ETHIC Act

The "Eliminating Thickets to Increase Competition Act," or ETHIC Act, proposes to address the issue of patent thickets, particularly within the pharmaceutical and biological product sectors. This legislation seeks to amend existing patent law by imposing a significant restriction on infringement actions. It mandates that a patent holder may assert not more than one patent per Patent Group when suing a generic drug or biosimilar manufacturer. This limitation applies to parties involved in the application for or commercialization of drugs approved via specific FDA pathways (505(b)(2) or (j)) or biological products licensed under section 351(k). A Patent Group is defined as commonly owned patents or applications linked by disclaimers under section 253. Furthermore, once a patent from a group is asserted, no additional actions can be brought asserting another patent from the same group against that party, with these provisions applying to applications submitted after the bill's enactment.