The pharmaceutical industry, like the technology sector, has become a focus of U.S. lawmakers seeking to revise competition law. In April 2021, House and Senate lawmakers introduced a package of legislation targeting conduct that supposedly prevents or slows competition from less expensive drugs.
Three bills propose antitrust changes targeting so-called "reverse payment" patent settlements, "product hopping," and "sham" citizen petitioning. The presumptions created by these bills would increase the risk associated with licensing and other business arrangements between parties settling patent cases, as well as with launching newer versions of existing drugs and petitioning the FDA.
The fourth bill caps the number of patents in an infringement action resulting from the "patent dance" information exchange in the abbreviated approval pathway for biosimilars.