Medication Affordability and Patent Integrity Act

The Medication Affordability and Patent Integrity Act requires drug and biologic manufacturers to submit consistent patent-related information to both the FDA and the U.S. Patent and Trademark Office (USPTO), including certifying that data provided to the FDA matches what was shared with the USPTO. If a company fails to comply with these disclosure requirements, the FDA cannot approve a new drug or biologic application. The bill also creates a new defense in patent infringement lawsuits for generic drug manufacturers if a brand company did not properly disclose required information to the USPTO. These provisions directly affect pharmaceutical companies seeking FDA approval and aim to improve transparency in patent disclosures.