[Federal Register Volume 59, Number 232 (Monday, December 5, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-29807]
[[Page Unknown]]
[Federal Register: December 5, 1994]
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DEPARTMENT OF COMMERCE
Patent and Trademark Office
Grant of Certificate of Interim Extension of the Term of U.S.
Patent No. 4,066,772; Motilium
AGENCY: Patent and Trademark Office, Commerce.
ACTION: Notice of Interim Patent 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. 4,066,772 that claims the human drug product known
as Motilium.
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, DC 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 18, 1994, the patent owner Janssen Pharmaceutica N.V.
filed an application under 35 U.S.C. Sec. 156(d)(5) for interim
extension of the term of U.S. Patent No. 4,066,772. The application
states that the patent claims the active ingredient domperidone in the
human drug product Motilium. 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
January 3, 1995. 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. Sec. 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. 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. 4,066,772 has been granted for a period of one
year from the original expiration date of the patent.
Dated: November 29, 1994.
Bruce A. Lehman,
Assistant Secretary of Commerce and Commissioner of Patents and
Trademarks.
[FR Doc. 94-29807 Filed 12-2-94; 8:45 am]
BILLING CODE 3510-16-M
