Cannabis Extract Patent Assertion Underscores Issue of Limited Prior Art for Marijuana Inventions

On July 30th, Golden, CO-based medical marijuana biotech firm United Cannabis Corporation filed a suit alleging patent infringement claims against Conifer, CO-based wellness company Pure Hemp Collective. The suit, filed in the District of Colorado, involves the assertion of cannabis patent claims which cover liquid formulations of highly enriched extracts of plant cannabinoids.

The patent at issue in this case is U.S. Patent No. 9730911, titled Cannabis Extracts and Methods of Preparing and Using Same. Issued last August, it claims a liquid cannabinoid formulation wherein at least 95 percent of the total cannabinoids is tetrahydrocannabinolic acid (THCa). The resulting invention addresses the need for providing more effective and safer cannabis extracts for medical uses through an extraction procedure that provides the desired active ingredients for the medical purpose.

In its suit, United Cannabis notes that it has been involved in the medical cannabis industry for nearly 20 years. The company’s proprietary technology includes the use of suspending both phytocannabinoids, chemical compounds which treat conditions and diseases by imitating compounds in the human body that mediate communication between cells, and cannabinoids with or without specific combinations of cannabis-derived fragrant oils. United Cannabis practices the ‘911 patent in its line of Prana Bio Nutrient Medicinals products which are useful in the alleviation the symptoms of various conditions such as chronic pain, neuropathy, Crohn’s Disease, post-traumatic stress disorder, epilepsy, autoimmune disorders and more.

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United Cannabis alleges that Pure Hemp has engaged in willful infringement of the ‘911 patent. Pure Hemp’s Vina Bell 5000mg product, which was purchased and tested for chemical composition by United Cannabis, contains a cannabinoid formulation which allegedly infringe upon at least claim 10 of the ‘911 patent, which claims a cannabinoid formulation wherein at least 95 percent of the cannabinoids is cannabidiol (CBD). United Cannabis attempted to engage Pure Hemp in licensing discussions in early May of this year but Pure Hemp continues to sell the allegedly infringing products without a license.

Such a case is interesting because of the unusual legal status of marijuana and cannabis products which creates a dichotomy in how such products are treated in the intellectual property sphere. Although cannabis-related formulations and products can be patented, the Schedule I status of marijuana under the Controlled Substances Act usually leads to the rejection of marijuana-related trademark applications. According to Neil Juneja of Gleam Law, there is no double standard where it comes to the availability of patents or trademarks for cannabis products. “Just because the patent and trademark offices are in the same building doesn’t mean they draw their power from the same constitutional provision,” he said. Whereas patent grants are derived from Article 1, Section 8, Clause 8 of the U.S. Constitution, Congress’ ability to grant trademarks comes from the Commerce Clause at Article 1, Section 8, Clause 3. “Trademarks require the legal use of the mark on commerce whereas patents don’t, they just have to claim a usefulness. One is requires use, the other is an exclusionary right,” Juneja said.

Neil Juneja.

Juneja had serious doubts, however, that the patent at issue in this case filed by United Cannabis would survive a validity challenge. “As far as the claims are concerned, I’ve never seen a weaker cannabis patent in my life,” he said. “All they did was take one secondary metabolite of cannabis and create the broadest independent claim.” Juneja said that there were a great many products in the cannabis market providing a THC concentration of 95 percent and that such products have been made for two generations. “All it takes is pouring some alcohol over cannabis to get a THC concentration in excess of 95 percent. You can do it at home if you buy some Everclear. I don’t understand how that could be considered patentable.”

One reason why such a weak patent might exist in the cannabis space is because of the lack of available prior art in the sector. “There’s two generations of practitioners trying not to be noticed and not to get arrested,” Juneja said. “You don’t really find prior art outside of High Times magazine.” Juneja recently gave a talk at an American Bar Association event and by that time, up to 11,000 patent applications mentioning cannabis had been filed and around 3,000 of those had resulted in issued patents. One of the earliest such patents was issued in 2003 to the U.S. Department of Health and Human Services covering a therapeutic formulation of cannabis for the treatment of diseases. “So simultaneously, while the U.S. federal government holds a patent for the use of cannabis to treat cancer patients, the Drug Enforcement Administration says that there’s no medical benefit to cannabis,” Juneja said. “It’s really tough to figure out why the government thinks that there’s no medical use in light of its own patent covering the use of cannabis for medical purposes.”

