This article was originally published on Psychedelic Spotlight
“If a small number of companies secure wide swaths of intellectual property early on, then the beneficial impact of that shift may be blunted,” warn researchers.
Psychedelic patents should be limited, according to Harvard Law School experts, who are also warning patent reform is necessary for the psychedelics sector to reach its full potential in addressing the global mental health crisis.
In recent years, as researchers have been granted exemptions to study the therapeutic potential of these controlled substances, companies have moved with enthusiasm to patent and commercialize psychedelics.
In a draft paper, Patents on Psychedelics: The Next Legal Battlefront of Drug Development, Senior Fellow at Harvard Law School’s Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics Mason Marks and Harvard Law School Professor I. Glenn Cohen analyzed the ethical, legal, and social implications of patenting psychedelics.
The authors noted two significant issues around psychedelic patents: granting meritless patents due to a lack of expertise in the field by Patent Office personnel, and biopiracy, which is the exploitation of Indigenous knowledge without compensation. They urged that the challenges around psychedelic patents be addressed immediately while the industry is in its early stages.
Patents on Psychedelics: The Next Legal Battlefront of Drug Development
20 Pages Posted: 28 Oct 2021
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