USPTO Appeals Review Panel Narrows Allergan and Proposes New Framework for OTDP Analysis

The ARP Decision in Ex Parte Baurin Narrows the PTO’s Application of Allergan but Signals the Willingness for Reconsideration by the USPTO of OTDP Policy

Overview

Key Takeaways

The Appeals Review Panel (ARP) of the U.S. Patent and Trademark Office (USPTO) has adopted a narrow interpretation of the Federal Circuit’s 2024 decision in Allergan USA, Inc. v. MSN Labs. (Fed. Cir. 2024), limiting its ruling that a later-filed patent is not a proper obviousness-type double patenting (OTDP) reference to the particular date-specific facts in the case.
The ARP decision permits OTDP rejections based solely on the anti-harassment rationale, even where there is no undue timewise extension of patent term.
The ARP recognized the potential innovation costs associated with that rationale and proposed a new framework that would balance priorities during examination, while opining that Federal Circuit guidance would be necessary to implement.
The pending appeal in In re Ablynx N.V., as well as any subsequent appeal in Ex parte Baurin, may give the Federal Circuit an opportunity to address the scope of Allergan, the anti-harassment rationale, and the USPTO’s proposed OTDP framework.

Recommended Client Actions

Applicants should expect the Allergan decision to provide limited protection against OTDP rejections unless Federal Circuit guidance changes the analysis.
Applicants should consider whether ALL commercially valuable claims can be pursued in a single patent where rapid grant is important.
Patent owners and applicants should monitor developments in In re Ablynx and other OTDP appeals for Federal Circuit guidance.
Universities, startups and licensing-focused organizations should continue to evaluate how OTDP risk affects prosecution, ownership and transaction planning.

Background and Procedural History

The examiner rejected the claims in Sanofi’s U.S. Application No. 17/135,529 (the “Baurin application”) for OTDP, including over U.S. Patent No. 10,882,922, a later-filed patent that was also projected to expire later.

Sanofi appealed, arguing that the ‘922 patent was not a proper OTDP reference under Allergan. The Patent Trial and Appeal Board (PTAB) agreed with Sanofi and reversed the rejection, denying the examiner’s request for reconsideration. On March 5, 2026, USPTO Director John A. Squires sua sponte convened an ARP review of the PTAB ruling, and requested briefing from Sanofi and amici.

On August 6, 2026, the ARP issued a precedential decision reversing the PTAB’s decision and reinstating the examiner’s OTDP rejections. In its decision, the ARP also discussed unanswered policy questions and proposed a framework that would focus OTDP analysis on unwarranted extensions of patent term, but stated that it lacked the authority to implement the framework absent Federal Circuit guidance.

What the ARP Held

The ARP concluded that Allergan did not control the outcome in Baurin because the facts in the Baurin application were distinguishable. The ARP read Allergan as being limited to holding that a “first-filed, first-issued, later-expiring” claim in a patent family cannot be invalidated by a “later-filed, later-issued, earlier-expiring” reference patent having a common priority date.

On that interpretation, Allergan requires consideration of at least three facts/prongs:

Prong 1: Whether the challenged application was actually “first-filed,” as opposed to having an earlier patent-term filing date.
Prong 2: Whether the challenged application was the first-issued patent in the family.
Prong 3: Whether the challenged application and the reference patent share a common patent-term filing date.

The ARP found that the Baurin application was not actually filed first, nor was it the first-issued patent; therefore, it fell outside Allergan. The ARP regarded patent-term filing date and actual filing date as different concepts, a distinction that may be important in continuation practice.

Practical Effect of Allergan Interpretation on Prosecution

The immediate significance of the ARP decision in Baurin is that Allergan is unlikely to broadly limit OTDP rejections during routine prosecution. In most scenarios involving an issued reference patent, the challenged application will not be the first-issued patent in the family. As a result, the applicant is unlikely to satisfy the ARP’s reading of Allergan.

