Terminal Disclaimer Practice To Obviate Nonstatutory Double Patenting

DEPARTMENT OF COMMERCE <SUBAGY>Patent and Trademark Office</SUBAGY> <CFR>37 CFR Part 1</CFR> <DEPDOC>[Docket No. PTO-P-2024-0003]</DEPDOC> <RIN>RIN 0651-AD76</RIN> <SUBJECT>Terminal Disclaimer Practice To Obviate Nonstatutory Double Patenting</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> United States Patent and Trademark Office, Department of Commerce. <HD SOURCE="HED">ACTION:</HD> Notice of proposed rulemaking. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The USPTO proposes to amend the rules of practice to add a new requirement for an acceptable terminal disclaimer that is filed to obviate (that is, overcome) nonstatutory double patenting. The proposed rule change would require terminal disclaimers filed to obviate nonstatutory double patenting to include an agreement by the disclaimant that the patent in which the terminal disclaimer is filed, or any patent granted on an application in which a terminal disclaimer is filed, will be enforceable only if the patent is not tied and has never been tied directly or indirectly to a patent by one or more terminal disclaimers filed to obviate nonstatutory double patenting in which: any claim has been finally held unpatentable or invalid as anticipated or obvious by a Federal court in a civil action or by the USPTO, and all appeal rights have been exhausted; or a statutory disclaimer of a claim is filed after any challenge based on anticipation or obviousness to that claim has been made. This action is being taken 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. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> Comments must be received by July 9, 2024 to ensure consideration. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> For reasons of government efficiency, comments must be submitted through the Federal eRulemaking Portal at <E T="03">www.regulations.gov.</E> To submit comments via the portal, one should enter docket number PTO-P-2024-0003 on the homepage and click “search.” The site will provide search results listing all documents associated with this docket. Commenters can find a reference to this proposed rule and click on the “Comment” icon, complete the required fields, and enter or attach their comments. Attachments to electronic comments will be accepted in Adobe® portable document format (PDF) or Microsoft Word® format. Because comments will be made available for public inspection, information that the submitter does not desire to make public, such as an address or phone number, should not be included in the comments. Visit the Federal eRulemaking Portal for additional instructions on providing comments via the portal. If electronic submission of or access to comments is not feasible due to a lack of access to a computer and/or the internet, please contact the USPTO using the contact information below for special instructions. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Susy Tsang-Foster, Senior Legal Advisor, Office of Patent Legal Administration, at 571-272-7711; or Nicholas Hill, Legal Advisor, Office of Patent Legal Administration, at 571-270-1485. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> Under U.S. law, a person is entitled to a patent, absent certain exceptions, for an invention that is new and not obvious as of the effective filing date of the claimed invention. Because a patent owner may file continuing applications and obtain follow-on patents with claims that have the same effective filing date as those of the original patent, patent owners may pursue multiple patents with claims that vary in only minor ways from each other. A patent owner may also, under certain circumstances (for example, when two applications are filed on the same day), obtain patents that are not part of the same patent family for obvious variants of an invention. As a result, obviousness-type double patenting (also referred to as nonstatutory double patenting) may exist between patents and/or applications in the same patent family or in a different patent family. Under the doctrine of obviousness-type double patenting, the USPTO rejects patentably indistinct claims filed in patent applications when these applications and the applications and/or patents whose claims form the basis of the nonstatutory double patenting: (1) have the same inventive entity, at least one common (joint) inventor, a common applicant, and/or a common owner/assignee; or (2) are not commonly owned but are owned by parties to a joint research agreement. Under current practice, a patent applicant or patent owner (also referred to as a patentee) may, in most instances, obviate nonstatutory double patenting by filing a terminal disclaimer meeting the requirements of 37 CFR 1.321(c) or (d). A terminal disclaimer will ensure that the term of the patent with the terminal disclaimer will not extend beyond the term of the patent forming the basis of the nonstatutory double patenting. To prevent the harassment of an alleged infringer by multiple parties, under current 37 CFR 1.321(c) or (d) a terminal disclaimer must state that the patent in which the terminal disclaimer is filed shall be enforceable only for and during the period that the patent is commonly owned, or commonly enforced, with the patent which formed the basis for the nonstatutory double patenting. Even with the protections currently provided by a terminal disclaimer, multiple patents tied by terminal disclaimers that are directed to obvious variants of an invention could deter competition due to the prohibitive cost of challenging each patent separately in litigation or administrative proceedings. Currently, a terminal disclaimer filed to obviate nonstatutory double patenting over a conflicting patent must include a disclaimer of term, if any, extending beyond the term of the conflicting patent and a common ownership or common enforcement agreement. Under the proposed rule, the USPTO will not issue a patent to a common owner or inventor with a claim that conflicts with a claim of a second patent unless the terminal disclaimer includes an additional agreement that the patent with the terminal disclaimer will not be enforced if any claim of the second patent is invalidated by prior art. That means to resolve a dispute where there are multiple patents tied by terminal disclaimers, competitors could focus on addressing the validity of the claims of a single patent. As is the case under current practice, a terminal disclaimer under the proposed rule would be unidirectional, encumbering only the patent with the terminal disclaimer and not the conflicting patent. The reason for this is that a terminal disclaimer is signed only by the owner of the patent with the terminal disclaimer, and that patent and the conflicting patent might not be commonly owned when the terminal disclaimer is filed. See 35 U.S.C. 253 (providing for filing of a terminal disclaimer by the owner of the patent in which it is filed). The proposed rule is intended to promote competition by lowering the cost of challenging groups of patents tied by terminal disclaimers, resulting in reduced barriers to market entry and lower costs for consumers. The proposed rule furthers the objectives of Executive Order 14036 on “Promoting Competition in the American Economy,” 86 FR 36987 (July 14, 2021). As an example of how the proposed rule would lower costs of challenging multiple related patents, in a litigation in which a patent owner is enforcing a patent along with several other patents that are tied by one or more terminal disclaimers to that patent, a competitor could seek to have the court narrow any validity disputes to address only that patent. Narrowing validity disputes in litigation to only one such patent could result in more focused claim construction hearings, lower litigation costs, and faster resolution. Similarly, a competitor could petition for an inter partes or post-grant review of just a single patent to which multiple patents are tied by one or more terminal disclaimers with the proposed agreement. The outcome of the post-grant challenge to the claims in the selected patent may also resolve the enforceability of the multiple patents tied to that selected patent. Because only one patent can be challenged per post-grant petition, the proposed terminal disclaimer rule would lower the cost of administrative proceedings by enabling a challenger to seek the freedom to operate through the review of only one patent, as opposed to seeking the review of a number of patents claiming obvious variants of a single invention. <HD SOURCE="HD1">I. Background</HD> <HD SOURCE="HD2">A. Request for Comments on Whether Any Changes Need To Be Made to the Patent System Regarding Nonstatutory Double Patenting</HD> In a recent request for comments, the USPTO sought public input on whether changes are needed in terminal disclaimer practice to help ensure that the U.S. patent system properly and adequately protects innovation while not unnecessarily harming competition. <E T="03">See Request for Comments on USPTO Initiatives To Ensure the Robustness and Reliability of Patent Rights,</E> 87 FR 60130 (October 4, 2022) (“Request for Comments”). In the Request for Comments, the USPTO recognized that existing practice may not adequately address concerns that multiple patents directed to obvious variants of an invention could deter competition if the number of patents is prohibitively expensive to challenge in post-grant proceedings before the PTAB or in district court. To address this issue, the Request for Comments asked whether applicants seeking patents on obvious variations to prior claims should be required to s ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 79k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━