Actualizing Therapy from Psychedelic Compounds Requires Acknowledging the Past Pioneers as well as Encouraging Cooperation from Current Market Players

This article was co-authored by Jonathan Shelnutt (J.D. Candidate at Georgetown Law School).

In this era of industrialized capitalism, there are serious economic incentives to promote products in nascent industries. Intellectual property and the corresponding legal framework help achieve this promotion. Applying existing legal constructs to manufacturing products in burgeoning fields allows both the industry itself to grow and allows the players within those industries to profit from the growth that their innovation furthers within those industries. These players, however, are not necessarily only limited to the employees within the companies that make up the early competitive landscape. These players also include those pioneers that invented the foundational knowledge that has provided the original opportunities for these industries to exist. For example, biotechnology—including pharmaceuticals and biologics—has benefitted from the guidance that the Food and Drug Administration (“FDA”) and the United States Patent and Trademark Office (“USPTO”) have promulgated over the years. While some of that has been codified statutorily, some only has been communicated outside of legislation through guidance and regulation. 

Compounds that have been traditionally traced to psychedelic practice (e.g., LSD, ketamine, and psilocybin) have recently been chemically modified to negate their hallucinogenic properties. Researchers have done so by replacing functional groups off of the integral carbon rings that make up the chemical compounds that hypothetically alter the binding behavior of the receptors. Thus, there exists a unique opportunity to apply these compounds therapeutically. Furthermore, there also exists an unmet need for such medicine as there has been an increase in mental health issues globally which therapies using these compounds may be able to address. Thus, the incentive to expedite the possibility of providing therapy derived from these compounds has become increasingly important. The vehicle enabling such a possible medical breakthrough has yet to be established. We propose applying the already-existing patent system to this nascent industry, which would not only improve the financial situation of the players within the field (pioneers and market participants) as well as validate the science such that the therapeutic options that come from it are safe and trusted.

As basic research continues to unlock the potential of psychedelic compounds to alleviate treatment-resistant symptoms of psychological illnesses like major depressive disorder and post-traumatic stress disorder, there are certain problems that arise with the regulation of the fruits of this research as well as the research itself. As the number of patents issued covering therapeutic uses for psychedelic drugs has escalated rapidly, the industry itself faces urgency in regulating the growth. 

Recently, Nature Medicine published online guidelines—Reporting of Setting in Psychedelic Clinical Trails (ReSPCT)—that outline a standardized protocol for psychedelic clinical trials that take into account the necessary safety considerations when administering psychedelics as well as the potential for their effective therapeutic potential. As of now, clinical trials for psychedelics do not provide the necessary framework to properly test the drugs for the FDA to readily rely upon the clinical endpoints that these protocols set. The ReSPCT framework consists of thirty variables, some of which include the environment in which the patients are administered the psychedelic drugs to be tested, how the drugs themselves are dosed and by whom, how the practitioners are supposed to intake the patients, and the actual therapeutic experience of the patients themselves. The guidelines acknowledge that there is fear within the industry that these drugs may in fact harm the patients, but these guidelines take such fear into consideration. While the ceiling for their therapy is high, there still needs to be motivation within the industry for a new regulatory framework as well as more attention toward basic research and clinical testing with the hopes that such attention to detail could ensure that the drugs work and that the patients would eventually not be harmed.

Such guidelines would help regulate the drug development of these dangerous compounds which would go a long way in ensuring the resulting therapies that such clinical research produces are both safe and effective. The FDA currently regulates the underlying clinical research required to approve pharmaceuticals and biologics, requiring market entrants to file a New Drug Application (“NDA”) for new pharmaceutical treatments and a Biologics License Application (“BLA”) for new biologic therapy. Within these submissions, drug manufacturers are required to include detailed information that must comply with the FDA’s strict quality standards before any medication can be administered to the public outside of those patients enrolled in the clinical trials detailed in these applications. These ReSPCT guidelines provide a framework that sets such a requirement in motion for treatment or therapy derived from psychedelic compounds. 

