For many drugs, some of the most valuable days are at the end of the patent life cycle. One of the strongest protections for drugs is through the Patent Term Extension (PTE) application that was created under the Hatch-Waxman Act. The consequences, therefore, of not securing PTE can be financially devastating for a drug program. 

The District of New Jersey (DNJ) recently granted summary judgment against Taiho regarding its PTE application for a patent covering a bile duct cancer treatment, finding that Taiho’s application was one day late. The FDA had originally approved the product on Sept. 30, 2022, and issued a corrected approval letter on Oct. 5, 2022, but stated that the “effective action date” remained Sept. 30, 2022. Taiho filed its PTE application on Nov. 29, 2022, and listed the approval date of Sept. 30, 2022. But the PTO concluded that the filing period ended the day before (i.e., Sept. 29, 2022) and rejected the application. Taiho then amended its PTE application and argued that the relevant approval date was Oct. 5, 2022, and that the application was, therefore, timely filed. The PTO also rejected this argument. Taiho sued, and the DNJ was not receptive to its arguments. 

The issue was how to calculate the filing period under 35 U.S.C. § 156(d)(1), which requires a PTE application to be filed “within the sixty-day period beginning on the date the product received permission” for commercial marketing or use. Taiho argued that the triggering day should be excluded, which the court rejected. The court relied upon prior decisions from The Medicines Company v. Kappos (2010) and Section 37 of the AIA, and held that the statute unambiguously starts the clock on the same business day that FDA permission is transmitted (if before 4:30 p.m. on a business day). Because the FDA transmitted approval before 4:30 p.m. on a Friday, Sept. 30 counted as day one.  

The court also rejected Taiho’s argument that the Sept. 30 approval was legally ineffective because the original approval letter contained errors that would have mislabeled the product. The court reasoned that FDA approval and permission for commercial marketing were materially the same for these purposes, that any mislabeling decision belonged to the FDA (not the PTO), and the PTO properly relied on Taiho’s representations and the FDA’s confirmation of the Sept. 30 approval date. 

The court acknowledged, however, that “[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.” Indeed, the court concluded that “[h]ad there been any discretion allotted under these circumstances, the Court would quite confidently have reached a different result.”