Wednesday, 16 March 2016

How GW Pharma Could Use U.S. Patents to Shape the Future of Medical Cannabis

By Bruce Barcott

When Britain’s GW Pharmaceuticals announced Monday that its cannabis-derived drug Epidiolex had successfully reduced seizures in children with a rare form of epilepsy, the news made headlines around the world. Investors snapped up shares of the little-known firm, effectively doubling the company’s market value overnight.

GW Pharma may be a new play for investors, but the Salisbury, England-based company is widely known in the cannabis world, where it enjoys the respect if not the love of many in the legalization movement.

That wariness has its roots in the 1990s (more on that below), but it continues to this day. And for good reason. GW Pharma is quickly becoming the world leader in FDA-approved cannabis medicine while American companies are effectively shut out of the game by their own government.

Here’s the kicker: While two federal agencies (the Justice Department and the Department of Health and Human Services) actively prevent Americans from developing cannabis medicine, another agency (the U.S. Patent and Trademark Office) is helping GW Pharma lock up the intellectual property rights to a broad swath of cannabis-derived medicines and techniques.

In other words: Epidiolex, the company’s epilepsy drug now moving through the FDA approval process, is only the beginning.

On its web page, GW Pharma lists a number of other pharmaceuticals in the development pipeline. Those drugs treat everything from glioma (a form of brain cancer) to diabetes and schizophrenia.
But the company is also, unbeknownst to many, applying for and receiving patents that cover substances and techniques already widely used in the cannabis world.

The company’s latest patent (No. 9,205,063), granted last December, covers the prevention and treatment of neural degeneration with a pharmaceutical formulation of cannabis obtained by running the plant through a common carbon dioxide (CO2) extraction method. The patent lists all the usual active components of cannabis: THC, CBD, terpenes, sterols, triglycerides, alkanes, flavonoids, etc.

The potential value of patent No. 9,205,063 is clear. GW Pharma is trying to claim ownership of cannabis as a drug in the prevention and treatment of Alzheimer’s disease, Parkinson’s disease, and multiple sclerosis.

That’s one patent. There are many.

CBD Holds Promise as Child Epilepsy Treatment, Studies Find

No. 9,168,278, issued last October, is for the use of the cannabinoid THCV as an appetite suppressant in a weight loss medication. No. 9,017,737, issued last April, is for the use of CBD and other cannabinoids to prevent or treat psychotic disorders. No. 8,771,760 deals with the use of cannabinoids for constipation.

No. 8,790,719 is a big one. It makes an intellectual property claim for the use of plant-derived cannabinoids in the treatment of prostate cancer, breast cancer, and colon cancer.

Some of these patents are pending. Others have already been issued.

The tension between GW Pharma and American cannabis culture goes back to the 1990s, when the U.S. and British governments both commissioned studies into the effectiveness of cannabis as medicine. The U.K. study was spurred by multiple sclerosis patients using cannabis to calm their spasticity. The U.S. study came in response to California’s passage of the first statewide medical marijuana law in 1996.

Both studies reached a similar conclusion: Cannabis actually seemed to have a medical effect. Research by the Institute of Medicine, an arm of the U.S. government, showed that the plant held therapeutic potential for specific conditions, including epilepsy, chronic pain, and glaucoma.

The British responded by issuing a license to GW Pharma, a startup lab in Salisbury. GW was allowed to grow its own strains of cannabis and develop cannabinoid drugs. The license allowed the company to custom-breed its own strains, with higher or lower levels of various cannabinoids like THC and CBD. The result: a $1.9 billion company with drugs in the FDA pipeline and patents certified by the U.S. Patent and Trademark Office.
The Americans, meanwhile, responded by doubling down on the War on Drugs.
The Clinton administration dismissed marijuana’s potential as medicine and threatened to arrest any doctor who recommended it. To this day it remains federally illegal for any American company to grow its own strain of cannabis, even for research purposes.

Hence the tension. American cannabis growers, medical patients, and dispensary owners continue to risk arrest and imprisonment for conducting the same kind of work that investors are rewarding GW Pharma for today. The British company has yet to enforce any of its patents against American purveyors of botanical medicine. But it is now armed with patents backed by the full faith, credit, and power of the U.S. government. And if cannabis turns federally legal, the day of patent enforcement may arrive.
  

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