On July 5, 2016, in Amgen v. Apotex (No. 2016-1308), the Federal Circuit again held that a biosimilar applicant must provide its biologic competitor with 180 days’ notice of intent to commercially market a biosimilar product. This time, however, the court elaborated that such notice is required even if a biosimilar applicant fully participated in the BPCIA’s so-called “patent dance,” the statutory-based information exchange process designed to narrow the inevitable patent disputes between biologic and biosimilar competitors.
Notably, the Federal Circuit took the opportunity to defend its previous holding in Amgen v. Sandoz that notice of intent to commercially market cannot be provided until the FDA approves the biosimilar product. In the wake of criticisms raised by Sandoz and various amici in certiorari briefing, the Federal Circuit suggested that its holding does not effectively extend the twelve-year biologic exclusivity period because the FDA may be able to tentatively license a biosimilar product any time after the application is submitted (i.e., at least six months before the end of the exclusivity period). But whether the FDA has the statutory authority to issue such tentative licenses or, even if it does, whether the FDA must do so, has yet to be litigated.
More information on the Federal Circuit’s Amgen v. Apotex decision, and its relationship to the Amgen v. Sandoz certiorari petitions currently before the Supreme Court, can be found here.