GENENTECH OPPOSES TRANSFER OF DELAWARE MVASI™ (BEVACIZUMAB-AWWB) LITIGATION TO CALIFORNIA

Biologics Litigation  •  Genentech v. Amgen (bevacizumab)

We reported earlier on Genentech’s complaint in the District of Delaware alleging that Amgen’s MVASI™ (bevacizumab-awwb) infringes over twenty Genentech patents, and Amgen’s motion to transfer that complaint to the Central District of California, where Amgen had previously filed a declaratory judgment action against the same patents that Genentech later asserted against Amgen.  A redacted version of Genentech’s opposition to Amgen’s motion to transfer the District of Delaware bevacizumab action to the Central District of California extensively addresses the private and public interest factors that Genentach contends weigh against transfer.

The Genentech opposition also states that Amgen’s “first filed” case should receive no deference when considering transfer because “Amgen was prohibited from suing by express provisions of the BPCIA.”  Opp. at 19.  Genentech states that Amgen failed to comply with § 262(l)(2)(A) by “refusing production of anything except its aBLA” and that “[s]ection (l)(9)(C) prohibits declaratory judgment lawsuits by any biosimilar applicant who fails to comply with its obligation under § 262(l)(2)(A) to provide the reference product sponsor with a copy of the aBLA ‘and such other information that describes the process or processes used to manufacture the biological product that is the subject of such application.’”  Id.  Genentech, states that even if Amgen had complied with § 262(l)(2)(A), Amgen’s DJ complaint would have been barred under § 262(l)(9)(B):

Section (l)(9)(B) prohibits biosimilar applicants from suing before the “patent dance” has concluded, in particular before the applicant has satisfied its obligations under, among other provisions, § 262(l)(5).  It is undisputed that did not occur.  After Amgen sued Genentech, it sent a letter suggesting the parties complete the “patent dance” the following week.”

Opp. at 20.

Genentech also points to its second District of Delaware complaint regarding MVASI™ (bevacizumab-awwb) (1:17-cv-01471-GMS), which we reported on here, as further support for denying transfer.  Genentech states that the second case contains “the claims under 35 U.S.C. § 271(e)(2) that Genentech was required to file after the ‘patent dance’ concluded, and that only Genentech is authorized to bring.”  Opp. at 14.  Genentech further states that “[t]here is no basis for transferring that [second] case” and “because the patents at issue in Genentech’s claims under § 271(e) overlap entirely with the patents at issue here, where Genentech seeks, inter alia, infringement damages under § 271(a) for Amgen’s pre-approval manufacturing, that is an additional reason to deny the transfer motion.”  Id. (footnote and citations omitted).

We will continue to follow the developments in the Delaware and California MVASI™ (bevacizumab-awwb) actions.

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