[Federal Register Volume 65, Number 33 (Thursday, February 17, 2000)]
[Notices]
[Pages 8124-8125]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-3836]


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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. 4,229,449; roboxetine mesylate

AGENCY: Patent and Trademark Office, Commerce.

ACTION: Notice of Interim Patent Term Extension.

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[[Page 8125]]

SUMMARY: The Patent and Trademark Office has issued a certificate under 
35 U.S.C. 156(d)(5) for a subsequent one-year interim extension of the 
term of U.S. Patent No. 4,229,449.

FOR FURTHER INFORMATION CONTACT: Karin Tyson by telephone at (703) 305-
9285; by mail marked to her attention and addressed to the Assistant 
Commissioner for Patents, Box Patent Ext., Washington, D.C. 20231; by 
fax marked to her attention at (703) 872-9411, or by e-mail 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 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 October 9, 1998, patent owner Pharmacia & Upjohn, S.p.A., filed 
an application under 35 U.S.C. 156(d)(5) for interim extension of the 
term of U.S. Patent No. 4,229,449. On November 12, 1999, a request for 
a second interim extension under 35 U.S.C. 156(d)(5) was filed. The 
patent claims the active ingredient roboxetine mesylate. The 
application indicates that a New Drug Application for the human drug 
product roboxetine mesylate has been filed and is currently undergoing 
a regulatory review before the Food and Drug Administration for 
permission to market or use the product commercially. The original term 
of the patent expired on January 8, 1999, and has been previously 
extended under 35 U.S.C.. 156(d)(5) for a period of one year.
    Review of the 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. Since 
it is apparent that the regulatory review period will extend beyond the 
date of expiration of the patent, 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 of U.S. Patent No. 
4,229,449 has been granted for a period of one year from January 8, 
2000, the expiration date of the patent as previously extended.

    Dated: February 10, 2000.
Q. Todd Dickinson,
Assistant Secretary of Commerce and Commissioner of Patents and 
Trademarks.
[FR Doc. 00-3836 Filed 2-16-00; 8:45 am]
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