Help Stop Government from Issuing Exclusive License for Medical Cannabis

By The Union of Medical Marijuana Patients on December 15th 2011

As you well know, our federal government maintains that marijuana has “no currently accepted medical use” as a schedule I substance per the Controlled Substance Act. Although sixteen states and the District of Columbia have now passed medical marijuana legislation, the Department of Justice (DOJ) continues to enforce federal law and prosecute those who cultivate, distribute, or possess medical marijuana in compliance with state law. While the DOJ intimidates and incarcerates medical marijuana patients based upon federal position that cannabis has no medical value, another cabinet-level department within the federal executive branch, the Department of Health and Human Services (HHS), holds the legal right to certain medical applications of cannabinoids; since October 2003, the United States of America, as represented by the Department of Health and Human Services, has been official assignee of U.S. Patent #6630507, entitled “Cannabinoids as antioxidants and neuroprotectants. ” The Union of Medical Marijuana Patients (UMMP) has been well aware of this outrageous hypocrisy for several years now. However, recent developments beg immediate attention and action from the broader community of medical marijuana advocates, as well as from all Americans who disagree with government-driven financial exploitation and monopolization of the very plant for which hundreds of thousands of American citizens are currently incarcerated.

The notion that one federal bureaucracy claims ownership rights to medical marijuana while its sister department prosecutes the patients who depend upon this government patented “invention” is outrageous enough. However, the Union of Medical Marijuana Patients discovered this week that the federal government now intends to grant an exclusive license to “practice the invention embodied in U.S. Patent 6,630,507” to a single New York based pharmaceutical corporation. In accordance with regulations that dictate how exclusive licenses may be granted on Government owned inventions, 37 CFR part 404.7 (a)(1) (i), the HHS published notice of its intentions in the November 17th edition of the Federal Register. With a posting entitled “Prospective Grant of Exclusive License: Development of Cannabinoid(s) and Cannabidiol(s) Based Therapeutics to Treat Hepactic Encephalopathy in Humans,” the Department of Health and Human Services announced its plan to grant KannaLife Sciences, Inc. an exclusive license to “development and sale of cannabinoid(s) and cannabidiol(s) based therapeutics as antioxidants and neuroprotectants for use and delivery in humans. ”

We at the Union have always found a bit of inspiration in the fact that a player seated so highly within the federal government recognizes medical efficacy of cannabis to such an extent that it secured a patent on it. As an organization devoted to the well-being of patients, we are excited that the Department of Health and Human Services may be empowering further research, development, and distribution of therapeutic cannabis. Nonetheless, as this recent move by the HHS advances the scientific study of cannabis in the United States, it also serves to highlight the contradiction within our federal government. While the government patents and licenses commercial development of medical marijuana with one hand, they prohibit medical marijuana and prosecute patients with the other hand.

Though UMMP welcomes any potential new research that could come from KannaLife Sciences’ federal endorsement, it is highly disconcerting that the contemplated grant is an exclusive one. Per 37 CFR part 404.7 (C)(iii), exclusive licenses for Government owned inventions may only be granted if “the Federal agency has not determined that the grant of such a license will tend substantially to lessen competition or create or maintain a violation of the Federal antitrust laws. ” As a weed that grows naturally, with or without human intervention, in the broadest possible array of climates, cannabis has been widely used as medicine all over the world for more than 5,000 years. Amid federal context of enforced prohibition, how can the government contend that granting one corporation the exclusive license to sell medical marijuana does not guarantee substantially less competition for the lucky license holder? If the HHS moves forward with the contemplated grant, will state-sanctioned medical marijuana infringe upon KannaLife’s patent? Furthermore, 37 CFR part 404.7(A) holds that the Government may only grant exclusive licenses if “the public will be served by the granting of the license. ” Electoral majorities in the array of states who’ve passed voter-driven medical marijuana legislation indicate a preference for safe and reliable patient access. The Union of Medical Marijuana Patients does not believe that granting one corporation the exclusive right to develop and sell medical cannabis will serve the greater public interest in ensuring patient access.

It is a grave injustice that patient association in California are now facing a coordinated and comprehensive attack by the DOJ, while one pharmaceutical company in New York stands to profit tremendously from the monopolization of medical cannabis thanks to the HHS. While such discrepancy among federal departments frustrates the democratic principle of equal protection, inconsistency exhibited within the Department of Health and Human Services itself is even more reprehensible. The very same federal player that is assignee of a patent on therapeutic cannabis and poised to grant an exclusive license for KannaLife to develop and sell cannabinoid-based medicines has played a pivotal role in maintaining the U.S. government’s position that marijuana has absolutely no medical use. Upon intervention of a federal appeals court this past summer, the DEA was forced to finally answer a petition submitted by the Coalition for Rescheduling Cannabis in October of 2002. After nine years of government inaction, DEA Administrator Michele Leonhart formally rejected the advocacy association’s request to reclassify cannabis citing official recommendation “that marijuana remain in schedule I” from none other than the Department of Health and Human Services. Per Controlled Substance Act provisions on rescheduling, the DEA sought “scientific and medical evaluation and scheduling recommendation” from the Department of Health and Human Services. Three years after acquiring U.S. Patent #6630507 on “Cannabinoids as antioxidants and neuroprotectants,” the HHS concluded in its evaluation for the DEA that marijuana “has no accepted medical use in the United States. ” Although the HHS had sufficient scientific evidence and research to substantiate a patent in 2003, the department claimed it was unable to find any indication of medical efficacy in a 2006 evaluation of cannabis for the DEA.

Based upon 37 CFR part 404.7 (a)(1) (i), only days remain until expiration of the public comment period for this matter on December 19, 2011. The Department of Health and Human Services cannot have it both ways, acknowledging the medical efficacy of cannabis by way of securing a patent, and yet claiming “no accepted medical use” when faced with the question of moving cannabis into a schedule that would allow doctors nationwide to administer it. While the Union can only speculate as to the particular implications of a single pharmaceutical company owning the exclusive commercial right to therapeutic cannabis under contract with the federal government, we must all unite and act now to try and prevent the fruition of such a scenario. According to the government’s Federal Register posting, the “prospective exclusive license territory may be worldwide,” and the only stated recourse is submission of written comment and/or applications for this license to the National Institutes of Health (NIH) Office of Technology Transfer. The NIH will only consider written comments and applications received on or before December 19, 2011 in making its final determination about the contemplated exclusive license. The Union of Medical Marijuana Patients is currently in the process of drafting and submitting our impassioned objection to this grant as it is further indication of federal hypocrisy. We urge you to join in our efforts.

All comments and applications should be submitted in writing to Betty B. Tong, Ph.D., Senior Licensing and Patenting Manager, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD  20852-3804. If you’d prefer to send your documents via fax, the number is (301) 402-0220; alternately, you may email Dr. Tong at tongb@mail. nih. gov. The November 17th Federal Register notice gives Dr. Betty B. Tong’s phone number as (301) 594-6565, do take notice that the NIH Office of Technology Transfer will only accept written comments for consideration. Thorough research and conscientious legal strategy are the Union’s modus operandi, however due to the extreme time constraint we face in this matter it is imperative to spread the word about impending potential for government sanctioned financial exploitation and monopolization of medical cannabis now. As the Union continues to look in to this matter and devise plans for moving forward, we will be sure to keep you informed of any developments and opportunities to participate in our effort to prevent the corporate control of our medicine.