Impact of DNA patents on pharmacogenomics research and development: economic and policy issues

The science of pharmacogenetics and pharmacogenomics (or collectively PGx) has advanced rapidly in recent years, and some technologies based on these developments have entered into use. It is notable that these advances have occurred in parallel with related advances in genetic testing, led by developments in testing services for the diagnosis of rare disorders that share Mendelian patterns of inheritance. However, a profusion of patents on nucleotide sequences (often termed ¿gene patents¿) has led to widespread concern that disputes over intellectual property could hamper the development and diffusion of these technologies. This article outlines the recent evidence from major empirical studies on the complex landscape of diagnostic DNA patents in the United States and Europe and discusses the traditional arguments in favor and against gene patenting in PGx and genetic testing. It also explores the extent to which concerns in clinical genetics might be relevant to PGx. We find that although recent evidence on genetic testing suggests that many of the issues might have been overestimated or overemphasized, no dedicated studies have been published on the intellectual property aspects of PGx. Drug Dev Res 71: 485¿491, 2010. © 2010 Wiley-Liss, Inc