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  1. mrsolearyscow
    The U.S. federal government's Department of Health and Human Services seems about ready to award exclusive rights to apply marijuana as a medical therapeutic. You read that correctly: "exclusive rights."

    Now, I don't think of myself as a conspiracy theorist. But when the federal government keeps taking actions that, even when considered separately but especially when viewed together, all seem to be part of a bigger plan to pave the way for the pharmaceutical industry to bulldoze the cottage medical marijuana industry, I start getting antsy.

    "We find it hypocritical and incredible that on the one hand, the U.S. Department of Justice is persecuting cannabis patient associations, asserting that the federal government regards marijuana as having absolutely no medical value, despite overwhelming clinical evidence," said Union of Medical Marijuana Patients director James Shaw. "On the other hand, the Department of Health and Human Services is planning to grant patent rights with possible worldwide application to develop medicine based on cannabis."

    "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," the organization posted on its website.

    "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," UMMP posted.

    You may recall that Toke of the Town columnist Ron Marczyk pointed out that the U.S. federal government, a few years back, took out patents on "cannabinoids as antioxidants and neuroprotectants," even while officially denying that cannabis has any medical value.

    Well, turns out they weren't just holding onto that patent for the fun of it. The latest piece of the puzzle to fall into place is the announcement last month in the Federal Register.

    After years of inaction, it seems they are "contemplating" the grant of an exclusive patent license to practice the invention embodied in its U.S. Patent to a company called KannaLife Sciences, Inc., which has offices in New York.

    According to Shaw, "it makes no sense for the government to provide U.S. Patent 6,630,507, which the government owns, to a single company with exclusive rights."

    Shaw urged medical marijuana patient associations and patients using cannabis for medicinal reasons to protest this giveaway to one pharmaceutical firm.

    Who, exactly, is this "KannaLife Sciences," based at 4 Tradewinds Drive in Bayville, N.Y.?

    Here's their Facebook page, on which they proudly shared a link to the Federal Register notice, but as yet haven't responded to this question posted 14 hours ago from a Facebook user: "you guys get exclusive rights to a USD Gov't patent on medical marijuana as they put CA & CO dispensaries out of business?!"

    Nor to a comment to that post: "If your company is as socially responsible as you claim to be, you will answer this."

    The founder of KannaLife Sciences is one Thoma Kikis, according to AngelList, who apparently also founded Inventlab and something called Ovie Entertainment. Kikis, a designer, filmmaker and entrepreneur, co-produced the film Alps (by Oscar-nominated director Yorgos Lanthimos), produced Darkon (being remade by Brad Pitt's Plan B and distributed by IFC), and was executive producer of It's A Disaster (with Julia Stiles and David Cross).

    According to the LinkedIn profile of CEO Dean Petkanas, "KannaLife Sciences, Inc. is a socially responsible, developmental stage phyto-medical/bio-pharmaceutical company that specializes in the research, development, and packaging of pharmacological products derived from botanical sources, including the cannabis taxa."

    KannaLife's plan for generating revenue and growth is intended to come from (i.) KannaLife's proprietary branding POS and hermetic packaging systems for the medical marijuana industry; (ii.) KannaLife's branded anti-oxidant and recovery skin care ointments and creams; and (iii.) the development, marketing and sale of KannaLife biopharmaceutical and phyto-pharmaceutical products derived from cannabis for the treatment of patients suffering with neuro-degenerative, neuro-toxic and oxidative stress related diseases and disorders.

    The Company's focus on product development was born from the burgeoning market in the United States in the use of traditional healthcare models of treatment, utilizing medicinal marijuana and other APIs found in the genus of the cannabis taxa.

    ​KannaLife intends to profit from the acquisition, development, marketing and sale of phyto-medical drugs and products derived from cannabinol ("CBN") and cannabidiol ("CBD") compounds as art and parcel to the Company's drug development plan. The disease indications to which the Company intends to target for the development of its products are centered on patients suffering from diseases with neuro-degenerative and/or neuro-toxic profiles.

    In addition the Company has developed a unique "blue ocean" approach to participating in the fast growing multi-billion dollar medical marijuana industry in establishing a "Gold Standard" in QA for delivering a consistent and reliable product to the consumer for dispensing medicinal marijuana in hermetically sealed packaging.
    ​"The prospective exclusive license territory may be worldwide, and the field of use may be limited to:

    "The development and sale of cannabinoid(s) and cannabidiol(s) based therapeutics as antioxidants and neuroprotectants for use as delivery in humans, for the treatment of hepatic encephalopathy, as claimed in the Licensed Patent Rights." [Italics added.]

