Attorneys for Amgen and Apotex appeared before the Federal Circuit yesterday to argue about whether the notice of commercial marketing provision, 42 U.S.C. § 262(l)(8)(A), is optional when a biosimilar applicant has provided its application and information to the reference product sponsor (RPS) under paragraph (l)(2)(A). The notice of commercial marketing triggers a 180-day period for the RPS to assess and resolve patent disputes in court.
In the proceedings below, Apotex triggered the patent dance by providing Amgen with a copy of its biosimilar application and related manufacturing information, but refused to provide notice of commercial marketing. The U.S. District Court for the Southern District of Florida granted Amgen a preliminary injunction enjoining Apotex from launching its biosimilar pegfilgrastim product until 180 days after it receives FDA approval and gives notice of commercial marketing. Apotex appealed, arguing that notice of commercial marketing is not required where a biosimilar applicant provided its application and manufacturing information.
The panel consisted of Judges Bryson, Taranto, and Wallach. Interestingly, none of these judges were on the panel that decided Amgen v. Sandoz.
Judges Bryson and Wallach had several questions for the attorneys. A key issue was whether the notice and declaratory judgment provisions describe the parties’ rights and exclusive remedies. Under these provisions, a biosimilar applicant cannot seek a declaratory judgment on patent disputes unless it provides notice of commercial marketing.
The judges’ questions also focused on the practical implications of the parties’ various interpretations of the law. For example, Judge Wallach wondered why a biosimilar applicant would participate in the information exchange under paragraph (l)(2)(A). Apotex’s counsel responded that a biosimilar applicant may wish to avoid the risk of launching a product while facing unknown patent disputes. Also, counsel continued, the notice provision at issue provides another optional mechanism to clear potential patent disputes before launching a product. Depending on the particular situation, a biosimilar applicant may feel the notice mechanism is not beneficial or that that information exchange is sufficient to address patent disputes before launching a product.
Judge Bryson expressed concern about the notice provision’s potential to effectively extend the reference product’s exclusivity period in all cases. Under the current regime, a biosimilar applicant may not be able to provide notice to the reference product sponsor before the 12-year exclusivity period runs. Therefore, requiring notice 180 days before commercial marketing would create a de facto extension of the exclusivity period.
Discussion with Amgen’s counsel took a similar course. Judge Wallach again questioned the purpose of the information exchange if notice of commercial marketing is mandatory. Like Apotex, Amgen’s counsel said that the exchange is useful to address patent disputes before launch. Amgen’s counsel argued that the notice and 180-day period provide needed certainty before a potentially infringing product launches. He argued that without notice and the 180-day exclusivity period, an RPS would be forced to seek a preliminary injunction in most cases, leading to chaos and putting a significant burden on parties and the judicial system. He also argued that there is a risk to the public if products have to be taken off shelves. Thus, Amgen’s counsel argued, the notice mechanism protects the status quo to encourage rational and reasoned dispute resolution while avoiding undue risk and constant emergency motion practice.
The Federal Circuit’s recent decision in Amgen v. Sandoz was a significant issue as well. As we covered here, both Amgen and Sandoz petitioned the Supreme Court to review various aspects of that decision, and Apotex submitted an amicus brief in support of Sandoz’s petition.
Big Molecule Watch will continue to track this case and other litigation involving biosimilars, so check back for the latest news and analysis.