In 2013, the United States Supreme Court delivered its landmark decision in Ass’n for Molecular Pathology v. Myriad Genetics, Inc., holding isolated DNA unpatentable, thereby invalidating the claims of thousands of DNA patents in the process. The opinion, delivered by Justice Thomas, reasoned that the act of separating DNA from the body did not sufficiently transform the molecule beyond what naturally exists. Yet the Court found that line to be crossed when it held certain artificially synthesized complementary DNA molecules coding for the exact same gene patentable. Unlike the Federal Circuit, the Court focused its analysis not on the structural differences in DNA molecules but on the genetic information held within Myriad’s BRCA genes. Since genetic information is not a tangible quantity, categorizing isolated DNA unpatentable as a product of nature causes tension with the Court’s current characterization of DNA. Should the patent law continue to view DNA as a physical entity and base patentability on those differences? Or should it instead view DNA as an abstract idea based on the application of a gene’s information to an invention?
This note adopts the latter approach and proposes a test for DNA patentability as a biological algorithm, using the Myriad case as an example. As biotechnology continues to evolve, scientists are increasingly concerned about the coding information in genes. The patent law accordingly should accommodate this shift in principle, even if it means crafting a new legal fiction by no longer treating DNA as a purely tangible entity. By doing so, this note seeks to reconcile the tension in Myriad and provide a standard for future DNA patentability.
Is DNA Really a Natural Product? It's Time to Separate Fact from (Legal) Fiction: An Examination of DNA Patentability as a Biological Algorithm in the Post-Myriad Era,
Chi.-Kent L. Rev.
Available at: https://scholarship.kentlaw.iit.edu/cklawreview/vol94/iss1/10