US SB1096

Prohibits "reverse payment" or "pay-for-delay" settlement agreements between brand-name drug companies and generic/biosimilar manufacturers that delay market entry of lower-cost alternatives

Creates a presumption of anticompetitive effects when a generic or biosimilar filer receives anything of value and agrees to limit or delay their product's development, manufacturing, or sales for any period of time

Establishes civil penalties up to 3 times the value received by violating parties, enforced by the Federal Trade Commission as an unfair method of competition under Section 5 of the FTC Act

Permits settlements that include early market entry dates, reasonable litigation expenses up to $7.5 million (adjusted annually for inflation), or covenants not to sue for patent infringement

Requires CEO certification that filed settlement agreements are complete and include all related ancillary agreements, with a 6-year statute of limitations for FTC enforcement actions