Pubdate: Sun, 28 Aug 2016
Source: Denver Post (CO)
Copyright: 2016 The Denver Post Corp
Contact:  http://www.denverpost.com/
Details: http://www.mapinc.org/media/122
Author: Alicia Wallace

CANNABIS PLAYS ROLE IN ANOTHER NUMBER

Pot Advocates Decry "Hypocrisy" in Feds' View of Medical Use.

It may not have quite the same ring to it as a certain seven-digit 
phone number made famous by a 1980s pop hit, but 6,630,507 has become 
internet-famous since the U.S. Drug Enforcement Administration opted 
not to reschedule marijuana, leaving it in the category of drugs with 
no legitimate medical uses.

Since then, proponents of legalization have responded with a storm of 
social-media posts highlighting U.S. Patent No. 6,630,507, granted in 
2003 to the U.S. Department of Health and Human Services and covering 
the potential use of non-psychoactive cannabinoids to protect the 
brain from damage or degeneration caused by certain diseases, such as 
cirrhosis.

They're telling the DEA to "talk to the hand," writing "6,630,507" on 
their palms, hashtagging the number and linking to past articles on the topic.

The intent of the posts is symbolic, said Sam Mendez, an intellectual 
property and public policy lawyer who serves as the executive 
director of the University of Washington's Cannabis Law & Policy Project.

"Naturally, it shows that there is a certain amount of hypocrisy that 
there is 'no accepted medical use' for cannabis according to federal 
law," Mendez said. "And yet here you have the very same government 
owning a patent for, ostensibly, a medical use for marijuana."

Mendez - like patent lawyers, the research arm of the HHS and the New 
York biopharmaceutical firm that's working as an exclusive licensee 
under the patent - cautions that the existence of Patent No. 
6,630,507 doesn't signal that legalization is on the horizon.

"The government is allowed to file and obtain patents, and that has 
no bearing on the Controlled Substances Act," Mendez said. But it 
does indicate what could result if cannabis were rescheduled: an 
explosion of marijuana-related patents, Mendez said.

Its inception

The National Institutes of Health employs roughly 6,000 Ph.D.-level 
scientists, said NIH special adviser for technology transfer Mark 
Rohrbaugh, who holds doctorates in biochemistry and law. When one of 
those scientists invents a new technology or makes a new discovery, 
the NIH evaluates the result and determines whether to file for a patent.

Over the years, the NIH has conducted and funded research involving 
cannabis - both as a drug of abuse and for its potential therapeutic 
properties, NIH spokeswoman Renate Myles said.

In the case of No. 6,630,507, the researchers discovered that 
non-psychoactive compounds in cannabis may have antioxidant 
properties that could be beneficial in the treatment of certain 
neurological diseases, she said.

"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," 
Myles said in an e-mail.

The patent doesn't prove the chemical compound is effective in the 
stated treatment, Rohrbaugh said. The compound would have to be 
purified, synthesized in a lab setting, subjected to extensive 
testing in animals and humans, and ultimately require U.S. Food and 
Drug Administration approval to show that it's safe and effective for 
the intended purpose.

The intent behind patenting and licensing NIH discoveries is to keep 
technology that could potentially benefit the public from sitting 
idle, he said.

This sometimes requires looping in the private sector, he said. Laws 
made in the 1980s help entities such as universities and the 
government to make their discoveries accessible to others who are in 
a position to further the research and potentially commercialize the 
developments. The entities behind the discoveries typically receive 
payments as part of the licensing agreement.

Available for licensing

NIH's Technology Transfer Office advertises patents - including those 
related to cannabinoids - available for licensing on its website, and 
officials sometimes conduct outreach as well. The licenses often are 
packaged with some elements of exclusivity, Rohrbaugh said.

"It's like a piece of land," he said. "You wouldn't build a 
million-dollar house on a piece of land you wouldn't have some title to."

Five years ago, the NIH granted New York-based Kannalife Sciences 
Inc. an exclusive license for the part of the technology outlined in 
the patent to develop cannabinoid and cannabidiol-based drugs for the 
treatment of hepatic encephalopathy - brain damage that could result 
from conditions such as cirrhosis. Kannalife also has a non-exclusive 
license to develop drugs to treat chronic traumatic encephalopathy, a 
rare and progressive degenerative brain condition likely caused by 
repeated head trauma, Myles said.

"Other companies may also apply for licenses to use this patented 
technology to develop drugs to treat other neurological diseases 
where antioxidant properties of cannabinoid drugs may be beneficial," 
she said. "The patent expires on April 21, 2019, after which anyone 
would be free to develop drugs based on these cannabinoids that, like 
all drugs, would require FDA approval to demonstrate safety and 
effectiveness in humans."

No other companies have licensed portions of the 6,630,507 patent, she said.

Kannalife CEO Dean Petkanas did not disclose the specific terms of 
the licensing agreement, but he told The Cannabist that the deal 
includes milestone payments, a percentage of sales as well as 
royalties in "the six figures" to the government. The patent is valid 
in several jurisdictions, including the United Kingdom and Australia, he said.

Petkanas said his company "could not have gotten a better ruling" from the DEA.

"We've been building our business from the pharmaceutical side from 
Day One," said Petkanas, a former executive at the investment firm 
depicted in the film "The Wolf of Wall Street." "We want to be on the 
pharmaceutical side; everything we do has to be by the book."

CTE research

Kannalife, recently featured in a football-related Sports Illustrated 
report regarding its research into therapies for chronic traumatic 
encephalopathy, is about to begin raising $15 million in private 
investments. The money would allow it to start clinical trials 
related to hepatic encephalopathy as soon as the first quarter of 
2018. Petkanas said Kannalife anticipates eventually seeking orphan 
drug status - a special FDA designation for treating rare conditions. 
The company also contemplating conducting chronic traumatic 
encephalopathy-related trials in Europe.

"Does marijuana have medicinal benefit? Well, yeah," Petkanas said. 
"But it can't be targeted and qualified for repetitive use (without 
the FDA-approved research)."

That one arm of the federal government is poised to make money from 
cannabis-derived compounds, and another has approved synthetic 
cannabinoid drugs such as Marinol and Syndros, tells a story 
different from the one told by the DEA, which lumped together the 
hundreds of chemical compounds of cannabis as a Schedule I substance, 
said Gregory F. Wesner, a Seattle-based patent and trademark attorney 
for Lane Powell PC.

"The interesting thing here is basically the government being 
two-faced," Wesner said.

If and when national legalization comes, it'll trigger a swarm of new 
patent applications, said the UW Cannabis Law Project's Mendez.

"That's massive growth that does not occur every day or every year. 
That's the kind of growth you're talking about once in a generation," 
he said of the potential sales growth in the industry. "As part of 
that, you're going to see many people and many businesses research 
this far more intensely and file for patents."

An analysis conducted by Christopher Freerks, a Lane Powell patent 
administrator, shows that the PTO already has granted at least four 
dozen cannabis-related utility patents, including No. 6,630,507. The 
analysis does not include plant patents, which have been tougher to 
come by for some cultivators.

San Diego patent attorney Dale C. Hunt, an Open Cannabis Project 
board member who has degrees in botany, genetics and biology, said 
one would need to develop a completely new strain in order to land a patent.

If marijuana is rescheduled, it's realistic to believe that the 
innovation could carry on in the laboratories of NIH scientists, he 
said. But for now, the federal government's technology transfer and 
patenting actions around cannabis do not appear to be widespread.

"(Tech transfer) happens all the time," Hunt said. "It obviously 
doesn't happen all the time in cannabis."
- ---
MAP posted-by: Jay Bergstrom