Let The Cannabis Patent War Begin
War for Cannabis Patents Heating Up: Protect Your Strains, Now!
Patent 6,630,507 is set to expire just in time for the Hemp Farming Act to be implemented. Meanwhile, cannabis patent trolls ready themselves for a looming battle to claim the rights of strains and other cannabis industry intellectual property.
“A well-written patent is like a declaration of war – you write a patent in a way that covers those who can sue you, and those you can sue.” – Reggie Gaudion, PhD.
In October, Axim Biotechnologies Inc. was granted a patent for a cannabis-based suppository to treat irritable bowel syndrome.
GW Pharma, who hosts the only FDA approved cannabis extract medicine on the market, Epidiolex, is now seeking patent protection for another cannabis drug to treat eczema.
Now, Colorado-based company United Cannabis Corporation is involved in ongoing cannabis patent litigation. They’re accusing Pure Hemp Collective Inc. of infringing on its patent for liquid formulations of cannabis extract rich in cannabinoids.
There is no doubt that the cannabis patent war has not only begun, it’s intensifying.
What is the current state of cannabis patents and what rights will breeders have to their intellectual property?
What can industry leaders do to protect themselves from nefarious groups who would take advantage of new laws and weak patents in an attempt to monopolize the legalization of cannabis?
Let’s take a look at what’s happened; what’s happening now, and what’s about to happen for cannabis patents.
Did you know that a U.S. federal agency has held a patent for the medical use of cannabinoids for over 15 years? All while, the DEA and FDA have continued its war on drugs.
Patent 6,630,507 is held by the U.S. Department of Health and Human Services (HHS) :
“[The] invention concerns pharmaceutical compounds and compositions that are useful as tissue protectants, such as neuroprotectants and cardioprotectants.” – NIH CBD patent
The patent claims that cannabinoid compositions could be used in the treatment of acute ischemic neurological injuries or chronic neurodegenerative diseases.
In particular, it mentions CBD, or cannabidiol a non-psychoactive cannabinoid with extensive therapeutic properties, and points to cannabinoids as antioxidants and neuroprotectants with the potential to treat conditions such as :
- Ischemic, age-related inflammatory and autoimmune diseases
- Stroke or trauma
- Alzheimer’s disease
- Parkinson’s disease
- HIV dementia
How many people could have been helped with better, safer medicines in the 15 years that the government has been sitting on this patent?
How many children with epilepsy died who could have been saved with cannabis oil while the feds have upheld such hypocritical policies on a plant?
The HHS is an arm of the National Institute of Health (NIH). They have some 6,000 doctoral scientists employed to work on researching and developing pharmaceuticals in hopes to bring them to market.
While the patent doesn’t grant the NIH any claim or right to the whole cannabis plant, it simply claims right to the use, “a process”, of cannabinoids in the ways we just described; in other words – medicinally. A corporation called “Kannalife” is the only entity ever granted a license to the patent, which it has held since 2012.
Its licensed permissions include the exclusive right to develop cannabis-based drugs for the treatment of brain damage caused by oxidative disease, and another non-exclusive right to develop cannabis drugs for treating chronic traumatic encephalopathy (CTE), a neurodegenerative disease likely triggered by repeated head trauma.
Here’s the good news, and the bad: That patent is set to expire in just about 16 weeks. After its expiration, anyone will be legally allowed to patent the medicinal use of cannabis.
And if they succeed, they could (theoretically) charge whatever price they wanted to license the right to medical cannabis treatments.
It’s good news because the soon-to-expire patent won’t block anyone with a new cannabis-based medicine or therapeutic formulation from patenting his or her invention, or proprietary intellectual property.
But it’s also bad news because ‘anyone’ includes massive corporations or government agencies that could use wide-reaching and broad patents to monopolize cannabis.
The question then is, when this patent expires will someone try to make a similar one? Will cannabis breeders be blocked from the rights to their own intellectual properties, such as medicinal and novel strains of cannabis or proprietary formulations?
It’s clear that there are those out there ready and waiting to exploit new cannabis laws with weak patent claims in an effort to monopolize the industry.
No one is really sure how federal courts will respond to conflicting patent claims for a number of reasons, but mainly because cannabis is still federally illegal and considered as a Schedule I substance by the DEA.
All this uncertainty is causing growing concern in the industry, breeders need to make moves immediately to ensure their intellectual property is protected.
Patent No. 9095554
Patent no. 9095554, issued in 2015, validates the notion that cannabis legalization, which is closer than you may think, is going to bring a fast-paced onslaught of patent and trademark battles. Growers should be concerned!
This patent granted to BioTech Institute LLC, a mysterious company tied to international billionaires, grants an outrageously far-reaching claim to the proprietary rights of any type of plant containing significant amounts of THC.
According to investigative reports detailing a memo written by cannabis geneticist, Reggie Gaudino, Biotech’s full list of desired cannabis patents would be worth hundreds of millions of dollars and might affect every single strain of cannabis currently in existence. Read that again.
“This broad patent would remove most land-based strains – the genetic forefathers of modern cannabis that first appeared in Central Asia as far back as 2900 B.C. – from the public domain if the patents were to be enforced by litigation,” says journalist and NORML activist, Angela Bacca.
According to Erich Veitenheimer, a patent lawyer and partner at Cooley LLP in Washington, DC, who represented the patent holders of patent no. 9095554,
“If the laws change and the big companies move in, I think we’ll have a period of turmoil around ownership, patenting, the whole business”.
Landrace Strains & Public Domain of Cannabis Intellectual Property
Let’s skip the legalese and long-winded explanations and get down to what all of this really means for the cannabis industry, breeders, and medical cannabis patients.
Right now, there is only one thing that can prevent any big corporation, like Monsanto or Marlboro who denies that they are keeping tabs on the industry, from moving in to monopolize cannabis.
