SB 269 - Generic Pharmaceuticals Availability

• Creates a presumption that patent settlement agreements between brand drug companies and generic/biosimilar drug makers have anticompetitive effects and violate state law if the generic maker receives payment or benefits while agreeing to delay or limit product sales.

• Establishes specific exceptions where settlements do not constitute violations, including: the right to market before patent expiration, covenants not to sue, capped litigation cost compensation ($7.5 million maximum or 5% of projected three-year revenue), and agreements allowing earlier entry if the brand company launches a different dosage or strength.

• Prohibits courts from presuming patents are valid or that delayed entry is procompetitive without evidence, and requires courts to presume the relevant market consists of the brand drug and competing generic/biosimilar products.

• Imposes civil penalties of up to three times the value of consideration received or $20 million (whichever is greater) per violator, plus additional damages as determined by the court, with actions enforceable by the Attorney General within four years.

• Takes effect October 1, 2021 and applies to abbreviated new drug applications (ANDAs) and biosimilar product applications filed with the FDA.