Amgen and the BPCIA Patent Dance – Redux

By Sara W. Koblitz

2017 is already shaping up to be a big year in court for Amgen and the Biologics Price Competition and Innovation Act (“BPCIA”). As regular readers know, Amgen’s challenge to Sandoz’s refusal to participate in the patent dance after filing of an aBLA relying on Amgen’s Neupogen is heading to the Supreme Court this term (see our previous coverage here, here, here, and here). In a twist, Amgen will be headed back to court to litigate the BPCIA, but this time as the aBLA sponsor.

On Wednesday February 15, Genentech brought an action for declaratory judgment against Amgen for failure to comply with the patent dance provisions of the BPCIA. In November 2016, Amgen submitted an aBLA to FDA relying on Genentech’s cancer drug Avastin as the reference product. The aBLA was accepted for review on January 4, 2017, triggering the patent dance (should Amgen choose to participate). In an interesting footnote, Genentech distinguished this case from the aforementioned Amgen Inc. v. Sandoz because Amgen did, indeed, choose to participate rather than attempt to opt out of the BPCIA patent dance altogether.

According to Genentech, Amgen started the patent dance and provided Genentech a copy of its aBLA within 20 days, but refused to provide any information on the manufacturing process as required under 42 U.S.C. § 262(l)(2)(A). Additionally, Amgen allegedly insisted that Genentech’s patent counsel could evaluate proposed infringement and withheld consent to expert participation in violation of 42 U.S.C. § 262(l)(1)(C).

With only 60 days to deliver a list of patents that “could reasonably be asserted” against Amgen’s proposed aBLA, Genentech stresses in its complaint that it needs the “other information” under § 262(l)(2)(A) to preserve its applicable patent rights. For this reason, Genentech requests a declaratory judgment as well as 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 until the statutory process is complete.

In a clever bit of lawyering, Genentech uses Amgen’s own words in a similar matter to make its points. In 2015, Amgen sued Hospira when Hospira pulled the same stunt in the Epogen case (the complaint is here, and our prior coverage is here). The case is still ongoing, but it looks like Amgen took a page from the Hospira playbook.