US Government Patent About Cannabinoids
How Does the US Patent on Cannabinoids Affects CBD
In the 1990’s, the endocannabinoid system was discovered. Although CBD had already been discovered many years earlier in 1940, it was only after the discoveries in the ‘90s, that researchers saw the potential of CBD as a drug. Since then, a lot of research has been done regarding the medicinal use of cannabidiol.
Upon the discovery of the potential health advantages of cannabinoids, the US Department of Health and Human Services (HHS) filed for a patent on cannabinoids. But what are the implications of the patent on the CBD industry?
What is Patent 6,630,507 and How Does It Affect CBD?
In 1999, the US Department of Health and Human Services (HHS) filed US patent no. 6,630,507. This patent recognized that cannabinoids are beneficial to human health, stating the antioxidant properties as one of the key benefits of cannabinoids in treating oxidation associated diseases.
CBD Patent 6,630,507 also singled out cannabidiol, mentioning that cannabinoids such as cannabidiol are advantageous to use because it avoids toxicity commonly faced in using psychoactive cannabinoids. The US government patent specifically addressed the use of cannabinoids for pharmaceutical and health purposes.
After undergoing routine examination, the patent was approved by the United States Patent and Trademark Office in 2003.
In the US, patents are used to protect intellectual property. An individual, business, or even the government can file for a patent in order to take ownership of an invention.
Once a patent is approved, the patent holder owns all the rights to their patented work. These rights include the right to prevent others from using, selling, importing or advertising the patented work. In short, the patent holder owns all rights to exclude any other individual or entity to use the patented invention in any way.
If any business or individual wants to sell a patented invention, they must first obtain patent rights from the original patent holder. This is usually done by negotiating with the original patent holder to obtain a patent license. Usually, the patent holder will charge another individual or entity for a patent license. The patent holder will possibly also set certain limitations regarding the exact rights granted under the patent license.
Thus, the direct implication of the US government’s patent on cannabinoids, is that cannabinoids are an invention, and that the patent for the invention of cannabinoids belong to the US government.
This means that cannabinoids are viewed as the intellectual property of the US government and that any individual or entity wishing to distribute, use or import cannabinoids, has to obtain the right to do so from the HHS.
The HHS did grant a patent license to a pharmaceutical company in 2012. By granting this license, the US government gave this company exclusive rights for the commercialization of cannabinoids as anti-oxidants.
The patent license granted to the company didn’t prevent anyone from doing research on cannabinoids, but under the license, no one else who discovered benefits of cannabinoids for treating neurological conditions, would be allowed to develop and sell a drug for this purpose.
However, enforcing the US government patent rights has been rather complicated. As a result, most businesses selling CBD products have no permission from the US government to do so. When considering how CBD products are freely distributed on the market, it almost seems as if the patent on cannabinoids doesn’t even exist.
Complications Regarding Cannabis-Related Patents
One of the main reasons why enforcing patent 6,630,507 (and other cannabis-related patents) is so complicated, is because CBD and other cannabinoids are obtained from Cannabis Sativa plants.
Cannabis is currently classified as a Schedule I controlled substance by the Drug Enforcement Agency (DEA). A Schedule I controlled substance, is defined as any drug that currently has no accepted medicinal use and has a high potential for abuse. Examples of other drugs classified as Schedule I substances include heroin, LSD and ecstasy.
This means that the classification of cannabis by the DEA technically makes it highly illegal. However, the legality of the DEA’s classification is often contested and controversial in many ways.
The Hemp Farming Act recently legalized the commercial production of certain cannabis plants. Meaning, unlike other Schedule I substances, it is no longer illegal to own, or even distribute cannabis.
In fact, despite the DEA’s restrictions on cannabis, it’s legal to own cannabis plants and even to use cannabis for recreational purposes in many states. This leads to another point of controversy – how can cannabis be legal on a state-by-state basis, but illegal under federal law?
All of these questions on the FDA’s restrictions, combined with the legalization of farming industrial hemp, makes laws regarding cannabis and cannabis derivatives all the more complicated.
Although patent 6,630,507 is the most well-known cannabis-related patent, it certainly isn’t the only one. The problem with defending a cannabis-related patent, however, is that cannabis is a Schedule I substance. This means that defending a cannabis-related patent in court, can also mean pleading guilty to owning or distributing a Schedule I substance.
