While more than two thirds of U.S. states and the District of Columbia have legalized marijuana for medical treatments—and more are considering bills to do the same—the U.S. Food and Drug Association (FDA) has approved it only for treatment of two rare and severe forms of epilepsy: Dravet syndrome and Lennox-Gastaut syndrome. The single approval1 is likely because research into medical marijuana requires a special license as the U.S. Drug Enforcement Administration (DEA) considers it a Schedule I drug. As a result, medical research is subject to stringent regulations that can impede new developments. A bill titled Cannabidiol and Marihuana Research Expansion Act, which passed unanimously in the Senate last week, aims to make medical research of marijuana much more accessible.2

The bill was sponsored by Senators Dianne Feinstein, D-Calif., Brian Schatz, D-Hawaii, and Chuck Grassley, R-Iowa. According to Feinstein: “This important legislation will cut the red tape around the research process, helping get FDA-approved, marijuana-derived medications safely to patients.”3

The ability to analyze and research medical marijuana products will surely lead to rapid growth in innovation. Advancements in the cannabis field are varied and come from areas like extraction, agriculture and cultivation, clinical use, formulations, modes of administration, and payment processing, to name a few. And such innovation deserves protection. Indeed, early protection of intellectual property rights is critical to secure a competitive advantage in the marketplace and to prevent others from encroaching upon a novel space.

As we’ve previously reported, patenting activity in the medical use of cannabis space has been happening for decades and continues to increase in popularity.4 Applications directed to methods of treatment, receptor targeting, pharmaceutical compositions, and the like are, for the most part, being claimed in the same manner as one would expect to see in a traditional biopharma application. One notable difference, however, is the relative infrequency with which applicants appear to be disclosing associated clinical and pharmacokinetic data for the claimed drug or dosage form. This is likely attributable to the limited number of clinical studies conducted to date on cannabinoid therapies, due to the challenges associated with obtaining the necessary permission to conduct them.5 The Cannabidiol and Marihuana Research Expansion Act will hopefully move forward and remove such barriers to research, enabling more ready collection of clinical data for cannabis products in the medical field. And, assuming the barriers to research into medical uses of marijuana are removed, and innovation progresses in a more unhindered fashion, many of the principles and strategies that have proven successful in traditional biopharma intellectual property protection should serve as logical guideposts for cannabis patent applicants.

[1] The FDA has approved two man-made cannabinoid medicines to treat nausea and vomiting from chemotherapy: dronabinol (Marinol, Syndros) and nabilone (Cesamet).
[2] A second bill, titled Marijuana Opportunity Reinvestment and Expungement (MORE) Act, seeks to remove marijuana from the Controlled Substances Act list and is scheduled to be heard in the House on March 30, 2022: https://www.rules.house.gov/bill/117/hr-3617
[5] 21 C.F.R. § 1301.18 (requiring researchers conducting cannabis-based clinical trials under an FDA Investigational New Drug Application to have a DEA research registration)

This article appeared in the March 2022 issue of MarkIt to Market®. To view our past issues, as well as other firm newsletters, please click here.

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