Thursday, July 13, 2017

US Patent 6630507:

Cannabinoids as Antioxidants and Neuroprotectants


Dear Attorney General Session:
Please take time to schedule a visit with the U.S. Patent and Trademark Office, it’s just a short drive from your office on Pennsylvania Avenue down the George Washington Memorial Parkway. There, in the U.S. Patent and Trademark Office, you will find US Patent 6630507: Cannabinoids as Antioxidants and Neuroprotectants. The U.S. Patent Office issued Patent 6630507 to the U.S. Department of Health and Human Services filed on 2/2/2001. U.S. Patent No. 6,630,507 covers the potential use of non-psychoactive cannabinoids — chemical compounds found within the plant species cannabis sativa — to protect the brain from damage or degeneration caused by certain diseases, such as cirrhosis. U.S. Patent No. 6,630,507 was granted to the U.S. Department of Health and Human Services in 2003.

Since one part of the government applied for the patent of medical cannabis, and another part of the government approved that patent, it's only logical to conclude that the federal government knows that cannabis does indeed have valid medical properties.

What have other US Attorney General’s said about cannabis; former U.S. Attorney General Eric Holder in the interview released as part of Frontline’s “Chasing Heroin” documentary said,
“I certainly think it ought to be rescheduled. You know, we treat marijuana in the same way that we treat heroin now, and that clearly is not appropriate. So at a minimum, I think Congress needs to do that. Then I think we need to look at what happens in Colorado and what happens in Washington”.

Former President Obama had contended that rescheduling cannabis is a job for Congress, while others rightly argue the administration has the authority to do so unilaterally. Going back to 1961 to present day, 11 US Surgeons General have been asked their views on medical cannabis and only two of them had a negative stance-David Satcher (appointed by President Clinton) and C. Everett Koop (appointed by President Reagan). There are two ways by which the scheduling of cannabis can be changed: congressional action and administrative action.

Congress has the power to reschedule cannabis, either through new legislation specific to cannabis or through tailored amendments to the Controlled Substances Act. The first bill that proposed to move cannabis from Schedule I to Schedule II was introduced by republican Representative Stewart McKinney from Connecticut in 1981. Similar bills have been introduced perennially since then, most recently by republican Rep. H. Morgan Griffith of Virginia (H.R. 4498), all of which died in committee. In 2011, Reps. Ron Paul (R-TX) and Barney Frank (D-MA) introduced a bill to remove cannabis from the schedules entirely “de-scheduling” it, which also died in committee.



The bipartisan CARERS Act, introduced in Congress this year, reduces the role of the federal government in formulating drug policy and allows states to make determinations on their own drug policies. Giving the power to decide drug policy to the states reinforces the principles of federalism on which our country was founded. CARERS stands for Compassionate Access, Research Expansion, and Respect States. The original version of the bill would have ended the drug war, at least with regard to cannabis. This latest version is softer.

As advocates for safe access to medical cannabis, you know that removing the fear of federal prosecution for patients is crucial, particularly since our new Attorney General Jeff Sessions, has made his negative views of medical cannabis clear.

Medical Cannabis Is Safe & The Federal Government Has A Patent For It.
Under U.S. federal law, cannabis is defined as having no medical use. So it might come as a surprise to hear that the government owns one of the only patents on cannabis as a medicine.
The patent (US6630507) is titled “Cannabinoids as antioxidants and neuroprotectants” and was awarded to the Department of Health and Human Services (HHS) in October 2003.
It was filed four years earlier, in 1999, by a group of scientists from the National Institute of Mental Health (NIMH), which is part of the National Institutes of Health (NIH).

What is Patent No. 6630507?

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The patent claims exclusive rights on the use of cannabinoids for treating neurological diseases, such as Alzheimer’s, Parkinson’s and stroke, and diseases caused by oxidative stress, such as heart attack, Crohn’s disease, diabetes and arthritis.
Cannabinoids are a diverse class of compounds that include many of the unique compounds found in cannabis. It is easy to think of the patent as a patent on cannabis itself. However, this would be inaccurate, since the patent actually covers non-psychoactive cannabinoids (both synthetic and natural), meaning those that don’t cause a high.
The patent also covers only a specific application of these cannabinoids and not the production or use of cannabis and cannabinoids overall. The patent claims to “provide a new class of antioxidant drugs, that have particular application as neuroprotectants.”
According to the description, the inventors recognized “a previously unanticipated antioxidant property of the cannabinoids in general (and cannabidiol in particular).” Importantly, the patent does not cover cannabinoids that act through cannabinoid pathways, also known as receptors.
“This new found property makes cannabinoids useful in the treatment and prophylaxis of wide variety of oxidation associated diseases, such as ischemic, age-related, inflammatory and autoimmune diseases. The cannabinoids are found to 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.”
In addition to the fact that even the NIDA itself states on their website that cannabis can successfully kill cancer cells, they also state that it helps with nausea, sleep, appetite stimulation, and pain relief. Furthermore, there are now several drugs either containing synthetic forms of cannabinoids or direct extracts that are either FDA-approved as medicines or on their way to being approved. How much more “evidence” does Attorney General Jeff Sessions and the DEA need?

