Health Law Daily Wrap Up, DRUGS AND BIOLOGICS—D.N.J.: Drugmaker loses cancer drug patent term extensions after missing statutory filing deadline by one day, (Oct 28, 2026)

By Ravindra Kumar Singh, B.L.

The drugmaker’s attempt to rely on a corrected FDA approval letter failed because the original approval triggered the statutory 60-day filing period, leaving its patent term extension applications one day late.

A pharmaceutical company lost its bid to extend two patents associated with a cancer drug after a federal district court in New Jersey has upheld the U.S. Patent and Trademark Office’s (USPTO) rejection of its applications as untimely. The court held that the 60-day filing period under the Hatch-Waxman Act began on the date the FDA originally approved the drug, rather than the following day or the date of a subsequently corrected approval letter. Finding no legal error or arbitrary agency action, the court granted summary judgment to the federal government (Taiho Pharmaceutical Co., Ltd. v. Squires, No. 3:25-cv-17280 (D.N.J. Oct. 26, 2026)).

Patent extensions. Taiho Pharmaceutical Company and Taiho Oncology held U.S. Patent Nos. 9,108,973 and 10,434,103, covering formulations relevant to their cancer drug LYTGOBI. The patents were issued in 2015 and 2019, respectively.

The Hatch-Waxman Act permits pharmaceutical companies to seek patent term extensions (PTEs) to compensate for patent protection lost during the FDA’s regulatory review process. Under 35 U.S.C. § 156(d)(1), an application must be submitted within 60 days beginning on the date the product receives permission for commercial marketing or use.

On September 30, 2022, the FDA approved LYTGOBI at 12:08 p.m. Eastern Time. Taiho subsequently identified two errors in the approval materials: a placeholder instead of the approval year in the prescribing information and incorrect storage instructions on the carton label.

The FDA issued a corrected approval letter on October 5, 2022, expressly retaining September 30 as the effective approval date. Taiho submitted its PTE applications on November 29, 2022, seeking extensions through September 30, 2036. Although the company initially identified September 30 as the approval date, the USPTO determined that the filing deadline had expired on November 28.

Taiho subsequently amended its applications to identify October 5 as the operative approval date, arguing that the original labeling errors prevented valid authorization for commercial marketing. The USPTO rejected that position and denied reconsideration, prompting Taiho to challenge the decision under the Administrative Procedure Act (APA).

Approval day counts toward deadline. Taiho argued that the FDA approval date should be excluded when calculating the 60-day filing period. It relied on Federal Rule of Civil Procedure 6(a)(1)(A), which generally excludes the triggering event's date when computing procedural deadlines.

The court rejected that interpretation, finding that Section 156(d)(1) unambiguously requires the filing period to begin on the date the product receives FDA permission. The statute also provides a specific exception for approvals transmitted after 4:30 p.m. Eastern Time or on nonbusiness days, when permission is deemed received on the next business day.

Because the FDA issued its approval before that cutoff on a business day, September 30 constituted the first day of the filing period. The court found that importing the civil procedural rule would disregard the statutory language. Legislative history surrounding the America Invents Act further confirmed that Congress intended to clarify how to calculate the 60-day period, particularly for approvals transmitted outside normal business hours.

Although the court acknowledged that strict application of the statute produced a harsh result, it concluded that its remedial purpose did not justify extending the filing period beyond Congress's prescribed limits.

Labeling errors did not invalidate approval. Taiho separately contended that the original approval was ineffective because the labeling errors rendered LYTGOBI misbranded under the Federal Food, Drug, and Cosmetic Act.

The court disagreed. FDA regulations provide that a drug may enter interstate commerce upon approval of its application, and the approval date is the date the agency issues its approval letter. The FDA had neither withdrawn the September 30 approval nor conditioned it on subsequent labeling corrections.

The corrected letter expressly preserved the original effective date. Taiho had also repeatedly acknowledged September 30 as the approval date before attempting to revise its PTE applications. The court emphasized that determining whether a drug was misbranded fell within the FDA's authority, not the USPTO's. The patent agency was responsible for assessing extension eligibility based on the application and relevant regulatory information, rather than independently determining whether labeling errors invalidated FDA approval.

The USPTO had also adequately explained its rejection of Taiho's amended applications. Its determination was supported by the original approval letter, the corrected letter, the FDA's confirmation and Taiho's own representations.

One-day delay. The court concluded that the USPTO had neither acted contrary to law nor arbitrarily or capriciously in treating September 30 as the approval date and rejecting Taiho's applications.

The court acknowledged the severity of the outcome, observing that the company had lost valuable patent rights because of what appeared to be an administrative oversight involving a single day.

“The drastic consequences of today’s decision are not lost on the Court,” the court observed, noting that it would have reached a different result if the statute permitted discretion, but any relief would have to come through appellate review or legislative intervention.

Accordingly, the court upheld the USPTO's determination, granted the government's summary judgment motion, and denied Taiho's motion.

The case is No. 3:25-cv-17280.

Judge: Quraishi, Z.

Attorneys: Brendan Ashe (McCarter & English, LLP) for Taiho Pharmaceutical Co., Ltd. Matthew David Tanner, U.S. Department of Justice, for John Squires.

Companies: Taiho Pharmaceutical Co., Ltd.

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