On February 15, Genentech filed a complaint against Amgen in the District of Delaware seeking “urgent declaratory and related relief” under the Biologics Price Competition and Innovation Act (“BPCIA”). Unlike many other BPCIA cases, Genentech is not asserting infringement of any particular patent, but is rather solely seeking declaratory judgment related to alleged violations of the BPCIA disclosure requirements.
According to the Complaint, Amgen filed an aBLA to commercialize ABP 215, its biosimilar of Genentech’s Avastin®, and has opted into the “patent dance” by producing a copy of its aBLA—but now Genentech claims it faces “an imminent statutory deadline to provide Amgen a list of potentially infringed patents [under provision 3(A)]” that it cannot meet. Genentech contends it is unable to properly evaluate its patent portfolio and provide a complete patent list due to Amgen’s violations of two sections of the BPCIA. First, Genentech asserts that Amgen failed to produce complete information under §262(l)(2)(A) –Amgen allegedly ignored Genentech’s specific request for certain categories of additional information and instead claimed the disclosure of the aBLA was sufficient to meet the statutory requirements. Second, Genentech claims that Amgen unreasonably refused to allow Genentech to share the aBLA with outside expert consultants, violating §262(l)(1)(C). Genentech points to “potentially disastrous” consequences that would result from failing to list a patent on its 3(A) list under the BPCIA, including being barred from later asserting the missing patents. The Complaint thus seeks “an order declaring that Amgen has failed to comply with its obligations under 42 U.S.C. § 262(l)(1)(C) and § 262(l)(2)(A), directing Amgen to comply, resetting the BPCIA deadlines for resolving patent disputes, and prohibiting Amgen from selling its proposed biosimilar to Avastin®, ‘ABP 215,’ until the statutory process is completed and Genentech has an opportunity to vindicate its patent rights.” (Complaint at 5.)
Genentech distinguishes the factual scenario it now faces from that before the Supreme Court in Sandoz (cert. granted Jan. 13, 2017). There, the Supreme Court is reviewing whether an applicant can opt out of the patent dance altogether. Here, in contrast, Amgen has apparently opted into the dance by providing Genentech with the aBLA, triggering the other deadlines outlined in the BPCIA.
Amgen is a repeat play in the biosimilar litigation to date, and interestingly, has taken a position against Genentech that is inconsistent with its position in Amgen v. Hospira (15-cv-00839, D. Del; CAFC 16-2179). In Amgen v. Hospira, Amgen, as the reference product sponsor, complained that Hospira refused to provide information outside its aBLA, and Amgen even contended that it could end up facing Rule 11 sanctions for proceeding with the patent dance (and eventual BPCIA litigation) without the allegedly missing information. (See CAFC 16-2179, Dkt. 39 at 11.) Amgen thus tried to obtain the allegedly withheld information during discovery in a subsequent BPCIA litigation, and was barred because the discovery was not directly relevant to the patents at issue in that suit – an issue now teed up on appeal before the Federal Circuit. In this case, Amgen is on the other side of the table, proceeding as the biosimilar applicant and withholding information beyond its aBLA. The tension between Amgen’s position against Hospira and Amgen’s position against Genentech, noted in Genentech’s recent complaint, will hopefully work to clarify the contours of the disclosure requirements under the BPCIA.
Amgen’s aBLA was accepted by the FDA on January 4, 2017. Assuming Amgen’s disclosure of its aBLA meets the requirements of § 262(l)(2), Genentech has until March 24, 2017 to provide Amgen with a patent list under §262(l)(3)(A). We will continue to monitor this case and provide updates.
Authors: Jenny Shmuel, Tasha Francis
The opinions expressed are those of the authors on the date noted above and do not necessarily reflect the views of Fish & Richardson P.C., any other of its lawyers, its clients, or any of its or their respective affiliates. This post is for general information purposes only and is not intended to be and should not be taken as legal advice. No attorney-client relationship is formed.
Dr. Jenny Shmuel represents clients on a range of intellectual property matters, with an emphasis on medical device and pharmaceutical technologies. She has extensive experience in pre-suit diligence, case management, expert and fact discovery, and brief writing, and has examined and...