2025 third_quarter Filing

Issues related to biopharmaceutical innovation and intellectual property (no bill); issues related to intellectual property and Bayh-Dole in the Genomic Data Protection Act (S. 863 / no House bill); induced infringement.

Proposed amendments to the Inflation Reduction Act (P.L. 117-169); Biosimilars Access and Affordability Act (no bill number); REMEDY Act (S. 2620); FDA Modernization Act 3.0 (S. 355 / H.R. 2821); issues related to reauthorization of the Prescription Drug User Fee Act (no bill); proposed amendment to the National Defense Authorization Act for Fiscal Year 2026 (S.Amdt.3236 to S.2296); issues related to vaccine access (no bill); Interagency Patent Coordination and Improvement Act of 2025 (S. 1097); Medication Affordability and Patent Integrity Act (S. 2658 / no House bill); Expedited Access to Biosimilars Act (S. 1414); Biosimilar Red Tape Elimination Act (S. 1954, HR 5526); Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2026 (S.2256); conditional approval; orphan-drug exclusivity; FDA reform.