[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]
BILLING CODE 3510-16-M
