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 second complaint in Delaware for infringement of 25 patents. Subsequently, Genentech filed a motion to dismiss Amgen’s DJ complaint, while Amgen moved to transfer the Delaware actions to California.
On January 11, 2018, Judge George Wu of the Central District of California, issued a Tentative Ruling on Defendant Genentech, Inc.’s motion to dismiss Amgen’s DJ Complaint. In the Tentative Ruling, Judge Wu held that “pursuant to the discretion provided by the Declaratory Judgment Act” the court would grant the motion and decline jurisdiction over Amgen’s declaratory judgment action, but stayed its decision pending Judge Sleet’s determination of Amgen’s motion to transfer Genentech’s suit in Delaware to the Central District of California.
In the Tentative Ruling, which has been entered on the docket, Judge Wu discussed the language in the BPCIA, the parties’ exchanges during the patent dance, and the Supreme Court’s ruling in Sandoz Inc. v. Amgen, 137 S.Ct. 1664, 1670 (2017). Judge Wu concluded that “[t]he BPCIA is thus structured so that after the applicant provides notice of commercial marketing, either party can bring suit with respect to any of the leftover patents that were not selected for litigation through the parties’ exchanges and negotiations”, but not the patents that were to be litigated in a “first phase” litigation. Ruling at 4-5. Thus, Judge Wu rejected “Amgen’s argument that it was entitled to bring suit after providing its notice [of commercial marketing] but before completing the rest of the BPCIA’s patent list exchange steps.” Id. at 5. The Court also recognized that “for all intents and purposes” Genentech had filed the “litigation contemplated by the BPCIA in the District of Delaware” that concerned many of the same patents. Id. Therefore, dismissing the Amgen DJ action would “avoid significantly duplicative litigation.” Id. The court stayed issuance of a final order on dismissing Amgen’s DJ complaint pending a determination on the motion to transfer the Delaware case to the Central District of California, and stated that if the case was transferred to California, “some of the Court’s concerns [about hearing Amgen’s DJ case] would be ameliorated.” Id.
Yesterday, Amgen filed a supplemental brief to address whether an applicant may seek declaratory relief pursuant to § 262(l)(9)(A) upon providing its notice of commercial marketing, under the holding in Sandoz and the text of the BPCIA. Amgen argues that its DJ complaint is properly before the Court under Sandoz and that the statutory text of the BPCIA further supports its DJ action.