Delaware District Dismisses BPCIA "Private Right" Claim; Says Controversy not Sufficiently Immediate

Delaware District Dismisses BPCIA "Private Right" Claim; Says Controversy not Sufficiently Immediate

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.

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