Patenting Psychedelic Drugs
Research and investment in psychedelic drugs have exploded in recent years. Clinical trials have shown promising results using long-stigmatized drugs like psilocybin (found in magic mushrooms), LSD, and MDMA to treat various mental-health conditions. Dozens of newly launched companies have started to patent these compounds and rapidly advance them toward FDA approval and commercialization.
Because psychedelics are often derived from natural products that have been used in Indigenous communities for centuries, the known compounds themselves are unpatentable. However, it is possible to obtain “secondary patents” on new formulations, methods of treatment, or manufacturing methods. For example, UK-based Compass Pathways (“Compass”), a leading company in the psychedelics space, has obtained a patent claiming a new formulation of synthetic psilocybin used in its therapy for depression. Compass also has a pending patent application claiming methods of administering the drug in a room with muted colors, soft furniture, a bed or a couch, or a therapist holding the patient’s hand.
Patenting psychedelics has been a controversial issue. In a recent Harvard Law Review Forum article, Mason Marks and I. Glenn Cohen, both of Harvard Law School, raise concerns surrounding the quality of these patents. Because psychedelics have been criminalized for decades under the Controlled Substances Act, the U.S. Patent and Trademark Office lacks patent examiners with expertise in the field. Moreover, prior art searches are difficult because psychedelic methods are often documented in secret, hard-to-locate, or old sources. Both of these factors increase the likelihood of meritless psychedelic patents being granted. Even meritless patents that would be overturned if later challenged can have a chilling effect on competitors who cannot afford to pay the costs of litigation.
Compass’s pending patent application claiming methods of administering its drug in a room with certain features arguably highlights this concern. Critics allege these methods have long been used in Indigenous ceremonies and underground settings but that examiners are not familiar with this history, nor do they have access to relevant prior art. Some worry that owning these kinds of patents will enable monopolistic control of the industry. One solution has the creation of resources like Porta Sophia (literally, “doorway to wisdom”), a non-profit library for psychedelic prior art that aims to ensure references are not overlooked.
Another category of concerns that Marks and Cohen raise is one of patent policy. They argue that patents on psychedelics might promote “biopiracy” — the exploitation of Indigenous knowledge and technologies without permission, compensation, or acknowledgement. They also criticize the pharmaceutical industry’s common practice of patenting insubstantial modifications to old drugs. This is arguably what Compass has done with its synthetic psilocybin patent, as it has not shown a therapeutic advantage of its synthetic psilocybin to psilocybin itself. One proposal that Marks and Cohen suggest is tightening patent requirements of novelty and nonobviousness so that uninventive drugs are not granted patents in the first place. Another is using “patent pledges”, where companies pledge not to enforce their patent rights in certain cases that would be against their values, like what some did for COVID-19 technologies. In the meantime, Compass’s patent has been challenged in post-grant review by a nonprofit watchdog called Freedom to Operate.
Supporters of psychedelic patents argue that patents are necessary because they help offset the exorbitant cost of putting a drug through clinical trials, which is required for FDA approval and insurance reimbursement. They claim a for-profit approach is the best way to incentivize investment and ultimately ensure access to patients. In contrast, two nonprofits currently running psychedelics clinical trials, Multidisciplinary Association for Psychedelic Studies and Usona Institute, have chosen not to patent.
Psychedelics have increasingly shown great potential in helping to alleviate society’s mental-health crisis. However, their unique history and qualities have elicited concerns and debate as to what role the patents should play in advancing them. Patents walk a fine line between encouraging innovation and hindering it. It remains to be seen what approaches will be taken.