THE MISSTEP WITHIN THE PATENT DANCE THAT SANDOZ INC. V. AMGEN INC. REVEALED AND HOW IT CAN BE CORRECTED

摘要

Biological pharmaceuticals will be important therapies for the future of healthcare,~(239) but these products have been costly to develop.~(240) To help consumers and promote the manufacture of generic biologics, Congress enacted the BPCIA in 2010.~(241) But the Supreme Court opinion in Sandoz Inc. v. Amgen Inc. revealed a flaw within this legislative scheme.~(242) Specifically, 42 U.S.C. §262 (1)(9)(C) may be adversely affecting the BPCIA's achievement of its legislative intent and policy goals by allowing for the circumvention of the Patent Dance. ~(243) Therefore, Congress should amend § 262(1)(9)(C) so that a RPS can enforce § 262(1)(2)(A) solely through federal injunction. This amendment will better achieve the legislative intent and the policy goals of the BPCIA by (1) ensuring that RPSs receive the subsection (k) applicant's application, (2) stimulating completion of the Patent Dance, and (3) protecting the investment backed expectations of RPSs while not overburdening subsection (k) applicants.