Legal, Social and Policy Implications of Genetic Patents: Issues of Accessibility, Quality of Research and Public Health

Abstract

Patenting of human gene and gene fragments has significant legal, social and policy implications as it exerts a wide range of effects on the accessibility of genetic research tools, genetic innovation, health policies, patients’ rights, clinical practice and the society at large. The potential of genetic research to produce commercial results has led to the rapid commercialisation of basic genetic research through commercial agreements and patents. The commercialisation of basic genetic research has threatened the free flow and open sharing of academic knowledge. The increased commercialisation of upstream (basic) genetic research has led to patenting of gene fragments such as expressed sequence tags (ESTs) and single nucleotide polymers (SNPs), which are basically research tools. Patenting of these genetic research tools may stifle genetic innovation as a researcher has to negotiate with the patentee about the license terms before using such a research tool. Patenting of genetic testing especially in the field of diagnostics has also become a very controversial issue. Overbroad patent claims and aggressive licensing strategies stifle the innovation process. A US-based multinational healthcare company Myriad Genetics’ patents on breast and ovarian cancer genes, BRCA1 and BRCA2, reflect various social and policy implications involved in patenting of genetic testing.