Medication Affordability and Patent Integrity Act

S 2658, the Medication Affordability and Patent Integrity Act, requires drug manufacturers to certify that patent information submitted to the FDA for new drug approvals matches what they provided to the U.S. Patent and Trademark Office (USPTO). It mandates that sponsors submit patent-related data to the USPTO and certify its accuracy, ensuring consistency between FDA and patent filings for drugs and biologics. The bill creates a new legal defense for generic drug makers in patent lawsuits if a brand-name company failed to disclose required patent information. This applies to new drug applications filed after the law's enactment, directly affecting pharmaceutical companies seeking FDA approval for new medications.