By Alicia Wallace, The Cannabist
It may not have quite the same ring to it as a certain seven-digit number made famous in song in 1981, but 6,630,507 has been growing increasingly internet-famous since last week.
Following the U.S. Drug Enforcement Administration’s inaction on rescheduling marijuana, legalization proponents have responded by taking to the internet to highlight Patent No. 6,630,507 — telling the DEA to “talk to the hand” by writing “6,630,507” on their palms, hashtagging the number and linking to past articles on the topic.
Since not all Americans are intimately familiar with patents — and because of the reams of misinformation out there regarding this patent in particular — here’s a handy explainer about Patent No. 6,630,507:
U.S. Patent No. 6,630,507 covers the potential use of non-psychoactive cannabinoids — chemical compounds found within the plant species cannabis sativa — to protect the brain from damage or degeneration caused by certain diseases, such as cirrhosis.
U.S. Patent No. 6,630,507 was granted to the U.S. Department of Health and Human Services in 2003.
The recent social media flurry has consisted of posts varying in allegations and accuracy — some have claimed that the government patented the marijuana plant in its entirety. But the overall intent is one that is symbolic in nature, 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.
“It’s certainly hypocritical, but there’s no laws against doing so.”
Mendez, patent lawyers, the research arm of the HHS and the New York biopharmaceutical firm that’s working as an exclusive licensee under the patent also caution that the existence of Patent No. 6,630,507 isn’t necessarily so black and white.
“(The federal government is) a very large organization with hundreds of thousands of federal employees and innumerable number of departments,” he said. “It’s much more complicated than to think about them as a single organism. … The government is allowed to file and obtain patents, and that has no bearing on the Controlled Substances Act.”
More broadly, the existence of Patent No. 6,630,507 shines a light on what could result from legalization — an explosion of marijuana-related patents, he said.
No. 6,630,507’s inception
The National Institutes of Health has roughly 6,000 doctoral-level scientists in its employ, working mostly in Maryland, said Mark Rohrbaugh, who holds doctorates in biochemistry and law and is special adviser for technology transfer at the NIH. 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.
In this case, the researchers discovered that non-psychoactive compounds in cannabis may potentially 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 wrote via e-mail. “It should be noted that the patent is for the use of cannabinoid compounds similar to and including those that naturally occur in marijuana (cannabis), but not for the whole marijuana plant.”
The DEA’s decision has nothing to do with the NIH’s cannabis-related patent, Rohrbaugh said. The patent doesn’t yet prove the chemical compound is effective in the stated treatment, he said, adding that 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 not have technology that could potentially benefit the public sit idle, he said.
To ensure this, it sometimes requires looping in the private sector, he said. Laws in the 1980s further established the technology-transfer capabilities of entities such as the federal government and universities to have discoveries accessible to others who are in a better position to progress research and potentially commercialize the developments. The entities behind the discoveries typically receive payments as part of the licensing agreement.
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.”
DEA spokesman Russ Baer declined to comment about the patent, directing queries to the NIH.
Five years ago, the NIH granted New York-based Kannalife Sciences Inc. an exclusive license to utilize 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 (CTE), a rare and progressive degenerative brain condition likely caused by repeated head trauma, Myles said.
“NIH allows investigators inside and outside NIH to conduct ongoing research with the patented technology, and 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 yet licensed portions of the 6,630,507 patent, she said.
Headed by a former VP of the firm depicted in the film “The Wolf of Wall Street,” Kannalife was recently featured in a football-related Sports Illustrated report regarding its CTE efforts.
Kannalife CEO Dean Petkanas did not disclose the specific terms of the license agreement, but he told The Cannabist this week that the agreement does include 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,” he said. “We want to be on the pharmaceutical side; everything we do has to be by the book.”
Kannalife is about to begin raising $15 million in private investments, which would allow it to start clinical trials related to hepatic encephalopathy as soon as the first quarter of 2018, he said, adding that Kannalife anticipates eventually seeking orphan drug status — a special FDA designation for treating rare conditions. Petkanas also is evaluating the potential of conducting CTE-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).”
Petkanas said there is a concern that cannabinoid chemicals could exhibit toxicity at high dosing, so he believes additional research is beneficial.
Staking a claim
That one arm of the federal government is poised to make money from cannabis-derived compounds — and another arm has approved synthetic cannabinoid drugs such as Marinol and Syndros — tells a different story than that 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.
Embodying that contradiction is the U.S. Patent and Trademark Office, he said. Patents have been granted for the utility of cannabinoids and other compounds.
However, the issuance of trademarks will be murky until the legalization of marijuana is resolved on a federal level, he said.
“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 HHS’ Patent No. 6,630,507. The analysis does not include plant patents, which have been tougher to come by for some cultivators.
Earlier this year, Vice took a deep dive into the “looming patent war” and examined Patent No. 9,095,554, the “first-ever patent for a plant containing significant amounts of THC:”
Concern is rising among legal-pot pioneers about the need to lawyer up to defend their creations from imitators and patent trolls, as well as from multinational corporations in the agriculture, tobacco and pharmaceutical industries that are thought to be watching the fast-growing industry from the sidelines, despite overt denials.
“If the laws change and the big companies move in, I think we’ll have a period of turmoil around ownership, patenting, the whole business,” said Erich Veitenheimer, a patent lawyer and partner at Cooley LLP in Washington, DC, who represented the patent holders of No. 9095554.
The Vice article noted the rise of the Open Cannabis Project, an organization that is cataloging and classifying marijuana strains already in existence and, hence, the public domain.
Patent attorney Dale C. Hunt, an Open Cannabis Project board member who has degrees in botany, genetics and biology, told The Cannabist that one would need to develop a completely new strain in order to land a patent. But beyond strains, legalization likely will open the doors to protection of intellectual property across all aspects of the industry, said Hunt, an attorney for Hahn Loeser’s office in San Diego.
“I think there will be a greater emphasis on innovation,” he said.
If legal, it’s realistic to believe that the innovation could carry on in the laboratories of NIH scientists; but for now, the federal government’s technology transfer and patenting actions around cannabis do not appear to be widespread, he said.
“This happens all the time,” Hunt said. “It obviously doesn’t happen all the time in cannabis.”
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