Drug Patents: New Information Sharing Rules
The Senate must act next: a Senate floor vote.
While the bill has support from both parties, it faces a tough path because large drug companies often spend a lot of money to lobby against changes to patent laws.
Scores run from -100 (strongly harmful) to +100 (strongly beneficial) for each group, combining impact, certainty, scope, and duration ratings of 1-5. How impact scoring works
Generic and biosimilar drug makers gain a new legal defense against patent infringement suits if a brand-name patent holder failed to disclose required information to the Patent Office. This makes it easier and less risky to challenge patents that were obtained using inconsistent or incomplete data, potentially speeding market entry for smaller manufacturers.
Placed on Senate Legislative Calendar under General Orders. Calendar No. 528.
The bill is now on the schedule for the full chamber to consider. It's in line for debate and a vote.
Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
The committee approved this bill and is sending it to the full chamber for a vote. This is a significant step — most bills never get this far.
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
The committee approved this bill and is sending it to the full chamber for a vote. This is a significant step — most bills never get this far.
Committee on Health, Education, Labor, and Pensions. Hearings held.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Sent to a congressional committee for expert review. The committee decides whether this bill moves forward.
The Senate HELP Committee advanced the Medication Affordability and Patent Integrity Act (S. 2658) in a 16-6 vote. The bill requires applicants for FDA approval to certify that their submissions are consistent with information provided to the USPTO for patent protection.
The Association for Accessible Medicines welcomed the advancement of the Medication Affordability and Patent Integrity Act, stating it will improve transparency and coordination between the FDA and USPTO while strengthening the integrity of the pharmaceutical patent system.
As part of a broader investigation into drug pricing, the ICIJ noted that the Medication Affordability and Patent Integrity Act aims to reform patent review and facilitate the entry of generics by closing coordination gaps between the FDA and the Patent Office.
No votes or related bills recorded for this bill yet.
Document Type
Congressional Bill
Official Title
Medication Affordability and Patent Integrity Act
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