Federal policy relating to providing incentives and federal funding to strengthen capabilities for domestic manufacturing of generic drugs and their ingredients; Federal policy relating to amending the Hatch-Waxman Act to provide incentives for manufacturing generic pharmaceuticals and their ingredients in the United States and allied nations. Federal policy relating to addressing drug shortages and strengthening pharmaceutical supply chains through partnerships with North American and other allied countries; and Federal policy relating to providing preferential federal direct and indirect purchasing treatment for domestic and North American manufactured pharmaceuticals.
Federal policy relating to the review of the United States-Mexico-Canada trade agreement and the North American generic drug supply chain; and Federal policy relating to the United States-Mexico-Canada trade agreements rules of origin requirements for pharmaceuticals.
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; HR 3269/S. 2276, the Eliminating Thickets to Increase Competition (ETHIC) Act, provisions relating to capping the number of patents that can be asserted against biosimilar and generic manufacturers to one per terminally disclaimed group; 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.