Individuals with common sense have been lobbying for the rescheduling of marijuana for decades. Ever since the Controlled Substances Act of 1970, as part of Nixon’s ‘war on drugs,’ marijuana has been classified as a Schedule I drug. It apparently has ‘no current accepted medicinal value in the United States.’ While deadly opioids run rampant through the nation, the DEA has steadfastly refused to see the light and make marijuana more accessible.
When the DEA announced its refusal to reschedule cannabis in August 2016, it triggered a backlash and a startling revelation which was previously only known by those with interest in marijuana and/or patents: that is, that the United States Department of Health and Human Services (HHS) has a patent (patent no. 6,630,507) which covers “the potential use of non-psychoactive cannabinoids to protect the brain from damage or degeneration caused by certain diseases, such as cirrhosis.”
Sound a little bit like gross hypocrisy?
It is important to clear up one misconception about patent no. 6,630,507, though; it is not a patent on marijuana itself. Instead, it only covers synthetic and natural non-psychoactive cannabinoids (which refer to the ones that don’t get you high). Of course, though, it isn’t as simple as that. A little bit of digging revealed that a few companies are set to benefit big time. But first, let’s review the background behind patent no. 6,630,507.
The Inception of Patent No. 6,630,507
The 2016 DEA decision marks over four decades of federal agencies proudly ignoring evidence that marijuana does have medicinal use. Nixon wanted cannabis placed under the most restricted type of scheduling, and so he created the Schafer Commission to try and prove the dangers of marijuana. Instead, what ended up happening was research showed the benefits of the herb, and the National Commission on Marihuana and Drug Abuse actually recommended the decriminalization of the drug!
Predictably, Nixon ignored these findings and marijuana remained as a Schedule I drug. Since then, ‘lack of evidence’ has been cited as the reason for cannabis to remain in limbo. In reality, there are well over 20,000 positive studies, but the National Institute on Drug Abuse (NIDA) insists on publishing studies with negative results.
In 1999, Hampson, Axelrod, and Grimaldi filed patent no. 6,630,507 and it was awarded by the HHS in 2003. These three scientists are from the National Institute of Mental Health (NIMH), which is part of NIDA. Even though NIDA is perpetually against marijuana, it had no problem granting a patent for non-psychoactive cannabinoids for the treatment of neurological conditions and illnesses caused by oxidative stress.
According to the patent, the scientists discovered that cannabinoids possessed antioxidant properties – a finding that was ‘unanticipated.’ Also, it is important to note that the patent doesn’t cover cannabinoids that act through receptors (like THC). However, it does specifically mention CBD.
What is the Rationale?
Angry cannabis users want to know why there is a patent of this nature yet the plant remains on the controlled substance list. Mark Rohrbaugh is a specialist hired by the National Institute of Health (NIH), and he points out that the organization hires approximately 6,000 Ph.D scientists to look at and analyze the results of studies. When one of these scientists makes a discovery or invents a new technology, the organization then decides whether or not to file a patent.
Also, according to Renate Myles, spokesperson for the NIH, patent no. 6,630,507 was applied for and granted because research showed there was a “possibility of non-psychoactive compounds in cannabis [that are] effective when treating neurological diseases.” As a result, patients can now enjoy relief without suffering from the negative side effects associated with THC.
Rohrbaugh weighed in again, though, by stating that the patent doesn’t prove the compound is effective for the stated treatment. He claims that it would need purification before being synthesized in a lab, and it would need to be tested on animals and humans extensively. Then, he says, it would have to be approved by the FDA to prove it is both safe and effective for its stated purpose.
While the statements by Rohrbaugh and Myles seem reasonable on the surface, they don’t explain the reasons why some firms are set to make an absolute fortune from patent no. 6,630,507.
For example, Kannalife Sciences Inc., a New York-based company, received an exclusive license from the NIH in 2011 that allowed the company to use part of the technology in patent no. 6,630,507, with the goal being to develop cannabinoid and CBD-based drugs that treat a form of brain damage called ‘hepatic encephalopathy’ (CTE).
Myles said that companies were allowed to apply to use technology patented by the NIH for research. He also said they are able to apply for licenses to create drugs for neurological diseases in instances where the antioxidant properties of cannabinoids were potentially useful. Oddly enough, Kannalife Sciences Inc. was the only company to have a licensed portion of the patent. That is, until GW Pharmaceuticals got in on the act in November 2017. The patent expires on April 21, 2019, and from that day forward, everyone is allowed to create drugs based on the cannabinoids outlined in the patent, although they still have to be approved by the FDA.
While the CEO of Kannalife, Dean Petkanas, did not give the specifics of the licensing agreement, he did say the government would receive a percentage of sales; ‘six figures’ in royalties, as well as milestone payments. He also said that the DEA’s ruling was the best possible outcome for his company. Kannalife began the process of raising $15 million investments in late 2016, with a goal of starting initial CTE clinical trials in the first quarter of 2018.
In November 2017, GW Pharmaceuticals, known as Greenwich Biosciences in the U.S., completed its new drug application for Epidiolex, which is a formulation of CBD to treat seizures. If it gets approved, Epidiolex could earn over $2.2 billion a year by 2025, according to analysts at Goldman Sachs.
According to patent and trademark attorney, Gregory F. Wesner, the government is being decidedly two-faced on the 6,630,507 topic. On the one hand, the DEA has lumped all cannabis products into the Schedule I category, but on the other hand, synthetic cannabinoid drugs are being approved. It seems that the FDA and NIH can pick and choose who gets to jump in on the money train.
If marijuana were ever approved at a federal level, the party would be all but over for the likes of Kannalife because an enormous number of patents would be filed in a short space of time. It would trigger a huge level of growth in the industry, and while the likes of GW Pharmaceuticals would still profit, it would face immense competition. Meanwhile, cultivators would be left on the outside since plant patents are far more difficult to get.
Final Thoughts on Patent No. 6,630,507
The medicinal benefits of marijuana have been known for centuries, if not millennia. However, the federal government refuses to reschedule the plant and make it legal across the nation. Meanwhile, patent no. 6,630,507 uses careful language to ensure that non-psychoactive compounds can be used to create drugs – but only for certain conditions. To apply, you have to be part of the cozy cartel of Big Pharma. In short, the really ridiculous thing about the whole situation is this: the federal government is banning the use of something that grows naturally in the ground!