DEPARTMENT OF COMMERCE
                          Patent and Trademark Office

                   Grant of Certificate of Interim Extension
              of the term of U.S. Patent No. 4, 177,290: PROVIGIL
   
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. 4,177,290.

FOR INFORMATION CONTACT: Karin Tyson by telephone at (703) 305-9285; by
mail marked to her attention and addressed to the Assistant Commissioner
for Patents, Box DAC, Washington, D.C. 20231; by fax marked to her
attention at (703) 308-6916, or by e-mail to karin.tyson@uspto.gov.

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(e)(1), 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 that one year. The owner of
record of the patent or its agent may apply for subsequent one-year
interim extensions.

On February 20, 1998, Cephalon, agent of the patent owner Laboratoire L.
Lafon, filed an application under 35 U.S.C. 156(d)(5) for interim
extension of the term of U.S. Patent No. 4,177,290. The patent claims
the active ingredient modafinil in the human drug product "PROVIGIL."
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.

Review of the application suggests 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 will extend beyond the date
of expiration of the patent, 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.
4,177,290 is granted for a period of one-year from the original
expiration date of the patent, March 9, 1998.

April 6, 1998                                               BRUCE A. LEHMAN
                                        Assistant Secretary of Commerce and
                                     Commissioner of Patents and Trademarks