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?
Because enforcement of patent rights in the U.S. is governed by federal law, the Schedule I status of cannabis continues to cast uncertainty over whether cannabis patent rights can actually be challenged or enforced. That uncertainty diminished with the filing of the first patent infringement case in federal court on a patent covering a cannabis-related technology on July 30, 2018 when United Cannabis Corporation (“UCANN”) sued Pure Hemp Collective, Inc. (“Pure Hemp”) in the United States District Court for the District of Colorado (United Cannabis Corporation v. Pure Hemp Collective, Inc.(Case No.: 1:18-cv-01922-NYW) for patent infringement. (https://www.duanemorris.com/articles/patent_litigation_cannabis_industry_2_cases_to_review_0319.html) UCANN alleged that Pure Hemp is selling products that are encompassed by the claims of its patent, US 9,730,911. Pure Hemp denied infringement and counterclaimed that the UCANN patent is invalid and should never have been granted because similar products were well known long before the filing date of the patent.
These proceedings have now moved to the claim construction stage, a stage specific to patent litigation, The claims in a patent specify the rights to which the patent owner is entitled, just as language in a deed to real property specifies the boundaries of the real property. But, unlike the quantitative verifiable measurements taken to define the boundaries of real property, claim language can be imperfect and open to more than one interpretation. Continue reading Cannabis patent litigation update: construing cannabis claims
Cannabis patent proceedings are no longer something reserved for a hypothetical future when cannabis becomes legal at the federal level. On January 3, 2019, the Patent Trial and Appeal Board at the United States Patent Office (USPTO) issued its decision in the Inter Partes review, Insys Development Company, Inc. v. GW Pharma Limited and Otsuka Pharmaceutical Co., (IPR 2017-00503). This is the first time that a patent covering a cannabis-related technology has been the subject of an inter partes proceeding at the USPTO. Even though cannabis remains a Schedule I controlled substance under U.S. federal law, the USPTO, a federal agency of the U.S. Department of Commerce, routinely grants patents covering cannabis-related technologies. 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 recent PTAB proceeding shows that they can be challenged.
Inter Partes Review (IPR) is a trial proceeding at the Patent and Trial Appeal Board (PTAB) of the USPTO that permits a third-party to challenge the validity of claims of a granted patent. If the challenger demonstrates that the claimed technology was known to the public before the patent application was filed, then the claims fail to meet the novelty and/or nonobviousness requirements and the Board can declare the patent invalid. Continue reading 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