Department of Commerce Patent and Trademark Office Grant of Certificate of Interim Extension of the term of U.S. Patent No. Re. 34,617 of U.S. Patent No. 4,005,196; Olestra 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 second one-year interim extension of the term of U.S. Patent No. Re. 34,617 of U.S. Patent No. 4,005,196 that claims the food additive known as olestra. For Further Information Contact: Gerald A. Dost by telephone at (703) 305-9285; or by mail addressed to the Commissioner of Patents and Trademarks, Washington, D.C. 20231 marked to the attention of Gerald A. Dost, Special Program Examiner, Office of the Deputy Assistant Commissioner for Patent Policy and Projects. 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. The owner of record of the patent or its agent may apply for a subsequent one-year interim extension. On January 7, 1994, The Procter & Gamble Company, owner of record in the Patent and Trademark Office of U.S. Patent No. Re. 34,617 of U.S. Patent No. 4,005,196, filed an application for interim extension of the term of the patent under 35 U.S.C. 156(d)(5). The application states that the patent claims a composition of matter comprising the food additive product olestra. 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 expired on January 25, 1994. On January 14, 1994, a first one-year interim extension was granted under 35 U.S.C. 156(d)(5). The extended term of the patent expires on January 25, 1995. On December 1, 1994, applicant requested a second one-year interim extension of the term of the patent. 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 first one-year interim extension of the original patent term, a second one-year interim extension of the patent term under 35 U.S.C. 156(d)(5) is appropriate. Accordingly, a second one-year interim extension under 35 U.S.C. 156(d)(5) of the term of U.S. Patent No. Re. 34,617 of U.S. Patent No. 4,005,196 has been granted from the expiration of the first one-year interim extension of the original expiration date of the patent. January 17, 1995 BRUCE A. LEHMAN Assistant Secretary of Commerce and Commissioner of Patents and Trademarks