An exception to infringement for genetic testing – addressing patient access and divergence between law and practice

Abstract

Many patents on human genes have been granted by the major patent offices around the world, and these patents highlight some of the key difficulties of patents in fields of new technology. A particular concern which has arisen in both academic and popular literature has been the effect that gene patents have on the development and delivery of genetic tests, and authors have theorized that gene patents will decrease patient access to vital genetic testing services. However, empirical research in Europe has found that these theoretical problems do not exist in practice, not because patents are appropriately managed, but because they are largely ignored. Gene patents thus give rise to two distinct difficulties in practice: concerns about patient access, and concerns about divergence between the law and practice. The purpose of this paper is to critically examine the nature of these two problems, and their relationship to each other, and to propose and evaluate a novel solution, in the form of an exception to infringement for diagnostic testing. It is argued that this solution appropriately addresses the divergence between the law and practice, and at the same time, allows optimization of innovation and patient access to medical care.