[Federal Register Volume 87, Number 188 (Thursday, September 29, 2022)]
[Notices]
[Page 59063]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-21118]


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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, at 571-272-7728 or 
[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 (RRP) is 
reasonably expected to extend beyond the expiration date of the patent.
    On September 6, 2022, 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 fourth 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 a RRP as described in 35 
U.S.C. 156(g)(5)(B)(ii) began for ECI[supreg] (ELIAS Cancer 
Immunotherapy) and is ongoing before the United States Department of 
Agriculture, Center for Veterinary Biologics, for permission to market 
and use the product commercially.
    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 is apparent that the RRP will continue 
beyond the thrice-extended expiration date of the '699 patent, i.e., 
October 5, 2022, a fourth interim extension of the patent term under 35 
U.S.C. 156(d)(5) is appropriate.
    A fourth 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 
thrice-extended expiration date of the '699 patent.

Robert Bahr,
Deputy Commissioner for Patents, United States Patent and Trademark 
Office.
[FR Doc. 2022-21118 Filed 9-28-22; 8:45 am]
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