ANOTHER GREAT QUESTION FROM PEOPLE IN THE BIZ
Whiskey Tango Foxtrot?
I have been asked many times, in one form or another, the question in the title of this post. More often than not, it uses different pronouns and is phrased a little more emphatically — like “Can they really do this?” or “How is it possible that someone could patent a chemotype?!” or “What the $&#*!?!?” (in this latter phrasing, the question is implicit in the context of the patent(s) the questioner is referring to at that moment).
Like most good questions people ask of lawyers, there’s a technically correct answer and a more informative explanation of the practicalities. So let’s unpack this as efficiently as possible, with the usual caveat that this is simplified around the edges to make it more suitable as a blog post than a week or two of a law school course.
Everyone Loves Etymology, Right?
First we can define some terms: genotype, phenotype, chemotype. The common denominator in these terms is type — as in something that is typical or representative. The variables in these terms are:
- geno — referring to the genes associated with or causing the plant’s ‘type’;
- pheno — referring to the observable characteristics of the plant (the various phenomena, more or less); and
- chemo — referring to the chemistry of the plant.
Chemotype is a subset of phenotype; it is focused on the chemical aspects of the phenotype, whereas the entire phenotype would be any and all outwardly observable characteristics. The characteristics of the phenotype are dictated by the way the genotype interacts with the environment over time, as well as by variations in which parts of the genotype are expressed at different stages in the life cycle, growing season, etc.
A plant’s genotype will remain the same throughout its life, and all of the clones of a given cultivar will have the same genotype; however, the phenotype can vary a lot with the age of the plant, as well as with how the plant is cultivated. For anyone who has ever grown clones, this is not news: even though clones all have the same genotype, they are still very dependent on other factors for how fast and well they grow and for what their terpene and cannabinoid profiles look like in any given test. There are some broad ranges within which the plants will always be limited by their genetics; however, within those ranges, a huge amount of what will be observed — the phenotype or the chemotype — will depend upon the cultivation of the plant.
Back to the Question Everyone is Asking
This takes us back to the question: Can someone patent a particular chemotype without being limited to one specific and exact genotype that could produce the chemotype? Is it possible:
- to generalize the expression of a given chemotype as an invention and, if so,
- what would it take to get such a patent and have it stand up as being truly valid?
The answer to the first question is a qualified “yes” — yes because IF you could fully meet all of the requirements of patentability, then that particular chemotype really would be your original and unique invention — your contribution to the “progress of science and useful arts”* and the system (as it’s presently set up) would reward you with a patent. The answer to the second question is, “Good luck, buddy — you’re going to need that and a lot more for your chemotype patent to be valid and enforceable.”
*This phrase is an exact quote from the US Constitution forming the basis for the patent system. It’s why Congress will never be able fully to abolish the patent system — it’s written into the Constitution itself. But Congress and the USPTO can create laws and rules, respectively, defining what it takes to get a patent. And those laws and rules are stacked against any kind of chemotype patent being validly granted. It’s not impossible; but, if all the rules are followed and all the right questions are asked along the way, it would be very damn hard to patent a chemotype.
Here’s why…
You Can’t Patent Mother Nature
Your first hurdle in patenting a chemotype:
Valid patents cannot cover (or claim) a product of nature. If a patent claim is written so broadly that it covers something found in or produced by nature, that claim is simply not patentable subject matter; if it somehow gets through the USPTO anyway, it is invalid. This is a long-established Supreme Court interpretation of §101 of the Patent Statute. The statute describes a patentable invention as “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.” Products of nature do not fit within that description. Fundamentally, they aren’t new and should never be the subject of someone’s legal monopoly. Another way of looking at it is that no human can ever be named as the correct and legitimate inventor of something that nature itself originated.
Now before readers interpret this as meaning that plants of the genus Cannabis, per se, having originated in nature, are all unpatentable — not so fast, friends. The product-of-nature doctrine is applied strictly and narrowly. The unpatentable product of nature must be the SAME as what is found in nature, or whatever changes were made to it must be below the threshold of human action such that they do not amount to invention. An example of this from a Supreme Court decision is the doctrine that merely isolating something found in nature is not, without more, an invention. If a gene is found in nature, that exact gene isn’t patentable just by being isolated and sequenced. But many kinds of modifications to it would still be patentable.
You’re Saying This Chemotype Never Existed Anywhere, Ever?
To patent a chemotype, the first requirement would be that such a chemotype NEVER EXISTED before as a product of nature. Never. Anywhere. Period. If you ever get sued for infringing a chemotype patent, one thing you can do to defend yourself is to show ANY example of a naturally occurring plant with the same chemotype. If your evidence is accurate and credible, that would end the matter.**
** Time for more fine print: All of this discussion about outcomes assumes that the judges and juries involved will understand and follow the law. This is part of why litigation is such a headache — you can’t be sure the court is going to get it right, even if you KNOW you are right; you might have to win on appeal.
Is It Genuinely New – Not Just a Minor Variation?
