Proposed changes to terminal disclaimer practice to promote innovation and competition

The United States Patent and Trademark Office (USPTO) has issued a notice of proposed rulemaking (NPRM) to add a new requirement for terminal disclaimers filed to obviate (overcome) nonstatutory double patenting. 

Under U.S. law, an inventor, patent owner or joint researchers may obtain more than one patent with claims that vary in only minor (patentably indistinct) ways from each other. The USPTO will reject such claims under “obviousness-type double patenting” (also known as “nonstatutory double patenting”) and will allow claims to issue only as long as the practice of obtaining similar claims across patents isn’t used to extend the patent exclusivity term or allow multiple parties to harass an alleged infringer. Both conditions aim to strike a balance between incentivizing innovation in the first instance while providing more certainty to competitors and the public. 

The proposed rule responds to public feedback and proposes to add a third condition that would further promote innovation and competition by reducing the cost of separately challenging each patent in a group of multiple patents directed to indistinct variations of a single invention. Under the proposed rule, to overcome double patenting the patentee would need to agree that the patent with the terminal disclaimer will be enforceable only if the patent is not tied and has never been tied through one or more terminal disclaimers to a patent in which any claim has been finally held unpatentable or invalid over prior art. In addition to reducing costs, the proposed rule is expected to streamline and expedite patent disputes, narrow validity issues, and provide greater certainty to competitors and to the public. The proposed rule is prospective in nature and would apply to terminal disclaimers filed on or after the effective date of any final rule. 

The USPTO recognizes that, as with any proposed rule change, patentees will need to consider and potentially adapt their practices. While the USPTO moves forward with rulemaking, the Office is considering ways the Office can support stakeholders. Comments on the proposed rule, as well as comments on USPTO practice as related to the proposed rule, are welcome. 

“Our mission at the USPTO is to drive U.S. innovation and global competitiveness for the benefit of all Americans,” said Under Secretary of Commerce and Director of the USPTO Kathi Vidal. “This proposed rule is part of a holistic, thoughtful and balanced approach to bolstering our strong intellectual property system. We must remain steadfast in incentivizing and protecting the investments in innovation that drive U.S. leadership, while recognizing that surgical changes can create efficiencies that reduce costs and promote competition.” 

The full text of the notice is available at the Federal Register and on the USPTO’s Patent Related Notices webpage. You must submit comments on the NPRM by July 9, through the Federal eRulemaking Portal, to ensure consideration.