 

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13 comments so far.

  • [Avatar for Anon]
    Anon
    August 13, 2018 10:03 am

    Mr. Ryan,

    Your view of “spurious” need not be tied to a view of “stifling.” If in fact the patent is spurious, this will be determined in the proper role that a defense to infringement brings. Your statement then takes a larger shadow of NOT recognizing the legal standard that a granted patent is be deemed presumed valid (and that, to a clear and convincing level).

    Doing as you do here – dismissing based on feelings – is simply an improper application (non-application) of the controlling law.

    Not to overly dramatize the situation, but your “view” is indeed inimical to the concept of “innocent until proven guilty,” as your dismissal of the clear and convincing presumption of validity on mere feelings finds a parallel to the conviction by feelings that the concept of “innocent until proven guilty” protects against.

    Are many guilty people actually protected by the concept of “innocent until proven guilty?”

    Absolutely.

    Do real guilty people escape justice just because something could not be proven (for any number of reasons)?

    Again, absolutely.

    But such is a conscience decision of our justice system, one that has made this choice based on a full consideration of the pros and cons of both employing the standard and of not employing the standard.

    If your position were to be backed up with more than a feeling, then that might open a path for discussion. If you want to advocate for a change in the system, for example, for removing the presence (and level) of the presumption of validity, then a discussion on the merits of your suggestion could be entertained.

    To Gene @ 11, I was going to simply let pass Mr. Morgan’s reply, but now that I have provided a comment to Mr. Ryan, let me add that Mr. Morgan’s reply was merely a misdirection to the conversation. He wanted to somehow implicate the fact that some patents may “get through” and not meet the utility requirement as a form of rebuttal that there IS a utility requirement that must be met, and that THAT requirement is the sufficient proxy to the presence or absence of efficacy testing (in other words, he attempts to dismiss my counter point at 7, but does so with a logical error), and further, his absence from the dialogue in light of the additional post from me at 12 reinforces the weakness of his advocated position here.

  • [Avatar for Bruce Ryan]
    Bruce Ryan
    August 12, 2018 12:24 pm

    ‘Serious doubts that the patent at issue in this case filed by United Cannabis would survive a validity challenge.’ “As far as the claims are concerned, I’ve never seen a weaker cannabis patent in my life.”
    Pretty well sums up an attempt to stifle a fledgling industry with a spurious patent.

  • [Avatar for Gene Quinn]
    Gene Quinn
    August 10, 2018 10:30 am

    Paul-

    You say: “They don’t even catch all the perpetual motion applications.”

    Not to go too far off topic here, but they do a great job catching those applications that claim perpetual motion. But in many instances the inventor will have a working machine (I’ve seen it) that does something useful. The inventor is convinced the machine will run forever (which of course it won’t). If the inventor allows the patent attorney to describe and claim what the machine actually is/does then a patent can be obtained. I suspect that is why there are so many battery charging related innovations patented by independent inventors.

    Newman would have gotten a patent too if he had only claimed the most efficient machine ever created. When tested it was something closed to 90% efficient. But a perpetual motion machine it was not.

  • [Avatar for Anon]
    Anon
    August 10, 2018 10:03 am

    I have not heard of any “utility testing laboratory” for ANY art unit, Mr. Morgan.

    Of what point do you wish to make with such a statement?

    As to “don’t even catch all the perpetual motion applications” – how is that germane? Do you think that such applications pose any type of real problem to the world? Are such items ever going to present an enforcement issue?

    As to your last comment, I will merely point out that IPR is not – nor was ever intended to be – the answer to everything. Why would you (apparently) think otherwise?

