Deeva Shah | 2012 In 1996, Myriad became the first company to officially file for a patent on the isolation of the BRCA1 and BRCA2 genes, genes that helped diagnose breast cancer. When granted the patent, and thus a monopoly over all commercial uses of the gene, Myriad became embroiled in a conflict that included philosophers, politicians, public health specialists, doctors, researchers, lawyers, and many more. In 2009, the American Civil Liberties Union, working with the Public Patent Foundation, filed a joint lawsuit stating that patents on the BRCA1 and BRCA2 genes were unconstitutional. In this case, Association for Molecular Pathology, et al. v. U.S. Patent and Trademark Office, et al., they argued that Myriad Genetics was using the patents to limit access to diagnostic testing and to prevent others from researching the genes and actually finding a cure for mutation-based breast cancer.
Regardless of the court’s ruling in Association for Molecular Pathology, et al. v. U.S. Patent and Trademark Office, et al., the case over Myriad Genetics and its patents created legal, ethical and political questions that lingered even after a verdict had been issues. While the District Court of New York found in favor of the plaintiffs, the Association of Molecular Pathology, et al., the Federal Circuit Court found in favor of the defendants, the United States Patent and Trademark Office and Myriad Genetics. They attempted to address whether or not patents on isolated DNA constituted patents on ‘products of nature’ or were patents that were legally permitted; however both courts interpreted the statute quite differently from each other, leading to much confusion over the standard. Furthermore, the deeper constitutional and especially moral issues remained largely unaddressed by the courts.
I aim to take a deeper look at the Myriad case and use the case as a vehicle to understand the legal and moral arguments regarding a critical question: Should we allow individuals, companies, or even a well-meaning government to essentially own portions of isolated human DNA through patent protection? This case also provides a basis on which to judge the overall effect patenting human DNA has on businesses, researchers, patients, and many other stakeholder groups that are involved. In order to address this larger question, I focus on the following areas. First, I will give an introduction to the basics of patent law and biological patents in order to set a framework to assess the legal issues before the District and Circuit courts. Specifically, I will look at the introduction of biological inventions to patent protection and the conflicts that have arisen in recent history. Second, I will consider whether these existing standards can be applied to the case of patenting isolated DNA. In order to do that, I will discuss the decisions of both the District Court and Circuit Court in Association of Molecular Pathology, et al. v. USPTO and consider the courts’ differing reasons for why isolated DNA patents are or are not legally permissible. Third, I will take a look at the deeper questions the judiciary has failed to consider in the Myriad case. I will take a deeper look at the ethical issues of allowing property and commercial rights over isolated DNA sequences. Finally, I will conclude by addressing the policy concerns of allowing or denying patents on isolated DNA and how the international community has dealt with this apprehension. I will argue that the judiciary is not the only arena in which these conversations regarding patents on isolated DNA should take place.