A year after analyzing the patent dance and notice requirements of the Biologics Price Competition and Innovation Act (BPCIA) in Amgen Inc. v. Sandoz Inc., the US Court of Appeals for the Federal Circuit has ruled that a follow-on biologic or biosimilar applicant is alwaysrequired to provide a 180-day notice of marketing to the reference product sponsor (RPS) after the biosimilar product is licensed by the US Food and Drug Administration (FDA). Amgen Inc., v. Apotex Inc., Case No. 2016-1308 (Fed. Cir. July 5, 2016), (Taranto, C.J.).

BPCIA Background

The BPCIA allows biosimilar applicants to gain approval for a drug that is biosimilar to a reference product without repeating all of the testing done by the original RPS. Instead the biosimilar applicant can use publicly available information about the reference product’s safety, purity and potency in support of the application. In order to balance innovation with consumer interests, the BPCIA prohibits a biosimilar application from being submitted until four years after the reference product was licensed, and prohibits biosimilar approval until 12 years after the reference product was licensed.

The most heavily litigated part of the BPCIA is 42 USC § 262(l), which established a patent-dispute-resolution regime related to biosimilars. Section 262(l) includes provisions related to what has been called the “patent dance”—the exchange of patent information between the biosimilar applicant and the RPS that potentially culminates in a patent infringement lawsuit brought by the RPS. The BPCIA also describes a scenario in which the biosimilar applicant is required to give a 180-day notice prior to the first marketing of the biosimilar, to allow the RPS to seek a preliminary injunction based on patents not subject to an infringement suit pursuant to the “patent dance.”

In Amgen Inc. v. Sandoz Inc., the Federal Circuit first dealt with the dispute resolution provisions, ultimately ruling that a biosimilar applicant could opt out of the “patent dance.” However, even if the applicant chose not to be involved in the “patent dance” it was still required to give a 180-day notice to the RPS after the biosimilar had been licensed by the FDA and prior to the marketing of the biosimilar.

180-Day Notice Is Required Even if the Biosimilar Applicant Engages in the Patent Dance

In 2014, Apotex filed a biosimilar application for pegfilgrastim, identifying Amgen’s Neulasta® product as the reference product. Apotex initiated the patent dance by providing Amgen with a copy of the Apotex application on December 15, 2014. After completing the statutorily required steps, Apotex identified one Amgen patent that it believed was invalid and not infringed by its biosimilar product. Apotex also sent a letter stating that it was providing 180-day notice of future marketing—even though Apotex’s product had not yet been licensed by the FDA.

In August 2015, Amgen brought an infringement suit against Apotex. As part of that lawsuit, Amgen filed a preliminary injunction, asking the court to require Apotex to provide notice after the FDA licensed its pegfilgrastim biosimilar and preventing Apotex from marketing its product for 180 days following that notice. Apotex argued that its participation in the patent dance rendered the 180-day notice not mandatory and unenforceable by an injunction. The US District Court for the Southern District of Florida disagreed and granted the injunction. Apotex appealed.

The Federal Circuit reviewed the district court’s interpretation of the BPCIA de novo, and affirmed the granting of the preliminary injunction.

The Federal Circuit focused on the statutory language of the notice provision, and relied on its prior interpretation of the section inAmgen Inc. v. Sandoz Inc. The court pointed out that the relevant language of the statute:  the “applicant shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biologic product licensed under subsection (k)” includes the word “shall” which indicates that the notice period is mandatory. The court also emphasized that none of the statutory language suggested any connection between the “patent dance” and the 180-day notice requirement. Instead, the 180-day notice requirement is a standalone provision not dependent on the “patent dance.”

The Federal Circuit also dismissed Apotex’s policy arguments. While the court acknowledged that in some cases the 180-day notice period would extend RPS exclusivity past the 12 year mark, it reasoned: (1) many RPS products get more than 12 years of exclusivity because of delays in biosimilar application or FDA licensing, so the additional 180-day notice is consistent with the statutory regime as a whole; and (2) the FDA can license a biosimilar product before 12 years have passed and simply make the license effective at the 12-year mark—which would allow the 180-day notice to overlap with the end of the 12-year period. The court also noted that the 180-day notice period was consistent with the overall goals of the statute—permitting the parties to conduct patent litigation without time pressure that would impair its fairness and outcome.

Finally, the Federal Circuit addressed Apotex’s argument that the exclusive remedy for violating the 180-day notice provision is a declaratory judgment action. While the BPCIA does include a section authorizing a RPS to bring a declaratory judgment action for patent infringement if the biosimilar applicant fails to complete either the “patent dance” or the 180-day notice requirement, the court rejected Apotex’s argument that a declaratory judgment action was the only possible remedy. The court emphasized that none of the statutory language suggested that the declaratory judgment remedy was exclusive, and pointed out that a declaratory judgment action would serve no purpose as a remedy for violating the 180-day notice requirement.

Ultimately, the court ruled that the BPCIA’s 180-day notice requirement is always mandatory and can be enforced by a preliminary injunction.