Theory and practice of intellectual property
№ 6 / 2018

ISSN (Print) 2308-0361
ISSN (Online) 2519-2744

PDF (Ukrainian)

DOI: https://doi.org/10.33731/62018.162529

Published      2018-12-26

The extension of patent term for an invention, the object of which is a drug product

Liudmyla Rabotiagova
Ukraine

Gennadii Androshchuk
Ukraine

Abstract
The article devoted to the analysis of United States Code Title 35–Patents, Manual of Patent Examining Procedure, Code of Federal Regulation Title-37 (37 CFR). There are considered regulatory issues the extension of the term of a patent, which claims a human drug product, a method of using a human drug product, or a method of manufacturing a human drug product. The extension of patent term is necessary because a human drug product has been subject to a regulatory review period, which conducts Food and Drug Administration (FDA) before its commercial marketing or use. A regulatory review period consists of two periods: a testing phase and an approval phase. For human drug product, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. There are considered an agreement between the FDA and the United States Patent and Trademark Office, which establishes procedures for the exchange of information between these government agencies to determine a regulatory review period. The determination of the length of the regulatory review period is shown on the example of the human drug GlucaGen®. If the patent is found to be eligible for extension, the United States Patent and Trademark Office then calculates the length of extension for which the patent is eligible under the appropriate statutory provisions (35 U.S.C. 156(c); 37 CFR 1.750). The period of extension is calculated using the FDA determination of the length of the regulatory review period published in the Federal Register.

Keywords: patent for invention, a drug product, the extension of patent term, permission for the commercial marketing or use of the product