    Hepatic encephalopathy's effects are due to liver impairment or liver failure, and can range from forgetfulness, confusion and irritability to inverted sleep-waking patterns, tremor, difficulties with coordination and trouble writing. More severe cases result in lethargy, somnolence, and eventually coma. In the intermediate stages, a characteristic jerking of the limbs -- asterixis -- is observed. There is disorientation and amnesia, and "uninhibited behavior" may occur.

    Coma and seizures are found in the most advanced stages of hepatic encephalopathy; cerebral edema (brain swelling) leads to death.

    Now, does the phrase "for the treatment of hepatic encephalopathy" mean the license is limited to that one condition, or is this a broader license to cover more or all medicinal applications of cannabinoids?

    A mid-day Friday email from Toke of the Town to KannaLife got a response from founder Thoma Kikis, who referred me to CEO Dean Petkanas; a follow-up call to Petkanas hadn't yet been returned by late afternoon.

    In the meantime, let's look some more at the language of the Federal Register notice.

    "The technology describes pharmaceutical compositions of cannabinoids that are useful as tissue protectants, such as neuroprotectants and cardioprotectants," the notice reads. "The cannabinoids compounds may be used, for example, in the treatment of acute ischemic neurological insults or chronic neurodegenerative diseases."

    The next paragraph gets really interesting, because it clearly reveals the anti-scientific and even superstitious way our United States government views the psychoactive effects of cannabis. (Please note that there is a real difference between "toxicity" -- which means it's poisonous, and can produce death -- and "psychoactivity," which can mean, in the case of cannabis, that it just changes your mental state.)

    "Nonpsychoactive cannabinoids, such as Cannabidiol (CBD), are particularly advantageous since they avoid toxicity that is encountered with psychoactive cannabinoids at high doses," [italics added], the notice reads.

    See how they just turned "psychoactivity" into "toxicity," folks?

    There you have it, right from the eminently trustworthy United States Government, that same government which has patented the medical use of natural compounds occurring in the cannabis plant: THC is toxic.

    Of course, it's demonstrably not only nontoxic, but is, as DEA Administrative Law Judge Francis L. Young pointed out, "one of the safest therapeutically active substances known to man."

    Should it really surprise anyone to find the federal government telling an outright lie when it comes to marijuana?

    This is, after all, the same government that has been handing out free marijuana for 30 years to patients in the Compassionate Investigative New Drug program, even while claiming cannabis has no medical value and thus classifying it as a Schedule I narcotic.

    According to the notice in the Federal Register, public comments will be accepted through Monday, December 19.

    Comments need to be submitted in writing by Monday, Dec. 19, 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

    Telephone (301) 594-6565 (note that NIH will only accept written comments for consideration)
    Fax (301) 402-0220
    Website http://anonym.to/?http://www.ott.nih.gov/contactus/licensing_and_patenting.aspx
    Email tongb at mail.nih.gov


    Source: http://www.tokeofthetown.com/2011/12/feds_to_grant_exclusive_cannabinoid_license_to_pha.php

Comments

  1. Mindless
    There's a couple of disconcerting attitudes evident in this decision. The US government is not alone in making decisions based on dogma rather than evidence about policy and law.

    The relationship between the pharmaceutical industry and government is even more disturbing. How on earth can exclusive rights be awarded? Did KannaLife Sciences invent cannabis?

    I try to stay clear of conspiracy theories as well, but it does look like the US government is trying to bulldoze the cottage medical marijuana industry, so that it can be handed over to one centralised organisation. KannaLife stand to make a great deal of money. Is something is rotten in the state of Denmark? I hope as many of our US members as possible will write to the patenting manager, and maybe their legislators as well.
  2. Terrapinzflyer
    Does anyone with knowledge of medical patent law have any input on this? I can find very little info except the original story being repeated with little to no knowledgeable commentary.

    How is this different from the patents issued for marinol, dronabinol, sativex, the THC patch etc...? Is there real world implications of this? Or is it just a patent for narrow use of selected and vey specific constituents of cannabis?

    This patent was applied for over a decade ago. The actual patent is here: Anonyomized link to US patent office
  3. Terrapinzflyer
    Cannabinoid Patent Exclusivity Only Applies To One Condition

    Exclusive Interview: Dean Petkanas, CEO, KannaLife
    (The Company Just Awarded An Exclusive Cannabinoid License By The Federal Government)


    The exclusive rights to apply the cannabinoids found in marijuana as therapeutic agents awarded by the U.S. federal government to the firm KannaLife only apply to one specific medical condition, KannaLife's CEO told Toke of the Town Monday night.

    Dean Petkanas, chief executive officer at KannaLife Sciences, told us that the exclusivity applies only for the development and sale of cannabinoid based therapeutics as antioxidants and neuroprotectants for use in the treatment of hepatic encephalopathy.

