HB3729 - Preserving Access to Affordable Drugs Act

• Creates the Preserving Access to Affordable Drugs Act to regulate patent settlement agreements in pharmaceutical products, presuming such agreements have anticompetitive effects and violate the act if a generic/biosimilar filer receives value and agrees to limit or forgo research, development, manufacturing, marketing, or sales.

• Establishes exceptions to the presumption if parties demonstrate settlement consideration consists solely of: right to market before patent expiration, covenant not to sue, reasonable litigation cost compensation (capped at $7.5 million or 5% of projected revenue), entry triggers based on reference product changes, regulatory approval facilitation, or forgiveness of damages from at-risk launches.

• Provides that fact-finders cannot presume marketplace entry could not occur until patent expiration, that patents are valid/infringed without final adjudication, or that agreements caused no delay absent FDA approval issues for competing products.

• Imposes civil penalties on violators of up to 3 times the value received or $20 million (whichever is greater), recoverable by the Attorney General, with penalties attributed based on Illinois' share of the brand drug market.

• Requires enforcement actions to be commenced within 4 years of the cause of action accruing and preserves rights to assert antitrust and unfair competition claims under federal and state law.