Federal policy relating to providing federal funding to strengthen capabilities for domestic manufacturing of generic drugs and their ingredients; and Federal policy relating to amending Hatch-Waxman Act 180-day exclusivity eligibility to provide incentives for manufacturing generic pharmaceuticals and their ingredients in the United States and allied nations.
Federal policy relating to the review of the United States-Mexico-Canada trade agreement and the North American generic drug supply chain.
HR 6485/S. 43, Skinny Labels Big Savings Act, provisions relating to providing a safe harbor from infringement for a method of use patent relating to drugs or biological products; Federal policy relating to the Patent and Trademark Offices Revisions to Rules of Practice before the Patent Trial and Appeal Board notice of proposed rulemaking [Docket No. PTO-P-2025-0025] requiring Inter Partes Review (IPR) filers to choose between district court litigation and IPR; and Federal policy relating to Patent and Trademark Office discretionary denials of IPR institution.
HR 5526/S. 1954, the Biosimilar Red Tape Elimination Act, provisions relating to deeming a biosimilar interchangeable with its reference product immediately upon approval.