[Federal Register Volume 87, Number 46 (Wednesday, March 9, 2022)]
[Notices]
[Page 13278]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-04969]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office

[Docket No. PTO-P-2022-0009]


Grant of Interim Extension of the Term of U.S. Patent No. 
8,858,612; Reducer[supreg]

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. 8,858,612.

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: Section 156 of Title 35, United States Code, 
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, and that the patent may be extended for interim 
periods of up to one year if the regulatory review is anticipated to 
extend beyond the expiration date of the patent.
    On February 22, 2022, Neovasc Medical Ltd., the patent owner of 
record, timely filed an application under 35 U.S.C. 156(d)(5) for a 
third interim extension of the term of U.S. Patent No. 8,858,612. The 
patent claims methods of using a catheter delivered implantable device 
known by the tradename Reducer[supreg]. The application for patent term 
extension indicates that a Premarket Approval Application (PMA) P190035 
was submitted to the Food and Drug Administration (FDA) on December 31, 
2019.
    Review of the patent term extension application indicates that, 
except for permission to market or use the product commercially, the 
subject patent would be eligible for an extension of the patent term 
under 35 U.S.C. 156, and that the patent should be extended for one 
year as required by 35 U.S.C. 156(d)(5)(B). Because the regulatory 
review period will continue beyond the extended expiration date of the 
patent, March 27, 2022, interim extension of the patent 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. 8,858,612 is granted for a period of one year from the 
extended expiration date of the '612 patent.

Robert Bahr,
Deputy Commissioner for Patents, United States Patent and Trademark 
Office.
[FR Doc. 2022-04969 Filed 3-8-22; 8:45 am]
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