Amgen seeks declaration that Sandoz may not exit patent dance early

On Friday, March 4, 2016, Amgen filed a complaint (available here) seeking a declaratory judgment in the U.S. District Court for the District of New Jersey against Sandoz. The complaint accuses Sandoz of violating BPCIA procedures by failing to participate in certain aspects of the patent dance relating to Sandoz’s Neulasta (pegfilgrastim) biosimilar application.

By way of background, Amgen alleges the following timeline:

  • In November 2015, Sandoz notified Amgen that the FDA had accepted Sandoz’s pegfilgrastim aBLA, and Sandoz provided Amgen files identified as the aBLA and information about Sandoz’s manufacturing process on November 13, 2015.
  • On January 12, 2016, Amgen provided Sandoz the list of patents that Amgen believed Sandoz’s biosimilar would infringe: U.S. Patent Nos. 8,940,878 and 5,824,784.
  • On February 2, 2016, Sandoz provided invalidity and non-infringement contentions, and stated that it no longer wished to follow the strictures of the BPCIA, because Sandoz had Amgen’s positions pursuant to 42 U.S.C. § 262(l)(3)(C), and that further exchanges and negotiations under the BPCIA were unnecessary. According to Amgen, Sandoz “then insisted that [Amgen] file an action for patent infringement pursuant to 42 U.S.C. § 262(l)(6) within 30 days, i.e., by March 4, 2016. Sandoz Inc. asserted that, ‘Otherwise, the penalty for an untimely suit—that the ‘sole and exclusive remedy’ for any infringement be limited to a ‘reasonable royalty’—applies. See 35 U.S.C. § 271(e)(6)(B).’”

In its complaint, Amgen seeks a declaratory judgment that Sandoz’s attempt to skip the negotiations specified in 42 U.S.C. § 262(l)(4) and (5) is impermissible and that Amgen is not barred from seeking injunctive relief or lost profits for failing to file a patent infringement before March 4, 2016. Notably, Amgen’s Complaint includes no patent infringement claims.

Stay tuned to Big Molecule Watch for more updates as this case develops.