Pot & Patents: How the Federal Government has Monopolized Marijuana

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The growing conflict between America’s drug enforcement policies and the federal government’s control of the marijuana-based pharmaceutical market is laden with contradictions and a healthy dose of bureaucratic hypocrisy.  On one side of the conflict is the Department of Health and Human Services (“HHS”), which holds a patent for the development of marijuana-based medicines.  The agencies that enforce the federal drug laws are on the other side of the conflict, loudly insisting that marijuana has no acceptable medical use.  HHS has even managed to simultaneously stand on both sides of the battle, and consistently talks out of both sides of its mouth by promoting the value of its patent while also agreeing that marijuana has no medical use.[3]

Marijuana has been a Schedule I controlled substance since the 1970s, which according to the Food and Drug Administration’s (“FDA”) Schedule I definition, means that it has  “no currently accepted medical use,” “a lack of accepted safety for use under medical supervision,” and “a high potential for abuse.”[4]   This classification also places marijuana on a list with the most dangerous drugs in the world, including the opioids Heroin and Fentanyl.  The Drug Enforcement Administration (“DEA”) supported this definition and reinforced its stance on marijuana’s Schedule I status when it followed recommendations from the FDA and HHS and declined to remove marijuana from the list of Schedule I drugs in 2016[5] .  This controversial DEA decision brought renewed attention to one of the biggest contradictions in the federal government’s marijuana policies.  [6]

If the 2016 DEA decision confirmed the government’s position that marijuana has no medical use, how did HHS get a patent to develop marijuana-based medicines, in 2003?  The answer is relatively simple—scientists working at the National Institute of Mental Health (“NIMH”) in the late 1990s discovered that cannabinoids, the naturally-occurring compounds found in marijuana plants, have powerful antioxidant and neuroprotective properties that can treat and prevent diseases (i.e., medical uses).  Had this discovery not involved an otherwise illegal substance, it might have prompted a renaissance in the medical marijuana and pharmaceutical industries.  The reality is that the federal government’s continued insistence that marijuana has no medical use has made a renaissance nearly impossible.

The most obvious effect of the NIMH discovery is the ongoing series of contradictory and conflicting actions by different factions of the federal government.  The conflicted relationship between the different HHS agencies and HHS marijuana polices is a prime example of government dysfunction.  The NIMH and the National Institute on Drug Abuse (“NIDA”), the agency responsible for the “study and control of drug abuse,” are both part of HHS. Not surprisingly, the NIDA follows HHS policy and continues to classify marijuana among the “drugs of abuse.”  In stark contrast to its own polices, HHS was granted Patent No. 6,630,507 in 2003, which is based on the NIMH discovery that cannabinoids have legitimate medical uses.  Why would HHS so willingly contradict its own policies by holding a patent for the medical uses of a “drug of abuse” with “no currently accepted medical use?”  The application for Patent No. 6,630,507 reveals the answer.  The NIMH discovery, and the subsequent application for Patent No. 6,630,507, confirm that cannabinoids, and in particular cannabidiol (“CBD”), have legitimate medical uses.  The hypocrisy is that HHS continues to publicly insist that marijuana has no medical use, while at the same time using Patent No. 6,630,507 to capitalize on the lucrative commercial market for CBD-based prescription medicines.

The United States Patent and Trade Office (“USPTO”) granted Patent No. 6,630,507 to HHS because the NIMH scientists discovered cannabinoids could treat a host of “inflammatory, autoimmune, and age-related diseases.”  The abstract of Patent No. 6,630,507 specifically states that “non-psychoactive cannabinoids . . . have particular application as neuroprotectants, for example in limiting neurological damage following ischemic insults, such as stroke and trauma, or in the treatment of neurodegenerative diseases, such as Alzheimer’s disease, Parkinson’s disease and HIV dementia.” These findings confirm that HHS knows marijuana and its non-psychoactive derivatives, those will not get you “high”, have legitimate medical uses.  This recognition by HHS begs another question: if HHS knows marijuana and its derivatives can help treat diseases, why did they recommend that the DEA leave marijuana on the list of Schedule I controlled substances?  A historical perspective helps to partially explain this hypocritical stance.

The history of America’s current marijuana policies reveals an ugly truth from our political past.  This history may also explain why HHS so willingly contradicts its own policies and those of the DEA and FDA.

