Notice2021-21472
Grant of Interim Extension of the Term of U.S. Patent No. 7,199,162; GRAFAPEXTM (dihydroxybusulfan)
Primary source
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Published
October 4, 2021
Issuing agencies
Commerce DepartmentPatent and Trademark Office
Abstract
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).
Full Text
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<title>Federal Register, Volume 86 Issue 189 (Monday, October 4, 2021)</title>
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[Federal Register Volume 86, Number 189 (Monday, October 4, 2021)]
[Notices]
[Pages 54680-54681]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="/cdn-cgi/l/email-protection#0a786b7f66247e6b676b73654a7f797a7e65246d657c"><span class="__cf_email__" data-cfemail="15677460793b617478746c7a55606665617a3b727a63">[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
[[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
GRAFAPEX<SUP>TM</SUP> (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
GRAFAPEX<SUP>TM</SUP> (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]
BILLING CODE 3510-16-P
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