[Federal Register Volume 86, Number 189 (Monday, October 4, 2021)]
[Notices]
[Pages 54680-54681]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21472]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office

[Docket No. PTO-P-2021-0052]


Grant of Interim Extension of the Term of U.S. Patent No. 
7,199,162; GRAFAPEXTM (dihydroxybusulfan)

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. 7,199,162 (`162 patent).

FOR FURTHER INFORMATION CONTACT: Raul Tamayo, Senior Legal Advisor, 
Office of Patent Legal Administration, by telephone at 571-272-7728 or 
by email to [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

[[Page 54681]]

approval phase of the regulatory review period is reasonably expected 
to extend beyond the expiration date of the patent.
    On September 23, 2021, Medac Gesellschaft fur Klinische 
Spezialpraparate mbH, the owner of record of the `162 patent, timely 
filed an application under 35 U.S.C. 156(d)(5) for a first interim 
extension of the term of the `162 patent. The `162 patent claims a 
method of using the human drug product known by the tradename 
GRAFAPEXTM (dihydroxybusulfan). The application for interim 
patent term extension indicates that a regulatory review period (RRP) 
as described in 35 U.S.C. 156(g)(1)(B)(ii) began for 
GRAFAPEXTM (dihydroxybusulfan) 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 `162 patent would be eligible for an extension of the patent term 
under 35 U.S.C. 156. Because it is apparent that the RRP will continue 
beyond the original expiration date of the `162 patent, i.e., October 
12, 2021, interim extension of the patent 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. 7,199,162 is granted for a period of one year from the 
original expiration date of the `162 patent.

Robert Bahr,
Deputy Commissioner for Patents, United States Patent and Trademark 
Office.
[FR Doc. 2021-21472 Filed 10-1-21; 8:45 am]
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