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

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.