US SB1095

Authorizes the Federal Trade Commission to bring civil actions against persons who file "sham" citizen petitions designed to delay FDA approval of generic drugs or biosimilars, treating such filings as unfair methods of competition under the FTC Act

Defines a "sham" petition as one that is objectively baseless and attempts to use the governmental process itself (rather than its outcome) to interfere with a competitor's business, or a series of petitions with the same anticompetitive intent

Creates a rebuttable presumption that a petition is a sham when the Secretary of Health and Human Services determines it was filed primarily to delay approval and refers it to the FTC in writing

Establishes civil penalties of up to the greater of: (A) all revenue earned from sales of the referenced drug while the sham petition was under review, or (B) $50,000 per calendar day each sham petition remained under review

Applies to petitions filed after enactment and preserves existing antitrust remedies under the Clayton Act and other FTC enforcement authorities