The federal government considers marijuana a schedule 1 drug, a controlled substance that has some potential for abuse and no medical value. But the federal government also owns, through the US Department of Health and Human Services (HHS), a patent that appears to acknowledge marijuana can act as medicine.
Marijuana’s medical use is illegal under federal law. It’s also patented by the feds.
The potential contradiction is a big deal for supporters of marijuana legalization and medical marijuana. If the federal government thinks marijuana has some medical value, then the drug should be rescheduled to a lower legal restriction — one that could give state governments the ability to implement relaxed marijuana laws without as much federal interference.
But the federal government maintains that its patent doesn’t contradict marijuana’s current legal classification, which illustrates why it’s so difficult to reschedule the drug — even as some studies suggest it has medical value and could act as an alternative to more dangerous medicines.
What is the federal government’s patent?
Sylvia Burwell heads the US Department of Health and Human Services, which owns a patent on marijuana's components. (Alex Wong / Getty Images News)
The federal government's patent (US6630507), issued to HHS in 2003, claims the legal rights to several non-psychoactive components — meaning compounds that don't get someone high — in marijuana, including CBD (cannabidiol), which made headlines recently for its ability to treat seizures in children. The patent claims the cannabinoids can act as antioxidants and neuroprotectants that are useful for treating ischemic, age-related, inflammatory, and autoimmune diseases; Alzheimer's disease; Parkinson's disease; and HIV dementia.
The patent allows for further research into the cannabinoids, and it lets companies apply for licenses they could use to develop drugs based on the components.
The National Institutes of Health (NIH) previously granted an exclusive license to the company KannaLife to develop drugs based on these non-psychoactive compounds for the treatment of brain damage caused by a diseased liver. Before the drugs reach the market, the company will have to conduct clinical trials and obtain Food and Drug Administration (FDA) approval.
Does this contradict marijuana’s federal classification as a substance with no medical value?
Francis Collins, director of the National Institutes of Health, stands by President Barack Obama. (Jewel Samad/AFP via Getty Images)
NIH officials say the patent acknowledges medical potential in some cannabinoids, not proven medical value. Even then, the patent only addresses some specific components of marijuana, so it doesn’t contradict the federal government’s schedule for marijuana as a whole.
As an NIH spokesperson wrote in an email, “This patent describes the therapeutic potential for cannabinoid chemical compounds that are structurally similar to THC, but without its psychoactive properties, thereby treating specific conditions without the adverse side-effects associated with smoked marijuana. It should be noted that the patent is for the use of cannabinoid compounds similar to and including those that naturally occur in marijuana (cannabis), but not for the whole marijuana plant.”
What would be needed to reschedule marijuana?
Activists protest a federal crackdown on medical marijuana in California. (Justin Sullivan/Getty Images News)
To reschedule marijuana, the federal government first needs to conduct a review of the scientific evidence and conclude there is some medical value in marijuana. A review is underway, but the results aren’t expected for months or even years.
The evidence threshold for this review is very high: the federal government requires large-scale trials, akin to what the FDA requires for other drugs going to the market, that prove marijuana has medical value in a controlled clinical setting. To date, no study on medical marijuana has met this standard.
Part of the reason for the lack of sufficient evidence is marijuana’s schedule. Because marijuana is considered to be a controlled substance with no medical value, the federal government, through HHS and the Drug Enforcement Administration (DEA), keeps very tight restrictions on how the drug can be used for both research and medical purposes. This has turned rescheduling marijuana into a bit of a catch-22: there needs to be a certain level of scientific research proving marijuana has medical value, but the federal government’s restrictions make it difficult to conduct that research.
A doctor sits with medical marijuana. (Shutterstock)
Alternatively to this whole process, marijuana could be removed from the schedules altogether. To do that, Congress would need to pass a law, or researchers would need to prove marijuana has no potential for abuse — a likely impossible requirement to meet. (Even tobacco and alcohol would likely be schedule 1 substances today, according to UCLA drug policy expert Mark Kleiman, if they weren’t statutorily exempt from the federal government’s scheduling system.)
Kevin Sabet, cofounder of the anti-legalization Smart Approaches to Marijuana, says marijuana doesn’t need to be rescheduled for its components — including CBD and other parts claimed by the federal government’s patent — to go to market. The government could instead conduct a special program that researches marijuana and its components in a clinical setting while allowing patients to access the drug. “We have advocated that the FDA start a compassionate research program now for components or different parts of marijuana, including the whole plant,” Sabet said in August.
The patent essentially takes Sabet’s approach. By acknowledging some components in marijuana have medical potential but not the plant as a whole, the federal government can bring CBD and other cannabinoids to the market without contradicting its overall assessment of marijuana.
