On June 3, the parties in Amgen v. Sandoz presented oral arguments to the Federal Circuit as part of their dispute over the Biologics Price Competition and Innovation Act (BPCIA). The appeal is focused on two questions: whether the BPCIA’s patent dispute provisions – the so-called “patent dance” – are mandatory, and whether the biosimilar applicant’s notice of commercial marketing may be served before the product receives FDA approval. In March, a district court ruled against Amgen on these issues and denied its motion for a preliminary injunction. More recently, the Federal Circuit granted Amgen a temporary injunction pending appeal blocking Sandoz from launching its biosimilar version of Amgen’s Neupogen product.
During hour-long oral argument (audio file), both the patent dance and notice of commercial marketing issues were discussed in detail. The argument was closely watched in the industry and has generated a fair amount of commentary online and in the press. The consensus seems to be that the Federal Circuit panel keenly “tested both sides” and was aware that their decision on the issues in the case will have far-ranging implications for other biotech litigation. One commentator suggested that the judges “seemed to favor Amgen’s position” over Sandoz – noting, for example, that Judge Chen had skeptically likened Sandoz’s reading of the statute to a “choose your own adventure” game. Along similar lines, Law360 noted that the court “seemed skeptical” of Sandoz’s arguments on the 180-day notice issue and may be leaning towards a holding that effective notice of commercial launch can only be given after FDA approval.
At the end of its argument, Sandoz’s counsel pointed out that the Federal Circuit has not yet issued an order determining the size of bond that Amgen should post for the injunction pending appeal, and asked the court to order the bond or dissolve the injunction. To date, the Federal Circuit has not ordered a bond or dissolved the injunction.
There is no timetable for the Federal Circuit’s decision, but given the expedited nature of the litigation, it may be as soon as this summer. The decision should provide much-needed guidance for innovators and biosimilar applicants that seek to navigate the new regulatory pathway charted by the BPCIA. However, as Judge Lourie mentioned during the argument: “If the purpose of the statute is to avoid litigation” over procedural issues, “it’s already failed.”