Grant of Interim Extension of the Term of U.S. Patent No. 4,977,138; ISTODAX

Federal Register: July 7, 2009 (Volume 74, Number 128)

Notices

Page 32116

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr07jy09-30

DEPARTMENT OF COMMERCE

United States Patent and Trademark Office

Docket No. PTO-P-2009-0027

Grant of Interim Extension of the Term of U.S. Patent No. 4,977,138; ISTODAX\TM\

AGENCY: United States Patent and Trademark Office.

ACTION: Notice of Interim Patent Term Extension.

SUMMARY: The United States Patent and Trademark Office has issued an order granting interim extension under 35 U.S.C. 156(d)(5) for a one- year interim extension of the term of U.S. Patent No. 4,977,138.

FOR FURTHER INFORMATION CONTACT: Mary C. Till by telephone at (571) 272-7755; by mail marked to her attention and addressed to the

Commissioner for Patents, Mail Stop Hatch-Waxman PTE, P.O. Box 1450,

Alexandria, VA 22313-1450; by fax marked to her attention at (571) 273- 7755, or by e-mail to Mary.Till@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 five 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, and that the patent may be extended for interim periods of up to a year if the regulatory review is anticipated to extend beyond the expiration date of the patent.

On June 12, 2009, Gloucester Pharmaceuticals, Inc., a licensee of

Astellas Pharma Inc., the patent owner, timely filed an application under 35 U.S.C. 156(d)(5) for an interim extension of the term of U.S.

Patent No. 4,977,138. The patent claims the human drug product

ISTODAXTM(romidepsin). The application indicates that a New

Drug Application (NDA No. 22-393) for the human drug product

ISTODAXTM(romidepsin) has been filed and is currently undergoing 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, and that the patent should be extended for an additional one year as required by 35 U.S.C. 156(d)(5)(B). Because it is apparent that the regulatory review period will continue beyond the original expiration date of the patent (July 6, 2009), an interim extension of the patent term under 35 U.S.C. 156(d)(5) is appropriate.

An interim extension under 35 U.S.C. 156(d)(5) of the term of U.S.

Patent No. 4,977,138 is granted for a period of one year from the original expiration date of the patent, i.e., until July 6, 2010.

June 30, 2009.

John J. Doll,

Acting Under Secretary of Commerce for Intellectual Property and Acting

Director of the United States Patent and Trademark Office.

FR Doc. E9-15863 Filed 7-6-09; 8:45 am

BILLING CODE 3510-16-P