[Federal Register Volume 89, Number 190 (Tuesday, October 1, 2024)]
[Notices]
[Page 79899]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-22480]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office

[Docket No. PTO-P-2024-0047]


Grant of Interim Extension of the Term of U.S. Patent No. 
7,199,162--GRAFAPEX<SUP>TM</SUP> (Treosulfan)

AGENCY: United States Patent and Trademark Office, Commerce.

ACTION: Notice of interim patent term extension.

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SUMMARY: The United States Patent and Trademark Office has issued a 
certificate for a one-year interim extension of the term of U.S. Patent 
No. 7,199,162.

FOR FURTHER INFORMATION CONTACT: Kathleen Kahler Fonda, Senior Legal 
Advisor (telephone (571) 272-7754; email <a href="/cdn-cgi/l/email-protection#b1dad0c5d9ddd4d4df9fd7dedfd5d0f1c4c2c1c5de9fd6dec7"><span class="__cf_email__" data-cfemail="a7ccc6d3cfcbc2c2c989c1c8c9c3c6e7d2d4d7d3c889c0c8d1">[email protected]</span></a>). 
Alternatively, mail may be addressed to Commissioner for Patents, Mail 
Stop Hatch-Waxman PTE, P.O. Box 1450, Alexandria, VA 22313-1450, and 
marked to the attention of Ms. Fonda.

SUPPLEMENTARY INFORMATION: Section 156 of title 35, United States Code, 
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, and that the patent may be extended for interim 
periods of up to one year if the regulatory review is anticipated to 
extend beyond the expiration date of the patent.
    On August 20, 2024, Medac Gesellschaft f[uuml]r Klinische 
Spezialpr[auml]parate mbH, the patent owner of record, timely filed an 
application under 35 U.S.C. 156(d)(5) for a fourth interim extension of 
the term of U.S. Patent No. 7,199,162. The patent claims a method of 
using the human drug product GRAFAPEX<SUP>TM</SUP> (treosulfan). The 
application for patent term extension indicates that New Drug 
Application 214759 was submitted to the Food and Drug Administration on 
August 11, 2020, and its review in order for the patent owner to obtain 
permission to market and use the product commercially is ongoing.
    Review of the patent term extension application indicates that, 
except for permission to market or use the product commercially, the 
subject patent would be eligible for an extension of the patent term 
under 35 U.S.C. 156, and that the patent should be extended for one 
year as required by 35 U.S.C. 156(d)(5)(B). Because the regulatory 
review period will continue beyond the thrice-extended expiration date 
of the patent, October 12, 2024, interim extension of the patent term 
under 35 U.S.C. 156(d)(5) is appropriate.
    A fourth interim extension under 35 U.S.C. 156(d)(5) of the term of 
U.S. Patent No. 7,199,162 is granted for a period of one year from the 
thrice-extended expiration date of the patent.

Charles Kim,
Deputy Commissioner for Patents, United States Patent and Trademark 
Office.
[FR Doc. 2024-22480 Filed 9-30-24; 8:45 am]
BILLING CODE 3510-16-P


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