Over the summer, representatives introduced bills and amendments of interest to the pharmaceutical industry. First, Senator Orrin Hatch, co-author of the Hatch-Waxman Act, filed an amendment in the Senate Judiciary Committee that would require a generic manufacturer wishing to challenge a brand-name drug patent to choose between Hatch-Waxman litigation and IPR, removing the option to use both. According to Senator Hatch, this Hatch-Waxman Integrity Act of 2018 would ensure that Hatch-Waxman continues to operate as originally intended by protecting the ability of generic drug companies to develop lower-cost drugs, while at the same time providing innovators a period of exclusivity to recoup investments. Specifically, Senator Hatch commented that the availability of an alternative path to challenge patents through IPRs has threatened to upend the carefully-crafted Hatch-Waxman balance by enabling companies to put added litigation pressure on drug innovators above and beyond what Hatch-Waxman already provides. This Act is an amendment to the CREATES Act, legislation designed to assist generic drug companies in acquiring samples needed to develop generic drugs, and would add a section entitled “Preventing the Inter Partes Review Process for Challenging Patents from Diminishing Competition in the Pharmaceutical Industry and with Respect to Drug Innovation; Preventing the Manipulative and Deceptive Use of Inter Partes Review.”
Second, Representatives John Sarbanes and Bill Johnson introduced the Biosimilars Competition Act of 2018, which would require certain agreements between biosimilar applicants and reference product sponsors to be reported to the DoJ and FTC. Specifically, the bill would amend the Public Health Service Act to require the reporting of any agreement between two or more biosimilar applicants, or a biosimilar applicant and a reference product sponsor, regarding the manufacture, marketing, or sale of the biosimilar product or reference product. And while the House considers this bill, the Senate is considering legislation concerning the reporting of patent settlement agreements involving biosimilars in the Patient Right to Know Drug Prices Act, which would require certain agreements reached between biosimilar applicants and reference product sponsors to be reported to the FTC, similar to the requirements currently in place for drug products regulated under the FDC Act. We will continue to monitor this proposed legislation.