The BPCIA’s 180-Day Commercial Marketing Notice Provision is Mandatory for Applicants Exchanging Patent Information Under § 262(l)(2)(A).
In its recent decision, Amgen Inc. v. Apotex Inc., No. 2016-1308 (Fed. Cir. July 5, 2016), the Federal Circuit further interpreted the commercial marketing notice provision of the Biologics Price Competition and Innovation Act (“BPCIA”) and held that the 180-day commercial marketing notice provision under § 262(l)(8)(A) is mandatory even where the applicant exchanges patent information under § 262(l)(2)(A), affirming the district court’s grant of a preliminary injunction against Apotex.
The Federal Circuit reinforced its previous holding in Amgen Inc. v. Sandoz Inc., 794 F.3d 1347 (Fed. Cir. 2015), that the word “shall” in § 262(l)(8)(A) was mandatory and expanded its application to circumstances in which (l)(2)(A) patent information is exchanged. To the Court, the mandatory nature of the notice provision is supported by the statutory language throughout the BPCIA. The Court also reasoned that market entry 180 days after the afforded 12-year exclusivity period was not inconsistent with § 262(k)(7), which only establishes the earliest date for approval, and that such “delay” would be rare since newer biosimilar applicants would seek approval long before the 12-year exclusivity period expires. The Court further emphasized that the legislative history confirmed that the aim of the 180-day notice period is to avoid uncertainties and deficiencies associated with the two-stage litigation contemplated by § 262(l). Finally, rejecting Apotex’s argument to the contrary, the Court concluded that the 180-day notice provision did not conflict with § 262(l)(9), as a declaratory judgment action under § 262(l)(9) is not the sole remedy for violating § 262(l)(8)(A).