Department of Commerce Patent and Trademark Office 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 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. 4,062,848 that claims the human drug product known as Remeron. For Further Information Contact: Gerald A. Dost by telephone at (703) 305-9282; or by mail marked to his attention and addressed to the Commissioner of Patents and Trademarks, Office of the Deputy Assistant Commissioner for Patent Policy and Projects, Office of Special Programs, Washington, D.C. 20231. 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, 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. On November 25, 1994, the patent owner Akzona Incorporated filed an application under 35 U.S.C. 156(d)(5) for interim extension of the term of U.S. Patent No. 4,062,848. The application states that the patent claims the active ingredient mirtapazine in the human drug product Remeron. 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. The original term of the patent is set to expire on December 13, 1994. Applicant requests an 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. 156. Since it is apparent that the regulatory review period may extend beyond the expiration of the original patent term, an 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. 4,062,848 has been granted for a period of one year from the original expiration date of the patent. December 5, 1994 MICHAEL K. KIRK Acting Assistant Secretary of Commerce and Acting Commissioner of Patents and Trademarks