[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] ----------------------------------------------------------------------- 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,
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] BILLING CODE 3510-16-P