Medical marijuana advocates, like those who petitioned the DEA to remove marijuana from the Schedule I list in 2016, consistently argue that marijuana never should have been a Schedule I drug.  The original classification of marijuana as a Schedule I controlled substance was not meant to protect the American people from a dangerous drug.  Instead, it was motivated solely by President Nixon’s desire to disrupt the anti-Vietnam ‘hippie’ culture of the 1960s.  John Ehrlichman, a Nixon White House aide, confirmed Nixon’s true motivation in a 2016 Harper’s Bazaar article.  According to Ehrlichman, Nixon was convinced that if the administration could associate marijuana use with hippies, and then criminalize marijuana under the Controlled Substances Act of 1970 (“CSA”), they could “arrest their leaders, raid their homes, break up their meetings, and vilify them night after night on the evening news.”

Nixon’s rationalization contributed to the passing of the CSA and the organization of the National Commission on Marihuana [sic] and Drug Abuse the same year.  According to Ehrlichman, the sole purpose of the commission, which became known as The Shafer Commission, was to find a negative link between marijuana use and what Ehrlichman said Nixon described as the “adolescent rebellion, social turmoil, widespread social protest and ‘deviant’ behavior” of Vietnam-era hippies. 

Ironically, Nixon’s plan almost went ‘up in smoke’ when the Shafer Commission’s two-year study concluded that marijuana use “had no links to criminal behavior and that marijuana smokers were no different than average Americans.”[8]  

Even more damaging to Nixon’s plan to subvert the hippie culture was the Shafer Commission’s recommendation to decriminalize marijuana.  Furious that his plan to limit the political impact of the hippie culture was temporarily thwarted, Nixon ignored the Shafer Commission findings and publicly confirmed that he remained vehemently opposed to “the legalization of marijuana and that includes sale, possession, and use.”  Refusing to back down from the president’s plan to marginalize the hippie movement, the Nixon administration made marijuana a Schedule I drug when it passed the CSA.  It has been stuck there since.

As long as marijuana is a Schedule I drug, it will bear the burden of having “no currently accepted medical use,” which makes the research and commercialization of marijuana and cannabinoid-based medicines extremely difficult.  However, HHS has used Patent No. 6,630,507 to circumvent the federal marijuana laws and policies, and now HHS is set to profit from the hypocrisy of Patent No. 6,630,507.

The scientific study into the use of marijuana and cannabinoid-based medicines can also help explain some of the contradictory government policies, and why marijuana cannot shake its Schedule I status. Unlike the history of recreational marijuana use in America, which traces its roots to Spanish explorers who brought it here in 1545, research into the medical uses of marijuana and cannabinoids is relatively new, and was only recently accepted as legitimate science.  While working to better understand the physiological effects of tetrahydrocannabinol (THC) and other cannabinoids (THC is the cannabinoid that can get you “high”), several teams of scientists in the 1990s, including those at the NIMH, discovered a number of potential health benefits of cannabinoids.  Most importantly, the scientists discovered that humans have an endocannabinoid system that affects the entire body and reacts in various way to cannabinoids.

Some researchers have referred to the endocannabinoid systemas “the most important physiologic system involved in establishing and maintaining human health.” 

For example, in a November 6, 2018 article in Wired magazine, Adie Wilson-Poe, a cannabis researcher at Washington University in St. Louis, stated that CBD, which is one of over one-hundred cannabinoids in marijuana, “has at least 14 distinct mechanisms of action in the central nervous system. So it does a little bit of something at a whole bunch of places . . . .”  The discovery of the endocannabinoid system has led to a spike in legitimate marijuana research worldwide, but marijuana’s Schedule I status has remained a consistent barrier to meaningful researcher in America.  Fascinatingly, this barrier did not stop HHS from applying for and getting Patent No. 6,630,507.  It has also not stopped the USPTO from issuing other patents for the medical use of cannabinoids, including the patent granted to GW Pharmaceuticals, the British company that just introduced Epidiolex, “the first FDA-approved drug that contains a purified drug substance derived from marijuana.”

