A leaked letter from the Department of Health and Human Services indicates that the Biden Administration intends to encourage and support the FDA approval of 3,4-methylenedioxymethamphetamine (MDMA), a club drug known as “Molly” or “ecstasy,” depending on the form, for the treatment of Post-Traumatic Stress Disorder, and psilocybin or other tryptamine compounds (derived from mushrooms) for the treatment of depression, within the next two years.
Hallucinogenic compounds have been around since before the country was formed and were used by indigenous peoples in Shamanic rituals. Over the past decade, there has been a strong push to loosen regulation around these taboo substances. The 2019 drug approval of Spravato (esketamine), a ketamine-based antidepressant indicated for treatment-resistant depression, signaled that the FDA was now ready to entertain the possibility of such products going to market. The new action around hallucinogenic compounds is a test on the Agency after the disastrous consequences and deadly outcome of the prescription opioid crisis.
Psilocybin has been of significant interest recently with over 60 patents filed in the last five years. Opposition against the patenting of natural products has existed for some time but has reemerged owing to Supreme Court decisions within the last decade prohibiting the patenting of “natural phenomenon.” Patents may be pursued on specific formulations and methods of treatment, but such claims may be difficult to obtain owing to prior art. MDMA is also a known compound, so patents on this drug would be limited to formulations or methods of treatment. This creates a triple-clash between FDA drug approval, patent protection for the compounds or uses, and DEA’s restrictions on the marketing and sale of scheduled controlled substances. Schedule 1 controlled substances such as psilocybin typically have a high potential for abuse and are alleged to have no valid medical use by the DEA.
Before getting to market, companies developing new drugs with these compounds would need to pursue and obtain FDA drug approval, and that process would surely be more rigorous than that for traditional compounds. While drugs go through the FDA’s expensive review and approval process for safety and effectiveness, patents provide protection on the investment and the exclusivity attaches to the patent term. However, patents can be difficult to obtain on natural products such as psilocybin or on known compounds such as MDMA. Despite the progress made with the approval of Spravato, these three intersecting factors still create definite challenges for the drug industry moving forward.
Michael Best’s FDA Regulatory and Intellectual Property Teams are keeping a close eye on developments to proactively manage and capitalize on these changes for our clients and can help companies develop strategic plans to obtain both drug approvals and potentially overcome the hurdles to patent protection.
“SAMHSA [on behalf of the Secretary of the Department of Health and Human Services] agrees that too many Americans are suffering from mental health and substance use issues, which have been exacerbated by the ongoing COVID-19 pandemic, and that we must explore the potential of psychedelic-assisted therapies to address this crisis.”