By Kevin E. Noonan --
Sandoz successfully (at least for now) has overcome conventional wisdom, the plain language of the Biologics Price Competition and Innovation Act (BPCIA) (or, at least those provisions regarding patent litigation) and Amgen in obtaining approval for its figastrim biosimilar product, Zarxio™ in Amgen v. Sandoz. The only thing standing between this biosimilar biologic drug and the marketplace was an injunction imposed by the Federal Circuit during the pendency of the parties' cross appeals from the District Court's decision, favoring Sandoz with regard to the patent litigation provisions and Amgen with regard to the timing of the 180-day marketing notice provisions of the Act.
That injunction was lifted today (technically, it expired and the Court refused to extend it), in an opinion by Judges Lourie and Chen (Judge Newman disagreed). These types of orders rarely contain any reasoning and this one is no different, merely announcing the outcome. The Court could have maintained the injunction, at least until the entire Court decided whether to reconsider the merits panel's decision en banc (both parties have filed petitions request en banc reconsideration). The decision not to do so is consistent with the panel decision and this Court's (and courts generally) looking beyond the law to what they perceive to be Congress's (or their own) policy goals and aspirations. Here, getting biosimilar Neupogen® to market is undoubtedly believed to be the fastest way to get the drug to patients at a lower price, and that is likely to be true. But Sandoz's motivations are not entirely altruistic: their decision to launch (if they make that decision) will likely be due to the presence of other biosimilar applicants who have filed filgastrim biosimilar applications. Such a launch also will be at risk, in view of the ongoing litigation with Amgen, posing the question for Sandoz of whether to risk treble damages if Amgen's asserted patents are determined to be not invalid and infringed or risk competition from other biosimilars applicants. In other times, this situation might lead to a settlement with Amgen to permit Sandoz to reap the benefits of the combination of its early approval and its creative lawyering. However, any such agreement would likely run afoul of the Federal Trade Commission, in view of its "victory" before the Supreme Court in FTC v. Actavis. This confluence of factors cannot be what Congress intended in passing the BPCIA; perhaps its Members could set aside the partisanship that has produced legislative gridlock and correct those provisions of the law that have caused the current situation and its attendant confusion about what Congress intended in passing the Act.