By Andrew Williams --
On July 21, 2015, the Federal Circuit decided the Amgen v. Sandoz appeal in a case of first impression regarding the interpretation of the disclosure and notice provisions of the Biologics Price Competition and Innovation Act ("BPCIA"). As we reported at the time, the decision from the three judge panel was seriously fractured, with an outcome that would make neither party happy. Not surprisingly, therefore, on August 20, 2015, both Amgen and Sandoz filed petitions for an en banc rehearing. Amgen, of course, argued that the disclosure provisions of the BPCIA required that Sandoz supply a copy of its biosimilar application within 20 days after its application was accepted for review by the FDA. Sandoz, in turn, argued that the BPCIA does not require waiting until the FDA approves the biosimilar application before 180-day notice has to be provided. In essence, Sandoz argued, the Court's decision resulted in an improper extension of exclusivity by six months. And, in turn, on September 8, 2015, both parties filed responses, explained how the three-judge panel got its part of the case correct.
In addition to that briefing, three amicus curiae briefs were either filed, or requested to be filed -- all of which supported the Sandoz petition. These briefs were submitted by (1) the Biosimilars Council, a division of the Generic Pharmaceutical Association ("GPhA"), (2) Mylan Inc, and (3) Hospira, Inc. and Celltrion.
The one issue that all of the parties agreed upon was that it is appropriate for en banc rehearing to occur at this time. This was due in part to the fractured nature of the decision, and because this case was a matter of first impression. In addition, as Amgen put it, this case was one "of critical importance to the biopharmaceutical industry." Therefore, "to help guide this developing industry," Amgen asserted that the full Court should rehear the decision now. Sandoz highlighted the fact that if the fragmented panel decision were to be left unreviewed, "the ruling would delay access by patients to all biosimilars . . . ." Because "[e]ach panel member had a different interpretation of this important statute," Sandoz continued, the full Court should weigh in to prevent "the fragmented interpretation [from binding] industry, district courts, and subsequent panels of this Court." And, Hospira pointed out that en banc review was required now because "resolving this case will establish the competitive framework that governs the biosimilars industry."
Amgen, naturally, focused on the rehearing the outcome of the disclosure and exchange provisions of the BPCIA. Amgen explained the balance that Congress attempted to create by allowing biosimilar applicants to rely on the approval data obtained by the innovator company, on the one hand, and protecting the public's interest in innovation by requiring the disclosure of information necessary to determine whether patent infringement has or will occur on the other hand. In fact, Amgen identified five ways in which Congress made clear that the disclosure provisions were mandatory. First, Congress tied the applicant's choice of the biosimilar "(k)" pathway to providing the requisite information (like the aBLA application) to the reference product sponsor by its use of the word "shall": "When a subsection (k) applicant submits an application under subsection (k), such applicant shall provide . . . the information required to be produced pursuant to" the BPCIA. Second, Congress used the mandatory word "shall." Third, Congress demonstrated its ability to use non-mandatory language elsewhere. Fourth, in several other places in the statute, Congress referred to the aBLA and manufacturing information as the "required" information. And fifth, Congress included manufacturing-process patents in the dispute-resolution regime (in other words, the type of information that is supposed to be discussed). This is, of course, in contradistinction to the Hatch Waxman scheme, which does not provide for the assertion of such patents prior to launch.
Most of the substance of Amgen briefing, however, focused on the remedy. This is likely because the panel appeared to agree in principle in the opinion that the "shall" provision was mandatory. However, because the statute appeared to already include a remedy (the ability to bring a patent infringement suit), the majority held that this was the sole remedy. Therefore, the Court found that it was not possible to compel compliance with this section, recover damages, or otherwise seek relief. Amgen also addressed the wording of newly added 35 U.S.C. § 271(e)(2)(C)(ii), which appears to define the act of infringement in such cases. Amgen argued to the contrary, asserting that this section of the Patent Act determines the "scope" of infringement -- that under this section, the reference product sponsor is free to bring an infringement suit with regard to any patent that could have been identified during the "patent dance." This was not meant to be the only remedy, however, according to Amgen.
Sandoz, in turn, explained why the Court's holding with regard to the 180-day notice provision was incorrect. The problem, according to Sandoz, was that by requiring approval of the application before notice can be provided necessarily increases the exclusivity period from 12 years to 12 ½ years. The excuse that the Congress established the 180 days to allow the reference product sponsor time to seek a preliminary injunction was unconvincing to Sandoz. This goal does not require that notice be "post-approval," but instead is accomplished simply by giving notice prior to marketing. And allowing notice to be pre-approval does not subvert the larger role that this provision is supposed to play, according Sandoz, in lifting the "stay" on artificial-infringement declaratory judgement suits. Of course, Sandoz ignores the fact that this advantage is illusory for reference product sponsors in cases such as this one, where the biosimilar application was not provided. In these cases, the reference product sponsor can already bring a declaratory judgment infringement suit as the statutory remedy (although only for patents claiming the biological product or a use thereof). Therefore, very little is gained by the reference product sponsor if notice can be provided pre-approval. Because of this, if a biosimilar applicant chooses to withhold its application, it has little disincentive to giving notice of commercial marketing on the day the application is accepted by the FDA.
We will continue to monitor this case and report on any decision by the Court.