On September 9, 2016, Apotex Inc. filed a petition for a writ of certiorari in the Amgen Inc. v. Apotex Inc. case decided by the Federal Circuit on July 5, 2016. Apotex’s petition was placed on the Supreme Court’s docket on September 14, 2016 as No. 16-332. Amgen’s response is due on October 14, 2016.
There are two issues raised in Apotex’s petition: (1) whether a biosimilar applicant must provide notice of commercial marketing when it complied with the patent dance; and (2) if notice of commercial marketing is required, whether notice can be effective prior to FDA approval of the biosimilar application. The Federal Circuit held that notice of commercial marketing is mandatory and not effective until after the biosimilar application is approved. Amgen, 2016 U.S. App. LEXIS 12353, at *36 (“We conclude that an applicant must provide a reference product sponsor with 180 days’ post-licensure notice before commercial marketing begins, regardless of whether the applicant provided the (2)(A) notice of FDA review.”).
Apotex makes two arguments in its petition: (1) the notice of commercial marketing provision provided by the Biologics Price Competition and Innovation Act (“BPCIA”) is not mandatory, especially where the biosimilar applicant engaged in the patent dance; and (2) even if notice is required, it can be provided before a biosimilar application is approved.
Apotex argues that notice of commercial marketing is not required based on the text and structure of the BPCIA. Petition at 11–14. Apotex recognizes that 42 U.S.C. § 262(l)(8)(A), the notice of commercial marketing provision, provides that a biosimilar applicant “shall” provide notice of commercial marketing, but Apotex argues that 42 U.S.C. § 262(l)(9)(B), one of the declaratory judgment provisions, sets forth a remedy where the biosimilar applicant does not provide such notice. Id. at 11. Apotex relies on the Federal Circuit’s earlier decision interpreting the BPCIA, Amgen Inc. v. Sandoz Inc., which found that the declaratory judgment provision in 42 U.S.C. § 262(l)(9)(C) provided the exclusive remedy when a biosimilar applicant failed to engage in the patent dance. Id. at 11–12. Apotex asserts that the declaratory judgment provision in 42 U.S.C. § 262(l)(9)(B) would be “superfluous” if notice of commercial marketing was required when a biosimilar applicant complied with the patent dance. Id. at 12.
Apotex also argues that mandatory notice is contrary to legislative history and public policy. Petition at 14–19. Apotex asserts that requiring notice of commercial marketing would extend the exclusivity of the reference product and would delay introduction of biosimilars. Id. at 14. According to Apotex, such an extension would be contrary to legislative intent, which was to promote the introduction of biosimilars. Id. It would also be inconsistent with the compromise reached by the legislature to provide twelve years of exclusivity to the reference product. Id. at 16 (explaining that the legislature considered period of exclusivity ranging from five to fourteen years). Lastly, Apotex asserts that delaying the introduction of a biosimilar is contrary to public policy because biosimilars offer cost savings to the public. Id. at 19.
Apotex argues that nothing in the text of 42 U.S.C. § 262(l)(8)(A) requires that notice be provided after FDA approval of a biosimilar application. Petition at 12. According to Apotex, when a biosimilar applicant engages in the patent dance, the reference product sponsor is “adequately informed” and can “take all necessary steps to vindicate its legal rights.” Id. at 13. Thus, a “race to the court” to seek a preliminary injunction (the purpose of the notice) is “unlikely ever to come to pass.” Id. at 12. Accordingly, notice to the reference product sponsor before FDA approval is adequate. Id. at 12–13.
Apotex also makes a factual argument based on the district court’s decision that Apotex did not infringe Amgen’s patents. Petition at 13. According to Apotex, “Amgen has exhausted its patent rights and the 180-day injunction imposed by the Federal Circuit serves no logical purpose.” Id.