ETHIC Act

The ETHIC Act (HR 3269) limits how many patents pharmaceutical companies can assert in lawsuits against generic drug and biosimilar manufacturers. Specifically, it prohibits a company from claiming more than one patent per "Patent Group" (commonly owned patents linked through disclaimers) in an infringement case involving a generic drug applicant or biosimilar product. This directly affects generic drug makers (under FDA's 505(b)(2) or 505(j) pathways) and biosimilar developers (under the Public Health Service Act), reducing the ability of brand-name companies to use stacked patents to delay competition. The law applies to applications submitted after its enactment date.