Janssen v. Celltrion: Janssen’s Reply Brief in light of Amgen v. Sandoz

As we’ve covered in previous posts (here and here), the parties in Janssen v. Celltrion have been supplementing their briefings on whether Celltrion’s notice of commercial marketing, given before FDA approval of its biosimilar application, was legally effective under the BPCIA as interpreted by the Federal Circuit in Amgen v. Sandoz.

Janssen has argued that the Federal Circuit’s opinion in Amgen requires all biosimilar applicants to give at least a 180-day notice of commercial marketing to reference product sponsors, and that such notice cannot be legally effective until after FDA licenses the applicant’s biosimilar product.

In its opposition brief, Celltrion argued that Janssen has misread the Federal Circuit’s opinion, and that “the notice of commercial marketing provision is mandatory only where the biosimilar applicant ‘completely fails’ to participate in the statutory information-exchange process” of the BPCIA by not disclosing its biosimilar application or manufacturing information to the reference product sponsor.  In this case, where Celltrion has provided its biosimilar application, including manufacturing information, Celltrion argues that notice of commercial marketing is not mandatory.

Janssen has now submitted its reply brief in the latest round of supplemental briefing on this issue.  In its brief, Janssen argues that the Federal Circuit was clear in its holding that “[p]aragraph (l)(8)(A) is a standalone notice provision.” Janssen argues that Celltrion’s  citation of Judge Chen’s dissent, which noted that “nothing in the majority opinion suggests” that notice is mandatory where the applicant has provided its biosimilar application to the reference product sponsor, is unavailing and merely an “odd misreading…by a dissenting judge.”  Janssen instead cites Judge Newman, who joined Judge Lourie’s majority opinion on this issue, and who “stated without ambiguity that the notice of commercial marketing was mandatory.”

Janssen further argues that the notice of commercial marketing must be considered mandatory in order to achieve the “statutory purpose” of “ensuring a ‘fully crystallized controversy regarding the need for injunctive relief'” by providing a “pre-launch notice period to allow [the reference product sponsor] to assess the need for and seek such relief.”  The declaratory judgment remedy provided for in the statute, which Celltrion has argued is Janssen’s sole remedy to redress Celltrion’s alleged violation of the notice provision, is not an adequate remedy, Janssen argues, because it “does not address the irreparable injury of launch.”

Janssen finally adds that it is entitled to a preliminary injunction regardless of “whether the basis [for the injunction]” is the traditional four-factor test in eBay, “or the BPCIA itself,” because Janssen’s arguments “closely track” those that Amgen had made in its successful motion for an injunction pending appeal: “that price erosion, loss of patent certainty, and harm to goodwill and customer relationships constituted irreparable harm.”

This is the final scheduled round of supplemental briefing on this issue, but if there is a further sur-reply, we will be sure to cover it here on the Big Molecule Watch.