The landscape for FDA-approved, cannabis products is changing rapidly
In recent months, the landscape for the use of CBD in the treatment of medical conditions and the value of the intellectual property rights associated with cannabis-derived pharmaceuticals has shifted dramatically. On June 25, 2018, the Food and Drug Administration (FDA) made history when it approved Epidiolex for the treatment of seizures associated with two rare forms of epilepsy. The action was unique in that one of the active ingredients of Epidiolex is CBD, which is derived from cannabis and classified by the DEA as a Schedule I substance (a substance with high abuse potential and no known medical use).
Subsequently, on Sept. 27, 2018, the DEA announced it was placing Epidiolex on Schedule V of the Controlled Substances Act, which is the least restrictive schedule of the law. However, the reclassification applied only to Epidiolex. Other cannabis products remain on Schedule I.
As the landscape for FDA-approved, cannabis-derived pharmaceutical products has shifted, pharmaceutical companies are moving ahead with clinical trials to evaluate the efficacy of CBD in numerous and diverse medical conditions. For example, GW Pharmaceuticals is engaged in clinical trials for treatment of seizures, constipation and pain; Insys Therapeutics is evaluating CBD in the treatment of pediatric epilepsy; Kalytera Therapeutics reported a pre-investigational new drug application (pre-IND) meeting with the FDA to evaluate CBD for the treatment of acute graft-versus-host disease; and Tetra Bio-Pharma announced that the FDA has granted Orphan Drug Designation to its PPP001 drug (delta-9-tetrahydrocannabinol 9.5% and cannabidiol 2.5%) for the treatment of complex regional pain syndrome.
Parallel to clinical trials, companies have rushed to obtain patents on the use of CBD and other cannabis derivatives in the treatment of medical conditions with or without ongoing clinical trials in support of their claims. Notable examples include U.S. Patent No. 6,630,507, assigned to the U.S. Department of Health and Human Services and licensed to Kannalife, which is utilizing its license to develop CBD-based therapeutics to treat hepatic encephalopathy and chronic traumatic encephalopathy. GW Pharmaceuticals is also the assignee of multiple patents, including those titled “Use of cannabinoids in the treatment of epilepsy” and “Use of one or a combination of phyto-cannabinoids in the treatment of epilepsy.”
Meanwhile, the battle for intellectual property rights ownership has heated up, and the first disputes over validity and infringement of these patents have already been initiated. In the first CBD patent litigation filed in a federal court, the plaintiff alleged infringement of claims directed at liquid cannabinol (CBN) formulations using THC, CBD and various terpenes (See United Cannabis Corporation v. Pure Hemp Collective, Inc., case no. 1:18-cv-01922-NYW (D. Colo.)). Prior to that, in proceedings before the Patent Trial and Appeal Board, Insys moved to invalidate GW Pharmaceutical’s patent for the use of cannabinoids in the treatment of epilepsy.
These proceedings are currently pending, and the outcome will likely provide guidance to others seeking to enforce their intellectual property rights in this space. A critical question that is likely to confront patent lawyers will entail how to identify prior art, or what was known to the general public as of the date of the patent application. Prior art is a critical factor in patent law since it affects the validity of the patent and may be difficult in the world of cannabis because much of the development occurred at a time when cannabis-derived products were illegal. Further, patent lawyers may also have to contend with overly broad patents which may have been granted when the understanding behind the science of cannabinoids — and their chemistry — was less developed, and patent owners were able to make broad claims and thus obtain broad protections that could potentially be used to prevent their competitors from entering the marketplace.
In sum, companies will be investing heavily in CBD-based therapeutics as FDA approval and market entry at a federal level become reality for cannabis-derived drug products. This increases the incentive to seek and enforce patent rights derived from CBD.
Understanding this shifting legal landscape will be critical to commercial success in this space.
Tom Zuber is the managing partner of Zuber Lawler & Del Duca LLP, a firm of 40 attorneys with offices in California, Illinois and New York. He holds a law degree from Columbia Law School, a master’s degree in public policy from Harvard University and a biomedical engineering degree from Rutgers University, where he graduated with highest honors. He can be reached at email@example.com.
Jayashree Mitra is a partner in the New York office of Zuber Lawler & Del Duca. She has a Ph.D. in pharmacology from Yale University and focuses on patent and product liability litigation and trade secret matters. She can be reached at firstname.lastname@example.org.