Along with cannabis, the Controlled Substances Act of 1970 designated many psychedelic compounds as Schedule I controlled substances. Schedule I controlled substances are considered to have no legitimate medical use and their possession and sale is illegal under U.S. federal law. Recent efforts to legalize psychedelics have followed in the wake of legalization of medical and recreational cannabis by multiple states. In the last two years, Denver, Colorado, and Oakland and Santa Cruz, California, decriminalized possession of psilocybin-containing mushrooms and/or plants having psychedelic properties. In February 2020, the Washington, D.C., Board of Elections decided to advance an initiative to decriminalize possession of any plant or fungus containing psilocybin and other psychedelic compounds. At the same time, scientific researchers have been looking at old research in a new light. The FDA has even shown willingness to support approval of psychedelic therapeutics. The renewed interest in psychedelics has spawned an increase in commercial activity and an increase in the number of patent applications and granted patents covering psychedelics. This article addresses patent issues related to psychedelics.
What are psychedelics? In contrast to cannabinoids, which are derived from only a few species of plants and often share chemical structures, psychedelics are derived from diverse sources, can have diverse chemical structures, and are defined functionally based on their pharmacological profiles. Even medical dictionaries use the term loosely. Stedman's Medical Dictionary defines psychedelic as: "Pertaining to a rather imprecise category of drugs with mainly central nervous system action, and with effects said to be the expansion or heightening of consciousness, e.g., LSD, hashish, mescaline, psilocybin." (Stedman's Medical Dictionary, November 2014 at 735790, emphasis added.) Exemplary psychedelics include lysergic acid diethylamide (LSD), psilocybin, ayahuasca, 3,4-methylenedioxymethamphetamine (MDMA), ketamine, ibogaine, mescaline, dipropyltryptamine (DPT) and diethyltryptamine (DET).
Like cannabis, psychedelics were the focus of substantial scientific research between the 1940s and 1970s. Research was stifled following the classification of psychedelics as Schedule I substances. Over the past 15 years, researchers at both universities and in the private sector have reevaluated psychedelics as potential avenues to treat disorders that remain intractable to conventional therapeutics. In November 2018, the FDA awarded its Breakthrough Therapy designation to Compass Pathways, Ltd.'s psilocybin therapy for treatment-resistant depression. Breakthrough Therapy designation provides expedited development and review of drugs. In March 2019, the FDA approved esketamine, a compound from a family of compounds known to have hallucinogenic effects, for treatment-resistant depression. Universities in the U.S. and elsewhere have established centers for psychedelic research. In September 2019, Johns Hopkins University announced the launch of the Center for Psychedelic and Consciousness Research supported by $17 million in private funding. Still, the Schedule I status of psychedelics has limited the availability of research funding, which is reflected in the present numbers of granted patents.
The Schedule I status of cannabis and psychedelic compounds is not relevant to patentability. The United States Patent and Trademark Office (USPTO) routinely grants patents covering cannabis and psychedelics. Patent examination is carried out according to the same standards applied to other technologies. The claims must be new, useful and not obvious and the application must teach one of ordinary skill in the art how to make and use the invention―nothing more and nothing less. Examples of psychedelics that have been the subject of patenting activity include:
- Lysergic acid diethylamide (LSD): LSD was first synthesized in 1938 by Albert Hoffman at Sandoz Ltd. Sandoz was investigating alkaloid compounds derived from ergot, a fungus that infects grains and causes hallucinogenic effects, to identify compounds that might be effective for treating bleeding in women after childbirth. LSD proved ineffective and was set aside. In a story well-known in the field of psychedelics, when Hoffman resynthesized the compound in 1943, he inadvertently contaminated his fingers with the compound and experienced unusual psychic effects. Sandoz subsequently marketed LSD under the tradename of Delysid for use in psychotherapy. U.S. Patent No. 2,810,723 "Lysergic Acid Derivatives Isolated at the Indol Nitrogen" issued to Sandoz, Ltd. October 22, 1957. A gap in patenting activity followed, but between 1980 and 2020, the USPTO granted 30 patents containing the term "lysergic acid diethylamide" in the claims, with about a third of them having issued in 2015 or later. The USPTO database of published applications lists 52 applications published since 2001 containing the term "lysergic acid diethylamide" in the claims, with 12 of these having published between 2018 and 2020.