What is that one thing? It’s public domain, but there’s a complex issue that breeders are going to have to come to terms with involving public domain, also known as “prior art” in the patent world.
In order to patent a strain, it must be “new and unobvious” over existing strains and must exhibit “markedly different characteristics”, according to US Patent and Trademark Office.
Theoretically, the requirement of such novelty indicates that any strain already in the public domain would be safe from cannabis patent trolls.
However, that safety net is a double-edged sword. Any strain protected as “prior art” would be protected from patenting, but that protection would also prevent the true breeder of the strain to stake their claim of inventing it.
We’re still years away from differentiating ancient cannabis genetics that evolved naturally on earth from the designer strains, which are a product of decades-long illegal cultivation and breeding.
And there’s a long list of outlaw growers ready to claim they were the ones that originally bred iconic strains like Bubba Kush or Purple Haze.
Although cannabis is documented as possibly being mankind’s first agricultural crop, potentially influencing the development of civilization, as we know it, and is recorded as being used in ancient China medicinally as far back as 4,000 years ago, there is not a formally recognized public domain record of existing cannabis genetics, or “prior art”.
Lack of prior art is the Achilles heel of every outlaw cannabis grower who’s spent decades crafting the world’s most popular strains like Blue Dream, Green Crack, and the OG and Skunk families that would like to claim a patent to their original strain.
The non-existence of prior art in the cannabis industry is emphatically attributable to nearly a century of cannabis prohibition by the U.S. federal government.
The federal government has raked in six-figure fees for licensing a patent for medical cannabis. This, while simultaneously criminalizing the plant. There should (at the least) be some type of retributive offering recognizing the efforts of those who crafted life-saving medicines for children in the face of criminal persecution.
Lack of prior art in cannabis genetics leaves the entire genome of cannabis up for grabs unless industry leaders can do something about it quickly.
“Because of 80 years of prohibition, there is a massive lack of prior art documentation for cannabis … Folk knowledge and information that is clear to the industry might not be seen or considered by the patent office”, says Beth Schecter, executive director of the Open Cannabis Project, a cannabis patent-protesting non-profit.
The Open Cannabis Project is an organization that believes cannabis patents are absurd and that the only way to protect the rights of cannabis breeders is to lay it all out on the table and create a formally recognized “prior art” library.
They are working with other groups like the creators of an open source cannabis genetics database called Phylo’s Galaxy to document the genetic profile of as many cannabis strains in existence as fast as they can.
But not all breeders are cool with giving their prized creations over to public domain never to be monetized again.
“We figured everyone would love this”, Chief Scientific Officer at Phylo’s and Open Cannabis Project board member Mowgli Holmes told Vice.
Mowgli says the database project has received significant pushback in places like northern California, the birthplace of many popular modern strains. He says,
“A lot of people are worried about what’s going to happen with patents. There’s a polarization in the grower community between people who are scared of Monsanto and who want to stop them from patenting things, and other people are terrified of Monsanto but want to patent their own strains before Monsanto does.”
Open Source or Patent Protection?
A lot is riding on one thing: What will federal courts accept as public domain and prior art in regards to cannabis strains and proprietary secrets?
For most, it seems clear that landrace strains, or naturally occurring wild cannabis strains, will most likely fall into the public domain, and they should.
But will they? Or, will federal courts uphold ridiculous patents giving the right to claim that a plant existing naturally for millennia is someone’s intellectual property?
What should a grower or breeder do? Lawyer up and stake a claim or offer up your intellectual property to the public domain. It might be the only way to save the future of small craft cannabis farmers.
It could also be what keeps cannabis farmers from being forced into having to pay for a license, or for the right to grow a particular strain to a company like Monsanto.
If a federal court upholds U.S. patent no. 9095554, then that could possibly include all existing strains of cannabis, even the one you bred in your own backyard.
Honestly, there is no easy way around all of this.
It’s possible to use some instances of common law or state trademark protections to claim rights to strains, formulations, and other cannabis industry intellectual property, but none of it will be applicable if a US patent shows up making the same claims.
A federally granted patent trumps state trademarks, but we have yet to see what the courts have to say about it, as I’m sure we will soon enough.
State trademark and common law efforts to protect intellectual property are simply temporary solutions to a larger looming issue that affects the future of the entire industry.
The legal cannabis industry is nothing short of a Wild West green rush. I think one of the best options for growers is to utilize the Plant Variety Protection Act.
It might be the saving grace for growers if federal courts decide to uphold cannabis grower’s rights as legalization continues to roll out.
If a strain can be shown to be unique or novel, and substantially altered from existing versions of those already in existence (prior art) it could be granted protection.
That protection would grant the breeder the proprietary rights to licensing seeds, cuttings, propagation, and cultivation of that strain.
First-to-Patent vs. First-to-Sequence
Open source databases like Phylo’s Galaxy, Open Cannabis Project and others can be used to catalogue and document the first instance of a strains genetic sequencing.
In doing so, the sequencing could serve as a sort of record for a breeder to have been the first “recognized” originator of that strain. Or, the data could serve to simply recognize a strains existence.
By sequencing a strains DNA, geneticists can determine any of its genetic lineage and history. Like getting your ancestry report to find out where your ancestors came from.
Cannabis experts agree to some extent on a few legendary landrace strains, however, we don’t know if federal courts will recognize any historical evidence, databases, or anything else for that matter.
Either way, the growers truly responsible for inventing some of our most beloved strains (the ones who’ve been doing it since before it was legal) are now caught between a rock and a hard place as far as legalization goes.
There’s no doubt we will see some interesting battles surrounding what will and will not be upheld as “prior art” in federal courts when legalization inevitably takes place in the U.S.