Dismissal Demonstrates Need for Clarity on BPCIA Disclosure Steps

Fish & Richardson

On March 1, Judge Sleet of the District of Delaware granted Amgen’s Motion to Dismiss for lack of subject matter jurisdiction Genentech’s Complaint for Declaratory Judgment.  The Complaint sought a declaration that Amgen failed to comply with the disclosure requirements of the Biologics Price Competition and Innovation Act (“BPCIA”).  Judge Sleet’s Order gives Genentech 45 days to amend, and Genentech now faces a decision: take further steps in the “patent dance” and serve Amgen with a list of patents under 42 U.S.C. § 262(l)(3)(A) by March 24–based solely on Amgen’s abbreviated Biologic License Application (“aBLA”), or bring a declaratory judgement action for infringement under 35 U.S.C. § 271(e).

According to an official transcript of the hearing during which the Court granted Amgen’s oral motion, Genentech may pursue both lines of action in the coming weeks.  The dismissal illustrates the current need to clarify the BPCIA disclosure requirements, now before Supreme Court in Amgen v. Sandoz Inc., 794 F.3d 1347 (Fed. Cir. 2015) (cert. granted Jan. 13, 2017) (“Sandoz”).

After Amgen announced on January 4, 2017 that its biosimilar of Genentech’s AVASTIN® had been accepted for FDA review, the parties began the patent dance, with Amgen providing its aBLA to Genentech.  On February 15, Genentech filed a Complaint in the District of Delaware requesting “urgent” relief based on allegations that Amgen violated 262(l)(2)(A) of the BPCIA by refusing to provide its biosimilar manufacturing information.  Genentech argued that, without the manufacturing information, it could not complete the next step of the patent dance—providing Amgen with a list of patents that Genentech believes could be reasonably asserted.  Genentech also alleged that Amgen improperly refused to allow Genentech to share the aBLA with outside experts, but this issue was resolved before the oral arguments on March 1. (3/1/17 Transcript at 31:16-19).

In opposing Amgen’s Motion to Dismiss, Genentech argued that its action was proper because Amgen failed to comply with §§ 262(l)(2)(A).  Genentech’s arguments mirrored those made by Amgen in other cases, where Amgen took the role of the reference product sponsor. See Amgen v. Hospira, No. CV 15-839-RGA, 2016 WL 7013483 (D. Del. Nov. 30, 2016) (Amgen charging Hospira for BPCIA non-compliance for its refusal to provide information outside of its aBLA).  Genentech wanted to avoid a situation that “escalate[d] the stakes” by forcing Genentech to either produce a list of potentially infringed patents under § 262(l)(3)(A) without the benefit of expert assistance informing the list (potentially waiving rights on unlisted patents), or sue outside of the BPCIA and “wait and see whether that lawsuit was proper at some later time.” (Dkt. 13 at 12).

The Court declined to rule on the question of Amgen’s compliance with the BPCIA.  Instead, the Court sided with Amgen, stating that before it was “a request, styled as a complaint, ostensibly for declaratory judgment … to act on [Genentech’s] interpretation of what the [BPCIA] statute requires.” (3/1/17 Transcript at 10:16-18).  Amgen had previously described Genentech’s Complaint as seeking “an advisory opinion … to inform what decision [Genentech] should be making under the BPCIA.” (3/1/17 Transcript at 13:5-7).  The Court agreed with Amgen and concluded that it lacked subject matter jurisdiction.

To arrive at its holding, the Court relied on the Federal Circuit’s language in Sandoz, which states that “the BPCIA does not specify any non-patent-based remedies for a failure to comply with paragraph (l)(2)(A),” Amgen v. Sandoz, 794 F.3d at 1356.  The Court dismissed Genentech’s attempts to distinguish the facts of Sandoz (where Sandoz had clearly stated that it “opted out” of the patent dance) from the facts of this case (where Amgen had ostensibly “opted in” to the patent dance by providing its aBLA).  The Court found the distinction to be a “red herring” since there is no “opt in/opt out language” in the statute. (3/1/17 Transcript at 6:10-11).  Notably, although bound by the Federal Circuit’s decision, both Amgen and the Court expressed disagreement with the Sandoz majority, with Judge Sleet suggesting that “Judge Newman is correct in her dissent” that the disclosures of paragraph (2)(A) were mandatory for subsection (k) applicants.  The Court stated that making the steps of the patent dance optional “reward[s] bad behavior.” (3/1/17 Transcript at 5:24-25 and 26:16-17).

Addressing Genentech’s concerns during the hearing, the Court noted that because “[t]he law is evolving as we speak on this,” any future foreclosure is very unlikely.  In particular, the Court expressed skepticism that Genentech “would be forever shut out from asserting patents that were not listed as a result of [a] lack of information” since Genentech “would have almost by definition good cause to have those patents included in [any] already filed infringement action.”  Genentech expressed comfort in knowing that it is not “faced with a ‘list it or lose it’ deadline” in the event it can later show that there was manufacturing information it was not able to obtain. (3/1/17 Transcript at 28:19-24).

Genentech has 45 days to amend its Complaint and until March 24 to provide Amgen with a list of patents under § 262(l)(3)(A).  We will continue to monitor these issues and provide updates.


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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