Overview
- S.2658, sponsored by Sens. Maggie Hassan and Josh Hawley and scheduled for Senate HELP Committee markup this week, would force companies to give the U.S. Patent and Trademark Office copies of material they submit to the FDA and to certify the two filings are consistent.
- Opponents warn the bill would send confidential clinical and manufacturing information into a patent system that lacks the FDA’s secrecy infrastructure, a change they say could increase the risk of trade‑secret exposure.
- Critics highlight a harsh enforcement rule in the bill that makes noncompliance, even from an honest mistake, a bar to enforcing a patent, which they say effectively removes a constitutionally protected property right for procedural failures.
- Analysts and commentators argue the rule would shift many disputes into decades‑old regulatory records, invite new rounds of litigation and settlement pressure, and raise costs that could deter marginal drug research and follow‑on improvements.
- Coverage from policy groups and opinion writers suggests alternatives such as strict enforcement of existing fraud laws, expanded USPTO resources to cut backlogs, and targeted drug‑price reforms rather than broad disclosure mandates.