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Big Molecule Watch
June 3, 2024

USPTO Proposed Rulemaking Regarding Terminal Disclaimers

The USPTO recently issued a notice of proposed rulemaking regarding terminal disclaimers.   The proposed rule would require that, for patents where a terminal disclaimer was filed to overcome obviousness-type double patenting, the patentee must agree that the patent on which the terminal disclaimer was filed will be enforceable only if the patent is not tied, and has never been tied to a patent by one or more terminal disclaimers in which: 1) any claim has been finally held unpatentable or invalid under 35 USC §§ 102 or 103 (by a federal court or by the USPTO), and all appeal rights have been exhausted, or 2) a statutory disclaimer has been filed after the validity of the claim is challenged based on anticipation or obviousness.

The USPTO explained that the aim of the proposed rule is “to prevent multiple patents directed to obvious variants of an invention from potentially deterring competition and to promote innovation and competition by allowing a competitor to avoid enforcement of patents tied by one or more terminal disclaimers to another patent having a claim finally held unpatentable or invalid over prior art.”  The proposed rule came about after the USPTO sought public input on whether changes should be made to terminal disclaimer practice.  Request for Comments on USPTO Initiatives To Ensure the Robustness and Reliability of Patent Rights, 87 FR 60130 (October 4, 2022).  According to the USPTO, after receiving “comments expressing a range of views” the agency ultimately concluded to propose a rule that “does not concern the validity of claims” but instead “would require an agreement by the disclaimant that the patent with the terminal disclaimer will be enforced only under certain conditions.”

Comments on the proposed rule must be received by July 9, 2024.  Comments should be submitted using the Federal eRulemaking Portal at www.regulations.gov (search for PTO-P-2024-0003).

As of June 3, 2024, 26 comments have been submitted to the USPTO and nearly all have opposed the new rule or expressed concerns as to whether the USPTO has exceeded its statutory authority in promulgating the rule.  Garmin International Inc. wrote in favor of the proposed rule, stating that “[r]eforming the USPTO’s continuation practice by changing terminal disclaimer requirements is a major and easy, step towards improving patent quality.”

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