Medical-Process Patents

Abstract

A letter comments on issues raised in the recent article by Kesselheim and Mello (2006;355:2036–41) on patents relating to medical processes. The case of Laboratory Corporation of America vs. Metabolite Laboratories hinged on whether patent applicants can circumvent the long-standing rule against patenting natural phenomena and assert ownership over biologic correlations by characterizing them as step-wise processes. However, most importantly, this case has ramifications for patents that claim anomalous correlations between genetic variants and disease predisposition, therapeutic drug response, and susceptibility to pharmacologic side effects. Correlation patents are already limiting the availability of molecular genetic testing, leading to increased costs, reduced access, decreased innovation, and an inability to verify findings.