Chapter 36 - Human Gene Patents and Genetic Testing

Abstract

The Trade-related Intellectual Property Rights (TRIPS) agreement of the World Trade Organization was envisioned as a mechanism for creating and maintaining strong patent protection within all member countries. Patent reform, which greatly alters or appears to erode patent protection, may be challenging. This chapter provides an account of the gene patenting controversy, particularly emphasizing how gene patents may impact, for better or worse, the development and provision of genetic testing technologies. Despite the continued articulation of concerns regarding the impact of gene patents and the publication of numerous policy recommendations, there are many reasons why altering the existing system will remain a challenge. International trade agreements have the potential to create technical barriers for those seeking patent reform. At a minimum, existing international treaties add an element of uncertainty to the policy-making process. Moreover, the momentum of the biotechnology sector, and the imbedded perception that patent protection is crucially important to economic development, rightly or not, will create political barriers to significant patent reform. Benefits and social concerns associated with human gene patents are discussed. Related patent reform recommendations that have been proposed by various policy-making entities are also described.