Last month, a divided panel of the Federal Circuit issued a split decision in Amgen v. Sandoz (summary; opinion). Amgen (in which Patterson Belknap represented one of the amici supporting Amgen) is the court’s first decision interpreting the patent dispute resolution provisions of the Biologics Price Competition and Innovation Act (BPCIA). But if the parties have their way, the panel decision will not be the Federal Circuit’s last word on the issues in dispute – and the court’s next intervention may come sooner rather than later. Last week, both parties petitioned for en banc rehearing of the panel’s decision. And on Wednesday, Amgen filed an emergency motion for an injunction pending en banc consideration and review, asking the full court to make a preliminary assessment of the issues before September 2, when the injunction issued by the original panel expires.
In Amgen, the panel (Judges Lourie, Newman, and Chen) addressed two provisions of the BPCIA “patent dance.” The first was 42 U.S.C. § 262(l)(2)(A), which provides that biosimilar applicants “shall provide” reference product sponsors or innovators with “a copy of the application” and “such other information that describes the process or processes used to manufacture the biological product” after FDA accepts the application for review. Judge Lourie, joined by Judge Chen but with Judge Newman dissenting, ruled in favor of Sandoz on this issue, concluding that while paragraph (l)(2)(A) seems mandatory when “read in isolation,” an applicant does “not violate” the BPCIA by withholding the required information; instead, the innovator’s “only remedies” are to bring claims for patent infringement and declaratory relief under 35 U.S.C. § 271(e) and 42 U.S.C. § 262(l)(9)(C).
The second provision addressed by Amgen is 42 U.S.C. § 262(l)(8)(A), which states that an applicant “shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensed under” the BPCIA. On this issue, all three judges agreed with Amgen that the notice could not be given until the proposed biosimilar product had been “licensed,” or approved, by FDA. The majority, with Judge Chen dissenting on this issue, went on to hold that Sandoz could not market its biosimilar product Zarxio until 180 days after it provided a post-approval notice of commercial marketing. The majority therefore kept a previously issued interim injunction against Sandoz in place until September 2, when the 180-day notice period expires.
The parties’ petitions for en banc review largely track the arguments they made in their briefing on appeal. Amgen contends that the language of paragraph (l)(2)(A) is mandatory, full stop, and that the statutory right to bring a claim for patent infringement or declaratory relief are not, strictly speaking, remedies at all – let alone exclusive remedies – for failure to provide the specified pre-litigation information. Sandoz, in its petition, argues that the panel misread the statute as requiring post-approval notice of commercial marketing because the word “licensed” in paragraph (l)(8)(A) “simply refers to the product that will be marketed” not to the product at the time of notice – and that the majority “compounded its error” by holding that the notice was mandatory and enforceable. On Tuesday, August 25, the Federal Circuit called for the parties to respond to each other’s petitions. Those responses are due September 8.
Meanwhile, on Wednesday August 26, Amgen filed an emergency motion, for injunctive relief pending en banc consideration, asking the full court to “preserve the status quo” after the injunction issued by the Amgen panel expires on September 2. Yesterday, on August 27, Sandoz filed a letter response asking for permission to respond on August 31 and contending that “any ‘emergency’ is entirely of Amgen’s own making” since it could have moved for injunctive relief at any time since the July 21 panel decision. The Federal Circuit usually decides emergency motions for interim relief quickly. Although the court does not usually issue substantive opinions on these motions, its disposition of them is often informative (though by no means decisive) as to the ultimate outcome of the appeal. That was certainly the case for Amgen’s previous motion for interim relief pending the panel decision; the panel granted the motion without comment and later issued its opinion keeping the interim injunction in effect.
The Amgen panel’s decision to keep the interim injunction in place until September 2 also raises an interesting issue related to Sandoz’s en banc petition. Although the panel clearly ruled for Amgen as to paragraph (l)(8)(A) and granted Amgen full relief (i.e., a 180-day injunction), its formal disposition of the issue was to dismiss Amgen’s appeal as moot in light of its decision to extend the interim injunction for the full 180-day period. This disposition raises the question whether Sandoz’s en banc petition on paragraph (l)(8)(A) is also moot (or will become moot when the injunction expires on September 2). Sandoz argues that the issue is not moot because it requested a bond pending appeal on which it can recover, and because the paragraph (l)(8)(A) controversy falls under the “capable of repetition, yet evading review” exception to mootness. The issue certainly is capable of repetition, as it has already been raised in two pending BPCIA actions (Janssen v. Celltrion, where Patterson Belknap is co-counsel for the plaintiff, and Amgen v. Apotex). Whether or not the full court decides to take up the paragraph (l)(8)(A) issue (or Amgen’s paragraph (l)(2)(A) issue) in this appeal, it is unlikely that either question will evade en banc review in the long run.