The Federal Circuit Will Hear Apotex's Appeal From A Preliminary Injunction Under The BPCIA In Early 2016

In Amgen v. Apotex, Judge Cohn of the Southern District of Florida recently enjoined Apotex from selling its proposed biosimilar of Amgen's Neulasta for 180 days following FDA approval. In Amgen v. Sandoz, 794 F.3d 1347 (Fed. Cir. 2015), the first and only appellate decision interpreting the Biologics Price Competition and Innovation Act of 2009 (BPCIA), the Federal Circuit held that under 42 U.S.C. § 262(l)(8)(A), a biosimilar maker can only give effective 180-day notice of commercial marketing after FDA has licensed its product. Apotex argued that the notice of commercial marketing is only mandatory under Amgen v. Sandoz if the biosimilar maker fails to provide its abbreviated biologics license application (aBLA) to the innovator company under the BPCIA's pre-suit information exchange provisions. Judge Cohn disagreed and held that a notice of commercial marketing is mandatory under Amgen v. Sandoz whether the biosimilar maker provided the innovator company with its aBLA or not.

Apotex filed a notice of appeal and moved to expedite the proceedings, arguing that "FDA may approve its product(s) within the next several months." Amgen opposed, noting that Apotex refused to produce any evidence suggesting that approval of its proposed Neulasta biosimilar is imminent. Apotex replied that it does not and could not know when its product will be approved because there is no fixed deadline for approval and FDA has not informed Apotex when its biosimilar application might be approved. Notably, Apotex's reply made no mention of any upcoming advisory committee meeting for its proposed biosimilar and it did not...