On February 11, 2020, in the Biogen v. Amgen BPCIA litigation regarding MVASI (bevacizumab-awwb), Amgen’s biosimilar of AVASTIN, Judge Colm Connolly of the Delaware District Court denied most of Genentech’s motion to dismiss Amgen’s affirmative defenses and counterclaims. Amgen had pled counterclaims seeking declaratory judgments that the asserted patents are invalid, unenforceable, and not infringed. In the decision, the court decided two significant issues of BPCIA procedure. First, the court held that a biosimilar applicant can bring counterclaims of invalidity or noninfringement even if the applicant opted not to participate in the BPCIA’s “patent dance.” Second, the court held that in BPCIA litigation, a biosimilar applicant is not limited to the invalidity positions disclosed in its “section 3B” contentions to the reference-product sponsor during the patent dance.
In its motion, Genentech, the reference product sponsor (RPS), argued that because Amgen “failed to provide ‘such other information’ [in addition to Amgen’s aBLA] that describes its biosimilar manufacturing process,” as required in the information exchange of the BPCIA patent dance, “Amgen is barred… from asserting counterclaims that seek a declaratory judgment” that Genentech’s patents are invalid, unenforceable, or not infringed. The court held that it was unnecessary to resolve whether Amgen had satisfied the disclosure requirements of the patent dance because “the filing of counterclaims does not constitute ‘bringing an action’” under the statute. Therefore, according to the court, once sued for patent infringement by the RPS, a biosimilar applicant is permitted to bring counterclaims alleging invalidity or noninfringement of the asserted patents, regardless of whether the applicant participated in the patent dance.
Genentech also argued that Amgen’s counterclaims should be dismissed and its invalidity and unenforceability defenses should be struck, “to the extent the counterclaims and defenses rely on positions Amgen did not disclose during the patent dance.” Relying on the Supreme Court’s decision in Amgen v. Sandoz, the court held that the only consequences for a biosimilar applicant’s non-participation or inadequate participation in the patent dance is loss of control over the scope and timing of the patent litigation, and that a RPS’s only remedy is to bring a declaratory judgment action, as Genentech did. According to the decision, therefore, a biosimilar applicant is not precluded from introducing contentions or asserting defenses not disclosed during the patent dance. This decision brings BPCIA procedure in line with generally established procedures for Hatch-Waxman small molecule cases, in which defendants have not been limited in litigation to invalidity positions disclosed prior to litigation in Paragraph IV notice letters.
In its ruling, the court also addressed two other dismissal grounds raised by Genentech. The court denied Genentech’s motion to dismiss Amgen’s counterclaim asserting inequitable conduct during prosecution of one of the patents in suit. The court granted Genentech’s motion to dismiss Amgen’s counterclaims regarding two patents for which Genentech did not serve infringement contentions and had represented to Amgen that it did not plan to assert. The court held that there was no “actual controversy” regarding these patents and thus the court did not have jurisdiction to hear the claims.