Substitute House Bill No. 6619, also known as "AN ACT CONCERNING PROHIBITING PAY FOR DELAY," is designed to combat anticompetitive "pay-for-delay" agreements in the pharmaceutical industry. These agreements typically involve a brand-name drug manufacturer paying a generic drug manufacturer to delay the entry of a generic drug into the market. The bill presumes such agreements to be anticompetitive and a violation of the law if they involve a nonreference drug filer receiving anything of value from a reference drug holder and agreeing to limit or forego research, development, or sales of their product. Exceptions to what constitutes "anything of value" are specified, including rights to market a competing product before patent expiration and compensation for saved litigation expenses under certain conditions. The bill also clarifies that an agreement allowing a nonreference drug filer to sell their product if the reference drug holder launches a different dosage, strength, or form of the reference drug is included in the exceptions.

The bill sets forth penalties for violations, with civil penalties payable to the state of up to three times the value received or given due to the violation, or twenty million dollars, whichever is greater. The Attorney General is empowered to bring civil actions against violators, with a statute of limitations of four years. The bill's provisions are effective from October 1, 2023, and it may result in costs for the Office of the Attorney General to hire consultants to identify violations, as well as potential revenue gains from imposed civil penalties. The bill also requires parties to demonstrate by a preponderance of the evidence that the compensation was fair and reasonable for other goods or services, or that the agreement generated procompetitive benefits that outweigh its anticompetitive effects.