Patents on Psychedelics: The Next Legal Battlefront of Drug Development

This essay (2021) is one of the first publications to emerge from the POPLAR initiative at Harvard Law School. The essay explores issues regarding the patenting of psychedelics given their controversial history and offers suggestions on how to reduce the risk of biopiracy and the issuance of meritless psychedelic patents.

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.”

Authors: Mason Marks & I. Glenn Cohen

Notes

In recent years, there has been a renewed interest in psychedelics in research communities across the globe. Thanks to the efforts of these psychedelic researchers, solid clinical evidence is helping to change the narrative surrounding psychedelics. We are now beginning to realize that psychedelics are not ‘devoid of medical value’ as their classification as Schedule I substances implies.

Nonetheless, while evidence-based research is essential in proving the safety and efficacy of these compounds, it is important that we widen our lens beyond the walls of laboratories and clinics as psychedelics edge toward medicalization. Analyzing the various cultural, political and societal factors that are continuing to shape psychedelic medicine is necessary to ensure equitable access and governance of these substances.

The present essay is the first release from the POPLAR initiative at Harvard Law School. The Project on Psychedelics Law and Regulation (POPLAR) is the first academic initiative focused on promoting safety, innovation, and equity in psychedelics research, commerce, and therapeutics. Although only a draft version, the essay at hand provides food for thought to a number of issues surrounding the medicalization of psychedelic’s, primarily the ethical, legal, and social implications of patenting psychedelic substances.

Main concerns

• Awarding patents on psychedelics can be seen as contentious given their use in traditional practices for centuries and runs the risk of monopolizing a product of nature.
• The US Patent and Trademark Office lacks personnel with the necessary expertise in this field as a result of psychedelics being controlled substances for the past decades and could lead to the issuing of “meritless patents.”
• The patenting of psychedelics by Western corporations may promote biopiracy as they capitalize from the knowledge and practices of Indigenous groups who have long used psychedelics.

Proposed solutions

• The creation of prior art repositories, similar to Porta Sophia a recently released archive of psychedelic prior art, can help prevent the issuance of bad patents by ensuring that lesser-known references are not easily overlooked.
• Tightening of US requirements for novelty and non-obviousness e.g prohibiting patent claims on molecular variations of psychedelics because they lack inventiveness.
• The introduction of patent pledges meaning companies would not enforce their patent rights under certain conditions.
• The most radical proposal is to entirely forego granting patents on psychedelics.

The present essay is one of the first to take a deep dive into the implications surrounding the patenting of psychedelics. In the business of drug discovery, patents are ‘standard industry practice.’ However, given the unique relationship society has had with psychedelics, perhaps standard industry practice need not apply in order for the therapeutic potential of psychedelics to be truly widespread.

Ultimately, discussing the thoughts presented in this essay while the psychedelic industry is in its relative infancy is essential if psychedelics are going to be a solution for the global mental health crisis we are experiencing.