How this man got the only marijuana patent in the U.S.

Cannabis activists and celebrities were furious when they found out.

Apr 5, 2018
How This Man Got The Only Marijuana Patent In The U.S.

When the National Institutes of Health (NIH) first obtained US Patent No. 6630507 in 2003, they did not expect the fury they would incite in the cannabis community, says the patent’s only license holder. That license holder, Dean Petkanas—and his company KannaLife Sciences Inc.—holds the rights for cannabidiol (CBD) as a neuroprotectant.

After the DEA announced that it would not reschedule cannabis from its highest restrictive category and the internet caught wind of the patent, a social media storm erupted. Celebrities like Willie Nelson and Woody Harrelson as well as activists from the cannabis world came together to expose the hypocrisy of a government which held the patent for a medicine it also banned on the grounds that it had no medicinal value.

Under the DEA’s guidelines, in order to be placed in the highest restrictive category of Schedule I, a substance must have a high potential for abuse and no currently accepted medical use. The patent grants the National Institutes of Health (NIH) exclusive rights to develop medicine from non-psychoactive cannabinoids in the marijuana plant for the specific purpose of treating diseases which may cause brain damage. As holders of the patent, the NIH can offer licenses to any researchers or health care providers which apply. Critics argued that the existence of the patent, which is held by a division of the Federal Government’s Department of Health and Human Services, was proof that the government doesn’t believe cannabis has no medicinal use.

As a pharmaceutical research company, KannaLife first applied for the license in June of 2010 exclusively for the treatment of diseases like Hepatic Encephalopathy, a neurological disease caused by severe liver damage. It was a potential cure for that illness which interested Petkanas and his business partner Thoma Kikis, whose father had suffered from it.

That narrow focus, Petkanas says, is the reason they were approved for a license over other applicants in 2012. “That we didn’t ask for every disease under the sun was something that drew a lot of interest from the NIH,” he says, “because then it gave them the ability to relicense it elsewhere.”

But in 2011, problems began to arise for KannaLife after the NIH published the company’s name as a license holder in the federal register. “We got a tremendous amount of blowback from the activist marketplace,” says Petkanas.

But for Petkanas, that backlash was unwarranted. His company was playing by the rules. That was his business model: to do business, not to fight the law every step of the way.

“One of the things I certainly did not want to do is get into a fix with the Controlled Substances Act,” says Petkanas, pointing out that where activists get it wrong is that the government doesn’t hold a patent for the plant, but for a specific compound within it. This is significant because it means that the federal government isn’t acknowledging the potential medical value of cannabis, but one particular part of it used in a particular way.

“You can’t patent a naturally recurring substance,” he says, “but when you’re dealing with synthetic analogues and changes to structures I think it becomes a little different.”

For Petkanas, it’s a distinction which means that medical and recreational cannabis are not the same thing. For better or worse, his patent hinges on that belief. After all, if the whole plant is medicine, then there’s nothing to study and no cure to develop because the cure grows naturally. It defies regulations, serial numbers and even a doctor’s prescription pad. The claim that marijuana itself is medicine defies the whole system.

That’s the difference between the government patent holders and the rest of the cannabis industry, says Petkanas. KannaLife values the established regulations. They play the government’s game by the government’s rules.

Kannalife This doctor tried to convince Carl Sagan to stop smoking weed
Photo courtesy of Kannalife

That is exactly where activists disagree. They argue that a system which bans a plant is inherently flawed. That there is no separating CBD from THC and that they work together to provide the plant’s medicinal value.

“I sympathize to some degree,” Petkanas says, “and the government has been overly burdensome over the years,” pointing out that even KannaLife has to file with multiple government agencies to import Noramco’s synthetic CBD for their research in the lab. “Perhaps maybe the rule of thumb should be that it should be allowed for recreational use over the age of 21 and you can’t make medical claims.”

Petkanas doesn’t deny that cannabis has medicinal value, but the only way for cannabis to truly be medicinal, in his view, is to isolate its medical compounds to create something that can fit the mold of our current medical system. Something which can be produced over and over again in an exact dose with controlled and predictable effects.

“I do think that CBD can get rescheduled,” Petkanas says, but “you have to create the purpose and the means and go through the regulatory guidance to get it removed [from the Controlled Substances Act].”

The medical claim, he argues, should be reserved for those who have jumped the scientific and regulatory hurdles. Those who can deserve the protection that comes with a patent because they’ve put in the work.

When asked if a patent on medicine could restrict access to that medicine, he replied: “We put time, effort, energy and scientific research that’s going to have to go through clinical trials. That’s the inventiveness that gives you protection.”

Since prohibition was enacted, legalization advocates have fought to prove that cannabis has medicinal value and, whether they meant to or not, in the eyes of regulators they created two distinct categories of the same plant.

“That’s the real hypocrisy,” Petkanas says, “is that they jumped on the medical bandwagon to rationalize use of [a recreational] product, when the argument should be exactly what they started with.”

That argument, which was used as the activists’ go-to weapon against outright misinformation and Reefer Madness, has now opened the door for companies like KannaLife to carve out an exclusively medicinal path for themselves. Meanwhile, cannabis companies without the political savvy or resources to navigate regulations are at risk of getting left behind.

However, under the constant watch of the government, KannaLife is still years away from producing the medicine they hope to market. For now, they remain a research company conducting preliminary studies for neuropathic pain in chemo patients with a grant from NIDA and a partnership with Temple University.

Like him or not, Petkanas brings up an interesting debate. Today, legal states have codified the distinction between recreational and medicinal by forming two lines at the dispensary and limiting the amount of THC recreational consumers can have.

If this is our model, recreational and medicinal, then KannaLife can hardly be blamed for wanting to create the purest form of that medicine and make that distinction clearer than red and green gummies. But their argument, and the patent, only holds if the distinction does.

The question to KannaLife and canna-activists is whether it makes sense at all to legalize and regulate medical marijuana or whether marijuana itself is medicinal regardless of how it’s brought to market.

Apr 5, 2018