[Federal Register Volume 61, Number 43 (Monday, March 4, 1996)]
[Notices]
[Page 8263]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-4974]



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DEPARTMENT OF COMMERCE

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 Term Extension.

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SUMMARY: The Patent and Trademark Office has issued a certificate under 
35 U.S.C. Sec. 156(d)(5) for a one-year interim extension of the term 
of U.S. Patent No. 4,062,848 that claims the active ingredient of the 
human drug product ``REMERON.''

FOR FURTHER INFORMATION CONTACT:
Hiram A. Bernstein by telephone at (703) 305-9285; by mail marked to 
his attention and addressed to the Assistant Commissioner for Patents, 
Box DAC, Washington, DC 20231; or by fax marked to his attention at 
(703) 308-6916.

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 Sec. 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, Sec. 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 13, 1995, Akzona Incorporated, owner of record in the 
Patent and Trademark Office of U.S. Patent No. 4,062,848, filed an 
application for interim extension of the term of this patent under 35 
U.S.C. Sec. 156(d)(5). The application states that the patent claims a 
compound comprising the active ingredient of the drug product 
``REMERON.'' The application states 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 December 13, 1994. On December 5, 1994, 
the patent was granted a first interim extension under 35 U.S.C. 
Sec. 156(d)(5) for a period of one year. Applicant now requests another 
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. Sec. 156. 
Since it is apparent that the regulatory review period may extend 
beyond the date of expiration of the patent, as extended by the first 
interim extension, a second and final interim extension of the patent 
term under 35 U.S.C. Sec. 156(d)(5) is appropriate. Accordingly, an 
interim extension under 35 U.S.C. Sec. 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 
extended expiration date of the patent term in effect.

    Dated: February 21, 1996.
Bruce A. Lehman,
Assistant Secretary of Commerce and Commissioner of Patents and 
Trademarks.
[FR Doc. 96-4974 Filed 3-1-96; 8:45 am]
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