Biosimilar Litigation Updates: Joint Status Reports

Genentech v. Pfizer (trastuzumab): On February 12, 2018, the parties filed a joint status report.  Among other things, the parties offered their competing proposals for discovery deadlines.  The parties stated that they have been “engaged in the exchanges of information provided under the” BPCIA and that Pfizer provided its notice of commercial marketing pursuant to 42 U.S.C. § 262(l)(8)(A) on November 17, 2017.  The parties also stated that they “believe that they will be in a position to reduce the number of Asserted Patents when they complete their exchanges under the BPCIA and have proposed deadlines in March 2018 to facilitate narrowing the number of Asserted Patents.”  The parties jointly proposed a December 2019 bench trial date.  Neither party currently seeks a jury trial, but Genentech indicated that it believes a jury trial will be necessary if, before trial, Pfizer launches its biosimilar product or engages in activities outside the 271(e)(1) safe harbor.

Genentech v. Amgen (bevacizumab): On February 12, 2018 the parties filed a joint status report.  The parties offered competing proposals for schedules and the scope of discovery, and how to narrow the case by reducing the asserted claims and patents for trial.  For example, Genentech proposed that the parties should “conduct discovery in two phases in advance of a single trial,” the first phase would be an “initial, discrete phase of discovery directed to Amgen’s manufacturing processes” and discovery regarding Amgen’s safe harbor defense.  Under Genentech’s proposal, the second phase “will then proceed to discovery and claim construction proceedings” on a narrowed list of patents selected by Genentech.  Amgen proposed that discovery proceed in a single phase.  Regarding a trial date, Amgen proposed a trial on unexpired patents in May 2019, whereas Genentech proposed a trial in 2021.  Genentech requested a jury trial, while Amgen contends that Genentech is not entitled to a jury trial.

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