S-2658-119
Placed on Senate Legislative Calendar under General Orders. Calendar No. 528.
Sponsored by Margaret Hassan (D-NH)
What it does
This bill would require drug and biological product companies to share information they submit to the FDA with the U.S. Patent and Trademark Office (USPTO), and vice versa, when that information is relevant to whether a patent is valid. Companies would have to certify that the information they give each agency is consistent with what they told the other. If a company negligently or intentionally withholds required information, a generic or biosimilar competitor could use that failure as a legal defense against a patent infringement lawsuit — though that defense would not be available to certain foreign-linked entities as defined under the Defense Production Act.
Who benefits
Generic drug manufacturers and biosimilar developers, who would gain a new legal defense against patent infringement suits when brand-name companies fail to disclose required information. Patients and consumers broadly, who may benefit if more generic and biosimilar drugs reach the market sooner due to weakened or invalidated patents. Federal health programs (Medicare, Medicaid) that pay for prescription drugs and would benefit from lower prices if generic competition increases. Pharmacy benefit managers and insurers who negotiate drug prices. Domestic generic drug manufacturers specifically, as the non-disclosure defense is explicitly unavailable to certain foreign-linked entities.
Who is hurt
Brand-name pharmaceutical and biologic manufacturers, who would face new compliance burdens and potential loss of patent protection if they fail to meet disclosure requirements. Patent attorneys and regulatory affairs professionals at drug companies, who would need to coordinate disclosures across two separate federal agencies. Companies with large existing drug portfolios, who must apply the new rules to ongoing submissions and communications even for previously approved products. Innovator companies that rely on patent exclusivity to recoup research and development costs, who may face earlier generic competition. Smaller biotech firms with limited compliance infrastructure may face disproportionate administrative costs.
Supporters argue
Supporters argue that pharmaceutical companies currently exploit an information gap between the FDA and USPTO — submitting data to one agency that contradicts or omits what they told the other — to obtain or maintain patents that would not survive full scrutiny. They contend this practice, sometimes called "evergreening," extends monopoly pricing on drugs well beyond what Congress intended when it created the patent system, costing patients and federal programs billions of dollars annually. By requiring cross-agency consistency and creating a meaningful enforcement mechanism — the non-disclosure defense — the bill would deter bad-faith patent behavior without requiring the government to proactively police every application.
Opponents argue
Opponents argue that the bill creates significant legal uncertainty for legitimate patent holders, since the non-disclosure defense can be triggered by negligent — not just intentional — omissions, potentially voiding valid patents over inadvertent paperwork errors. They contend that forcing companies to share FDA submissions with the USPTO could expose competitively sensitive trade secrets and manufacturing data to broader disclosure, chilling investment in drug development at the margin. Critics also argue that the bill delegates broad regulatory expansion authority to the USPTO and FDA through the "other information as the Secretary may require" clause, raising concerns under the major questions doctrine and post-Loper Bright judicial scrutiny of agency rulemaking authority.
Constitutional context
Congress's authority to regulate drug approvals and patent law rests on the Commerce Clause (Art. I, §8, cl. 3) and its enumerated power to grant patents (Art. I, §8, cl. 8). The bill's delegation of additional rulemaking authority to the USPTO and FDA — particularly the open-ended "other information as the Secretary may require" clause — could face scrutiny under the major questions doctrine established in West Virginia v. EPA (2022) and heightened judicial review of agency statutory interpretation under Loper Bright v. Raimondo (2024), if agencies use that authority to significantly expand disclosure requirements beyond what the bill's text specifies.
Checks and balances
Congress gains authority by creating new cross-agency disclosure mandates and a statutory patent defense; the FDA and USPTO gain enforcement and rulemaking power, checked by judicial review under the post-Loper Bright independent-judgment standard and potential nondelegation challenges to the open-ended rulemaking clauses.
Historical precedent
The Hatch-Waxman Act (1984) and the Biologics Price Competition and Innovation Act (2010) previously structured the relationship between FDA approval and patent rights for generic and biosimilar drugs, but neither required cross-agency information sharing or created a non-disclosure defense to patent infringement.