Preserve Access to Affordable Generics and Biosimilars Act

The Preserve Access to Affordable Generics and Biosimilars Act would prohibit pharmaceutical companies from entering into agreements that resolve patent disputes over drugs in anticompetitive ways. Specifically, it targets "pay-to-delay" deals where generic or biosimilar manufacturers receive payments or other benefits in exchange for agreeing not to develop, manufacture, or sell cheaper alternative versions of drugs. The bill presumes such agreements are anticompetitive if the generic manufacturer receives anything of value while agreeing to limit their activities.

The bill includes narrow exceptions for legitimate business arrangements, such as when a generic manufacturer simply receives the right to market its product before patent exclusivity expires, receives payment for actual litigation costs, or receives a promise not to be sued. The Federal Trade Commission would enforce the law and could penalize violators by stripping them of valuable 180-day marketing exclusivity periods that generic drugs normally receive. Additionally, drug manufacturers would be required to fully disclose all agreements related to drug manufacturing, marketing, or sales to federal regulators.

If enacted, this bill could potentially lower drug prices for consumers by preventing manufacturers from using legal settlements to keep cheaper generic and biosimilar alternatives off the market longer than necessary. The bill has passed committee review and is eligible for a floor vote in the Senate.