Key Points

• Under Hatch-Waxman, the day of FDA approval counts as day one of the 60-day patent term extension filing window in § 156(d)(1), and the counting rule in Fed. R. Civ. P. 6(a)(1)(A) does not apply.
• The District of New Jersey upheld the USPTO's denial of PTE for two Taiho patents covering LYTGOBI because the application was filed on day 61, one day late.
• A corrected FDA approval letter did not reset the approval date, and the USPTO may rely on the applicant's own statement of that date.

A New Jersey federal judge’s recent dismissal of a patent dispute is a stark reminder that the 60-day patent term extension (PTE) filing window under the Hatch-Waxman Act is strictly construed and that the day of FDA approval counts as day one.

On October 26, 2026, U.S. District Judge Zahid N. Quraishi granted summary judgment to the government, upholding the USPTO’s refusal to extend the terms of two patents covering Taiho’s cancer drug LYTGOBI. The reason: Taiho filed its PTE application one day late.

Background

The Hatch-Waxman Act lets patent owners recover part of any patent term that may be lost due to FDA regulatory review. Under § 156(d)(1), application to extend the patent term may be submitted only within the 60-day period “beginning on the date the product received permission . . . for commercial marketing or use.”

Although the USPTO alone determines whether a patent is eligible for PTE, the FDA, upon request of the USPTO, may confirm certain details, such as the date the NDA was approved.

The FDA issued an initial approval letter for LYTGOBI at 12:08 p.m. on Friday, September 30, 2022 (“Original Approval Letter”), which it emailed to Taiho minutes later. That same day, Taiho flagged two minor errors: a “YYYY” placeholder in the prescribing information and an outdated storage condition on the carton label. On Monday October 3, 2022, Taiho sent the FDA a letter formalizing these noted errors, including clean and redline versions of the corrected information. The FDA issued a corrected letter on October 5, 2022 (“Corrected Approval Letter”) remedying these errors and expressly stating that the “effective action date” remained September 30, 2022.

Taiho filed its PTE application on November 29, 2022, representing that approval occurred on September 30 and that the 60-day period ran through November 29.

Notably, Taiho confirmed that the effective action date for approval was September 30, 2022. The USPTO wrote to the FDA to confirm certain details of the PTE applications, suggesting the applications were not timely filed. The FDA responded on January 24, 2024 that the approval date was September 30, 2022. Taiho then amended its application to claim an October 5, 2022 approval date, arguing that the original approval was ineffective because it “would have constituted false or misleading branding.”

On March 18, 2024, the USPTO rejected the applications as untimely and later denied reconsideration, stating the PTE applications should have been filed on November 28, 2022.

Taiho then filed suit against John Squires, in his official capacity as the Director of the United States Patent and Trademark Office, the United States Patent and Trademark Office, Martin A. Makary, in his official capacity as the Commissioner of the Food and Drug Administration, the United Sates Food and Drug Administration, Robert F. Kennedy, in his official capacity as the Secretary of Health and Human Services, and the United States Department of Health and Human Services (collectively, the “government”). Taiho argued the extension denials may cost it more than $1 billion “over the life cycle” of LYTGOBI.

The Court’s Holdings

Both sides moved for summary judgment. Because Taiho was seeking review of an agency action, the reviewing court “must set aside an agency action that is arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.” A decision is “arbitrary or capricious if it is not reasonable and reasonably explained.” The Court focused on Taiho’s arguments because it bears the burden in showing the “government acted contrary to law or arbitrarily or capriciously when it determined that Taiho’s PTE application was untimely filed.”

In so doing, the Court reached five conclusions.

