Patent Term Extended Under 35 U.S.C.   156

   Akzona Incorporated, owner of record in the Patent and Trademark
Office (PTO) of U.S. Patent No. 4,062,848, filed an application for
patent term extension under 35 U.S.C.    156(d)(1) on August 12, 1996.
The patent claims the human drug product REMERONĖtm which was given
permission for commercial marketing or use by the Food and Drug
Administration (FDA) on June 14, 1996. The patent was originally due to
expire before the product received permission for commercial marketing
or use. However, two interim extensions of the patent were granted under
35 U.S.C.    156(d)(5) which extended the term of the patent for two
successive one-year periods, until December 13, 1996. 35 U.S.C.
156(d)(5)(E)(ii) provides that, if certain additional information is
provided within the 60-day period beginning on the day on which the
product received permission for commercial marketing or use, the patent
shall be extended for an additional period of two years from June 14,
1996, the approval date. Furthermore, 35 U.S.C.    156(e)(2) provides
that if the term of a patent for which an application for patent term
extension has been filed will expire before a certificate of extension
is issued, the Commissioner shall extend the term of the patent for an
interim period.

   PTO review of the application to date indicates that the subject patent
would be eligible for a maximum extension of the patent term for a
period of two years from the effective date of receipt of permission for
commercial marketing or use (June 14, 1996) as set forth in 35 U.S.C.
  156(g)(6)(C) and (d)(5)(E)(ii). A final determination of the length of
the extension of the patent term and issuance of a patent term extension
certificate cannot be accomplished until a final determination of the
length of the regulatory review period is made by the FDA. Accordingly,
since the original term of the patent would have expired before a
certificate of patent term extension could be issued, an interim
extension under 35 U.S.C.    156(e)(2) of the term of U.S. Patent No.
4,062,848 has been granted for a period of one-year from the date of
approval for commercial marketing or use, June 14, 1996. Furthermore,
the patent has been further extended under 35 U.S.C.    156(e)(2) for an
additional period of six months from the extended expiration date of the
patent, June 14, 1997, until December 14, 1997.