Companies currently holding the exclusive rights to biologics should be celebrating the Federal Circuit’s decision released earlier this week. In Amgen v. Apotex, the Court held that all biosimilar applicants must provide a 180-day notice to owners of the NDA for the referenced biologic before engaging in commercial marketing of their biosimilars. Amgen Inc. v. Apotex Inc., No. 2016-1308, 2016 U.S. App. LEXIS 12353 (Fed. Cir. July 5, 2016). In its opinion, the Court emphasized the importance of providing the NDA-holder with enough time to enforce its patent rights before a new product enters the market.
As we wrote here , the Federal Circuit previously ruled that a biosimilar applicant cannot provide the requisite 180 days of notice until after the FDA has approved its license. Amgen Inc. v. Sandoz Inc., 794 F.3d 1347 (Fed. Cir. 2015).
Apotex attempted to distinguish the Sandoz decision because, unlike Sandoz, Apotex had previously exchanged the necessary patent information and manufacturing details with Amgen as required by the Biologics Act under 42 U.S.C. § 262(l)(2)(A). The Federal Circuit rejected this distinction, holding that the notice requirement applies regardless of whether the applicant has complied with other provisions of the Biologics Act. Accordingly, the Court affirmed the district court’s decision. Apotex is currently waiting for FDA approval of its version of Amgen’s Neulasta®, an anti-infection treatment for chemotherapy patients.
Apotex alternatively argued that a declaratory judgment is the exclusive remedy for a violation of the notice requirement. Apotex pointed to the language of the Biologics Act, which permits the NDA-holders to seek a declaratory judgment if an applicant fails to provide the 180-day notice. The Federal Circuit again rejected Apotex’s argument, reasoning that nothing in the text or legislative history implied that a declaratory judgment was intended to be the exclusive remedy.
The Court’s decision in Amgen v. Apotex underscores the value the Court places in protecting the interests of companies currently holding the exclusive rights to biologics, even if this increased protection comes at the expense of consumers paying higher prices for an extra 180 days. Recent activity in Congress, however, could disrupt this balance of priorities. Last month, Rep. Jan Schakowsky, Sen. John McCain, and Sen. Sherrod Brown introduced the Price Relief, Innovation, and Competition for Essential Drugs (PRICED) Act to shorten the period of exclusivity of biologics from twelve to seven years. If passed, PRICED would increase competition in the market, providing customers with lower-priced alternatives to current biologics.