[Federal Register Volume 88, Number 199 (Tuesday, October 17, 2023)]
[Notices]
[Pages 71533-71534]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-22836]


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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; GRAFAPEX\TM\ (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 
<a href="/cdn-cgi/l/email-protection#88fae9fde4a6fce9e5e9f1e7c8fdfbf8fce7a6efe7fe"><span class="__cf_email__" data-cfemail="96e4f7e3fab8e2f7fbf7eff9d6e3e5e6e2f9b8f1f9e0">[email protected]</span></a>.

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 28, 2023, Medac Gesellschaft fuer 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 third 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 
GRAFAPEX<SUP>TM</SUP> (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 GRAFAPEX<SUP>TM</SUP> (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 indicated 
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 was apparent that the RRP would 
continue beyond the twice-extended expiration date of the `162 patent, 
i.e., October 12, 2023, a third interim extension of the patent term 
under 35 U.S.C. 156(d)(5) was appropriate.

[[Page 71534]]

    A third interim extension under 35 U.S.C. 156(d)(5) of the term of 
U.S. Patent No. 7,199,162 was granted on October 10, 2023, for a period 
of one year from the twice-extended expiration date of the `162 patent.

Brian Hanlon,
Acting Deputy Commissioner for Patents, United States Patent and 
Trademark Office.
[FR Doc. 2023-22836 Filed 10-16-23; 8:45 am]
BILLING CODE 3510-16-P


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