Hatch, Tillis, and Flores Introduce Hatch-Waxman Integrity Act

Senator Orrin Hatch (R-UT), Senator Thom Tillis (R-NC), and Representative Bill Flores (R-TX), on Tuesday, December 11 2018, introduced H.R. 7251, the “Hatch-Waxman Integrity Act of 2018.” The bill would require a generic manufacturer wishing to challenge a brand-name drug patent to choose between the Hatch-Waxman framework and inter partes review. The bill would apply similarly to patents on biologics. In addition, the bill stipulates that filing IPR patent challenges and profiting from resulting stock price changes is a form of prohibited market manipulation.