Trastuzumab, Rituximab, and Bevacizumab Litigation Updates

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 Court for the Northern District of California, seeking declaratory judgments of non-infringement, invalidity and/or unenforceability of Genentech’s patents.  On February 28, 2018, Genentech filed a motion to dismiss in Case No. 3:18-cv-00276, relating to Celltrion’s Truxima®, its rituximab biosimilar.  On March 2, 2018, Genentech filed a similar motion to dismiss in Case No. 3:18-cv-00274, relating to Celltrion’s Herzuma®, its trastuzumab biosimilar.  On May 9, 2018, the Court granted Genentech’s motion to dismiss in both cases.

As we previously reported, on January 12, 2018, Genentech filed its own lawsuits against Celltrion and Teva.  Case No. 1-18-cv-00095, relating to Celltrion’s Herzuma® product, is pending in the District Court for the District of Delaware.  Case No. 1:18-cv-000-574, filed in the District Court for the District of New Jersey, relates to Celltrion’s Truxima® product.

Genentech v. Amgen (bevacizumab)

On May 1, 2018, Amgen filed its Answer to Genentech’s Amended Complaint in litigation pending in the District Court for the District of Delaware.  A redacted version was later filed on May 8.

On May 11, 2018, the parties filed a proposed scheduling order, which included proposals on filing summary judgment motions.  The parties agreed that Amgen “may file a summary judgment motion solely directed to the availability of damages for Plaintiffs’ claims for infringement arising from Defendant’s manufacturing activities and whether Plaintiffs are entitled to a jury trial.”  (Paragraph 9 of the proposed scheduling order.)  On May 16, 2018, the Court issued an order stating that “should the court determine that plaintiffs are not entitled to a jury trial in accordance with paragraph 9 [of the parties’ proposed scheduling order], the court will not contemplate any requests for summary judgment, as is consistent with this court’s practice for non-jury trial cases.”

On May 18, 2018 the Court issued a revised scheduling order.  The case is scheduled for trial beginning in July 2020.  Genentech has until August 31, 2018 to reduce the number of asserted patents from 31 to eight, and to identify no more than twenty claims for construction by September 17, 2018.  A claim construction hearing is scheduled for February 21, 2019.

On May 22, 2018, Genentech filed a motion to dismiss and to strike Amgen’s Counterclaims and certain affirmative defenses.  Genentech’s brief in support of its motion is currently under seal.