ETHIC Act

This bill aims to curb “patent thickets” that can delay cheaper generic drugs and biosimilars. It limits how many closely related patents a company can use in a lawsuit against a generic or biosimilar maker. If several patents are commonly owned and tied together through certain USPTO disclaimers (a “Patent Group”), the patent owner can only assert one of those patents in a single infringement case against that competitor, and cannot file new lawsuits using other patents from the same group against that same party . The rule targets cases involving FDA-approved generics and biosimilars or their applications, under specific drug and biologic approval pathways .

This change is meant to reduce repeat or overlapping lawsuits, which can slow competition and keep prices high. The new limit applies to relevant drug and biologic applications submitted on or after the date the law takes effect .

Key points

• Who is affected: Brand drug and biologic patent holders; companies making or applying to make generics or biosimilars; indirectly, patients and payers who may see earlier competition .
• What changes: Only one patent from a related “Patent Group” can be asserted per case against a generic/biosimilar party, and no follow‑on suits using other patents from that same group against that same party .
• When it applies: For generic or biosimilar applications submitted on or after the law’s enactment date .