Your second hurdle in patenting a chemotype:
Valid patents are only available for that which is genuinely new and non-obvious. Under §102 of the Patent Statute a person is entitled to a patent unless the claimed invention was already published, sold, or otherwise available to the public before the filing date of the person’s patent application. In other words, the invention has to be NEW or it’s not patentable. So, even if it’s not a product of nature, if someone else got there first and made it known or available to the public, it’s too late for you to patent it. And under §103, even if something is technically new, it’s still not patentable if the “new” thing is a trivial variation on something else that’s already known. This is because it would be considered obvious, and obvious variations on what is already known are not inventive enough to qualify for a patent.
To patent a chemotype, you would have to demonstrate that your invention wasn’t already known to the public and that it’s sufficiently different from what’s already known to qualify as being non-obvious. The way this works in real life is that you would describe your chemotype in your patent claim(s). Then the USPTO examiner would send a rejection listing all the reasons you aren’t entitled to a patent. In most cases, the examiner will at least try to argue that your invention isn’t new or is obvious and will cite whatever prior patents or scientific papers he/she could find in a search that are most like your invention. After the examiner cites this closest “prior art” available, you would need to explain why your invention is different enough to qualify for a patent.
But what about a chemotype that was available to and known by the public in a previously illegal industry? There probably won’t be any academic publications or prior patents describing that chemotype — but that doesn’t mean it wasn’t known; just not published. Essentially, the examiner is flying blind and can’t give the claim the rejection it deserves. This happens a lot in Cannabis patents precisely because of the lack of a full body of prior academic and patent literature thoroughly documenting what was known as of any particular date.
Your Defense and Your Evidence
If you ever get sued for infringing a chemotype patent, one of your defenses can be to show that the same or obviously similar chemotype already existed in one or more cultivars or strains known to the public before the filing date of the patent asserted against you. Just because it wasn’t published, it could still be known to the public in a shadow industry. You might have a hard time proving what was known but, if you can, you’ll be out of trouble.
How do you prove that? Find a cultivar that tests today within or very close to the boundaries of the claimed chemotype and show that the cultivar pre-dated the invention. You might need to collect some witnesses with personal knowledge of this. But, if your evidence is persuasive, you’ll be able to invalidate the patent for lack of novelty or for obviousness, and it won’t be a threat to you or anyone ever again. Once a patent claim is invalidated in court and all appeals are exhausted, that claim is gone — permanently invalid. Game over.
The Mother of All Cultivation Manuals
Your third hurdle in patenting a chemotype:
To have a valid utility patent, the description must be commensurate in scope with what is claimed and must also be “enabling.” Patent owners are given a temporary monopoly on their invention in exchange for disclosing enough about their technology to put the claimed invention fully into the hands of the public after the patent expires. This is an important exchange between the patent owner and the public. Basically, we give the inventor a monopoly for a while in trade for that invention belonging entirely and permanently to the public after expiration, and for the teachings in the patent becoming part of the public knowledge no later than when the patent is granted.
To qualify for a patent, the description of the invention must be enough that someone with the basic relevant skill set could read the patent and be able to follow it to make and use the invention in its full scope without a lot of trial and error (termed “undue experimentation” in patent jargon). This is referred to as an “enabling disclosure” having an adequate “written description” because it enables the practice of the invention to a degree that is commensurate with the full scope of what is claimed.
Of course, it’s impossible to teach someone how to make an exact, unique genotype that defines a single cultivar just by a written account of how the cultivar was made. Every product of a sexual cross is as unique and different as you and your siblings are unique and different. For example, unless you have an identical twin, you have a unique genotype that could never be recreated based on a description of your parents and how they made you.
Why Many Patents Claim Narrowly and Make Deposits
For patents that claim a specific cultivar, the enablement requirement and the written description (full scope) requirement are both met by making a deposit of tissue of the cultivar — something with the same genotype. In such a case, since the full scope is just that one genotype, it’s adequately matched by the deposit itself; and, as long as the deposit is viable, someone who later obtains the deposit after the patent has expired will be enabled to make and use the invention.
But there’s the rub: if you’re claiming to have invented a new chemotype that is not limited to one single genotype, you have to provide an enabling disclosure for that whole chemotype. You must teach someone how to get there without giving them your genetics as the starting point. You have to be able to describe how to do this on paper. Fully. You would need to teach them which cross(es) would work to get the right genetic background that could ultimately produce the chemotype. But that would not be enough. Since we all know that genotype by itself is not sufficient to dictate chemotype, you would also need to provide all the cultivation details that would be required for someone to produce that chemotype reliably and reproducibly without undue experimentation.
Good Luck with That
If you want to get a patent on a chemotype without being limited to a specific genotype, your patent application needs to include any and all cultivation techniques, details, and tricks necessary to get the chemotype consistently. Ask an experienced cultivator if that would be easy or hard or nearly impossible — WITHOUT any specific genetics to start with — just the results of a cross, if that. And, if a certain cross would be required to get started, the patent claims would need to be limited to include that cross. If the claims don’t require even that much genetic background, the written description would have to be even more detailed and thorough, giving examples of different crosses that would work (again, all of this without requiring the reader to engage in undue experimentation).
