On April 17, 2018, Judge Sleet of the District of Delaware dismissed Genentech’s declaratory judgment claim seeking to hold Amgen to representations made in its 42 U.S.C. § 262(l)(3)(B) patent dance statements that it would not launch its Avastin® biosimilar MvasiTM until December 2018, when several of Genentech’s patents would expire. (C.A. No. 17-1407, D.I. 86, 87; C.A. No. 17-1471, D.I. 84, 85.) After making such representations, Amgen provided Notice of Commercial Marketing to Genentech stating its intention to launch as early as April 4, 2018.
Genentech sued Amgen in October 2017, seeking to enforce Amgen’s representation that it would not launch its biosimilar until December 2018. In dismissing the count, the court did not reach Genentech’s “novel legal theory” that Genentech had a private right of action to bring such a declaratory judgment count under the Biologics Price Competition and Innovation Act (“BPCIA”). Instead, the court found that there was no “actual” and “immediate” controversy sufficient to warrant declaratory judgment jurisdiction over this count. The court pointed out that April 4, 2018 had come and gone, and there was no indication that Amgen would launch prior to December 2018. However, Judge Sleet promised that “[i]f this claim ripens into an actual controversy, where Amgen launches MvasiTM before December 18, 2018, there will be an opportunity for Genentech to seek a temporary restraining order or a preliminary injunction at that time.” Multiple counts of patent infringement remain in the case.
In a sense, this decision is in line with previous BPCIA decisions. As we explained here, courts seem to be wary of declaratory judgment claims in the BPCIA context. Courts have dismissed many BPCIA-related claims for lack of declaratory judgment jurisdiction without addressing the merits of the underlying claim. In fact, in February 2017, Judge Sleet dismissed a declaratory judgment complaint between these same parties (Genentech and Amgen) for alleged violations of the BPCIA. (See C.A. No. 17-165-GMS, D.I. 16.)
At the same time, this case exposes one of the many questions remaining about the role of the patent dance exchanges on later litigation. In Amgen v. Apotex, the Federal Circuit recently held that a biosimilar applicant’s positions on infringement during the patent dance are party admissions that have probative weight in a patent infringement analysis. However, the Federal Circuit held that these statements were non-binding, and, in fact, Apotex was permitted to change its position in that case. Despite the Federal Circuit’s guidance on infringement positions taken during the patent dance, no court has addressed the weight afforded to a biosimilar applicant’s pre-suit statement that it does not intend to launch prior to patent expiration.
As an initial matter, biosimilars may take the position that the outcome of this case was correct, and no “actual” dispute is present under its facts. As Amgen pointed out in its briefing, there is nothing inherently contradictory about stating an intention to launch after certain patents expire and giving Notice of Commercial Marketing long before that date. Nothing in the BPCIA or the current case law requires a biosimilar to wait until patents expire—or 180 days before then—to provide Notice. Amgen has not stated it will launch prior to patent expiration and, according to the court’s opinion, has shown no signs of preparing to launch early. But what would happen if a biosimilar did change its mind and decide to launch prior to date the biosimilar represented in the patent dance?
Analogous situations in the Hatch-Waxman context may shed some light on how a court may view a biosimilar’s decision to change its launch date after making representations in the patent dance. In a Hatch-Waxman dispute, a generic may convert its paragraph III certification (stating that it does not intend to launch prior to patent expiration) into a paragraph IV certification (challenging the patent as invalid, unenforceable or not infringed). When the generic makes this change, the branded company is entitled to notice prior to launch and can pursue patent infringement claims under 271(e)(2), but does not have a right to enjoin the generic from converting from a paragraph III to a paragraph IV certification or to enjoin the launch absent a preliminary injunction. A court may therefore find that a biosimilar can similarly change its position and only be exposed to a patent infringement claim under 271(e)(2). In this case, Genentech had already brought infringement claims on the earlier expiring patents under 271(e)(2) (in addition to declaratory judgment of infringement under 271(a)). And, presumably, Genentech could have filed a preliminary injunction motion to prevent an earlier launch of MvasiTM (although this would have likely been a harder path than simply arguing Amgen was bound to earlier representations).
However, reference product sponsors (RPSs) like Genentech may argue that the BPCIA requires a different outcome. In a Hatch-Waxman dispute, when a generic changes a paragraph III certification to a paragraph IV certification, the generic must provide its rationale for why the patent is invalid, unenforceable or not infringed. The conversion to a paragraph IV letter may also trigger a new 30-month stay for a patent listed in the Orange Book before the generic filed its ANDA.
In contrast, in the BPCIA patent dance, the times for providing contentions are circumscribed, and a biosimilar that changes its mind may escape the requirement of providing pre-suit invalidity or non-infringement contentions. RPSs may argue that such a result would upset the balance between RPSs and biosimilars set forth in the BPCIA. RPSs may claim that this is especially true because, unlike the steps in the Hatch-Waxman process, the biosimilar can forgo the dance altogether. Thus, if a biosimilar chooses to pursue the patent dance it should not be able to reap the benefits of the dance (e.g., controlling the first wave of litigation and obtaining the RPS’s validity and infringement contentions on certain patents) without fully adhering to the steps of the dance and being bound to its representations absent good cause. Further, RPSs may argue—as Genentech did in its briefing—that the Hatch-Waxman context is different because FDA enforces a generic applicant’s stated intent not to launch until patent expiry by not approving its product, whereas FDA does not enforce any procedural requirements of the BPCIA.
Indeed, MvasiTM was approved by the FDA on September 14, 2017, and Amgen can now launch at risk at any time. Should Amgen decide to launch before December 18, 2018, the court may have the opportunity to weigh in on the merits. 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.
Jenny Shmuel, Ph.D., 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 cross-examined witnesses at trial.
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