Policy Brief: Eliminating Thickets to Increase Competition (ETHIC) Act

Brand-name drug manufacturers accumulate thickets of patents on their drugs that they then use to delay generic and biosimilar competition. Studies show many of these patents are obvious variations of earlier patents, granted only after applicants file “terminal disclaimers.” The ETHIC Act allows one patent per group of obvious variation patents to be asserted against generic or biosimilar competitors in litigation, while maintaining brand-name manufacturers’ ability to enforce any patents that fall outside these patent groups. The ETHIC Act substantially reduces the number of patents that could be enforced against generic or biosimilar competitors in litigation, making market entry of generics and biosimilars faster and more efficient, leading to greater health care savings and broader patient access.