Can you imagine what kind of defense you could raise if you were ever sued for infringing a chemotype patent? You could definitely point to any inadequacies or incompleteness in the disclosure’s having complied with the written description or enablement requirements. You could simply provide evidence that, within the limits of a reasonable amount of work, a person with the basic skill set could not consistently replicate what is claimed. If your evidence is persuasive, that’s another way to invalidate the claims asserted against you; another way to kill the claims so they can’t be used against you or anyone else ever.
Still Want to Try? Here’s Your To-Do List
Do you still want to patent a chemotype so broadly that it doesn’t require someone to be using your particular genetics? OK. Just be sure:
- it’s not a product of nature;
- this is the first time this chemotype has ever existed, anywhere, ever; and
- to describe how someone without access to your genetics could read your instructions and consistently produce the chemotype.
If you can do all that, then you really did invent something worthy of a utility patent according to the current law. You have done your part to promote the progress of science and useful art. Congratulations.
On the other hand, if you simply put one over on the Patent Office because
- the current state of Cannabis-related publications didn’t give the examiner the tools to reject your application; and/or
- perhaps the examiner, being somewhat new to Cannabis, didn’t fully appreciate how variable Cannabis chemotypes can be;
then your “success” in getting a patent granted does not mean that your patent is valid; it means you spent a helluva lot of time and money getting a patent with some serious problems — a patent that will be (should be, if the system works) impossible to enforce.
And of course it’s possible that some have applied for overbroad patents in good faith, not fully knowing what they were up against. People and even companies can learn from experience as they pursue their goals; what may have seemed like a good idea at one time may not seem to have been worth the trouble and expense in retrospect. That happens plenty of times and in plenty of settings. The right approach could be just to leave those lessons learned and not make a bad thing worse by initiating litigation with a patent that may well be invalid.
Suing with an Invalid Patent – Everybody Loses, Especially the Patent Owner
If an owner of an overbroad patent were to sue someone for infringing it, expect the Cannabis community to band together to prove this and to invalidate the patent. There are enough people concerned about this issue as a matter of public policy that they are very unlikely to stand idly by while such a patent owner rolls up a series of small victories to the point of appearing to be invincible.
The opposition to overbroad, invalid chemotype patenting is wide and deep and energetic. Ideally there will never be a patent infringement suit requiring a demonstration of just how wide and deep and energetic the opposition is. But hopefully this explanation exposes how hard it would be to get a valid chemotype patent and how an invalid chemotype patent could be attacked and killed in court.
A Few More Things to Know
- This entire discussion is about utility patents. This is in contrast to plant patents, which leave no potential for general patenting of a chemotype, since they are always limited to plants of one single genotype.
- To read more about how a valid patent can never remove something from the public domain that is already in it, click here.
- To read more about plant patents and how they are like copyrights, click here.
By Dale Hunt – The opinions expressed here are the author’s own and do not necessarily reflect those of his professional colleagues or his clients. Nothing in this post should be construed as legal advice. Meaningful legal advice can only be provided by taking into consideration specific facts in view of the relevant law.
–image credit: Leafly
Now, tissue deposits/seeds can be tricky for THC cannabis, but there’s ways around that too: “While this deposit option raises a controlled substance issue similar to that of PVPA protection, at least one applicant has figured out a way to circumvent this issue by making their seed deposit at an approved repository located outside of the United States.[14] The applicant deposited seed samples with the National Collections of Industrial, Food and Marine Bacteria (“NCIMB”) facility in the United Kingdom. The seed deposit was accepted by the International Depositary Authority, and then later converted to a deposit under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purpose of Patent Procedures. This method provides a significant advantage to the applicant because it requires that all parties to the Treaty, regardless of depository authority location, recognize the seed deposit as part of the patent procedure.” https://www.jdsupra.com/legalnews/protecting-cannabis-are-plant-patents-34919/
Great comment, Kip. It adds some valuable info I had left out of my already long post. That’s definitely the current way to make a deposit and of course you’re right–making a deposit with Cannabis is tricky because a group of seeds will have some variability and clonal tissue is subject to some serious questions about long-term viability. And under the Budapest Convention, not only do other patent offices have to recognize the deposit, but (at least the US rules required this) anyone who requests it can access the deposited material after the patent has expired. But what if the deposited material isn’t by then viable (tissue) or isn’t the same as what is claimed (seeds). Could be YET ANOTHER validity problem for the patent owner. We need a better approach for making tissue deposits so that they can be kept viable at the depositor’s risk of the validity of his/her patent rights. We discussed this in a recent meeting of the Plant Special Interest Group at the national meeting of the Association of University Technology Managers in Austin. Anyway–things in the industry are definitely still a work in progress. The legalization and reliable Budapest Convention deposits among them. Thanks for reading and commenting!
True in concept but you need valid documentation to prove your strain existed in a business setting prior to the issuance of a patent that might claim your work. This is known as a prior use exemption. Many people don t have this proper documentation as the black market didn t like documentation and many websites censored cannabis content. This has led to the Biotech Institute LLC patents ( 9,642,317 , 9,370,164 , 9,095,554 ) that many attest describe plants they grew long before the 2013 application of the patent.