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1 1 (February 24, 2025)

handle is hein.crs/goveson0001 and id is 1 raw text is: Terminal Disclaimers of Patent Rights: Background and Issues for Congress Updated February 24, 2025 Terminal disclaimers are a legal mechanism that allows a patent holder or applicant to relinquish part of a patent's term, so that the patent expires earlier than it would without the disclaimer. While terminal disclaimers are sometimes used to dedicate a patented invention to the public domain, they may also be used during patent prosecution, the administrative process through which an inventor applies for a patent before the U.S. Patent and Trademark Office (USPTO). In particular, current practice allows patent applicants to use terminal disclaimers to prevent a rejection of their patent application based on a judicially created doctrine called obviousness-type double patenting. This practice means that if USPTO rejects a patent application based on obviousness-type double patenting, applicants can overcome that rejection-and potentially receive a patent on the invention claimed in the application-if they are willing to surrender part of any resulting patent's term through a terminal disclaimer. Some stakeholders have criticized this use of terminal disclaimers, arguing that it may allow applicants to secure a thicket of multiple, overlapping patents on a single invention. This concern is often raised in the context of patents on drugs and biological products (biologics), which are sometimes protected by many patents, some of which may be linked together by terminal disclaimers. Other stakeholders argue that terminal disclaimers make patent prosecution more efficient, and that there is no evidence that terminal disclaimers harm innovation or economic competition. On May 10, 2024, USPTO issued a notice of proposed rulemaking on terminal disclaimers. USPTO's proposed rule would have required patent applicants to agree that they will not enforce a patent tied to another patent by a terminal disclaimer, should that other patent have a claim invalidated on novelty or non-obviousness grounds by a court or USPTO. In other words, the proposed rule would have effectively tied the validity of a patent with a terminal disclaimer to the validity of the patent(s) underlying the initial obviousness-type double-patenting rejection. Following criticism from some stakeholders, USPTO formally withdrew its proposed terminal disclaimer rule on December 4, 2024. This Legal Sidebar explains the current law and regulations on terminal disclaimers, USPTO's now- withdrawn proposed terminal disclaimer rule, and options for Congress. Congressional Research Service https://crsreports.congress.gov LSB11209 CRS Legal Sidebar Prepared for Members and Committees of Congress

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