CBD and Non-Psychoactive Cannabinoids

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The government’s patent does not cover THC, the main ingredient in cannabis. On the other hand, cannabidiol (CBD) is specifically mentioned as an example of a cannabinoid that is covered. The patent describes CBD and other non-psychoactive cannabinoids as superior when taken in higher doses.
“Non-psychoactive cannabinoids, such as cannabidiol, are particularly advantageous to use because they avoid toxicity that is encountered with psychoactive cannabinoids at high doses.”
According to the description, CBD can be ingested in very large amounts without side effects.
“No signs of toxicity or serious side effects have been observed following chronic administration of cannabidiol to healthy volunteers, even in large acute doses of 700mg/day.”
The patent explains that cannabidiol previously had not been considered useful as a neuroprotectant. However, it cites various studies on cannabidiol as an antiepileptic and as a potential treatment for glaucoma.
Since one part of the government applied for the patent of medical cannabis, and another part of the government approved that patent, it only logical to conclude that the federal government knows that cannabis does indeed have valid medical properties. The U.S. government’s own National Institutes of Health researchers even concluded: “Based on evidence currently available the Schedule I classification is not tenable; it is not accurate that cannabis has no medical value, or that Information on safety is lacking.” Maybe there are some big pharma lobbyists and bigwig campaign finance contributors that would get a little upset.

How about the Patent?
The US patent office issued patent #6630507 to Aidan J. Hampson, Julius Axelrod (Julius Axelrod was an American biochemist. He won a share of the Nobel Prize in Physiology for Medicine in 1970) , and Maurizio Grimaldi ,who all held positions at the National Institute of Mental Health (NIMH) in Bethesda, MD. The patent, which declares the definitive accepted medical use of cannabinoids as antioxidants and neuroprotectants:
“Cannabinoids have been found to have antioxidant properties, unrelated to NMDA receptor antagonism. This new found property makes cannabinoids useful in the treatment and prophylaxis of wide variety of oxidation associated diseases, such as ischemic, age-related, inflammatory and autoimmune diseases. The cannabinoids are found to 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. Non-psychoactive cannabinoids, such as cannabidoil, are particularly advantageous to use because they avoid toxicity that is encountered with psychoactive cannabinoids at high doses useful in the method of the present invention. A particular disclosed class of cannabinoids useful as neuroprotective antioxidants is formula (I) wherein the R group is independently selected from the group consisting of H, CH3, and COCH3.”
Why would the US government obtain a patent on cannabidiol, a substance in cannabis, when it claims that cannabis has no therapeutic value? As a Schedule 1 drug, cannabis has been determined to have no therapeutic value, yet the patent claims substantial therapeutic value from one of its components.

What did the US government do with this patent?

“On November 17, 2011, the Federal Register published that the National Institutes of Health of the United States Department of Health and Human Services was “contemplating the grant of an exclusive patent license to practice the invention embodied in U.S. Patent 6,630,507” to the company KannaLife based in New York, for the development and sale of cannabinoid and cannabidiol based therapeutics for the treatment of hepatic encephalopathy in humans.”

“GW Pharmaceuticals plc (AIM:GWP) (Nasdaq:GWPH) (“GW”) announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for Epidiolex®, GW’s product candidate that contains plant-derived Cannabidiol (CBD) as its active ingredient, for use in treating children with Lennox-Gastaut syndrome (LGS), a rare and severe form of childhood-onset epilepsy. Epidiolex is an oral liquid formulation of a highly purified extract of CBD, a non-psychoactive molecule from the cannabis plant.”

The FDA obtained the patent on cannabidiol and now it is licensing it for use by big pharma drug companies.
What stands in the way of a broad role for medical science in cannabis policy is the Controlled Substances Act. Under this law, cannabis is listed as a Schedule I substance, meaning the government claims it has a high potential for abuse and no current accepted medical use. Substances classified in Schedules II-V are still subject to varying degrees of control, but have a recognized medical use and may be dispensed with a prescription under certain circumstances.

They are also subject to robust research, testing, and manufacture. For cannabis to enjoy the same benefits, it would need to be rescheduled.

Critics of the DEA have pointed out that cannabis researchers are caught in a Catch-22. In order to have more research, scientists need to do more studies. But in order to do that, their studies must be approved by federal agencies, including the DEA, the FDA and occasionally the National Institute on Drug Abuse, the largest public funder of cannabis research.

The institute currently contracts with the University of Mississippi, which has held the sole license to grow research-grade cannabis in the entire country since 1968. Any US study that looks at cannabis needs to get its strains from the institute, whose mission isn't to prove efficacy of the drug but rather its harm and abuse potential.

"Science has been shackled by politics for decades. Controlled trials couldn't be done without begging NIDA," said Dr. Sue Sisley, a psychiatrist formerly with the University of Arizona. Sisley says she was let go from the university because of her research into cannabis. In April 2016, the DEA approved Sisley's proposal to study the effectiveness of cannabis to treat PTSD in veterans. It is the first such study in the country.

"The American Medical Association has no objection to any reasonable regulation of the medicinal use of cannabis and its preparations and derivatives. It does pretest, however, against being called upon to pay a special tax, to use special order forms in order to procure the drug, to keep special records concerning its professional use and to make special returns to the Treasury Department officials, as a condition precedent to the use of cannabis in the practice of medicine."                     
~Wm. C. Woodward, Legislative Counsel - 11:37 AM Monday, July 12, 1937

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