[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: 2021-20765]
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DEPARTMENT OF COMMERCE
Patent and Trademark Office
[Docket No. PTO-P-2021-0050]
Grant of Interim Extension of the Term of U.S. Patent No.
7,524,879; 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. 7,524,879 (`879 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 `879 patent, timely filed an application under 35 U.S.C.
156(d)(5) for an interim extension of the term of the `879 patent. The
`879 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 `879 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
`879 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. 7,5242,879 is granted for a period of one year from the
extended expiration date of the `879 patent.
Robert Bahr,
Deputy Commissioner for Patents, United States Patent and Trademark
Office.
[FR Doc. 2021-20765 Filed 9-23-21; 8:45 am]
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