[Federal Register Volume 86, Number 189 (Monday, October 4, 2021)]
[Notices]
[Page 54681]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21471]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office

[Docket No. PTO-P-2021-0053]


Grant of Interim Extension of the Term of U.S. Patent No. 
6,406,699; ECI[supreg] (ELIAS Cancer Immunotherapy)

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. 6,406,699 (`699 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 August 25, 2021, TVAX Biomedical I, LLC, the owner of record of 
the `699 patent, timely filed an application under 35 U.S.C. 156(d)(5) 
for a third interim extension of the term of the `699 patent. The `699 
patent claims a method of using a veterinary biological product in the 
cancer immunotherapy treatment known by the tradename ECI[supreg] 
(ELIAS Cancer Immunotherapy). The application for interim patent term 
extension indicates that an application for a license for the 
veterinary biological product was submitted under the Virus-Serum-Toxin 
Act and is currently undergoing regulatory review by the United States 
Department of Agriculture, Center for Veterinary Biologics.
    Review of the interim patent term extension application indicates 
that, except for permission to market or use the product commercially, 
the `699 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 `699 patent, i.e., October 5, 2021, further interim 
extension of the patent term under 35 U.S.C. 156(d)(5) is appropriate.
    A third interim extension under 35 U.S.C. 156(d)(5) of the term of 
U.S. Patent No. 6,406,699 is granted for a period of one year from the 
extended expiration date of the `699 patent.

Robert Bahr,
Deputy Commissioner for Patents, United States Patent and Trademark 
Office.
[FR Doc. 2021-21471 Filed 10-1-21; 8:45 am]
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