Scholars have written about gene patents for almost 20 years. On June 13, 2013, in the case of the Association for Molecular Pathology v. Myriad Genetics, Inc., the Supreme Court of the United States ruled that human genes cannot be patented in the U.S. because DNA is a "product of nature." By patenting the gene, an agency can charge commissions or restrict research on specific gene therapies because they are in control of the patent on that gene. Filed Under: Healthcare Articles and Infographics, © 2020 - Privacy Policy, 14 Hysterectomy for Fibroids Pros and Cons, 12 Pros and Cons of the Da Vinci Robotic Surgery, 14 Pros and Cons of the Cataract Surgery Multifocal Lens, 11 Pros and Cons of Monovision Cataract Surgery. Associations between a DNA variant and a disease, condition, or function 2. Though fears that gene patents could stifle research have not been borne out, for the most part, commentators are now raising questions about how the many existing gene patents might be used in the future, particularly with the advent of high-speed, low-cost DNA sequencing and other technologies. In fact, Crichton even included an appendix in which he argues against gene patenting. “Gene patenting” Patent: A patent is a set of exclusive rights granted by a sovereign state to an inventor or assignee for a limited period of time in exchange for detailed public disclosure of an invention. Rat insulin was initially cloned at the University of California, San Francisco, and Genentech licensed cloned human insulin to Eli Lilly. Though gene patenting is widely accepted throughout the world, many countries limit the scope of gene patents as a way to minimize the negative impact on health care costs and on the free flow of information in research. Other top-selling drugs followed, including tissue plasminogen activator for stroke, growth hormone for small children deficient in the hormone, and erythropoietin for anemia—the latter two drugs finding substantial illegal use in sports doping (see chapter 33, “Sports Enhancement”). Genetic tests for colon cancer have no one dominant patent holder, and yet they are comparable in cost and present similar technical challenges in the form of false negatives and positives. Another provision would shift the U.S. standard for inventorship from a “first to invent” to a “first inventor to file.” This change would reduce protracted legal disputes like the dispute over the patent for the cystic fibrosis gene, which took almost 10 years to resolve. If lucrative markets emerge, the incentives to exercise intellectual property rights in gene patents will also rise, and that could influence what kind of—and how much—commercial research and development takes place. Gene patents have often resulted in companies having sole ownership of genetic testing for patented genes. It is used for many purposes, such as replicating DNA for research, producing important proteins, and devising gene therapies. Another fear is that gene patents may inhibit biomedical innovation by blocking scientists’ access to genes and genetic materials that are essential to research. Abstract. Director, Center for Genome Ethics, Law and Policy, Institute for Genome Sciences and Policy, Duke University, Professor of Law, Duke University School of Law, Professor and Research Director of the Health Law Institute, University of Alberta. Although gene patents often base their claims at least partly on whole genes, they also cover many kinds of inventions involving the components of genes and genetic technologies (see box, “Gene Patenting Glossary”), including: The first patent on a recombinant DNA method was granted in December 1980, just six months after the United States Supreme Court ruled in Diamond v. Chakrabarty that a life form could be patented.