On December 9, a federal district court in Florida issued a preliminary injunction prohibiting Apotex from selling a proposed biosimilar version of Amgen’s cancer drug Neulasta for 180 days after the biosimilar is approved. In the decision, the district court resolved in Amgen’s favor a dispute over the meaning of the Federal Circuit’s recent decision in Amgen v. Sandoz, the first and to date the only appellate decision addressing the Biologics Price Competition and Innovation Act of 2009 (BPCIA).
Amgen’s motion for a preliminary injunction was based on 42 U.S.C. § 262(l)(8)(A) of the BPCIA, which provides that a biosimilar applicant “shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the” biosimilar product. In Amgen v. Sandoz, the Federal Circuit held that under section 262(l)(8)(A) a biosimilar applicant could “only give effective notice of commercial marketing after FDA has licensed its product.” Before Sandoz, virtually every biosimilar applicant, including Apotex in the Amgen v. Apotex Neulasta dispute, had attempted to hasten the date of commercial marketing by serving a pre-approval notice. Sandoz clarified that such notices are not effective.
After Sandoz was decided, Apotex acknowledged that its previous 180-day notice of commercial marketing was not effective, but it argued that it did not have to provide any notice of commercial marketing under the reasoning of the Federal Circuit’s decision, because unlike Sandoz, Apotex had provided Amgen with the pre-litigation information called for by the BPCIA. (In another case, Janssen v. Celltrion, where Patterson Belknap represents the plaintiff/innovator Janssen, the biosimilar applicant has advocated the same reading of Amgen v. Sandoz in a motion that is currently pending). Although Apotex’s proposed biosimilar has not yet been approved by the FDA, Apotex notified Amgen that it did not intend to observe a 180-day notice period after approval. In response, Amgen moved for a preliminary injunction, arguing that the BPCIA requires biosimilar applicants to wait 180 days after approval before marketing their proposed drug.
In the December 9 decision, Judge James I. Cohn of the Southern District of Florida agreed with Amgen that the 180-day notice period is mandatory. Judge Cohn rejected Apotex’s argument that the § 262(l)(8)(A) 180-day notice period is mandatory only when the biosimilar applicant opts out of the BPCIA’s “patent dance,” opining that this reading of the statute “would result in confusion and uncertainty, as well as inconsistent results, depending on which route a subsection (k) applicant chooses to travel.” Judge Cohn also noted that the Federal Circuit, in the unanimous portion of the Sandoz decision, had explained that the purpose of the notice of commercial marketing was to provide a “defined statutory window” after approval so that the innovator can assess the scope of the approved license and effectively determine whether, and on which patents, to seek a preliminary injunction. According to Judge Cohn, “[t]hat defined statutory window exists for all biosimilar products that obtain FDA licenses, regardless of whether the subsection (k) applicant complies with” the BPCIA’s patent dance provisions.
Immediately after the district court’s decision, Apotex filed a notice of appeal to the Federal Circuit. Because it concerns a preliminary injunction, the appeal may be expedited. We will keep track of it here.