Big Molecule Watch frequently posts on BPCIA litigation, a recent summary of which can be found here. As our readers know, the interpretation of various provisions of the BPCIA is currently before the Supreme Court in Sandoz v. Amgen, which we most recently covered when cert was granted, the briefing schedule was announced, and Sandoz’s opening brief was filed. One of the issues in dispute is whether the BPCIA’s “patent dance” is mandatory or optional.
A new issue regarding the BPCIA’s patent dance has arisen by way of a complaint that Genentech filed yesterday against Amgen in the District of Delaware. Genentech seeks a declaratory judgment that Amgen is violating the patent dance provisions of the BPCIA in connection with its proposed biosimilar of Genentech’s Avastin® (bevacizumab). As discussed in more detail below, Genentech alleges in its complaint that Amgen opted in to the patent dance by providing a copy of its aBLA to Genentech, but Amgen has refused to disclose manufacturing information beyond its aBLA, and refused to authorize Genentech to provide the aBLA to Genentech’s external experts for review for the purpose of determining potential infringement. Based on these allegations, Genentech asserts that it is entitled to a declaratory judgment that (a) Amgen has not complied with the disclosure provisions of subsections (l)(2)(A) and (1)(C) of the BPCIA; and (b) Amgen has failed to trigger the 60-day statutory window under subsection (l)(3)(A) for Genentech to provide its list of potentially infringed patents.
According to Genentech’s complaint, FDA notified Amgen on January 4, 2017, that it had accepted the aBLA for review, triggering the 20-day window under subsection (l)(2)(A) for Amgen to provide Genentech with “a copy of the application submitted to [FDA] under subsection (k), and such other information that describes the process or processes used to manufacture the biological product that is the subject of such application.” (emphasis added in complaint). Amgen allegedly produced only its aBLA, but not any additional manufacturing information. Genentech argues that it requires the additional manufacturing information in order to have a reasonable opportunity to take the next step in the patent dance under subsection (l)(3)(A) of identifying and serving Amgen with a list of patents that Genentech believes could reasonably be asserted within 60 days of receiving Amgen’s information. In challenging Amgen’s alleged refusal to provide the additional manufacturing information that Genentech requested, Genentech points out that Amgen itself has emphasized the importance of such manufacturing information in other BPCIA litigations where Amgen is the innovator. See, e.g., Amgen Inc. v. Hospira, Inc., No. 15-cv-00839-RGA (D. Del. Sept. 18, 2015).
Genentech also alleges that Amgen has refused to allow Genentech’s external antibody manufacturing experts to review Amgen’s aBLA. Genentech asserts that it provided Amgen with the CVs of its four retained experts, but that Amgen improperly withheld consent without providing grounds for disqualification, except for a claim of conflict in one instance. Genentech argues that this violates subsection (l)(1)(C) of the BPCIA by unreasonably withholding consent to share disclosures with outside scientific consultants.
Genentech thus seeks a judgment and order from the court that Amgen has violated subsections (l)(2)(A) and (l)(1)(C) of the BPCIA and must comply with those provisions. Genentech further seeks a judgment that its 60-day window for providing its list of patents under subsection (l)(3)(A) be delayed until Amgen provides it with the statutorily required information, and that Amgen be enjoined from commercially marketing its biosimilar and continuing to seek FDA review of its aBLA until it meets its obligations under the BPCIA.
Stay tuned to Big Molecule Watch for further developments.