viernes, 3 de marzo de 2017

FDA Law Blog: The Demise of the BPCIA Patent Dance?

FDA Law Blog: The Demise of the BPCIA Patent Dance?



Posted: 02 Mar 2017 12:45 PM PST
By Sara W. Koblitz –

Well, that was quick! Only two weeks after filing, the U.S. District Court of Delaware dismissed Genentech’s Complaint under the Biologics Price Competition and Innovation Act ("BPCIA") against Amgen.  As we explained here, Genentech sued Amgen for failure to comply with the patent dance provisions of the BPCIA when Amgen provided Genentech with a copy of its aBLA referencing Avastin within 20 days, but refused to provide any information on the manufacturing process as required under 42 U.S.C. § 262(l)(2)(A).

This action comes after Amgen Inc. v. Sandoz, in which Amgen sued Sandoz for refusing to participate in the exchange of patent information under the BPCIA. There, the Federal Circuit determined that the patent dance was voluntary (see our prior coverage here). Genentech argued vigorously to distinguish this case from the Sandoz case, stating that the Federal Circuit did not foreclose declaratory judgment actions to determine whether an applicant complied with its statutory obligations. In a Letter to the Court, Genentech argued that Amgen is trying to “escalate the stakes” by “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.”

Conversely, Amgen argued in a similar Letter to the Court that the case could not be distinguished from Amgen v. Sandoz, and that any attempt to do so would penalize Amgen’s good faith effort to comply with the BPCIA patent dance.  Amgen argues that Genentech’s only recourse here is a patent infringement lawsuit.

The District Court did not buy Genentech’s distinction and dismissed Genentech’s action without prejudice after an oral hearing. The Court’s decision implies that the only recourse Genentech has is a patent infringement action.  The court gave Genentech 45 days to amend its complaint.  The Supreme Court isn’t set to hear arguments in Amgen v. Sandoz until April 26, 2017, after the 45 days expires.  We’ll have to wait to see if Genentech goes full throttle with a patent infringement case based on the information Amgen has provided thus far.  But if the Supreme Court decides that the patent dance is mandatory, then the issue of how much information is necessary to fulfill the obligations will surely come up again swiftly.

The dismissal raises some questions about what it actually means to opt-into the patent dance under the BPCIA. If it’s not mandatory under Amgen v. Sandoz, and there’s no mechanism to challenge compliance for those aBLA applicants who choose to participate, how can reference product sponsors get the information necessary to bring an infringement suit?  Should they just bring an infringement suit and hope to find out more during discovery?  With 35 U.S.C. § 271(e)(2)(C), there’s a presumption of infringement should the aBLA applicant fail to engage in the patent dance, so pleading isn’t an issue, but it’s a costly decision to sue for patent infringement.  Until Amgen v. Sandoz is decided, we’re unlikely to have any answers to a multitude of questions.