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CBD Roundup: Updates at the USPTO, Rescheduling, & More

Evoke Law Persuades USPTO to Register Trademark for CBD from Hemp Products

Mid-2017, the U.S. Patent and Trademark Office (USPTO) started emphatically refusing trademark registration for marks covering products containing CBD from industrial hemp. Previously, it seemed that so long as the applicant confirmed that the CBD was derived from industrial hemp that was internationally sourced and contained no more than 0.3% THC, the USPTO would grant registration. But last year, the USPTO changed its stance and required that the source of the CBD be from only the parts of the plant excluded under the CSA’s definition of “marihuana,” namely the mature stalks and seeds, without commingling with other resinous parts of the cannabis plant.

But here’s the catch – the USPTO took the position that there are no commercially appreciable amounts of CBD in mature hemp stalks, and therefore rejected the declaration from the applicant’s supplier of the hemp biomass expressly confirming that the source of the CBD was exclusively derived from the mature stalks without commingling of resin.

With the support and assistance of technical advisor, Sanford Wolgel, Phd., and expert testimony from Jake Stout, Phd., Evoke Law provided the USPTO with irrefutable scientific evidence that the mature stalks do indeed produce CBD in appreciable quantities without the commingling from other plant parts, including any ‘resinous’ secretions. And the application is now moving forward to registration.

DEA Reschedules (Some) CBD

On September 21, 2018, the U.S. Drug Enforcement Agency (DEA) announced that it was rescheduling certain drugs containing cannabidiol (CBD) from Schedule 1 to Schedule 5. This action comes on the heels of the FDA approving the cannabis-derived medicine Epidiolex® for the treatment of two severe forms of epilepsy: Dravet syndrome and Lennox-Gastaut syndrome.

Nearly all cannabis-based preparations are classified as Schedule 1 controlled substances under the Controlled Substances Act (see our post discussing the federal legality of hemp-derived CBD for more information). Schedule 1 is reserved for substances that have no accepted medical use and a high potential for abuse — despite the fact that the federal government has been dispensing cannabis to medial patients since the late 70’s, medical cannabis is already authorized in 30 states, and growing literature demonstrating that cannabis, in fact, possesses significant medicinal properties. Until now the federal government’s hand has previously not been forced to formally recognize any such benefits.

That said, it is significant to recognize that the DEA’s current action does not apply to all CBD or CBD products. The DEA’s rescheduling action only applies to CBD products that:

  1. have less than 0.01% THC

AND

  1. are FDA approved.

Schedule 5 drugs must be prescribed to patients by a doctor and can only be obtained through traditional pharmaceutical channels, namely pharmacies. As such, Epidiolex will not be available at cannabis dispensaries or from designated medical marijuana caregivers.

Though the DEA’s current action is extremely limited in application, it is nevertheless an important milestone toward federally legitimizing the cannabis industry.

FDA Opines that CBD Should Not be a Controlled Substance

After the U.S. Food and Drug Administration (FDA) approved Epidiolex, the first drug made with plant derived CBD, the FDA went further and noted that CBD should not be a controlled substance at all. In a 27-page memo, Dr. Brett Giroir, the assistant secretary for health in the U.S. Health and Human Services Department (FDA’s parent agency) stated “CBD has negligible potential for abuse” and CBD does not even meet the CSA’s description under Schedule V. That said, Giroir acknowledged that international treaties currently require the U.S. to treat CBD as a controlled substance.

The FDA’s findings echo a report from earlier this year from the World Health Organization (WHO), finding no adverse health effects associated with CBD, and instead, recognizing several medical applications.

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