[Federal Register Volume 59, Number 176 (Tuesday, September 13, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-22568]


[[Page Unknown]]

[Federal Register: September 13, 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. 4,048,306; Dynabac

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. Section 156(d)(5) for a one-year interim extension of the 
term of U.S. Patent No. 4,048,306 that claims the human drug product 
known as Dynabac.

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 Special Programs, Office of the Deputy Assistant Commissioner 
for Patent Policy and Projects, Washington, D.C. 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 August 22, 1994, Eli Lilly and Company, on behalf of the patent 
owner Boehringer Ingelheim GmbH, filed an application under 35 U.S.C. 
section 156(d)(5) for interim extension of the term of U.S. Patent No. 
4,048,306. The application states that the patent claims the active 
ingredient Dirithromycin in the human drug product Dynabac and a method 
of using the product under regulatory review. 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 September 13, 1994. 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. section 
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. section 156(d)(5) is appropriate. 
Accordingly, an interim extension under 35 U.S.C. section 156(d)(5) of 
the term of U.S. Patent No. 4,048,306 has been granted for a period of 
one year from the original expiration date of the patent.

    Dated: September 6, 1994.
Michael K. Kirk,
Acting Assistant Secretary of Commerce and Acting Commissioner of 
Patents and Trademarks.
[FR Doc. 94-22568 Filed 9-12-94; 8:45 am]
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