Dohme Corp. in the District of Delaware. As we reported here, Sanofi had sued Merck for patent infringement based on Merck’s proposed follow-on versions of Sanofi’s Lantus® and Lantus® SoloSTAR® ([rDNA origin]…
Below is a rundown of some recent developments in BPCIA litigations concerning biosimilars of Genentech’s Herceptin® (trasuzumab), Rituxan® (rituximab), and Avastin® (bevacizumab). Celltrion v. Genentech (trastuzumab) and Celltrion v. Genentech (rituximab) As we previously reported, on January 11, 2018, Celltrion and Teva filed two lawsuits against Genentech in the District…
As we previously reported, Sanofi-Aventis sued Merck Sharp & Dohme in the District of Delaware for patent infringement based on Merck’s proposed follow-on biologics of Sanofi-Aventis’s Lantus® and Lantus® SoloSTAR® ([rDNA origin] insulin glargine) prefilled cartridge products. On January 2, 2018, Merck moved for summary judgment of non-infringement on the grounds…
Below is a rundown of some recent developments in BPCIA litigations concerning biosimilars of Neupogen® (filgrastim) and/or Neulasta® (pegfilgrastim). Amgen v. Adello (filgrastim) As we previously reported, in March, Amgen filed a complaint for patent infringement against Adello Biologics based on its filing of an aBLA for a filgrastim biosimilar. …
Last week, the Federal Circuit issued a decision in Altaire Pharmaceuticals, Inc. v. Paragon Bioteck, in which the court held that Altaire had standing to appeal the PTAB’s final written decision in a post-grant review (“PGR”) of Paragon’s U.S. Patent No. 8,859,623 and reversed-in-part and vacated-in-part the PTAB’s Final Written Decision….
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…