“Heigh-ho” Taiho! The PTO Says LYTGOBI Patent is Ineligible for PTE Because of Untimely Application . . . And a Corrected NDA Approval Letter is No Saving Grace

April 22, 2024By Kurt R. Karst

If you’ve been following this blog since the early days, then you know we fervently followed the more-than-decade-long soap opera that was The Medicines Company’s efforts to obtain a Patent Term Extension (“PTE”) from the U.S. Patent and Trademark Office (“PTO”) for U.S. Patent No. 5,196,404 covering ANGIOMAX (bivalirudin) after the company’s patent counsel untimely filed for a PTE 62 days after the ANGIOMAX NDA 020873 approval at 5:18 PM on Friday, December 15, 2000 (see our summary and “coda” posts here and here).  The way that matter ended up—after touching all three branches of the U.S. Government—was that, despite having missed the statutory 60-day filing deadline, the patent was granted a PTE due to a change in the law created by Section 37 of the Leahy-Smith America Invents Act (“AIA”) (Pub. Law No. 112-029), titled “Calculation of 60-Day Period for Application of Patent Term Extension” and referred to by some as “The Dog Ate My Homework Act” or the “Medco Fix.”

Post-AIA, and a later change to the law to account for controlled substance FDA application approvals, the PTE statute at 35 U.S.C. § 156(d)(1) states (emphasis added):

To obtain an extension of the term of a patent under this section, the owner of record of the patent or its agent shall submit an application to the Director. Except as provided in paragraph (5), such an 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, or in the case of a drug product described in subsection (i), within the sixty-day period beginning on the covered date (as defined in subsection (i)). . . .

For purposes of determining the date on which a product receives permission under the second sentence of this paragraph, if such permission is transmitted after 4:30 P.M., Eastern Time, on a business day, or is transmitted on a day that is not a business day, the product shall be deemed to receive such permission on the next business day. For purposes of the preceding sentence, the term “business day” means any Monday, Tuesday, Wednesday, Thursday, or Friday, excluding any legal holiday under section 6103 of title 5.

Since the PTE statute was created with the September 1984 enactment of the Hatch-Waxman Amendments, and even post-AIA, there have been various instances in which FDA-regulated companies (or their counsel) have failed to timely submit a PTE application to the PTO within the statutory 60-day window (see, e.g., here).  On occasion,  PTE applicants try to fight a PTO determination that the application was untimely. . . . which brings us to the topic of this post.

Taiho Pharmaceutical Co., Ltd. (Taiho Oncology, Inc.) (“Taiho”) is the sponsor of NDA 214801 for LYTGOBI (futibatinib) Tablets.  Usually at this point in a post we would identify the date of approval of the relevant NDA.  But that’s the controversy here: Did FDA approve LYTGOBI NDA 214801 on September 30, 2022 when the Agency issued its initial approval letter, or on October 5, 2022 when FDA issued a corrected approval letter?  That’s important, because PTE applications for U.S. Patent Nos. 9,108,973 and 10,434,103 (here and here) covering LYTGOBI were filed with the PTO on November 29, 2022, putting the 60-day PTE application deadline outside of the September 30, 2022 approval date, but within an October 5, 2022 approval date.

In January 2024, FDA affirmed to the PTO in a letter that “NDA 214801 was approved on September 30, 2022, which makes the submission of the patent term extension application on November 29, 2022, not timely within the meaning of 35 U.S.C. 156(d)(l).”  Taiho’s counsel quickly followed up with a letter to FDA and a supplemental submission to the PTO in February 2024 arguing otherwise:

“[P]ermission for commercial marketing” was not effective under the September 30, 2022 FDA letter because the product would have been misbranded if marketed thereunder.  Rather, “permission for commercial marketing” was only effective upon FDA’s issuance of its corrected October 5, 2022 letter.  Calculating the 60-day period as beginning on that date renders the application timely. . . .

In this case, it is axiomatic that (a) the error in the approval date and (b) the inaccurate listing of the storage conditions for the product in the initial FDA notification were false.  The statute does not provide any applicable exception for such a falsity.  Accordingly, had Taiho marketed the product with labeling containing those errors, that labeling would have been false.  In addition, leaving the errors in the statement of storage conditions in place would have resulted in the product being labeled to be stored at 32°F-86°F, rather than the correct 59°F-86T Given this 27-degree colder temperature range, and the notation in the initial carton labeling “Do not refrigerate or freeze,” storing at the incorrectly-labeled conditions could have compromised product quality, possibly affecting safety and/or effectiveness of the product.  Thus, regardless of the technicality of an initial notification letter stating approval on September 30, 2022, Taiho was prohibited under the FDCA from marketing LYTGOBI with false labeling, 21 U.S.C. sections 331(a) and 352.(a)(l), and the actual, valid “permission for commercial marketing” of LYTGOBI did not exist until FDA corrected the labeling language in its October 5, 2022 “Corrected Approval” letter.

But on March 18, 2024, the PTO rendered its decision that the PTE applications were not timely filed because LYTGOBI NDA 214801 was approved on September 30, 2022:

As admitted by Taiho Pharmaceutical in the PTE application filed on November 29, 2022, LYTGOBI® (futibatinib) received FDA approval for commercial marketing or use of pursuant to section 505(b) of the Federal Food, Drug and Cosmetic Act by the approval letter transmitted on September 30, 2022 at 12:08 pm. . . .

As a result, the “next business day” proviso of under 35 U.S.C. § 156(d)(1) does not apply here because the approval was transmitted on a business day (a Friday) before 4:30 pm Eastern Time.  Therefore, the filing of the present application for patent term extension on November 29, 2022 was untimely, because the sixty-day period would have begun on September 30, 2022, and ended on November 28, 2022. . . .

The proposed approval date [] is wholly uncorroborated because applicant failed to provide any evidence on the record to support October 5, 2022 as the approval date.  Instead, the initial PTE application filed on November 29, 2022, the corrected approval letter, and the original approval letter all consistently indicate that September 30, 2022 is the effective approval date.  Thus, absent evidence to the contrary, the approval date remains September 30, 2022.

Because the PTE application was not timely, Taiho Pharmaceutical is not entitled to extension of the term of U.S. Patent No. 9,108,973 under 35 U.S.C. 156.

It’s not terribly uncommon for FDA to issue corrected approval letters (and corrected labeling).  Indeed, we found a slew of them spanning decades: here, here, here, here, here, here, here, here, here, here, here, here, here, here, here, here, here, here, here, here, here, here, here, here, here, here, here, here, here, here, here, here, here, here, here, here, here, here, here, here, here, here, here, here, here, here, here, here, here, here, here, and here.

While we didn’t perform our own analysis of the instances linked to above to determine whether or not each of the original approval dates was used for PTE application purposes, or whether the PTO accepted a corrected approval date, in at least one instance—see here and here—the corrected approval date was not used for PTE purposes, but instead, the original approval date.  But there may be more out there.  After all, as we posted in 2016, there have been approval date resets under certain circumstances.  So we’ll sit tight to see whether or not Taiho takes the next step of litigating the issue.

Categories: Hatch-Waxman