Bill > H5913

This bill establishes new regulations to prevent anticompetitive practices in pharmaceutical patent settlements, specifically targeting agreements between brand-name drug manufacturers and generic drug manufacturers that potentially delay generic drug market entry. The legislation creates a presumption that certain patent settlement agreements are anticompetitive if a generic or biosimilar drug manufacturer (nonreference drug filer) receives anything of value from the brand-name drug manufacturer and agrees to limit or delay the introduction of their competing product. The bill requires pharmaceutical manufacturers to disclose such arrangements to the attorney general within 30 days and imposes significant civil penalties for violations, with potential fines up to $20 million or three times the value received from the agreement. The law defines numerous terms related to drug applications, patent claims, and pharmaceutical markets, and provides detailed guidelines for determining whether a settlement agreement has anticompetitive effects. Notably, the bill allows some exceptions for settlements that can demonstrate procompetitive benefits or reasonable compensation for services, and it does not prevent drug companies from asserting claims under existing antitrust laws. The legislation aims to preserve competition in the pharmaceutical market and potentially reduce drug prices by preventing strategic patent settlements that delay generic drug market entry.

Justice

https://status.rilegislature.gov/