The FDA approved Epidiolex for the treatment of two specific types of pediatric  epilepsy; “Dravet Syndrome, a rare genetic dysfunction of the brain that begins in the first year of life, and Lennox-Gastaut syndrome, a form of epilepsy with multiple types of seizures that begins in early childhood, usually between ages 3 and 5.”  Epidiolex became available by prescription in all fifty states on November 1, 2018, but only after the DEA agreed to sidestep their existing policies and make Epidiolex a Schedule V controlled substance, even though its primary medicinal ingredient is CBD.  The DEA decision was based on a recommendation from HHS that was outlined in a May 16, 2018 letter from Assistant Secretary of Health for HHS Brett P. Giroir, M.D.,to Robert W. Patterson, Acting Administrator of the DEA, which included the HHS conclusions that “CBD and its salts . . . do not have a significant potential for abuse and could be removed from the [Controlled Substances Act]” and that “ . . . CBD does not meet the criteria for placement in any of Schedules II, III, IV, or V under the CSA.”

Unfortunately, because marijuana remains a Schedule I (illegal) drug, if CBD were completely de-scheduled, the federal government could not continue to meet its commitments under the 1961 Single Convention on Narcotic Drugs and the 1971 Convention on Psychotropic Substances.  These commitments forced the DEA and HHS to compromise, and led the DEA to make Epidiolex the only marijuana-based Schedule V drug.  In a statement that coincided with this unprecedented exception, Acting DEA Administrator Uttam Dhillon stated that  “DEA will continue to support sound and scientific research that promotes legitimate therapeutic uses for FDA-approved constituent components of cannabis, consistent with federal law.”  The new HHS position on CBD and the DEA compromise are positive signs for Americans who could benefit from CBD-based drugs, but that does not necessarily mean a renaissance is imminent.  Until marijuana is removed from the Schedule I list, it will carry the stigmas that go along with being one of the most dangerous drugs. However, there is nothing preventing the USPTO from continuing to issue patents for marijuana and CBD-based drugs, and HHS can continue to market Patent No. 6,630,507 as though marijuana is not illegal.

In fairness to the USPTO and the patent approval process, the USPTO is not required to consider drug enforcement laws or HHS and DEA policies when it reviews patent applications for marijuana or CBD-based drugs. The USPTO can grant marijuana or CBD-based drug patents, like Patent No. 6,630,507 and the patent for Epidiolex, as long as the patent applications establish that the proposed drug can use marijuana-derived compounds to treat medical conditions.  When the USPTO granted the existing CBD-based patents, it relied in-part on the landmark patent case Diamond v Chakrabarty, in which United States Supreme Court Chief Justice Warren Burger wrote in the majority opinion that “eligibility for patent protection does not depend on whether the substance is living or nonliving.  Rather, the key question is whether the inventor has altered nature’s handiwork to the extent the resulting invention can be deemed a non-naturally occurring substance.”  In addition, the 1930 Plant Protection Act, defines an inventor not only as someone who created something new, but also as someone who is “a discoverer, one who finds or finds out.”  Together, these qualifiers give the USPTO freedom to grant cannabinoid-based drug patents in isolation from the current federal marijuana policies.  The unfortunate reality is that even though the USPTO can continue granting cannabinoid and CBD-based drug patents, the only way American companies can legally research and develop CBD-based drugs is with a license from HHS to use Patent No. 6,630,507, which includes an agreement to share any profits.  Given the incredible costs associated with researching and developing new drugs, the prospect of sharing future profits in exchange for using Patent No. 6,630,507 has severely limited the pool of potential CBD-based drug developers.  So far, HHS has only issued one license to use Patent No. 6,630,507, and it is for the exclusive use of the patent.

In 2011, the National Institutes of Health, another HHS agency, granted an exclusive license to Kannalife Sciences Inc., a New York-based pharmaceutical company.  Kannalife plans to use the technology in Patent No. 6,630,507 to “develop cannabinoid and CBD-based drugs” to treat Chemotherapy Induced Peripheral Neuropathy (CIPN) and Chronic Traumatic Encephalopathy (CTE), a form of brain damage that gained notoriety when it was linked to high-impact sports and the regular concussions suffered by athletes in sports like boxing and football.

There is however one piece of very good news for the millions of Americans who suffer from diseases that could be treated with CBD-based drugs.  When Patent No. 6,630,507 expires on April 21, 2019, anyone may be able to use the technology in that patent to develop and market CBD-based drugs, as long as they can get the drugs through the FDA approval process.  The expiration of HHS’s patent, along with the DEA’s recent compromise, means that a renaissance in the research and development of marijuana and CBD-based drugs may be coming, albeit slower than some people would like.