Novartis came one step closer to becoming the first company to offer a biosimilar drug for sale in the United States. Last month, an independent panel voted 14-0 to recommend FDA approval of Sandoz’s (Novartis’ generics division) application for its proposed ZarxioTM cancer drug – a generic version of Amgen’s patented Neupogen®. The decision is noteworthy because it makes ZarxioTM the first product to go through the alternative FDA approval pathway for biosimilars provided by the Biologics Price Competition and Innovation Act of 2009.
The BPCIA establishes an FDA regulatory-approval process for biologic products shown to be biosimilar to a reference product (often a competitor’s patented drug) that has already been approved through a Biologics License Application. The BPCIA process is intended to be streamlined in comparison to the regular licensing process, and provides procedures for the reference product sponsor to assert patents against the applicant, and for the biosimilar applicant to challenge the validity or enforceability of the patents (or argue that the proposed biosimilar wouldn’t infringe the patents) before FDA approval. Unlike the Hatch-Waxman Act, which provides for patent litigation in the Abbreviated New Drug Application context, the BPCIA does not require a reference product sponsor to publish a list of patents for its product. Rather the BPCIA provides for a “patent dance” between the parties whereby the parties exchange proposals on which patents will be litigated.
In some instances, companies have attempted to avoid the patent dance and instead have filed lawsuits, seeking a declaration that their proposed products would not infringe on any valid competitor patents. The Federal Circuit recently ruled on one such case, Sandoz Inc. v. Amgen Inc., 2014 WL 6845165 (Fed. Cir. Dec. 5, 2014), and affirmed a district court’s judgment that the court did not have jurisdiction to hear the matter, because there was no case or controversy, as is required to hear actions for declaratory judgments. While the district court dismissed the case on both Article III grounds and under the BPCIA, the Federal Circuit relied only on Article III and did not consider whether the BPCIA itself prevented a potential applicant from bringing a declaratory judgment action against a reference product sponsor. Interestingly the Court left open the question of whether a district court would have declaratory judgment jurisdiction where the plaintiff, unlike Sandoz, has already filed an application with the FDA.
An excellent discussion on how the federal courts have dealt with biosimilar companies seeking declaratory judgments, rather than partaking in the “patent dance,” may be found in the recent Law 360 feature article, by our own Siegmund Gutman, chair of Proskauer’s life sciences patent practice.