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119-s-2620119th CongressWALLET

REMEDY Act

Sponsored By: Senator Durbin, Richard J. [D-IL]

Introduced

Summary

Requires brand drug sponsors to pick one binding "covered patent" for each newly approved drug. This bill would restructure the FDA's abbreviated new drug application (ANDA) patent-certification rules and limit which patents can trigger the 30-month stay and patent suits.

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  • Brand-name sponsors: would designate a single "covered patent" for each new drug approved after enactment. That choice is binding and cannot be changed.
  • Generic applicants: for post-enactment drugs they could be sued only over the chosen covered patent. For drugs approved before enactment, infringement actions can still target any certified patent submitted before the ANDA filing date.
  • Process and courts: the bill would clarify and align timing and scope language across approval provisions, replacing references to "the patent" with "the patent or the covered patent" to make infringement timing and the 30-month stay consistent.

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Bill Overview

Analyzed Economic Effects

2 provisions identified: 0 benefits, 1 costs, 1 mixed.

Existing patent rules kept for older drugs

If enacted, drugs approved before the law would keep the current rules. That means a patent lawsuit could be brought for any patent that was the subject of the certification and for which information was submitted before the ANDA filing date. The bill would also change statutory wording so timing triggers and decision references work differently depending on whether a drug was approved before or after enactment. Keeping the broader pre-enactment scope could preserve ongoing litigation and delay some generic entry for older drugs.

One chosen patent for new drugs

If enacted, drug sponsors would have to pick one "covered patent" when they first file patent information for a newly approved drug. That choice would be binding and could not be changed. For drugs approved on or after enactment, lawsuits tied to an ANDA filing could be brought only on the selected covered patent, and timing rules like the thirty-month stay would apply only to that patent. This would likely reduce the number of different patent lawsuits a generic applicant faces but would limit the brand holder to enforcing a single chosen patent.

Sponsors & CoSponsors

Sponsor

Durbin, Richard J. [D-IL]

IL • D

Cosponsors

  • Sen. Cassidy, Bill [R-LA]

    LA • R

    Sponsored 7/31/2025

Roll Call Votes

No roll call votes available for this bill.

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