- Psilocybin: Psilocybin is an alkaloid found in a number of fungal species, referred to collectively as "magic mushrooms." The psychoactive properties of such fungi were recognized by indigenous cultures in Central and South America and have played a role in traditional religious rituals for centuries. In the 1950s, a team of scientists, also led by Albert Hoffman at Sandoz Ltd., isolated psilocybin and its metabolite psilocin from various fungal species. U.S. Patent No. 3,183,172 "Obtaining Psilocybin and Psilocin from Fungal Material," issued to Sandoz, Ltd. May 11, 1965. U.S. Patent No. 3,192,111 "Method of Inducing Therapeutic Tranquilization with Psilocybin and Psilocin," issued to Sandoz, Ltd. June 29, 1965. A gap in patenting activity followed. Since the year 2000, the USPTO has granted 25 patents, with the majority having issued in 2015 or later, containing the term "psilocybin" in the claims. The USPTO database of published applications lists 65 applications published since 2009 containing the term "psilocybin" in the claims, with 16 of these having published in 2018 and 2019.
- Ayahuasca: Ayahuasca is a liquid brew prepared from the Banisteriopsis caapi vine in combination with leaves of other plants, typically Psychotria viridis, Diplopterys cabrerana and Mimosa tenuiflora. Indigenous peoples of the Amazon basin have been consuming the brew in a traditional ceremony going back at least a thousand years. The active agents in caapi and P. viridis were identified as harmine alkaloids and N,N- dimethyltryptamine, respectively. Since 1986, the USPTO has granted 25 patents, with nine of these having issued in 2015 or later, containing the terms "harmine" or "dimethyltryptamine" in the claims. The USPTO database of published applications lists 54 applications that have published since 2003 containing the terms "harmine" or "dimethyltryptamine" in the claims, with eight of these having published in 2018 and 2019. The USPTO database does not currently list any granted patents containing the term "ayahuasca" in the claims, although three patent applications containing this term published between 2018 and 2019.
- 3,4-methylenedioxymethamphetamine (MDMA): MDMA, commonly termed "ecstasy" or "Molly," was first synthesized by scientists at Merck and Co. in 1912 as an agent for control of bleeding. In the 1970s and 1980s, clinicians began exploring its use in assisted psychotherapy. MDMA also took hold as a recreational drug in those decades. Citing safety concerns, the DEA classified MDMA as a Schedule I drug in 1985. Since 1991, the USPTO has granted 52 patents, 22 of these having issued in 2015 or later, containing the term "MDMA" in the claims. The USPTO database of published applications lists 127 applications that have published since 2001 containing the term "MDMA" in the claims, with 22 of these having published in 2018 and 2019.
The scope of the claims covered by patents to these compounds obviously differs, but they share some commonalities. The specific psychedelic therapeutics were discovered years ago and are by themselves not patentable. But there is still ample room for patent protection relating to specific psychedelic therapeutics. Granted claims include:
- Formulations: therapeutic formulations containing the psychedelic along with adjuvants or other active ingredients, such as conventional pharmaceuticals, cannabinoids or other psychedelics;
- Consumer products such as beverages and cosmetics containing psychedelics;
- Methods of treatment of various disorders, for example, depression, Alzheimer's disease, immune disorders and microbial infections;
- Methods of drug detection; and
- Methods of deterring drug abuse.
Legalization of psychedelic therapeutics lags behind that of cannabis. However, companies in the psychedelic therapeutics area would do well to take a page out of the cannabis playbook. In the United States and most other countries, patents have a 20-year term. As commercialization in the psychedelic therapeutics area moves forward, those companies with strong patent portfolios will be at a competitive advantage.
The high stakes surrounding psychedelic therapeutics patents were starkly illustrated in February 2020. On Dec. 31, 2019, U.S. Patent No. 10,519,175 "Preparations of Psylocybin, Different Polymorphic Forms, Intermediates, Formulations and Their Use" was issued to Compass Pathways, a pharmaceutical company focused on therapies for mental health. Under the USPTO rules, there is a nine-month window following the issue date in which any third party can challenge a granted patent. Here, a petition for Post Grant Review of U.S. Patent No. 10,519,175 (the '175 patent) was filed with the Patent Trial and Appeal Board (PTAB) on February 21, 2020, less than two months post-issuance (Kohn & Associates v. Compass Pathways, Pet. for Post-Grant Review, PGR2020-00030, filed Feb. 21, 2020). The petitioner asserted that the claims in the '175 patent should never have been granted because they were obvious in view of articles in scientific literature that published before the priority date of the patent. The USPTO rules governing post grant review provide for a relatively rapid conclusion of the proceedings. We can expect a decision by the PTAB to either institute the review process or reject the petition within six months. We know from the cannabis industry that the PTAB treats disputes relating to claims covering cannabis no differently than claims to any other technology. (Insys Development Company v. GW Pharma Limited and Otsuka Pharmaceutical, (IPR 2017-00503)).
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