Stephanie Huang


The U.S. Supreme Court’s decision in Association for Molecular Pathology v. Myriad Genetics, Inc. established that an isolated fragment of a gene—the basic unit of heredity—is not patent-eligible subject matter while simultaneously holding that complementary DNA (cDNA) of a gene is patent-eligible subject matter. The decision has been controversial and criticized for including two holdings that are internally inconsistent from both scientific and patent law perspectives. But are the short- and long-term criticisms overstated? A decade after Myriad, the various impacts of the case remain relevant, particularly to the biotechnology and genetic testing fields.

First, this Note examines whether Myriad was properly decided for isolated genes and cDNA, respectively, under the modern framework for patent-eligible subject matter. Then, this Note argues that the Supreme Court correctly held that isolated human genes are not patent-eligible but wrongly held that cDNA was patent-eligible merely because it is different from its naturally-occurring counterpart. Lastly, this Note explores arguments for and against gene patenting and specifically focuses on the implications of Myriad’s “no gene patenting” holding on subsequent genetic research and diagnostic testing access with the benefit of hindsight.