The Human Patent: What Intellectual Property Rights Does an Individual Have in Their Own Genetic Material, and What Are the Global Biosecurity Implications?

Abstract

Abstract Under United States patent law, the landmark Supreme Court decision in Diamond v. Chakrabarty established the patentability of human-made life forms, except for those encompassing a human organism. The America Invents Act of 2011, and decisions from lower courts such as Moore v. Regents of University of California, reaffirm the unpatentability of human organisms and limit an individual’s rights to their own genetic material. Prior to Association for Molecular Pathology v. Myriad Genetics, Inc, which struck down the patentability of human genes as well, the decision in Diamond led to the proliferation of gene patents and the growth of the global biotechnology market. While the debate over the patenting of human genetic material, and individual rights, rages on, DNA-gathering companies such as 23andMe and Ancestry.com routinely utilize their customer’s genetic material for multi-million dollar pharmaceutical research. This research not only raises ethical concerns, but can also pose a potentially dangerous biosecurity threat based on the many ways this genetic material can be used to target individuals, groups, and nations.