  • [Avatar for Paul Morgan]
    Paul Morgan
    August 9, 2018 09:10 pm

    There is no utility testing laboratory in the PTO either. They don’t even catch all the perpetual motion applications. Nor was the reported recent change in Justice Department legal enforcement made with regard to medical efficacy. Hence, no government inter-departmental inconsistency in that sense or any reason to treat this patent any differently. If the best prior art is not published and a public use or on-sale defense is needed that will require presentation in a D.C. case with clear and convincing evidence since it cannot be raised in an IPR.

  • [Avatar for Cynthia]
    Cynthia
    August 9, 2018 06:50 pm

    Juneja discusses the claim as 95% THC, when it is actually at least 95% CBD, absolutely not the same, and no, they have not been making CBD rich medicinal treatments for two generations:)

  • [Avatar for Anon]
    Anon
    August 8, 2018 12:14 pm

    Effcicacy testing may not be done, but utility STILL is a legal requirement (and serves the point here).

  • [Avatar for Paul Morgan]
    Paul Morgan
    August 8, 2018 11:18 am

    “It’s really tough to figure out why the government thinks that there’s no medical use in light of its own patent covering the use of cannabis for medical purposes.”
    ? The PTO does not conduct medical efficacy testing. It is not the FDA or the Justice Dept. There are issued medical quackery patents on alleged medical devices.

  • [Avatar for Anon]
    Anon
    August 8, 2018 09:43 am

    Benny,

    Big pharma lobbying money is hardly malice.

    It’s money – and lot’s of it.

    With the level of money involved, hardly anything in the world affected by Big Pharma can truly be labeled “stupidity.”

    That is, under the classic understanding of that term in the context of the phrase with which you want to use it. Instead, these are very much thought-through and deliberate “plays.”

  • [Avatar for Bemused]
    Bemused
    August 8, 2018 08:57 am

    Benny, that’s a great quote but in this case its not applicable. Pharma is pouring huge sums of money into the fight. A Congressional bill to merely reschedule cannabis from a Schedule 1 to a Schedule 2 controlled drug (which would have kept cannabis on the controlled substance list but made it significantly easier for research to be undertaken on the medicinal properties of cannabis) was defeated earlier this year. Leading the charge to defeat this bill were pharma’s biggest lap dogs in Congress.

  • [Avatar for Benny]
    Benny
    August 8, 2018 05:10 am

    Benused,
    “it really isn’t that difficult to figure out: It all stems from big pharma lobbying money”

    Never attribute to malice that which is adequately explained by stupidity.

  • [Avatar for stefan pettge]
    stefan pettge
    August 7, 2018 08:35 pm

    patent trolls

  • [Avatar for Bemused]
    Bemused
    August 7, 2018 10:55 am

    “So simultaneously, while the U.S. federal government holds a patent for the use of cannabis to treat cancer patients, the Drug Enforcement Administration says that there’s no medical benefit to cannabis,” Juneja said. “It’s really tough to figure out why the government thinks that there’s no medical use in light of its own patent covering the use of cannabis for medical purposes.”

    With all due respect to Mr. Juneja, it really isn’t that difficult to figure out: It all stems from big pharma lobbying money.

    Keep in mind that marijuana is classified by the DEA as a Schedule 1 controlled drug. One of the requirements to classify a substance as a Schedule 1 controlled drug is that it have no known medical use (other drugs on the Schedule 1 list include LSD, heroin, ecstasy). Clearly, that is not the case with marijuana as evidenced by the US government’s patent on the use cannabis for cancer treatment (there are other US government patents on the medical use of cannabis for the treatment of epilepsy).

    Ignoring that rather inconvenient truth about the medical use of marijuana allows for continued Schedule 1 classification. It is much harder (and more time consuming and expensive) for medical researchers to obtain a license to conduct research on Schedule 1 controlled drugs. The end result is that by keeping marijuana on a Schedule 1 classification, research into potentially life saving cannabis-based medicines is stymied and big pharma continues to protect their multi-billion drug lines from competition.

    Yet another shining example of the corruption of the Washington DC swamp and how our elected officials prostitute their ethics and ignore what is in the best interests of their constituents in exchange for the almighty lobbying dollar(s).