Diagnostic tests have become indispensable in the rapidly growing field known as “precision medicine.” Precision medicine tailors treatments to individual patients by using these diagnostic tests to identify how a patient may respond to different therapies. Diagnostics are expensive to develop but show promise in optimizing patient treatment and creating healthcare savings. Even as the medical community has heralded precision medicine as the way of the future, the Supreme Court and Federal Circuit have handed down a dizzying array of decisions regarding attempts to patent diagnostics and precision medicine techniques. Subsequently, courts have struggled to apply the test for patent eligibility, leaving the interpretation of patentable subject matter under § 101 of the Patent Act in a state of chaos.
This chaos has created concerns that diagnostics may be unpatentable, providing minimal protection or incentive for pharmaceutical companies to invest in their development. To rectify this confusion, legislators have proposed overhauling the longstanding Patent Act and rewriting the patent-eligibility statute altogether. This Note argues that these legislative attempts are misguided. Though some remedy for the current patent-eligibility test is required, that solution should come from the courts, not the legislature. Courts can use a dynamic and nuanced common law approach to create a standard that can adapt to the continuously evolving technologies and scientific advancements that seek patent protection. A legislative override, on the other hand, could leave the patent statute in as much chaos as before. A judicial refinement of the patent-eligibility test would allow for the patenting of meritorious diagnostics, providing the necessary innovation incentives for their continued development.
Elaine H. Nguyen, Scalpels Over Sledgehammers: Saving Diagnostic Patents Through Judicial Intervention Rather Than Legislative Override, 70 Duke L.J. 1631-1662 (2021)
Available at: https://scholarship.law.duke.edu/dlj/vol70/iss7/3