[Federal Register Volume 85, Number 193 (Monday, October 5, 2020)]
[Notices]
[Pages 62713-62714]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21969]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office

[Docket No. PTO-P-2020-0049]


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 
17, 2020, TVAX Biomedical I, LLC, the owner of record of the '699 
patent, timely filed an application under

[[Page 62714]]

35 U.S.C. 156(d)(5) for a second 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, 2020, further interim 
extension of the patent term under 35 U.S.C. 156(d)(5) is appropriate.
    A second 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 Patent Examination Policy, United States Patent 
and Trademark Office.
[FR Doc. 2020-21969 Filed 10-2-20; 8:45 am]
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