Judge Cohn of the U.S. District Court for the Southern District of Florida has issued another decision interpreting the complicated provisions of the Biologics Price Competition and Innovation Action (BPCIA), ruling that the statute requires a biosimilar applicant to give 180 days’ pre-marketing notice after FDA approval even if it has engaged in the BPCIA’s patent dance. The decision came in an order granting Amgen’s motion for a preliminary injunction in Amgen, Inc. v. Apotex Inc. where the biosimilar at issue relates to Amgen’s Neulasta® (pegfilgrastim) product. 

The Neulasta® Biosimilar Dispute

Apotex has filed a Biologic License Application (BLA) seeking FDA approval to market a biosimilar version of Amgen’s Neulasta® (pegfilgrastim) product. The parties have exchanged information and statements under the “patent dance” provisions of the BPCIA, and, pursuant to those provisions, Amgen filed suit alleging that Apotex’s biosimilar product will infringe two of its patents.

The Pre-Marketing Notice Requirement

Amgen sought a preliminary injunction to prevent Apotex from marketing its biosimilar product “until 180 days after it notifies Amgen of approval by the [FDA].” Although the Federal Circuit held in Amgen v. Sandoz that the pre-marketing notice of 42 U.S.C. § 262(l)(8)(A) cannot be given until the biosimilar is approved, Sandoz took the position that pre-marketing notice is entirely optional when the biosimilar applicant has provided information under 42 U.S.C. § 262(l)(2) and engaged in the patent dance, as it has in this case.

The parties stipulated to most elements required for a preliminary injunction, such that the only issue before the court was the legal one: whether the commercial marketing notice and 180 day period in  § 262(l)(8)(A) is mandatory in all cases.

The biosimilar pre-marketing notice portion of the BPCIA states:

The subsection (k) applicant shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k).

While the term “shall” typically denotes a mandatory requirement, the Federal Circuit held in Amgen v. Sandoz that the term “shall” as used in § 262(l)(2) did not require a biosimilar applicant to share its biosimilar application with the reference product sponsor, at least in part because the statute sets forth detailed consequences of non-compliance. On the other hand, in the same decision, the Federal Circuit held that the pre-marketing notice provision of § 262(l)(8)(A) is a “standalone notice provision,” in which the term “shall” is mandatory.

Read more about the decision in Amgen v. Sandoz in this article.

Although in Amgen v. Sandoz the biosimilar applicant had “completely fail[ed] to provide its [biosimilar application] and the required manufacturing information” under § 262(l)(2), the court here found nothing in the statute or the Amgen v. Sandoz decision that limited the pre-marketing notice provision of § 262(l)(8)(A) to situations where § 262(l)(2) was not followed:

The [BPCIA] simply does not give the subsection (k) applicant the power to nullify the RPS’ statutory right to 180 days notice of approval prior to marketing based on whether or not the subsection (k) applicant complies with § 262(l)(2).

Injunction Will Be Felt Upon Approval

As noted in the court’s order, Apotex’s product is not yet approved by the FDA. Thus, the preliminary injunction itself does not keep Apotex’s product off the market now, but will “require Apotex to notify Amgen when and if it receives FDA approval and will prohibit Apotex from marketing the approved product for 180 days after the notice is provided.”

If Apotex appeals this decision, it will be interesting to see whether the Federal Circuit stands by its decision in Amgen v. Sandoz, or tries to wrestle anew with the complex provisions of the BPCIA.