As we previously reported, Genentech earlier this month filed a declaratory judgment action against Amgen. In this litigation, Genentech claims that Amgen has violated the patent dance provisions of the BPCIA by disclosing its aBLA for a proposed biosimilar of Genentech’s Avastin® (bevacizumab) but refusing to provide additional manufacturing information beyond that in its application.
The parties have now filed letter briefs on the issue of whether the action should be dismissed as procedurally improper in view of the Federal Circuit’s decision in Amgen v. Sandoz, which held that it is optional for a biosimilar applicant to disclose its aBLA under 42 U.S.C. § 262 (l)(2)(A).
In its letter brief, Amgen argues that, despite pending Supreme Court review of the Federal Circuit’s decision, the holding in Amgen v. Sandoz is binding on the district court. On the merits, Amgen argues that because disclosure is optional under § 262 (l)(2)(A), the only remedy for non-compliance, as the Federal Circuit held, is an infringement action. Genentech’s declaratory judgment complaint, Amgen argues, is procedurally improper in that it requests remedies not authorized by the statute, such as directing Amgen to comply with § 262 (l)(2)(A) or resetting the BPCIA patent dance deadlines. Finally, Amgen argues that Amgen v. Sandoz cannot be distinguished on the basis that, here, Amgen did choose to disclose its aBLA to Genentech, stating that enforcing such a distinction would be contrary to the purpose of the statute: “Under Genentech’s approach … biosimilar applicants who refuse to provide their application in the BPCIA exchange would be immune from compulsory compliance with § 262(l)(2)(A) and subject only to patent litigation with limited patent remedies, while biosimilar applicants who provided their application would paradoxically be subject to compulsory compliance with § 262(l)(2)(A) with no limitation on the litigations and remedies it might be subject to.”
Genentech filed a letter brief in response, arguing that Amgen v. Sandoz does not control because it addressed a scenario where the biosimilar application did not participate in the BPCIA patent dance provisions at all. Genentech further argues that the net effect of Amgen’s position, even if correct, is to delay, rather than foreclose, decision on these issues: “Amgen’s strategy is not to avoid resolution of the dispute but to defer it and escalate the stakes, forcing Genentech either to produce a list of potentially infringed patents under § 262(l)(3)(A), without the full production of materials or expert assistance that should have informed that list, or sue Amgen for infringement and wait and see whether that lawsuit was proper at some later time. Neither the BPCIA nor the Declaratory Judgment Act requires Genentech to gamble this way.” Instead of facing this gamble, Genentech argues, a declaratory judgment action is proper to resolve the dispute over the parties’ rights under the BPCIA now. Genentech therefore requests that the district court issue a declaration that Amgen has not complied with § 262(l)(2)(A), and that, accordingly, Genentech need not serve its § 262(l)(3)(A) list of potentially infringed patents by the current deadline of March 24.
The district court will hear arguments on this issue tomorrow. Stay tuned to Big Molecule Watch for further developments.