Richards Layton & Finger
 

Judge Sleet Grants Motions to Dismiss Declaratory Judgment Claim

June 14, 2018

In Genentech, Inc. v. Amgen Inc., No. 17-1407-GMS (D. Del. Apr. 17, 2018), and related action, Judge Sleet granted Amgen Inc.’s motions to dismiss the plaintiffs’ declaratory judgment claim for failure to state a claim and for lack of subject matter jurisdiction. According to the decision, during the pre-litigation BPCIA “patent dance,” Amgen had stated that it did not intend to begin commercial marketing of the accused product before December 18, 2018, but later changed that date to April 4, 2018. The plaintiffs sought a declaratory judgment that Amgen could not begin commercial marketing before the December date, claiming that the BPCIA gave them a private right of action to hold Amgen to the December date. (A BPCIA infringement claim was also at issue in these actions.) As the April 4 date had passed, and Judge Sleet found that there was no other indication that Amgen had launched the accused product, the Court found that there was not sufficient immediacy to the commercial marketing claim and thus no actual controversy. Accordingly, Judge Sleet granted the motions to dismiss (while recognizing that the Court may need to revisit the issue should Amgen seek to launch before the December date).

Key Point: Although stating that the plaintiffs were asserting a “novel legal theory not yet addressed by any court”—whether a biosimilar applicant may change the date on which it noticed its intent to begin commercial marketing—Judge Sleet ruled on other grounds, leaving this issue open.