Substitute Bill No. 6619 Summary

• Prohibits "pay for delay" agreements between brand drug companies and generic/biosimilar drug makers, effective October 1, 2023, where generic makers receive anything of value in exchange for delaying market entry.

• Establishes presumption that such agreements are anticompetitive violations if a nonreference drug filer receives value (exclusive license, promise not to launch authorized generic) and agrees to limit research, development, manufacturing, marketing or sales of their product.

• Allows exceptions for agreements providing: right to market before patent expiration, covenant not to sue, reasonable litigation cost compensation (capped at $7.5 million or 5% of projected three-year revenue), conditional entry if brand launches different dosage/form, or forgiveness of damages for at-risk launches.

• Permits defendants to avoid liability by demonstrating the value received is fair compensation for other goods/services or that procompetitive benefits outweigh anticompetitive effects, with burden of proof by preponderance of evidence.

• Establishes civil penalties up to three times the value received or $20 million (whichever is greater) recoverable by the Attorney General, plus liability for damages and other remedies, with four-year statute of limitations.