[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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