ETHIC Act

The ETHIC Act (S 2276) limits patent holders from asserting multiple related patents against generic drug and biosimilar manufacturers. It restricts claims to one patent per "Patent Group" (defined as commonly owned patents linked through specific disclaimer filings) in infringement lawsuits involving drug/biosimilar applicants. This applies to cases related to FDA applications under 505(b)(2), 505(j), or 351(k) pathways for new drug approvals. The law aims to reduce legal barriers for competition by preventing patent thickets from delaying generic/biosimilar market entry.