[Federal Register Volume 91, Number 140 (Thursday, July 23, 2026)]
[Notices]
[Pages 46412-46413]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-14939]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office

[Docket No.: PTO-P-2026-0496]


Grant of Interim Extension of the Term of U.S. Patent No. 
8,877,798; Centanafadine Hydrochloride

AGENCY: United States Patent and Trademark Office; Department of 
Commerce.

ACTION: Notice of interim patent term extension.

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SUMMARY: The United States Patent and Trademark Office has issued an 
order granting a one-year interim extension of the term of U.S. Patent 
No. 8,877,798 (`798 patent).

FOR FURTHER INFORMATION CONTACT: Raul Tamayo, Senior Legal Advisor, 
Office of Patent Legal Administration, at 571-272-7728 or 
[email protected].

[[Page 46413]]


SUPPLEMENTARY INFORMATION: 35 U.S.C. 156 generally provides that the 
term of a patent may be extended for a period of up to five years, if 
the patent claims a product, or a method of making or using a product, 
that has been subject to certain defined regulatory review. 35 U.S.C. 
156(d)(5) generally provides that the term of such a patent may be 
extended for no more than five interim periods of up to one year each, 
if the approval phase of the regulatory review period (RRP) is 
reasonably expected to extend beyond the expiration date of the patent.
    On July 7, 2026, Otsuka Pharmaceutical Co., Ltd., the agent of the 
owner of record of the `798 patent, i.e., Otsuka America 
Pharmaceutical, Inc., timely filed an application under 35 U.S.C. 
156(d)(5) for a first interim extension of the term of the `798 patent. 
The `798 patent claims the drug product centanafadine hydrochloride. 
The application indicates that a RRP as described in 35 U.S.C. 
156(g)(1)(B)(ii) for centanafadine hydrochloride is ongoing before the 
Food and Drug Administration for permission to market and use the drug 
product commercially.
    Review of the application indicates that, except for permission to 
market or use the drug product commercially, the `798 patent would be 
eligible for an extension of its term under 35 U.S.C. 156. Because it 
appears reasonable to expect that the RRP will continue beyond the 
original expiration date of the `798 patent, i.e., July 25, 2026, 
interim extension of the patent's term under 35 U.S.C. 156(d)(5) is 
appropriate.
    A first interim extension under 35 U.S.C. 156(d)(5) of the term of 
U.S. Patent No. 8,877,798 is granted for a period of one year from the 
original expiration date of the patent.

Stefanos Karmis,
Acting Deputy Commissioner for Patents, United States Patent and 
Trademark Office.
[FR Doc. 2026-14939 Filed 7-22-26; 8:45 am]
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