Despite legal exceptions on the ban of cannabis, cannabis-related patent holders might still feel hesitant to defend their patent in court, especially if the patent regards the use of cannabis as a drug, supplement or recreational substance.
So just because a patent has been granted by the United States Patent and Trademark Office, doesn’t mean it can be defended in court. The United States Patent and Trademark Office simply considers whether or not the patent is a unique invention. Anything that’s regarded as a new and unique invention can be granted a patent.
In practice, this makes a cannabis-related patent possible to obtain, but nearly impossible to enforce.
CBD Patent Expiration Date
The legality and distribution of cannabis-related products is still a hot topic. However, any concern about infringement of patent 6,630,507 will soon be a thing of the past.
Unlike copyrights, patents in the United States don’t last very long. The US government patent on cannabinoids is set to expire on 21 April 2019 – 20 years from the initial date the patent was filed. Once the patent has expired, the US government will no longer own a patent on cannabinoids.
But patents on cannabis products in general is a controversial topic. If, for instance, the DEA removes cannabis from its list of Schedule I substances, cannabis-related patent holders will be able to freely take their patent infringement cases to court. So while expired cannabis-related patents might not be eligible for court, current patents would be.
It’s uncertain whether the rescheduling of cannabis would allow past patent holders to also take up patent infringement cases in court. Although this is unlikely, as defending their patent would require admitting to owning or possibly even distributing cannabis during a time when it was illegal to do so.
Because of patents, the rescheduling of cannabis could, to some extent, make cannabis products less freely available than they currently are. This is because many businesses might take rescheduling of cannabis as an opportunity to file patents on the use of cannabis for treating various health conditions.
The current classification of cannabis as a Schedule I substance, can lead to a lack of evidence that cannabis was previously used for certain health conditions, allowing for businesses to obtain patents for unoriginal cannabis products.
However, cannabis has been in use for thousands of years for various health problems, which can serve as evidence that most patents aren’t original.
Regardless, the consequences of rescheduling cannabis are presently irrelevant. As the DEA is adamant on keeping cannabis on the Schedule I substance list, despite various gray areas in law enforcement regarding the use of cannabis-related substances.
Why is Cannabis a Schedule I Substance?
According to the Drug Enforcement Agency (DEA), Schedule I substances are highly dangerous substances that are very likely to cause addiction. Currently, marijuana is classified as a Schedule I substance because it contains high levels of a cannabinoid called tetrahydrocannabinol (THC).
THC is the constituent in marijuana mainly responsible for the euphoric effect or “high” obtained from consuming the plant. Repeated consumption of THC, especially in large quantities, has been proven to cause dependency on the substance, making marijuana potentially addictive.
However, CBD isn’t an addictive cannabinoid. In the scientific community, it’s commonly accepted that CBD doesn’t cause a “high” and that there’s no risk of dependency.
Even the FDA recognizes that CBD isn’t an addictive substance, as on 25 June 2018, they officially approved an anti-seizure drug containing CBD.
If the FDA believed CBD to be as highly addictive as heroin, no commercial drug containing CBD would ever be legalized. But there simply isn’t sufficient evidence or grounds for the FDA to classify CBD as a Schedule I substance, regardless of its origins.
The approval of a CBD drug by the FDA, led to further outcry to reschedule cannabis, as any cannabis product should be considered illegal by the FDA, making even the legality of the recent FDA approved drug questionable.
How Government Can Control Cannabis Addiction
The potentially addictive nature of cannabis, combined with the health benefits of CBD and its medicinal properties, still makes the control of cannabis a difficult balancing act for government. On the one hand, government isn’t looking to restrict the benefits of cannabinoids, but addictive constituents of cannabis still need to be controlled and restricted.
The legalization of industrial hemp is a positive step in the right direction. As it opens up opportunities for the restriction of THC, while allowing CBD and other potentially beneficial cannabinoids to be used for their health benefits.
All the conflict in laws and permissions has led to a lot of confusion, gray areas and controversy surrounding the use of cannabidiol. While the government patent on cannabinoids will soon be a thing of the past, many questions still exist regarding the future of CBD. Questions specifically pertaining to the implications of The Hemp Farming Act and its implications on the legality of CBD are now at the forefront of these discussions.
It’s hoped that government will take action in favor of the CBD industry, recognizing that addiction can be controlled and fought without the need for non-addictive substances to be classified as Schedule I substances.