    "It is narrowly defined exclusivity, in that field," Petkanas told us. "Our exclusivity is narrowly focused."

    Asked if KannaLife planned to get exclusive rights to development cannabinoids to treat other conditions, Petkanas answered, "At the present time, we have no desire to do that."

    In fact, the CEO told me, even if KannaLife wanted to target another condition or conditions for cannabinoid therapy, they'd have to start back at Square One in the application process, a marathon for which he seemed to have little enthusiasm.

    But as far as the specific application covered in the exclusive rights -- for treating hepatic encephalopathy -- Petkanas was animated.

    "Phytomedicines are the the forefront of treating many diseases," Petkanas told us. "We're looking for specific endpoints."

    According to the CEO, the controversy that erupted over the weekend, particularly after a Friday Toke of the Town story, has been a learning experience for him.

    "Maybe it was God's will that I've had to fight salvos from the friendly army today, yesterday and Saturday," he told me Monday night. "The obstructions up until this point have been mainly related to political and religious dogma."

    ​"Friends laugh at me and say, 'You're in the pot business,' " Petkanas said ruefully. "I'm not in the pot business.

    "People think I'm breaking laws, but I'm not breaking any laws," he told me. "We're not breaking any rules, but the perception that we are is a serious obstacle."


    KannaLife
    ​According to Petkanas, such misperceptions about the nature of both cannabis as medicine and the legal status of particular cannabinoids can make it very challenging to recruit financial backers for KannaLife.

    "People look at me like I have three heads," Petkanas said. "I've had hedge funds and private equity funds basically snub their noses at me. It's taboo."

    According to Petkanas, American society got more restrictive throughout the 20th Century, bringing us to the current tension between further development of marijuana's medical potential and the taboos associated with societal fears and superstitions.

    "We got more dogmatic over the years," he said. "There was more and more control through the 1950s and 60s, and at the apex of stupidity, President Nixon felt he could control this outgrowth, this 'problem' that existed.

    "Our policies in this country are almost humorous when it comes to the concept of the war on drugs," Petkanas said. "Marijuana is a states' rights issue."

    Petkanas said the Obama Administration reacted to the Fast and Furious fiasco -- in which it was discovered federal agents had allowed shipments of weapons to fall into the hands of Mexican drug cartels -- by asserting more control over the medical marijuana industry.

    "It's kind of sad to look at it that way," Petkanas said. "But they seem to be following up one screw-up with an even bigger screw-up."

    The KannaLife CEO didn't close the door on possibly working with existing medical cannabis access points, possibly through lab testing for potency and purity, and through improving standardization and labeling.

    "We don't want to be involved in the production, growth or dispensing of marijuana at the retail level," Petkanas was quick to clarify. "We just want to help [dispensaries] understand a little better the horticultural sciences involved in it.

    "Our people know plant life very, very well," Petkanas told me. "They were associated with Rutgers, second only to Harvard in the horticultural sciences.

    "We intend on improving the knowledge base," he said. "Because we have a packaging and formulary system, it would go a long way toward quality control and an approach toward the prescribing and dispensing. That also lends itself to the gravity of removing some of the dogma.

    "The standardization process and model not only makes the doctor more responsible for the patients, but it allows targeted therapeutic use," Petkanas said. "And it allows farmers and growers to better meet the needs of the market and specific uses. I'm sure they've already done a good job of blasting the market with a variety of strains."

    "In terms of palliative care and pain management, we need to improve that," Petkanas said. "We need more targeted therapy.

    "You want to use it responsibly, so I think standardization goes a long way toward improving the market, reducing leakage to the black market," he said. "It brings legitimacy to the marketplace, and offers the government an opportunity to stop classifying the drug as a criminal drug. That's very important."

    Petkanas told me there's no love lost between his firm, KannaLife, and the mainstream pharmaceutical industry, that is to say, Big Pharma.

    "We should regard the plant as medicine and use it accordingly," he said. "But the minute we launch this program, I'm going to have the hate of the pharmaceutical industry come down on my head like white hot rain.

    "The guy who gets a product for a migraine, or to improve appetite, or needs an energy strain to deal with those issues, or he just came out of the hospital and his brain bled because of a stroke, or he had a cardiomyopathic event, and he wants to get pharmaceutical grade marijuana that can deal with his issues rather than some pill that some other company wants to give them..." Petkanas lets the thought trail off.

    "Yeah, I could be putting myself in harm's way," he told me. "It could be problematic for me.

    "But we're not going to shy away from it."


    By Steve Elliott ~alapoet~ i
    Monday, December 19, 2011

    http://www.tokeofthetown.com/2011/12/cannabinoid_patent_exclusivity_only_applies_to_one.php
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