Gene Patents: Balancing the Myriad Issues Concerning the Patenting of Natural Products

Gene patents have been a subject of a great deal of controversy. However, the legal question regarding the patenting of genes can only be solved through a comprehensive doctrinal framework applicable to all other purified natural products. Unfortunately, the Federal Circuit’s recent explication of the doctrine in Association for Molecular Pathology v. United States Patent & Trademark Office suffered from a fundamental flaw arising out of the Court’s conflation of function and utility of products. The Court looked at the difference in structure and utility of a claimed product versus the natural product to determine patent-eligibility. But a new utility of a claimed product is not the appropriate indicator of the transformation in a product. While function and properties of a product are its inherent characteristics, utility is the exploitation of these characteristics by man to serve his goal. An inventor can find a new utility of an old product without any change in the product. Thus, a better standard for assessing the patentability of natural products should focus on its structure and properties (including function). Proposed here is a framework, which adequately considers these factors, including the fact that the relationship between structure and function is not always linear; that sometimes, small structural changes can lead to significant difference in properties and vice-versa.