Congress Considering Legislation Aimed at Increasing Competition in Pharmaceuticals

Abstract

The U.S. Congress is currently considering a large number of bills that would attempt to bring down drug prices by a variety or means, including some aimed at reform of certain patent-related aspects of the Hatch-Waxman Act and the Biologics Price Competition and Innovation Act of 2009 (BPCIA). This Article begins with a brief overview some key provisions of Hatch-Waxman and the BPCIA that have been targeted by these legislative initiatives. It then turns to a discussion of some specific bills currently being considered by Congress that would seek to promote greater competition in the market for pharmaceuticals by amendments to the Food, Drug, and Cosmetics Act (FDCA) and Public Health Service Act (PHS Act), i.e., the two statutes that were amended by Hatch-Waxman and the BPCIA, as well as aspects of the Patent Act relating to Hatch-Waxman. Also included in the discussion are bills that would seek to prevent pharmaceutical companies from settling patent litigation brought under Hatch-Waxman and/or the BPCIA through so-called “reverse payment settlements.”

Keywords: patents, drugs, Congress, legislation, patent reform