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