In 2019, the Patent and Trial Appeal Board (PTAB) of the United States Patent and Trademark Office (USPTO) issued a decision in the first inter partes review of a cannabis related patent (Insys Development Company, Inc. v. GW Pharma Limited and Otsuka Pharmaceutical Co., (IPR 2017-00503)) (“Insys”). That decision was of interest to stakeholders in the cannabis industry particularly for what was not stated in any of the proceedings. Because enforcement of patent rights is governed by federal law, the Schedule I status of cannabis has cast uncertainty over whether cannabis patent rights can actually be challenged or enforced. The Schedule I status of cannabis did not enter into the PTAB’s decision, which was based solely on the obviousness of the claims. The PTAB proceeding showed that just like any other patents, cannabis related patents can be challenged. (See the following link for more information: https://blogs.duanemorris.com/cannabis/2019/01/16/business-as-usual-at-the-patent-and-trial-appeal-board-the-first-cannabis-related-patent-and-trial-appeal-board-decision-at-the-united-states-patent-and-trademark-office/)
Now, in 2020 the PTAB has issued a decision denying a petition for post-grant review of a psychedelic therapeutics patent. (Kohn & Associates, PLLC v. Compass Pathways Limited, Pet. for Post-Grant Review, PGR2020-00030, filed February 21, 2020) (“Compass Pathways”). Post-grant review is a trial proceeding at the PTAB that permits a third party to challenge the validity of claims of a granted patent. The first step in the post-grant review process is the filing of a petition by the challenger requesting post-grant review. The challenger must convince the Board that it is “more likely than not” that at least one of the challenged claims is not patentable. If the Board is not persuaded by the challenger’s arguments, the petition is denied and no post-grant review will take place. This is what happened in Compass Pathways.
Similar to its decision in Insys, the PTAB’s decision on the psychedelic therapeutics patent in Compass Pathways had nothing to do with the Schedule I status of psychedelic therapeutics. This recent PTAB proceeding demonstrates that psychedelic therapeutics patents can be challenged and that the PTAB will consider that challenge in the same way that it considers challenges to patents on any other subject matter.
Continue reading “All in a day’s work at the PTAB: Post-grant review denied for psychedelic therapeutics patent-Schedule I status irrelevant”
As increasing numbers of U.S. states have legalized both medical and adult-use cannabis, another set of Schedule 1 controlled substances – psychedelics – has begun to emerge from the shadows. Psychedelics such as psilocybin, lysergic acid diethylamide (LSD), mescaline, and ayahuasca were designated along with cannabis as Schedule I controlled substances under the Controlled Substances Act of 1970. Recently, several U.S. cities, including Denver, Colorado and Oakland, California, have decriminalized possession of psilocybin-containing mushrooms and plants having psychedelic properties. In February 2020, the Washington D.C. Board of Elections voted to advance an initiative to decriminalize possession of plants and fungi containing psilocybin and other psychedelic agents. As was the case for cannabis, biomedical research into psychedelics ground nearly to a halt following the Schedule 1 designation. But, over the past 10 to 15 years, researchers at both universities and in the private sector have turned back to both cannabis and psychedelics as possible therapies for disorders that are intractable to standard pharmaceutical treatments. In 2019, FDA approved esketamine, a compound from a family of compounds known to have hallucinogenic effects, for treatment-resistant depression. As has been the case for cannabis, the renewed interest in psychedelics has brought with it an increase in patenting activity. Even though legalization of psychedelics has lagged behind that of cannabis, legal wrangling over patents covering psychedelics has not, as demonstrated by recent developments in the area of psilocybin-based therapeutics.
Psilocybin is a tryptamine alkaloid found in a number of fungal species, also known as “magic mushrooms.” The psychoactive and hallucinogenic properties of such fungi have been a part of traditional religious rituals of indigenous cultures in Central and South America for centuries. In the 1950s, scientists at Sandoz Ltd., isolated psilocybin from fungi. The first US patents covering psilocybin issued to Sandoz Ltd. in 1965: U.S. Patent No. 3,183,172, “Obtaining Psilocybin and Psilocin from Fungal Material” and U.S. Patent No. 3,192,111, “Method of Inducing Therapeutic Tranquilization with Psilocybin and Psilocin.” Continue reading “Patent protection of psychedelic therapeutics: a page from the cannabis playbook?”