5 Important Facts About Patent 6630507

Ever since the Nixon Administration made cannabis a wholly prohibited Schedule I substance in 1970, politicians and various groups have petitioned for a schedule change. The Drug Enforcement Administration (DEA) sent a letter to U.S. senators announcing that the agency hoped to address the latest petition in the first half of 2019, and leaks suggest the DEA is on track to move cannabis to Schedule II. The source for the leak is reportedly a Los Angeles-based DEA lawyer with knowledge of the proceedings.
While half the states have already legalized medical and/or recreational cannabis, federal prohibition trumps state law. At present, the feds largely practice non-enforcement in legal states, but rescheduling will have huge symbolic and tangible benefits. If moved to Schedule II, cannabis will remain highly restricted in the same category as cocaine, oxycodone and crystal meth, but it will mark the end of full-scale prohibition on the federal level. The move will allow doctors to prescribe (not just recommend) cannabis, and researchers will have greater access to the plant to conduct clinical studies on its medical properties.
When the DEA said it would consider rescheduling cannabis earlier this year, many were hopeful that their life-saving medicine would finally lose its Schedule I status and receive government recognition of its medicinal benefits. Not only was it not rescheduled, but the head of the DEA apparently had a hell of a time laughing about the prospect of these medicinal qualities. Rightly so, anti-prohibitionists were outraged and, like any well-organized community, took to social media with hashtags, links to articles like this one and even pictures of the numbers written on their palms next to a “talk to the hand” anecdote. Read on to find out the truth about what this patent really means because it’s probably not what you think. You don’t have to remember the number, just remember the facts.
1. How the U.S. Got Patent 6630507
Patent 6630507 was granted to the Department of Health and Human Services in 2003. When the National Institutes of Health (NIH), which operates under this department, uncovers potential innovations or other discoveries, they apply for a patent so that they can control the research and allow others to do testing. Scientists with the NIH were searching for antioxidant qualities to help in degenerative brain diseases when they applied for the patent in 1999.
2. What the Patent Really Says
You may have heard that the U.S. has a patent on cannabis, but that is only partly correct. Patent 6630507 only covers some non-psychoactive compounds found in the plant, rather than the whole plant, which means it has nothing to do with tetrahydrocannabinol (THC). Possibly the most medicinally important compound, cannabidiol (CBD), is mentioned, though, and quite often. The patent also states, “No signs of toxicity or serious side effects have been observed following chronic administration of cannabidiol to healthy volunteers, even in large acute doses….” So, basically, the government knows both that certain compounds in cannabis have medicinal properties and that they are not at all harmful for human consumption.
3. The NIH’s Medicinal Expectations for Cannabis
In the abstract alone, scientists express that non-psychoactive cannabinoids act as antioxidants which could aid in the treatment of Alzheimer’s, Parkinson’s and HIV dementia. They even state that it could be preventative in that these compounds could limit damage caused by stroke and other trauma. The patent goes on to speculate about the benefits of these compounds in treating glaucoma, seizures and more. Think of these compounds like plastic wrap or a ziplock, which you would use to cover food you don’t want getting old and dried out, otherwise known as oxidization. When they say CBD is an antioxidant, they mean it prevents your brain from oxidizing, better known as aging.
4. Why the Patent Doesn’t Make it Legal
The patent only proves the potential for these compounds to aid in degenerative diseases. The government says it needs to do more research in order to understand long-term effects, proper dosage and individual effects on specific diseases before it can be released to the public. That’s their reasoning at least, though it does call into question the plant’s Schedule I status, which is reserved for substances known to have zero medical benefits. The patent expires in 2019, which might make you think the NIH has been working hard to find out more about these compounds, and that’s where licensing comes in. This is the main reason for the patent; the NIH can make a deal with some other company to continue researching their findings with stipulations. For instance, Kannalife is the sole licensee of patent 6630507. They have been contracted to research possible effects on treatment for cirrhosis. The agreement also entitles the NIH to a percentage of royalties once the company starts making money off the patent. This is an example of a business that wants cannabis to stay illegal for most people so that they can invest in the pharmaceutical opportunities it presents, and the government is helping them do so.
5. Should You Be Up in Arms?
Oh, definitely. The patent proves that there are at least some medicinal properties to cannabis and that the government has known about it for decades. Patent 6630507 references 12 other U.S. patents related to cannabis dating back to 1942. The recognition of medicinal qualities in cannabis disqualifies it from its Schedule I ranking. Additionally, this juxtaposition between the patent and the DEA’s ruling shows there is a disconnect between our governmental departments.
Obviously, marijuana is nowhere as dangerous as heroin. And it's not more dangerous than schedule 2 drugs like cocaine and meth. So why the hell is pot schedule 1?
But the classification doesn't mean that the federal government thinks of marijuana and heroin as equally dangerous drugs. The schedule reflects a more complicated system — one that accounts for a drug's medical value as much as a drug's potential for abuse.
Still, a drug's schedule is an important policy guide. A stricter schedule lets the DEA more stringently limit access to a drug and its supply, which can make a drug more difficult to research — as has happened for marijuana, limiting researchers' ability to study the drug for its medical value. (As a result, advocacy and medical groups have long contended that pot's schedule is out of step with the available scientific evidence.)
Under the Controlled Substances Act, the federal government — which has largely relegated the regulation of drugs to the Drug Enforcement Administration (DEA) — puts each drug into a classification, known as a schedule, based on its medical value and potential for abuse.
To initiate a schedule, the DEA first asks if a drug can be abused. If the answer is yes, then it's put on a schedule. If no, the drug is left out. After that, the drug's medical value and relative potential for abuse are evaluated to decide where on the scale it lands.