The Government’s Interpretation of Section 156(d)(1) Was Not Contrary to Law.
Section 156(d)(1) provides that the PTE “application may only be submitted within the sixty-day period beginning on the date the product received permission under the provision of law under which the applicable regulatory review period occurred for commercial marketing or use . . . . “ Taiho argued that, because § 156(d)(1) does not specify a counting method, the Court should apply Federal Rule of Civil Procedure 6(a)(1)(A), which excludes the day of the triggering event. The Court disagreed, siding with the government that “a full reading of the plain language of Section 156(d)(1) leaves no room for equivocation.” Coupled with the provision that approvals transmitted after 4:30 p.m. Eastern Time on a business day, or on a non-business day, are deemed received on the next business day, it was clear that the day of approval is counted and included in the 60-day period commences.

The Court also found support for this interpretation in dicta from other cases interpreting Section 156(d)(1), the legislative history, and that Taiho identified no caselaw applying the computation method of Fed. R. Civ. P. 6(a)(1)(A) to “statutes with no relation to court processes or adjudicatory proceedings.” Finally, although it “recognize[d] that, in this instance, a literal reading of the statutory text provides a harsh result,” the Court found that doing otherwise would stretch the statute’s remedial purpose beyond the Congressional intent of the text.

The Government Did Not Act Arbitrarily or Capriciously When Applying Section 156(d)(1).
The Court credited the government’s explanation that “its PTE eligibility determination was based solely on Taiho’s representations.” Taiho admitted that it received permission from the FDA for marketing and commercial use on September 30, 2022 and that the 60-day period to file the PTE application commenced on the same date. Taiho filed its PTE application on November 29, 2022, which was one day late. The Court concluded that the government did not act arbitrarily or capriciously by finding the 60-day period began to run on September 30, 2022.

The Government Did Not Act Contrary to Law.
The court rejected Taiho’s argument that it lacked “actual permission” until October 5 because the original labeling was misbranded. Under 21 C.F.R. § 314.107, a drug may enter commerce on the date the FDA issues its approval letter, so there is no material difference between “approval” and “permission for commercial marketing or use.” The Court explained that here “the USPTO’s role is to base its decision solely on what information the applicant provides in its PTE application.” Thus, had the USPTO determined that Taiho’s product was misbranded, such an action would have been contrary to law. In other words, said the Court, “the USPTO did what it was supposed to do.”

The Government Did Not Act Arbitrarily or Capriciously When it Found Permission Was Granted September 30, 2022.
The Court found that the government’s recognition of the approval date as September 30, 2022 was not arbitrary or capricious because it reasonably relied on Taiho’s own admissions that approval occurred on September 30 and there was no evidence to suggest the corrections to the label actually changed the approval date.

The Government Did Not Act Arbitrarily or Capriciously When it Rejected the Amended PTE Application.
The Court also found that the governments rejected the amended PTE application “after fulsome consideration and with a substantial analysis.” In the denial decision, the government adequately explained that “there was no evidence in the record to corroborate Taiho’s amended representation that it received FDA approval on October 5, 2022 given that the Original Approval Letter, the Corrected Approval letter, and Taiho’s initial PTE application all provided September 30, 2022 as the approval date.”

The Court noted “[t]he drastic consequences of today’s decision are not lost on the Court. It is beyond unfortunate that Taiho has lost valuable patent rights to a drug product due to, what the Court infers was, a mere administrative oversight involving a single day.” The Court further pointed out it is “bound” by the statute and the administrative record, and “[h]ad there been any discretion allotted under these circumstances, the Court would quite confidently have reached a different result.”

For Taiho, the Court noted, such relief must be obtained through appellate review or legislative intervention.

Paul W. Kalish and Jonathan J. Madara are members of the IP Litigation team in Fox Rothschild’s Princeton, NJ office and write about patent litigation decisions in the District of New Jersey. Contact Paul at pkalish@foxrothschild.com or 609.895.6751 and Jonathan at jmadara@foxrothschild.com or 609.844.7428.

This information is intended to inform firm clients and friends about legal developments, including the decisions of courts and administrative bodies. Nothing in this alert should be construed as legal advice or a legal opinion. Readers should not act upon the information contained in this alert without seeking the advice of legal counsel. Views expressed are those of the authors and not necessarily this law firm or its clients.