Still, even with these guidelines, there remains a warranted recommendation to account for the pioneers that have been researching these compounds for hundreds of years privately. Porta Sophia is a nonprofit designed to address the difficulty in finding prior art that researchers and patent examiners face when designing and evaluating patent applications. Porta Sophia has collected thousands of prior art references from both common and uncommon spaces in an easily accessible database. Such a database’s benefit is at least four-fold: inventors can build on existing knowledge, investors can avoid losses on research that cannot be patented for lack of novelty, Indigenous practitioners are protected from external claims on their traditional knowledge, and potential patients have access to a broader scope of alternatives in the public domain. Thus, having a library that collects any sort of publicly-available information that chronicles the pioneering work of Indigenous traditional practice of psychedelic therapy would go a long way in preserving that knowledge for important laboratory-supported research that would inevitably legitimize the advancement of this knowledge as well as provide a verifiable collection of contemporaneous evidence to support any efforts to financially-reward the pioneers of the advancement of this field of study if such advancement were to transition into more scientifically-approved forums. 

Preserving the Indigenous people’s ability to continue their traditional practices also has to be acknowledged. One potential regulation could be created a “ceremonial use” defense to patent infringement for psychedelic compounds and their methods of use. This defense would protect users from claims of infringement related to religious practices when either the plant or the underlying psychedelic compound had a prior religious use. This defense would be analogous to the existing doctrine of prior user rights, where a patent owner cannot sue for infringement based on continued use of a technology which was practiced in private before the patent was issued. The protections could be similar to the “safe harbor” provision of the Hatch-Waxman Act, which allows for the use of patented technology in the development of drugs. The current statutory framework is insufficient to protect ceremonial users because it only covers commercial uses of a technology, so further legislation is needed.

Finally, if the market transitions from nascent to profitable, such that the number of entrants would require the members to compete, industry players could agree to cooperate, similar to how early mRNA companies agreed to coexist during the pandemic. Specifically, the concept of patent pledges amongst these companies became common place. A patent pledge is when inventors commit to limiting the enforcement of their patents, typically spurring market forces to produce affordable copies of the invention for the public benefit. For instance, the Open Covid Pledge was designed to address the public health emergency of the COVID-19 pandemic by curbing enforcement of intellectual property related to treatments. Although the empirical analysis of whether patent pledges work to foster follow-on innovation is thin, there is data to support the idea that pledged patents stimulate start-up activities and provide the basis for further research. The downside of a purely voluntary patent pledge is that it can be difficult to enforce in court, frequently including stipulations and reservations of enforcement rights under certain conditions, adding substantial risk to follow-on research investments. Further legislation may be needed to reform the regulatory framework and provide a clear and predictable legal foundation for research using patented technologies in order to spur additional discovery.

The shifting political landscape has also affected the tenor of the debate around psychedelic medications, with HHS Secretary R.F.K. Jr. pushing an ambitious plan in June 2025 to have new psychedelic drugs rolled out to clinical settings within twelve months. Meanwhile, earlier in the month, Texas Governor Greg Abbot signed a law that invested $50 million into psychedelic clinical trials. Psychedelic research has bipartisan support, uniting politicians like Rep. Alexandria Ocasio-Cortez, D-NY, with Rep. Dan Crenshaw, R-Texas, who both supported the House National Defense Authorization Act’s allowance of medical research on psychedelics. With both scientific and political aspects at an inflection point, psychedelic patent law is ripe for new regulatory legislation to provide structure, predictability, and support to all stakeholders.

It seems apparent at least to the authors of this article that therapy derived from psychedelic compounds providing treatment backed by the FDA and supported by the USPTO has entered or at least will very soon enter into this era of industrialized capitalism. Its foundations outside of the commonly-assumed origins of biotechnology—specifically, laboratory-backed basic research—should not be discounted, but acknowledged. Such acknowledgement not only extends to the science that has developed over centuries, but the pioneers who have fostered this development. The pioneers’ anti-establishment proclivities shouldn’t preclude us from rewarding these pioneers. Further, given psychedelic therapy’s entrance, we can be the arbiters of the industry’s success. Promoting legal systems and providing legislative structure that has helped grow other science-derived industries should help ensure that the resulting treatment is both safe and effective.