USPTO withdraws proposed changes to terminal disclaimer requirements

The United States Patent and Trademark Office (USPTO) has withdrawn its proposed rule to amend terminal disclaimer requirements to address non-statutory double patenting. Originally published in the Federal Register on May 10, 2024, the proposed rule sought to ensure patents tied by terminal disclaimers would only remain enforceable if no tied patent had been invalidated or disclaimed under specific circumstances. However, the USPTO recently decided not to move forward with the proposal.

Background on the proposed rule

The proposal addressed challenges related to tying patents with terminal disclaimers to overcome non-statutory double patenting rejections. Non-statutory double patenting occurs when multiple patents with overlapping claims, filed by the same entity or related parties, extend exclusivity beyond statutory limits. Current practices require terminal disclaimers to ensure patents are co-owned and terminated on the same date as the conflicting patent. However, they do not prevent cumulative litigation costs or barriers to competition created by enforcing tied patents with overlapping claims.

The proposed rule sought to introduce enforceability conditions for terminal disclaimers. Under the rule, a patent tied by disclaimers would only be enforceable if no tied patent had been invalidated or disclaimed due to anticipation or obviousness. This change was touted as being designed to reduce litigation costs, streamline challenges, and promote competition by allowing competitors to address the validity of one tied patent rather than multiple patents.

Decision to withdraw

Citing internal “resource constraints,” the USPTO withdrew the proposed rule after receiving more than 300 comments from various stakeholders, including commenters supporting and opposing the proposal. The Office acknowledged the “thoughtful perspectives” raised by stakeholders during the comment period and emphasized its commitment to engaging with the intellectual property community.

Implications of withdrawal

The decision not to implement the proposed rule means existing practices under 37 CFR 1.321(c) and (d) remain unchanged. Terminal disclaimers will continue to restrict patent terms and enforce co-ownership but will not include the proposed enforceability conditions for tied patents. While this maintains the status quo, challenges associated with tied patents, such as high litigation costs and competitive barriers, remain unresolved.

Patent practitioners should note that the USPTO’s withdrawal does not indicate a lack of attention to this issue. The Office intends to continue collaborating with stakeholders to foster a balanced and reliable intellectual property system. Future initiatives may revisit aspects of the withdrawn proposal.

Conclusion

While the USPTO has decided not to proceed with the proposed rule, the dialogue surrounding terminal disclaimers and non-statutory double patenting remains active. Stakeholders should stay engaged with the USPTO as it explores alternative measures to balance robust patent protections with the need to promote competition and innovation.

Critical points

• Withdrawal: Due to resource constraints, the USPTO has withdrawn its proposed rule to amend terminal disclaimer requirements.
• Proposed changes: The rule sought to ensure tied patents are enforceable only if no tied patent is invalidated or disclaimed for anticipation or obviousness.
• Implications: Existing terminal disclaimer practices under 37 CFR 1.321(c) and (d) remain in place, leaving issues with tied patents unresolved.
• Stakeholder engagement: The USPTO remains committed to engaging with stakeholders and addressing concerns about non-statutory double patenting in future initiatives.
• Future outlook: Patent practitioners should monitor ongoing discussions as the USPTO works toward a balanced intellectual property system.

Executive summary

The USPTO has withdrawn its proposed rule to amend terminal disclaimer requirements, citing resource constraints. The rule addressed non-statutory double patenting by making tied patents enforceable only if no tied patent was invalidated or disclaimed for anticipation or obviousness. While the decision maintains the status quo, challenges with cumulative litigation costs and competition barriers remain. The USPTO emphasized its commitment to stakeholder engagement and a balanced intellectual property system. Future efforts may revisit aspects of the withdrawn proposal to address ongoing issues.

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