Professor Erika Lietzan recently served as a panelist at the Supreme Court IP Review held at the Chicago-Kent College of Law.
She discussed Sandoz, Inc. v. Amgen. Inc., a case decided by the Supreme Court last June. In October 2014, Amgen, a biopharmaceutical company which manufactures Neupogen, an innovative bone marrow stimulant, sued Sandoz, a biopharmaceutical company which manufactures Zarxio, a “biosimilar” version of Neupogen.
Amgen claimed Sandoz violated requirements of the Biologics Price Competition and Innovation Act of 2009 because it failed to provide Amgen with a copy of its marketing application and because it gave notice of market entry prior to securing FDA approval of its product. Amgen sought injunctions to enforce those requirements.
Professor Lietzan was deeply involved in the legislative negotiations that resulted in enactment of this statute and filed an amicus brief in the Court explaining that the statute unquestionably requires biosimilar applicants to provide their marketing applications to the innovators whose products they copy. The Supreme Court unanimously agreed that biosimilar applicants are “required” to provide their marketing applications, but also held that Amgen could not obtain a federal court injunction enforcing the requirement. (The Court also held that Sandoz could give notice of market entry prior to FDA approval.) The case has been remanded to the Federal Circuit to determine whether Amgen can secure relief under state law.
Professor Lietzan has discussed the decision extensively on her blog, Objective Intent, and at Chicago-Kent she participated in a panel — alongside counsel for Sandoz in the litigation — discussing the decision and the remand to the Federal Circuit.