In a recent decision involving the Biologics Price Competition and Innovation Act ("BPCIA") (Genentech, Inc. and City of Hope v. Amgen Inc.) the Delaware District Court dismissed a claim seeking to enforce a statement of intended launch during the parties' patent dance on the grounds that the controversy was not sufficiently immediate to warrant issuance of a declaratory judgment.
The dispute arose when Amgen provided its 180-day notice of commercial marketing to plaintiffs Genentech, Inc. and City of Hope (collectively, "Genentech") under paragraph (8)(A) of the BPCIA for Mvasi™, a biosimilar version of Genentech's Avastin®. Under this notice, the 180-day period would expire on April 4, 2018, however, less than five months earlier, during the parties' patent dance, Amgen had stated that it would not launch Mvasi™ before December 18, 2018. In other words, Amgen's 180-day notice of commercial marketing provided a launch date 8 months earlier than the date provided in the patent dance.
Genentech moved for declaratory judgment that Amgen cannot market its biosimilar product before December 18, 2018, based on Amgen's statements during the parties' patent dance. Amgen moved to dismiss the counts for failure to state a claim and for lack of subject matter jurisdiction. Amgen argued that there was no legal basis to grant the relief requested by Genentech because Genentech relied on a quasi-contract theory and there was no binding representation, no breach of representation, and no detrimental reliance. Genentech, however, responded that its request for relief was based on a private right of action under the BPCIA itself, not a quasi-contract theory. The court acknowledged this was "a novel legal theory not yet addressed by any court," but it found "no need to delve into this unchartered territory at this time."
The court granted Amgen's motion to dismiss for a lack of subject matter jurisdiction because "it is unclear whether Amgen will actually launch Mvasi™ before December 18, 2018." The court stated Genentech's "claim is not of 'sufficient immediacy' to warrant an issuance of a novel declaratory judgment." At the same time, the court noted that Genentech's claim would ripen if Amgen launches Mvasi™ before December 18, 2018, and Genentech would have an opportunity to seek relief at that time through a temporary restraining order or a preliminary injunction.
This decision underscores the importance of statements made during the patent dance. Although the court did not address the merits of Genentech's "private right" claim, it expressed willingness to do so in future if Genentech's claim ripens and Genentech seeks the suggested relief from the court. We will continue to monitor the progression of this issue and provide updates as necessary.
For further information, please contact your principal Firm representative or one of the lawyers listed below. General email messages may be sent using our "Contact Us" form, which can be found at www.jonesday.com/contactus/.
Gasper J. LaRosa
Mital B. Patel
Jones Day publications should not be construed as legal advice on any specific facts or circumstances. The contents are intended for general information purposes only and may not be quoted or referred to in any other publication or proceeding without the prior written consent of the Firm, to be given or withheld at our discretion. To request reprint permission for any of our publications, please use our "Contact Us" form, which can be found on our website at www.jonesday.com. The mailing of this publication is not intended to create, and receipt of it does not constitute, an attorney-client relationship. The views set forth herein are the personal views of the authors and do not necessarily reflect those of the Firm.