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.

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 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 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.