Patents on Psychedelics: The Next Legal Battlefront of Drug Development
24 Pages Posted: 28 Oct 2021 Last revised: 22 Feb 2022
Date Written: October 23, 2021
In the past few decades, pioneering research has rekindled interest in the therapeutic use of psychedelic substances such as psilocybin, ibogaine, and dimethyltryptamine (DMT). Indigenous communities have used them for centuries, and researchers studied them in the 1950s and 60s. However, most psychedelics were banned in the 70s, when President Nixon launched the U.S. war on drugs. Fifty years later, rising rates of mental illness, substance use, and suicide are prompting researchers to revisit psychedelics, and some have gained permission to study them in limited quantities. Clinical trials are producing promising results, creating enthusiasm for commercializing and patenting psychedelics.
This Essay analyzes the ethical, legal, and social implications of patenting these controversial substances. Patents on psychedelics raise unique concerns associated with their unusual qualities, history, and regulation. Because they were criminalized for decades, the Patent Office lacks personnel with expertise in the field, increasing the likelihood of granting meritless psychedelic patents. Moreover, because Indigenous communities pioneered many aspects of modern psychedelic therapies, their patenting by Western corporations may promote biopiracy, the exploitation of Indigenous knowledge without compensation. Importantly, control of psychedelics by a small number of companies may stifle innovation and reduce access to these therapies. The Essay presents proposals to reduce the risk of biopiracy and the issuance of meritless psychedelic patents. Potential solutions include the implementation of psychedelic patent pledges, the creation of psychedelic prior art repositories, and the tightening of patentability requirements for novel drug therapies. The Essay concludes that ultimately, due to their importance to the advancement of science and public health, psychedelics are appropriately viewed as research tools, eligible only for limited patent protection.
Funding: Both Marks and Cohen receive research support from POPLAR, which is itself supported by a research grant from the Saisei foundation.
Declaration of Interests: Mason Marks is a Governor-appointed member of the Oregon Psilocybin Advisory Board. All other have nothing to declare.
Keywords: psychedelic, patents, intellectual property, Indigenous knowledge, FDA, USPTO, drug development, mental health, psilocybin, MDMA, ayahuasca, LSD, ketamine, esketamine, spravato, compass pathways, depression, overdose, suicide, PTSD, war on drugs, polymorph, enantiomer, evergreening, product hopping
JEL Classification: I1, I14, I18, K1, K14, K23, K42
Suggested Citation: Suggested Citation