[Federal Register Volume 87, Number 188 (Thursday, September 29, 2022)]
[Notices]
[Page 59064]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-21117]



[[Page 59064]]

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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 (Treosulfan)

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, at 571-272-7728 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 August 25, 2022, Medac Gesellschaft fuer Klinische 
Spezialpraparate M.B.H., the owner of record of the '162 patent, timely 
filed an application under 35 U.S.C. 156(d)(5) for a second 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 (treosulfan). The application for interim patent 
term extension indicates that a RRP as described in 35 U.S.C. 
156(g)(1)(B)(ii) began for GRAFAPEXTM (treosulfan) 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 once-extended expiration date of the '162 patent, i.e., 
October 12, 2022, a second interim extension of the patent term under 
35 U.S.C. 156(d)(5) is appropriate.
    A second 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 
once-extended expiration date of the '162 patent.

Robert Bahr,
Deputy Commissioner for Patents, United States Patent and Trademark 
Office.
[FR Doc. 2022-21117 Filed 9-28-22; 8:45 am]
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