Genentech’s lawsuit against Amgen has come to a quick (although perhaps temporary) end, with the Court dismissing Genentech’s complaint without prejudice on March 1, 2017 for lack of subject matter jurisdiction in light of Amgen Inc. v. Sandoz Inc., 794 F.3d 1347 (Fed. Cir. 2015). As discussed in our earlier post (which raised the question of whether Genentech had stated a claim on which relief could be granted), the Complaint for Declaratory Judgment filed by Genentech on February 15, 2017, alleged that Amgen failed to comply with the disclosure requirements of section (l)(2)(A) of the Biologics Price Competition and Innovation Act (“BPCIA”) in the “patent dance” involving Amgen’s bevacizumab product, a proposed biosimilar to Genentech’s Avastin®.
The whirlwind began on February 22, 2017—a week after the complaint was filed—with Genentech requesting a “speedy hearing” pursuant to Federal Rule of Civil Procedure 57. Genentech sought a quick resolution because Genentech itself alleges that it faces a statutory deadline of March 24, 2017 to provide Amgen with its patent list under section (l)(3)(A) of the BPCIA. Judge Sleet scheduled a teleconference with the parties on the morning of February 24, 2017 and then held follow-up teleconferences later that same day. The Court ordered the parties to submit 3-page letter briefs on February 27 and 28, 2017, respectively, and scheduled a hearing for March 1, 2017.
Amgen argued that although it disagreed with the Federal Circuit’s interpretation of 42 U.S.C. § 262(l)(2)(A) in Amgen v. Sandoz, the Federal Circuit’s decision in that case mandated that the only course of action provided by the BPCIA for non-compliance with the disclosure requirements of section (l)(2)(A) is a declaratory judgment action for patent infringement, and therefore the relief sought by Genentech’s declaratory judgment complaint was procedurally improper.
Genentech countered that “the Federal Circuit did not (and did not purport to) foreclose declaratory judgment actions to determine whether an applicant complied with its statutory obligations” in Amgen v. Sandoz and that “it is only after [the] dispute regarding Amgen’s compliance is resolved that Sandoz’s guidance on remedies even becomes relevant.” Genentech argued that Amgen was simply seeking to defer resolution and force Genentech’s hand into a potential procedural default because if Genentech files a declaratory judgment action for infringement, Amgen will then move to dismiss that action under § 262(l)(9)(A).
Section (l)(9)(C) of the BPCIA provides that if an applicant “fails to provide the application and information required under paragraph (2)(A),” then the reference product sponsor (but not the applicant) may bring a declaratory judgment action for infringement of “any patent that claims the biological product or a use of the biological product.” See 42 U.S.C. § 262(l)(9)(C). On the other hand, section (l)(9)(A) of the BPCIA expressly states that if the applicant “provides the application and information required under paragraph (2)(A),” the reference product sponsor may not bring a declaratory judgement for infringement of any patent that is described in clauses (8)(b)(i) and (ii), prior to the date notice of commercial marketing is received. Therefore, as explained in our earlier post, if Amgen has not provided sufficient information to satisfy the disclosure requirement of section (l)(2)(A), then Genentech is permitted to bring a claim for patent infringement, validity, or enforceability pursuant to section (l)(9)(C). But, if Amgen has satisfied the disclosure requirements of section (l)(2)(A), then Genentech is prohibited from bringing a declaratory judgment claim for patent infringement until after the notice of commercial marketing is received.
For now, Judge Sleet has agreed with Amgen and dismissed the suit in light of the existing Federal Circuit precedent (which is currently on appeal to the Supreme Court as discussed here). However, the order of dismissal expressly provides that the Complaint is being dismissed without prejudice, with leave to amend within forty-five days. While this case is dismissed for the moment, the dispute is surely not at an end.
This decision leaves for another day the answer to the question of what information, if any, in addition to the application, an applicant must provide to the reference product sponsor to satisfy the second clause of section (l)(2)(A). Stay tuned.