Bill > A08576

This bill aims to preserve access to affordable drugs by establishing new regulations on patent settlement agreements between brand-name drug manufacturers and generic drug developers. 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 a reference drug holder and agrees to limit or delay the research, development, or marketing of their competing drug product. Specifically, the bill defines various terms related to drug applications and patent claims, and establishes that such agreements will be considered presumptively harmful unless the parties can provide clear and convincing evidence that the agreement generates pro-competitive benefits or provides fair compensation for other services. The legislation allows for significant penalties, including civil penalties of up to three times the value received from the violation or $20 million, whichever is greater. The bill empowers the New York Attorney General to bring civil actions to enforce these provisions, with a six-year statute of limitations. The goal is to prevent pharmaceutical companies from using patent settlements to delay generic drug competition and keep drug prices artificially high.

Health and Social Services

https://www.nysenate.gov/legislation/bills/2025/A8576