Patents: PROVIGIL; U.S. Patent No. 4,177,290 one year interim extension,

[Federal Register: April 10, 1998 (Volume 63, Number 69)]

[Notices]

[Page 17821]

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

[DOCID:fr10ap98-43]

DEPARTMENT OF COMMERCE

Patent and Trademark Office

Grant of Certificate of Interim Extension of the Term of U.S. Patent No. 4,177,290: PROVIGIL

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 one-year interim extension of the term of U.S. Patent No. 4,177,290.

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, D.C. 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, Section 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 than one year. The owner of record of the patent or its agent may apply for subsequent one-year interim extensions.

On February 20, 1998, Cephalon, agent of the patent owner Laboratoire L. Lafon, filedan application under 35 U.S.C. 156(d)(5) for interim extension of the term of U.S. Patent No. 4,177,290. The patent claims the active ingredient modafinil in the human drug product ``PROVIGIL.'' The application indicates that the product 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 suggests 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, and 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 U.S. Patent No. 4,177,290 is granted for a period of one-year from the original expiration date of the patent, March 9, 1998.

Dated: April 6, 1998. Bruce A. Lehman, Assistant Secretary of Commerce and Commissioner of Patents and Trademarks.

[FR Doc. 98-9535Filed4-9-98; 8:45 am]

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