[Federal Register Volume 88, Number 223 (Tuesday, November 21, 2023)]
[Notices]
[Page 81063]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-25697]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office

[Docket No. PTO-P-2023-0049]


Grant of Interim Extension of the Term of U.S. Patent No. 
7,329,689; DUVYZATTM (Givinostat hydrochloride monohydrate)

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. 7,329,689 ('689 patent).

FOR FURTHER INFORMATION CONTACT: Ali Salimi, Senior Legal Advisor, 
Office of Patent Legal Administration, at 571-272-0909 or 
[email protected]; or Josephine Chang, Legal Advisor, Office of 
Patent Legal Administration, at 571-270-3522 or 
[email protected].

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 31, 2023, Italfarmaco SPA, the owner of record of the '689 
patent, timely filed an application under 35 U.S.C. 156(d)(5) for an 
interim extension of the term of the '689 patent. The '689 patent 
claims the drug product known by the tradename DUVYZATTM 
(Givinostat hydrochloride monohydrate). The application for interim 
patent term extension indicates that the approval phase of the RRP, as 
described in 35 U.S.C. 156(g)(1)(B)(ii), began on April 21, 2023, for 
DUVYZATTM (Givinostat hydrochloride monohydrate) and is 
ongoing before the Food and Drug Administration for permission to 
market and use the product commercially.
    Review of the interim patent term extension application indicates 
that, except for permission to market or use the product commercially, 
the '689 patent would be eligible for an extension of the patent term 
under 35 U.S.C. 156. Because it appears reasonable to expect the 
approval phase of the RRP to continue beyond the expiration date of the 
patent, i.e., January 15, 2024, interim extension of the '689 patent's 
term under 35 U.S.C. 156(d)(5) is appropriate.
    An interim extension under 35 U.S.C. 156(d)(5) of the term of U.S. 
Patent No. 7,329,689 is granted for a period of one year from the 
original expiration date of the '689 patent.

Brian Hanlon,
Acting Deputy Commissioner for Patents, United States Patent and 
Trademark Office.
[FR Doc. 2023-25697 Filed 11-20-23; 8:45 am]
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