Congress quietly adds patent-infringement loophole for generic drugmakers
S. 2658 — Medication Affordability and Patent Integrity Act · Filed by Maggie Hassan (D-NH) · 1 cosponsor · Introduced Aug 1, 2025 · Reported out
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What it does
This bill requires pharmaceutical and biologic drug sponsors to share information consistently between the FDA and the U.S. Patent and Trademark Office (USPTO), certifying that data submitted to each agency matches. It also creates a legal defense against patent infringement claims if a patent holder failed to disclose material information to the USPTO as required by the bill. The stated goal is to prevent drug makers from hiding information that could affect patent validity while pursuing FDA approval.
Why we flagged it
The bill's primary mechanism is a disclosure mandate (transparency), but its operative enforcement tool is a new legal defense that shields alleged patent infringers from liability if the patent holder failed to disclose—effectively creating a safe harbor for generic/biosimilar makers at the expense of patent holders.
What the text implies
- Section 274 creates a non-disclosure defense available to 'any person' asserting infringement, including generic and biosimilar manufacturers. This defense applies even if the infringer itself knew of the non-disclosure, shifting enforcement burden entirely to patent holders and potentially undermining patent validity as a barrier to market entry.
- The bill applies retroactively to patents issued before enactment for any submissions/communications made after enactment, creating ongoing compliance risk for patent holders and potential litigation exposure for patents already in force.
The full analysis lists 5 implications of this text.
Who stands to gain
generic drug manufacturers; biosimilar manufacturers; follow-on biologic developers