The two big issues, then, are a drug's potential for abuse and its medical value. Congress did not clearly define abuse under the Controlled Substances Act. But for federal agencies responsible for classifying drugs, abuse is when individuals take a substance recreationally and develop personal health hazards or pose other risks to society as a whole. To find medical value, a drug must have large-scale clinical trials to back it up — similar to what the Food and Drug Administration (FDA) would expect from any other drug entering the market.
Schedule 1 drugs have no medical value and high potential for abuse, while schedule 2 through 5 substances all have some medical value but differ in ranking depending on their potential for abuse (from high to low). In general, schedule 1 and 2 drugs have the most regulatory restrictions on research, supply, and access, and schedule 5 drugs have the least.
Schedule 1 and 2 drugs are both described as having "a high potential for abuse" — a vague description that doesn't rank drugs in the two categories as equal or different. The big distinction between schedule 1 and 2 substances, instead, is whether the federal government thinks a drug has medical value. The DEA says schedule 2 substances have some medical value and schedule 1 substances do not, so the latter receive more regulatory scrutiny even though they may not be more dangerous.
It may be helpful to think of the scheduling system as made up of two distinct groups: nonmedical and medical. The nonmedical group comprises the schedule 1 drugs, which are considered to have no medical value and high potential for abuse. The medical group comprises the schedule 2 to 5 drugs, which have some medical value and are numerically ranked based on abuse potential.
A drug's schedule sets the groundwork for the federal regulation of a controlled substance.
Schedule 1 and 2 drugs face the strictest regulations. Schedule 1 drugs are effectively illegal for anything outside of research, and schedule 2 drugs can be used for limited medical purposes with the DEA's approval — for example, through a license for prescriptions.
The DEA even sets strict limits on the production of schedule 1 and 2 drugs, although the limits vary from drug to drug. Only one place in the US — a University of Mississippi farm — is currently allowed to grow marijuana under federal regulations, and the pot is limited to research purposes. By comparison, several private companies produce oxycodone, a schedule 2 substance, and use the drug for prescription painkillers.
The DEA sometimes uses marijuana's classification to pressure physicians, hospitals, and pharmacies into not working with medical marijuana operations that are compliant with state law. If these medical providers don't comply, the DEA threatens to take back licensing that lets doctors prescribe drugs, such as prescription painkillers with oxycodone, that contain scheduled substances.
Congress could pass a law that changes or restricts a drug's schedule. But Congress mostly leaves scheduling to federal agencies like the DEA. (One exception: Congress previously passed the Hillory J. Farias and Samantha Reid Date-Rape Prevention Act of 2000 and added gamma hydroxybutyric acid, a date rape drug, to the scheduling system.)
The US attorney general can also initiate a review process that would look at the available evidence and potentially change a drug's schedule. Proving that a drug has no potential for abuse is also very difficult, if not impossible.
The two major recreational drugs not on the scheduling system — alcohol and tobacco — required a specific exemption in the Controlled Substances Act. Mark Kleiman, a drug policy expert, argues both would be marked schedule 1 if they were evaluated today, since they're widely used recreationally, addictive, detrimental to one's health and society, and deadly.
When marijuana's classification comes under review, its schedule 1 status is consistently maintained due to insufficient scientific evidence of its medical value.
Specifically, the scientific evidence available for marijuana doesn't pass the threshold required by federal agencies to acknowledge a drug's potential as medicine. No studies proved the drug's medical efficacy in controlled, large-scale clinical environments. No studies established adequate safety protocols for marijuana. And marijuana's full chemical structure has never been characterized and analyzed.
There have been some studies showing marijuana has medical benefits, particularly for pain and muscle stiffness. But these studies haven’t been large enough to meet the threshold the DEA and other federal agencies, such as the FDA, require to prove a drug has medical value — by proving its worth in controlled, large-scale clinical trials.
reason there isn't enough scientific evidence to change marijuana's schedule 1 status might be, in fact, the drug's schedule 1 status. The DEA restricts how much marijuana can go to research. To obtain legal marijuana supplies for studies, researchers must get their studies approved by HHS, the FDA, and the DEA.
Changing marijuana's schedule, in other words, is a bit of a Catch-22. There needs to be a certain level of scientific research that proves marijuana has medical value, but the federal government's restrictions make it difficult to conduct that research.
To address those issues, the DEA hopes to allow much more research into pot in other ways. For one, it’s increased the amount of pot grown for research over the past few years, and it plans to continue doing so. Crucially, it also plans to let more people and facilities grow marijuana for studies — aside from University of Mississippi, the only federally legal grower right now.
That could significantly open up research access to pot — including potentially higher-quality marijuana and different strains of the drug, which the University of Mississippi doesn’t currently meet demands for. But the effects of the changes remain to be seen.
While a reclassification would be a symbolic win for legalization advocates, Kleiman says it wouldn't have much practical effect. Schedule 2 substances typically require a prescription to be distributed, and the state-legal marijuana dispensaries and retail outlets don’t work through traditional prescriptions (they distribute "recommendations" for medical marijuana) — so even rescheduling may not open up access. (Cocaine and meth are schedule 2, and they’re definitely not easily legally available, after all.)
Still, if the federal government acknowledged CBD’s medical value through a schedule 2 classification, advocates hoped it would make federal agencies far more receptive to paying for and approving medical research into pot. But the DEA hopes its other steps will unlock far more research instead.
There would be some effects on policy, such as allowing state-legal marijuana business to deduct certain taxes, if marijuana was reclassified to schedule 3 or lower. But that’s extremely unlikely: Schedule 3 and lower drugs need to have some medical value and not meet criteria for "high potential for abuse." Since marijuana is widely used recreationally, it’s a lock-in for "high potential for abuse," keeping it at schedule 1 or 2.