[Federal Register Volume 86, Number 183 (Friday, September 24, 2021)]
[Notices]
[Page 53036]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-20764]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office

[Docket No. PTO-P-2021-0049]


Grant of Interim Extension of the Term of U.S. Patent No. 
7,259,184; Vernakalant Hydrochloride

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. 7,259,184 (`184 patent).

FOR FURTHER INFORMATION CONTACT: Ali Salimi, Senior Legal Advisor, 
Office of Patent Legal Administration, by telephone at 571-272-0909 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 approval phase of the regulatory review period is reasonably 
expected to extend beyond the expiration date of the patent.
    On July 14, 2020, Correvio International S[agrave]rl, the owner of 
record of the `184 patent, timely filed an application under 35 U.S.C. 
156(d)(5) for an interim extension of the term of the `184 patent. The 
`184 patent claims a method of using the product vernakalant 
hydrochloride. The application for interim patent term extension 
indicates that New Drug Application No. 22-034 for vernakalant 
hydrochloride was submitted to the Food and Drug Administration (FDA) 
on December 19, 2006, and that the FDA's review thereof is ongoing.
    Review of the interim patent term extension application indicates 
that, except for permission to market or use the product commercially, 
the `184 patent would be eligible for an extension of the patent term 
under 35 U.S.C. 156. Because it appears the approval phase of the 
regulatory review period will continue beyond the extended expiration 
date of the patent, i.e., October 6, 2021, interim extension of the 
`184 patent's term under 35 U.S.C. 156(d)(5) is appropriate.
    An interim extension under 35 U.S.C. 156(d)(5) of the term of U.S. 
Patent No. 7,259,184 is granted for a period of one year from the 
extended expiration date of the `184 patent.

Robert Bahr,
Deputy Commissioner for Patents, United States Patent and Trademark 
Office.
[FR Doc. 2021-20764 Filed 9-23-21; 8:45 am]
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