This does not affect all OTDP issues equally. Allergan applies only where a first-filed, first-issued claim is challenged based on a later-filed and later-issued reference patent that shares a common priority date but expires earlier (e.g., due to differing grants of PTA). This would not be a common situation during ordinary continuation practice, but the situation might arise during later litigation.

For licensing-focused applicants, the practical result is that continuation strategies may require careful timing and compromise. Applicants should assess whether commercially important claim sets can be pursued in the same patent rather than relying on filing multiple related applications that may issue at different times.

The Anti-Harassment Rationale and Innovation Policy

The ARP decision also held that existing Federal Circuit precedent recognizes an anti-harassment rationale for OTDP rejections, regardless of patent-term considerations. Federal Circuit cases, including In re Fallaux (Fed. Cir. 2009), were interpreted by the ARP as permitting an OTDP rejection based on concerns about separate ownership and multiple infringement suits, even when no unjustified extension of patent term is apparent.

The ARP acknowledged that this approach may have unintended consequences. In particular, numerous parties that filed amicus briefs argued that applying the anti-harassment rationale broadly could discourage follow-on research, collaborative development and sequential patenting. The ARP recognized these concerns, but concluded that any substantial change to the doctrine would have to come from the Federal Circuit.

Implications for Universities and Small Entities

The concern regarding the anti-harassment rationale is particularly acute for universities, research institutions and startups that depend on sequential patenting and licensing. Such organizations often seek protection as research findings develop, and then use the resulting patents to attract licensees, investors or startup partners.

Technology transfer programs translate federally funded and institutionally developed research into commercial products, including therapeutics, software and other technologies. The lifecycle of innovation at these institutions is well-documented,^1,2,3 as is their financial impact.^3,4,5 A patent portfolio may be developed over time as researchers refine a platform, pursue new applications or create improvements.

Critics of a broad anti-harassment rationale for OTDP argue that it may impose additional risks for those commercialization models. In their view, a doctrine that focuses on future ownership and potential litigation can make follow-on patenting more difficult, even when later claims represent genuine technical improvements.

These concerns also align with the policy objectives of the Bayh-Dole Act, which seeks to promote the use of university and small business inventions while avoiding unnecessary restrictions on future research and discovery. (See 35 U.S.C. § 200.) Whether those policy concerns justify a change to OTDP doctrine remains a question for the Federal Circuit.

The ARP’s Proposed OTDP Framework

The ARP’s proposed OTDP framework would focus OTDP analysis on the doctrine’s traditional concern: an unjustified extension of patent rights over time. Under that approach, the threshold question would be whether the asserted OTDP reference has a later patent-term filing date than the application under examination.

If so, the Office would end its OTDP analysis for that reference. The proposed approach would create a bright-line rule directed solely to patent-term extension, and could make examination and prosecution more predictable. The proposed framework is not binding law; adoption would depend on future Federal Circuit review or other lawful authority.

Why In re Ablynx Matters

OTDP issues similar to those raised in Baurin are pending before the Federal Circuit in Ablynx, an appeal arising from another Sanofi application, U.S. Application No. 17/409,019.

A Federal Circuit decision in Ablynx could address several unresolved questions:

The scope of Allergan,
Whether the anti-harassment rationale independently supports an OTDP rejection, and
Whether the ARP’s proposed patent-term-focused analysis is consistent with governing law.

Next Steps

Baurin largely preserves current OTDP practice while adopting a narrow interpretation of Allergan. The decision also expressly recognizes the tension between the anti-harassment rationale and modern, incremental models of research, licensing and commercialization.

For now, applicants should plan around the continued application of anti-harassment-based OTDP rejections.

A possible appeal by Sanofi from the ARP decision in Baurin may present yet another opportunity for the Federal Circuit to weigh in on these issues. Any such appeal would run slightly behind the timeline in Ablynx (with an upcoming USPTO brief due this Friday), which may provide the next significant opportunity for appellate clarification.

If you have any questions about how this ARP decision may affect your organization’s patent prosecution, ownership and transaction planning, please contact John Wizeman, Lisbeth Robinson, William Scofield or James Velema, or your regular Lathrop GPM attorney.

Selected References