[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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]
BILLING CODE 3510-16-M
