Big Molecule Watch
April 26, 2018

Court Grants Amgen’s Motion To Dismiss Genentech’s Declaratory Judgment Counts in Mvasi™ Litigation, and Sets June 2020 Trial Date

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 before December 18, 2018.  On April 17, the Court granted Amgen’s motion to dismiss.

According to the Court’s order, on March 23, 2017, after receiving Genentech’s list of patents during pre-suit patent exchanges (the “patent dance”), Amgen, pursuant to Section 262(l)(3)(B), declared that it does not intend to begin commercial marketing before December 18, 2018, when 8 of the 27 patents in the list will have expired.  Later, on October 6, 2017, when Amgen provided its notice of commercial marketing, Amgen stated that it would commence marketing no earlier than 180 days from that date, i.e., April 4, 2018.  Genentech’s commercial marketing claims sought to enforce Amgen’s earlier representation during the patent dance.  Amgen’s motion argued, among other things, that there was no cognizable legal theory under the BPCIA that would grant the relief that Genentech sought.

Without considering whether the BPCIA provided the relief that Genentech sought, the Court granted Amgen’s motion to dismiss.  In its opinion, Genentech’s claim was not of “‘sufficient immediacy’ to warrant the issuance of a novel declaratory judgment.”  The Court explained that “[i]t is unclear whether Amgen will actually launch Mvasi before December 18, 2018.  Genentech points to no evidence of an actual controversy other than the notice of commercial marketing.  The 180 days in the commercial marketing notice expired on April 4, 2018, and there is no indication that Mvasi has actually launched.”  The Court, however, dismissed the counts without prejudice, and stated that if an actual controversy were to arise by Amgen launching Mvasi prior to December 18, 2018, Genentech will have an opportunity to seek a preliminary injunction or temporary restraining order at that time.

In addition, in the same litigation, the Court issued an initial scheduling order which, among other things, instructs the parties to reduce the number of asserted patents from 26 to no more than 8 by August 31, 2018.  Further, the Court stated that it would like to “make an early determination” regarding whether Genentech can seek damages for activity that Amgen argues is protected by the safe harbor, and whether a jury trial would be appropriate for that issue.  The Court also set trial for June 1, 2020.  The Court instructed the parties to meet and confer to attempt to agree upon a proposed schedule for events not discussed in the initial order, and provided a schedule for resolving any disputes if the parties were unable to reach an agreement.

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