IP Law Daily, PATENT—E.D. Va.: USPTO justified in reducing AbbVie’s patent term adjustment by 129 days, (Jul 30, 2025)

By Saurabh Kashyap, B.A., M.A., LL.B., LL.M.

USPTO's application of the supplemental paper rule was upheld; APA claims dismissed due to a lack of jurisdiction.

The federal district court in Alexandria, Virginia, granted summary judgment in favor of the United States Patent and Trademark Office (USPTO), rejecting AbbVie Inc.'s challenge to a 129-day reduction in its patent term adjustment (PTA). The court ruled that the USPTO did not act arbitrarily or exceed its statutory authority under 35 U.S.C. § 154 by applying 37 C.F.R. § 1.704(c)(8) to AbbVie's March 2020 amendment. The court further held that AbbVie's claims under the Administrative Procedure Act (APA) were barred by 35 U.S.C. § 154(b)(4)(A), which provides the exclusive remedy for such disputes (AbbVie Inc. v. Stewart, No. 1:24-cv-02344-CMH-WEF (E.D. Va. July 29, 2025)).

Background. The plaintiff, AbbVie Inc., is a global pharmaceutical company that researches and markets advanced therapies for chronic diseases such as cancer and autoimmune disorders. The company’s business model relies heavily on patent exclusivity for its innovative formulations. The defendant, Coke M. Stewart, was sued in her official capacity as Acting Under Secretary of Commerce for Intellectual Property and Acting Director of the USPTO, which is responsible for granting patents and determining patent terms.

The dispute centered around U.S. Patent No. 11,369,599 (the '599 patent) issued from Application No. 14/340,435, titled "Melt-Extruded Solid Dispersions Containing an Apoptosis-Inducing Agent." The application, filed on July 24, 2014, underwent multiple rounds of examination over several years. After a complex prosecution history, including final rejections and requests for continued examination (RCEs), the USPTO ultimately allowed claims that included new claims filed by AbbVie in March 2020. The agency issued the '599 patent on June 8, 2022.

AbbVie filed this action on December 23, 2024, challenging the USPTO's decision to reduce its PTA by 129 days. AbbVie had initially requested a 568-day adjustment; USPTO granted only 439 days. The USPTO concluded that AbbVie's March 16, 2020, amendment—adding new claims 111-140—constituted a "supplemental paper" not expressly requested by the examiner, thus warranting a reduction under 37 C.F.R. § 1.704(c)(8). AbbVie sought reconsideration, which the USPTO denied, prompting AbbVie to sue.

As-applied challenge. AbbVie’s primary argument was that it took reasonable efforts to conclude prosecution and should not be penalized for responding to what it viewed as an erroneous USPTO notice. The court disagreed, holding that the USPTO properly exercised its authority under § 154(b)(2)(C)(iii) and the interpretive regulation in § 1.704(c)(8). Citing Gilead Sciences, Inc. v. Lee, 778 F.3d 1341 (Fed. Cir. 2015), the court noted that Congress delegated to the USPTO the authority to define “circumstances” that indicate a failure to engage in reasonable efforts.

The court found that the examiner’s February 2020 Notice merely requested AbbVie to correct the defect in its November 2019 amendment, not to submit new claims. The additional claims AbbVie included were not required and constituted a supplemental reply. Since the examiner did not expressly request them, the 129-day PTA reduction was justified.

Supernus. AbbVie relied on Supernus Pharmaceuticals, Inc. v. Iancu, 913 F.3d 1351 (Fed. Cir. 2019), to argue that delays beyond its control should not reduce the PTA. However, the court distinguished Supernus, noting that in that case the applicant had no way of acting until the European Patent Office issued a notice, whereas AbbVie could have submitted the additional claims earlier and had complete control over its filings. The court held that Supernus did not preclude the USPTO’s action in this case.

APA claim. In Count II, AbbVie asserted that the USPTO's application of § 1.704(c)(8) was arbitrary and capricious under the APA. The court dismissed this count due to a lack of subject matter jurisdiction. Relying on Randall v. United States, 95 F.3d 339, 346 (4th Cir. 1996), the court held that § 154(b)(4)(A) provides the exclusive remedy for challenging PTA determinations, thereby foreclosing any APA claim when an adequate statutory remedy exists.

Validity of regulation. In Count III, AbbVie challenged the validity of § 1.704(c)(8) itself, arguing that the USPTO exceeded its statutory mandate by penalizing the filing of supplemental papers even when they did not cause actual delay. The court rejected this challenge, holding that AbbVie forfeited this argument by failing to raise it before the agency. Even assuming the issue had been preserved, the court ruled the regulation was within the scope of authority delegated by Congress in § 154(b)(2)(C)(iii).

Citing Ancient Coin Collectors Guild v. U.S. Customs & Border Prot., 698 F.3d 171, 179 (4th Cir. 2012), the court reiterated that agency actions are unlawful only when they go beyond what Congress has authorized or act contrary to statutory limitations. The court found that USPTO acted squarely within its mandate to promote efficient patent examination, and that the regulation furthered Congress’s intent to discourage piecemeal submissions.

The court further clarified that Supernus did not invalidate the regulation itself, only its mechanical application in that specific case. Since the USPTO’s reduction here matched the exact period AbbVie was deemed to have failed to make reasonable efforts, there was no inconsistency with § 154.

The Case is No. 1:24-cv-02344-CMH-WEF.

Judge: Hilton, C.

Attorneys: Christopher Lee Crumbley (Bracewell LLP) for AbbVie Inc. Matthew J. Mezger, U.S. Department of Justice, for Derrick Brent.

Companies: AbbVie Inc.

Cases: Patent VirginiaNews USPTO