[Federal Register Volume 85, Number 193 (Monday, October 5, 2020)]
[Notices]
[Page 62714]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21963]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office

[Docket No. PTO-P-2020-0046]


Grant of Interim Extension of the Term of U.S. Patent No. 
7,057,053; 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. 7,057,053 (`053 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 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 `053 patent, timely filed an application under 35 U.S.C. 
156(d)(5) for an interim extension of the term of the `053 patent. The 
`053 patent claims 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 `053 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 original expiration 
date of the patent, i.e., October 16, 2020, interim extension of the 
`053 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. 7,057,053 is granted for a period of one year from the 
original expiration date of the `053 patent.

Robert Bahr,
Deputy Commissioner for Patent Examination Policy, United States Patent 
and Trademark Office.
[FR Doc. 2020-21963 Filed 10-2-20; 8:45 am]
BILLING CODE 3510-16-P