[Federal Register Volume 61, Number 43 (Monday, March 4, 1996)] [Notices] [Page 8263] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 96-4974] ----------------------------------------------------------------------- DEPARTMENT OF COMMERCE Grant of Certificate of Interim Extension of the term of U.S. Patent No. 4,062,848; REMERON AGENCY: Patent and Trademark Office, Commerce. ACTION: Notice of Term Extension. ----------------------------------------------------------------------- SUMMARY: The Patent and Trademark Office has issued a certificate under 35 U.S.C. Sec. 156(d)(5) for a one-year interim extension of the term of U.S. Patent No. 4,062,848 that claims the active ingredient of the human drug product ``REMERON.'' FOR FURTHER INFORMATION CONTACT: Hiram A. Bernstein by telephone at (703) 305-9285; by mail marked to his attention and addressed to the Assistant Commissioner for Patents, Box DAC, Washington, DC 20231; or by fax marked to his attention at (703) 308-6916. 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 Sec. 156, 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 than one year. On November 13, 1995, Akzona Incorporated, owner of record in the Patent and Trademark Office of U.S. Patent No. 4,062,848, filed an application for interim extension of the term of this patent under 35 U.S.C. Sec. 156(d)(5). The application states that the patent claims a compound comprising the active ingredient of the drug product ``REMERON.'' The application states that the product 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 December 13, 1994. On December 5, 1994, the patent was granted a first interim extension under 35 U.S.C. Sec. 156(d)(5) for a period of one year. Applicant now requests another interim extension of the term of the patent 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. Sec. 156. Since it is apparent that the regulatory review period may extend beyond the date of expiration of the patent, as extended by the first interim extension, a second and final interim extension of the patent term under 35 U.S.C. Sec. 156(d)(5) is appropriate. Accordingly, an interim extension under 35 U.S.C. Sec. 156(d)(5) of the term of U.S. Patent No. 4,062,848 has been granted for a period of one year from the extended expiration date of the patent term in effect. Dated: February 21, 1996. Bruce A. Lehman, Assistant Secretary of Commerce and Commissioner of Patents and Trademarks. [FR Doc. 96-4974 Filed 3-1-96; 8:45 am] BILLING CODE 3510-16-M