It was global news when GW Pharmaceuticals (GWPH) recently announced that Epidolex, its cannabis-derived pharmaceutical, reduced seizures in children who had Dravet syndrome.
Dravet syndrome is a rare form of childhood epilepsy that is estimated to affect somewhere between one in 16,000 and one in 21,000 children. In most cases the seizures don’t respond well to conventional medications.
Over a treatment period of fourteen weeks, Epidiolex reduced the frequency of seizures by 39% in children with the syndrome, compared to a 13% reduction in the control group. The Phase III trials were conducted under U.S. Food and Drug Administration (FDA) protocols.
Epidiolex’s active ingredient is the cannabis-derived, cannabinoid cannabidiol or CBD, which is extracted from plants grown at GW Pharmaceuticals’ facility in southern England.
With the success of its Phase III trials, GW Pharmaceuticals intends to file a new drug application with the FDA. If it is approved, which I believe is likely, Epidolex would be the first plant-derived cannabis-based drug to be approved in the United States.
If Epidolex is approved, it would be great news for sufferers of Dravet syndrome, but it could be devastating news for the 23 states and the District of Columbia that have legalized medical marijuana businesses.
The legalization of marijuana on a state-by-state basis in the United States was propelled to a large extent by the success that Colorado’s Stanley brothers had in treating children with Dravet’s syndrome with a strain of cannabis they developed which became known as Charlotte’s Web. They named the strain after Charlotte Figi.
Charlotte’s parents and physicians credited the reduction in the number of her epileptic seizures to a liquid extracted from cannabis that they administered to her starting at the age of five. Her success in being treated with medical cannabis was featured in Sanjay Gupta’s CNN documentary “Weed” in 2013.
The success of Charlotte’s treatment with a cannabis extract led to the development of other cannabis strains that, similar to Charlotte’s Web were also high in the non-psychoactive cannabinoid cannabidiol or CBD, and low in the psychoactive cannabinoid tetrahydrocannabinol or THC. These included AC-DC, Ringo’s Gift and Avidekel which was developed by the first and largest supplier of medical cannabis in Israel, Tikun Olam.
A problem for America’s medical marijuana industry is that GW Pharmaceuticals has been quietly applying for and receiving patents for a variety of cannabis-based pharmaceuticals.
As it relates to the use of CBD derived pharmaceuticals for epilepsy, GW Pharmaceuticals announced on January 8, 2015:
“GW also announces today that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Application Serial Number 13/380,305, a patent which protects the use of CBD in the treatment of partial seizures.”
“The subject patent specifically covers a method of treating partial seizure comprising administering CBD to a patient wherein the CBD is present in an amount which provides a daily dose of at least 400mg. A Notice of Allowance is issued after the USPTO makes a determination that a patent can be granted from an application. The issued patent from this application will provide an exclusivity period until June 2030.”
“GW has rights to a portfolio of intellectual property covering CBD and CBDV in epilepsy. This portfolio includes fourteen patent families containing one or more pending and/or issued patents with claims related to the use of CBD and/or CBDV in the treatment of epilepsy as well as compositions, extraction techniques, CBD and CBDV extracts and pure plant-derived CBD.”
The big unknown for America’s medical cannabis industry is what action GW Pharmaceuticals will take if it receives FDA approval for Epidolex. Will GW take legal action to protect its FDA approved drug and patent-protected intellectual property against growers or dispensaries who are growing or selling cannabis-based medicine for Dravet’s syndrome? Or, will GW seek to have the FDA do its dirty work and prohibit state-licensed medical marijuana businesses from selling medicine for the syndrome?
The outcome will be significant. It will set the stage for a likely battle between state-licensed medical marijuana growers, extractors and dispensaries and patent holders and companies who obtain FDA approval for cannabis-based formulations for other specific disorders and conditions.
Copyright 2016 - Jeffrey Friedland