Lowering Drug Costs by Addressing Patent Quality and Incremental Drug Innovation

For this project, researchers will aim to: 1) study the prevalence of low-value and invalid patents and their impact on spending; 2) identify ways to decrease such patents without action by Congress; and 3) identify policies that would direct pharmaceutical companies away from incremental advances and toward innovation that benefits patients. The study team will build a database of patents for recently approved drugs. It will then examine patent policies in Europe and Japan to identify methods that weed out low-value and invalid patents before they are issued. Next, these policies will be modeled to determine their effects on drug spending and exclusivity in the United States. The researchers will examine the frequency of incremental innovations that are not clinically beneficial and investigate the impacts of potential solutions. Data will be drawn from the Organisation for Economic Co-operation and Development Triadic Patent Family database, Drugs@FDA, the National Drug Code Directory, and Optum-Clinformatics Data Mart.