Volume 108, Issue 4

Note

Tripping on Patent Hurdles: Exploring the Legal and Policy Implications of Psilocybin Patents

Jennifer S. Seidman

J.D., Cornell Law School, 2023; B.S. in Public Health, B.A. in Chemistry, University at Buffalo, 2020.

25 Jul 2023

Ask any hippie and they will tell you about the euphoric and therapeutic properties of psychedelic “magic” mushrooms (psilocybin). While the therapeutic effects of psilocybin have been long known among indigenous and underground practices, the medicalization of psilocybin therapy is a new phenomenon. Psilocybin poses a unique and promising solution for the growing mental illness public health crisis. Recent studies have shown positive results for psilocybin treatment, particularly for treatment-resistant depression and major depressive disorder.

In 2019, the United States Patent and Trademark Office (USPTO) issued the ‘175 Patent to Compass Pathways, a mental health care company that focuses on the research and development of psilocybin therapies. This patent claimed several processes for “treating drug resistant depression” by administering a synthetic, crystalline form of psilocybin, called Polymorph A.1 In 2021, the USPTO subsequently granted two composition of matter patent continuations for several forms of Polymorph A and several forms of a different polymorph, Hydrate A: the ‘259 and ‘044 Patents, respectively.

In 2020, Compass Pathways filed several other patents with the World Intellectual Property Organization (WIPO) for psilocybin treatment of numerous disorders, including, anxiety disorders, headache disorders, eating disorders, neurocognitive disorders, chronic pain and inflammation, and depression. The patent applications included broad claims that describe fundamental components of psilocybin therapy, including the use of concurrent psychological support and the use of non-sterile treatment rooms.

I argue that the Compass Pathways process patent claims for psilocybin treatment with naturally occurring psilocybin should be rejected because the claims are obvious. Psilocybin has been used for centuries by indigenous groups and in underground settings. Additionally, many of the claims in the patent applications include settings and concurrent therapies already used in other psychedelic therapies.

In Part I, this Note discusses the background of the mental illness public health crisis and how psilocybin-assisted therapy can treat mental illness. In Part II, this Note discusses the requirements that must be met to gain a patent, in particular patentable subject matter and non-obviousness. Additionally, it describes the history of Compass Pathways’ ‘175 Patent and the broad claims of its three WIPO psilocybin patent applications. In Part III, this Note analyzes the different permutations of process and composition of matter patents for natural psilocybin and Polymorph A. In Part III, I argue that while United States courts will likely uphold the composition of matter patents, the process claims for treatment with naturally occurring psilocybin are obvious based on indigenous knowledge, treatments with other psychedelic therapies, and general knowledge among psychedelic users. In Part IV, this Note discusses the patent system’s balance between innovation and access and the policy implications of allowing broad psilocybin treatment patents, such as biopiracy and exploitation. In Part V, this Note discusses the discrepancy between the goals of reducing biopiracy and promoting access to potentially life-saving psilocybin therapies and analyzes how potential solutions interact with these goals.

To read this Note, please click here: Tripping on Patent Hurdles: Exploring the Legal and Policy Implications of Psilocybin Patents