In the May and June newsletters, we wrote about a proposal by the U.S. Department of Justice (DOJ) to transfer marijuana from Schedule I to Schedule III. Under the Controlled Substances Act (CSA), Schedule I substances are considered to have no currently accepted medical use and a high potential for abuse. Possession and sale of cannabis is illegal under U.S. federal law despite the fact that 38 states have legalized medical cannabis. In contrast, Schedule III substances are defined as drugs with a moderate to low potential for physical and psychological dependence.
The Drug Enforcement Agency (DEA), the federal agency under the DOJ responsible for combatting illegal drug distribution, provided a 60-day period for the public to comment on the Notice of Proposed Rulemaking (NPRM). That 60-day period ended on July 20, 2024. On August 29, 2024, the DEA formally announced that it would hold a public hearing with respect to the proposed rulemaking on December 2, 2024. Such hearings are presided over by an Administrative Law Judge, who will review the record and provide a recommendation to the DOJ.
The path and timetable for review of an NPRM are relatively well defined. What was unexpected and unprecedented in this case was the number of public comments that the DEA received – more than 43,000. In general, the majority of the comments supported rescheduling. The Drug Policy Alliance, a nonprofit organization seeking to “reduce the harms of drug use and drug prohibition” reported that nearly 70% of those comments were in favor of rescheduling. Forbes also reported a similar number.
What’s next? Following the hearing, the DEA will review and analyze public comments, consult with other federal agencies, and only then draft the final rule. If that rule is deemed to be “a major rule” (defined as an economically significant rule that requires review by the Office of Information and Regulatory Affairs), the DEA will be required to submit a report to Congress, which then has 60 days to review the proposed new rule. Taken together, the timing of the hearing combined with the upcoming election, makes it extremely unlikely that any new rule will go into effect for some time.
Despite the uncertainty surrounding the proposed rule change, stakeholders in the cannabis industry can take comfort in the fact that patent applications directed to cannabis and ancillary technologies will continue to be examined at the U.S. Patent and Trademark Office exactly as any other patent application. Companies considering filing a patent application in this area should not delay doing so because of the proposed rescheduling. Such a delay could potentially result in failure to obtain the earliest priority date possible, which could then put the company at a competitive disadvantage.
Do you have a cannabis-related invention? Contact Lipton Weinberger & Husick for advice.
— Gretchen L. Temeles, Esq.