98-9535. Grant of Certificate of Interim Extension of the Term of U.S. Patent No. 4,177,290: PROVIGIL

[Federal Register Volume 63, Number 69 (Friday, April 10, 1998)]
[Notices]
[Page 17821]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-9535]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office


Grant of Certificate of Interim Extension of the Term of U.S. 
Patent No. 4,177,290: PROVIGIL

AGENCY: Patent and Trademark Office, Commerce.

ACTION: Notice of interim patent term extension.

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SUMMARY: The Patent and Trademark Office has issued a certificate under 
35 U.S.C. 156(d)(5) for a one-year interim extension of the term of 
U.S. Patent No. 4,177,290.

FOR INFORMATION CONTACT: Karin Tyson by telephone at [phone]; by 
mail marked to her attention and addressed to the Assistant 
Commissioner for Patents, Box DAC, Washington, D.C. 20231; by fax 
marked to her attention at [phone], or by e-mail to 
[e-mail].

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 5 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. Under Section 156(e)(1), a patent is eligible for 
term extension only if regulatory review of the claimed product was 
completed before the original patent term expired.
    On December 3, 1993, Section 156 was amended by Pub. L. No. 103-179 
to provide that if the owner of record of the patent or its agent 
reasonably expects the applicable regulatory review period to extend 
beyond the expiration of the patent, the owner or its agent may submit 
an application to the Commissioner of Patents and Trademarks for an 
interim extension of the patent term. If the Commissioner determines 
that, except for permission to market or use the product commercially, 
the patent would be eligible for a statutory extension of the patent 
term, the Commissioner shall issue to the applicant a certificate of 
interim extension for a period of not more than one year. The owner of 
record of the patent or its agent may apply for subsequent one-year 
interim extensions.
    On February 20, 1998, Cephalon, agent of the patent owner 
Laboratoire L. Lafon, filed an application under 35 U.S.C. 156(d)(5) 
for interim extension of the term of U.S. Patent No. 4,177,290. The 
patent claims the active ingredient modafinil in the human drug product 
``PROVIGIL.'' The application indicates that the product is currently 
undergoing a regulatory review before the Food and Drug Administration 
for permission to market or use the product commercially.
    Review of the application suggests 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. Since 
it is apparent that the regulatory review period will extend beyond the 
date of expiration of the patent, and interim extension of the patent 
term under 35 U.S.C. 156(d)(5) is appropriate. Accordingly, an interim 
extension under 35 U.S.C. 156(d)(5) of the term U.S. Patent No. 
4,177,290 is granted for a period of one-year from the original 
expiration date of the patent, March 9, 1998.

    Dated: April 6, 1998.
Bruce A. Lehman,
Assistant Secretary of Commerce and Commissioner of Patents and 
Trademarks.
[FR Doc. 98-9535 Filed 4-9-98; 8:45 am]
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