STOP GAMES Act of 2026

Increased Transparency and Accountability: The bill requires the Secretary to report specific details to Congress, including the identity of petitioners, the resources spent on petitions, and the estimated delay caused by each petition. (Section 2(c))

Prevention of Delay Tactics: The Secretary is granted the authority to deny petitions that do not raise valid scientific or regulatory issues or are submitted primarily to delay the approval of an application. (Section 2(a)(1)(E)(i))

Standardized Evaluation of Delay: The bill provides specific factors to identify delay tactics, such as submitting multiple serial petitions, submitting petitions close to patent expirations, or submitting petitions without supporting data. (Section 2(a)(1)(E)(ii))

Enforcement Against Improper Delay: If a petition is determined to be submitted with the primary purpose of delaying an application, the Secretary is required to refer the matter to the Federal Trade Commission. (Section 2(a)(1)(E)(iii))

Increased Burden on Petitioners: The bill introduces several factors that could lead to the denial of a petition, such as taking an unreasonable amount of time to submit it or failing to provide comments during public input opportunities. (Section 2(a)(1)(E)(ii))

Restrictions on Legal Recourse: The bill mandates that courts dismiss certain civil actions without prejudice if the person has not first exhausted administrative remedies via a petition, or dismisses them with prejudice if the petition was not filed timely. (Section 2(b)(2))

Stricter Petition Submission Requirements: The bill amends the requirement for petitions to be submitted no later than 60 days after the information upon which the petition is based first became known to the party. (Section 2(a)(1)(i))