[Federal Register Volume 64, Number 42 (Thursday, March 4, 1999)]
[Notices]
[Pages 10449-10450]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-5291]
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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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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. 4,229,449.
FOR 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 DAC, Washington, DC 20231; by fax marked
to her attention at (703) 308-6916, or by e-mail to
karin.tyson@uspto.gov.
SUPPLEMENTARY INFORMATION: Section 156 of Title 35, United States Code,
[[Page 10450]]
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, Sec. 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 that one year.
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. 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.
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 is granted for a period of one year from the original
expiration date of the patent, January 8, 1999.
Dated: February 22, 1999.
Q. Todd Dickinson,
Acting Assistant Secretary of Commerce and Acting Commissioner of
Patents and Trademarks.
[FR Doc. 99-5291 Filed 3-3-99; 8:45 am]
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