New, innovative genetic diagnostic methods are rapidly changing the way diseases are diagnosed, prevented, and treated. While personalized medicine remains it its early stages, its potential to improve patients’ lives cannot be overstated. As advances in biotechnology offer patients the promise of improved healthcare choices, a heated debate has arisen over the propriety of patents on genetic diagnostics, and whether anyone has the right to own the information that is encoded in a person’s genes. This paper outlines recent litigation surrounding genetic and advanced diagnostic patents and examines whether they constitute patentable subject matter under 35 U.S.C. § 101. Part II recounts the jurisprudence surrounding the boundaries of patentable subject matter. Part III presents a brief background on the science of genetics and the history of gene patents. Part IV traces the ongoing litigation in Association for Molecular Pathology v. United States Patent and Trademark Office, and concludes by arguing that diagnostic genetic patents, as well as other advanced diagnostic method patents, constitute non-patentable subject matter under 35 U.S.C. § 101. Part V lays out policy arguments against the patenting of diagnostic methods.
Tiana Leia Russell,
Unlocking the Genome: The Legal Case Against Genetic Diagnostic Patents,
16 Marq. Intellectual Property L. Rev. 81
Available at: https://scholarship.law.marquette.edu/iplr/vol16/iss1/5