Bill > S03203

This bill aims to preserve access to affordable drugs by establishing new regulations for patent settlements between brand-name drug companies and generic or biosimilar drug manufacturers. Specifically, the bill creates a legal presumption that certain patent settlement agreements are anticompetitive if a non-reference drug filer (such as a generic drug manufacturer) receives something of value from the original drug company and agrees to limit or delay the development, marketing, or sale of their competing drug product. The bill defines extensive terms and provides that such agreements will be presumed harmful unless the parties can prove by clear and convincing evidence that the settlement is fair and reasonable or generates pro-competitive benefits. Violators can face significant financial penalties, with potential fines up to three times the value received from the agreement or $20 million, whichever is greater. The legislation is designed to prevent brand-name pharmaceutical companies from paying generic manufacturers to delay entering the market, a practice known as "pay-for-delay" that can keep drug prices artificially high by blocking competition. The bill allows the New York Attorney General to bring civil actions to enforce these provisions and recover penalties, with a six-year statute of limitations for such actions.

Budget and Finance, Health and Social Services

https://www.nysenate.gov/legislation/bills/2025/S3203