Patents on Psychedelics: The Next Legal Battlefront of Drug Development

20 Pages Posted: 28 Oct 2021

See all articles by Mason Marks

Mason Marks

Harvard Law School; Yale Law School; University of New Hampshire Franklin Pierce School of Law; Leiden Law School, Center for Law and Digital Technologies

I. Glenn Cohen

Harvard Law School

Date Written: October 23, 2021

Abstract

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.

Note:
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

Marks, Mason and Cohen, I. Glenn, Patents on Psychedelics: The Next Legal Battlefront of Drug Development (October 23, 2021). Harvard Law Review Forum, Vol. 135, 2022 (Forthcoming) , Available at SSRN: https://ssrn.com/abstract=3948757 or http://dx.doi.org/10.2139/ssrn.3948757

Mason Marks (Contact Author)

Harvard Law School ( email )

1563 Massachusetts Avenue
Cambridge, MA 02138
United States

Yale Law School ( email )

P.O. Box 208215
New Haven, CT 06520-8215
United States

University of New Hampshire Franklin Pierce School of Law ( email )

Two White Street
Concord, NH 03301
United States

Leiden Law School, Center for Law and Digital Technologies ( email )

P.O. Box 9520
2300 RA Leiden, NL-2300RA
Netherlands

I. Glenn Cohen

Harvard Law School ( email )

1525 Massachusetts Avenue
Griswold Hall 503
Cambridge, 02138
United States

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