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Protecting Your Cannabis Genetics in Canada and Internationally

Genetics, Grow Your Business, International Commerce, Naming, PBR, Plant Breeding, Plant Propagation, Trademarks, UPOV

Since I live and work in the US, my blog is obviously US-centric. However, I have helped plant breeders in many different countries obtain IP protection for their cultivars all over the world. In the US, protection for plant cultivars can be in the form of plant patents, utility patents, and/or USDA PVP registrations. In the rest of the world, the IP protection is more uniform, and is generally referred to as Plant Breeders’ Rights (PBR) or, less commonly, Plant Variety Rights (PVR).

Plant Breeders’ Rights through UPOV in Nearly 100 Countries

In almost all countries where such rights are available, they arise under a mostly-standardized system known as UPOV (Union internationale pour la protection des obtentions végétales, or International Union for Protection of New Varieties of Plants). There are currently 75 members of UPOV, most of which are individual countries but some of which are groups of countries — like the European Union (28 member states) and the African Intellectual Property Organization (17 member states). Most of the EU countries are also separately members of UPOV, so the total number of countries that participate in UPOV — individually and/or through a regional authority — is currently 94. You can check the current membership of UPOV here.

This post is primarily for Cannabis breeders and mainly for Canadian breeders who are interested in protecting their

genetics that may include some cultivars that are seed-propagated and some that are clonally propagated. However, what is covered here should be informative for anyone interested in PBR, so don’t click away just yet.

Seeds and Clones – The Difference Matters

While the approaches for seed-propagated and asexually-propagated cultivars are very different in the US, they are not nearly as different in other UPOV countries, including in Canada. However, there are still some important differences in the requirements, cost, and planning required for making successful applications, especially foreign applications (anywhere you’re not! — you’ll see what I mean if you keep reading). So please be aware that you cannot treat your seed-cultivars the same as your clones when applying for PBR.

What are the differences and why do they matter so much? The main difference is that almost all UPOV countries require a so-called D-U-S test which requires viable plant material in the country where you are applying for the rights. DUS testing examines the cultivar’s Distinctness from other known varieties*, Uniformity of plants within the cultivar, and Stability of the cultivar’s traits from one generation to the next. (*If you’re curious about why I used the term “varieties” in one place and “cultivar” everywhere else in this paragraph, you may be geeky enough to enjoy this post.)

You Can’t Just Put a Few Dozen Clones in an Envelope

Since live plants must be examined, this is where the difference between seed-propagated and clonally-propagated plants becomes so important for applications outside your “home” country. Compared with living cuttings of a cloned parent line, seeds are obviously much easier to sterilize and ship while still viable, certify as being phytosanitary, and maintain dormant prior to testing. Such cloned cuttings are often referred to as “witness plants.” Usually, numerous live witness plants must be phytosanitary-certified (if they are to be exported), shipped, received, and test-grown in each country where a PBR application is filed. Clearly, this requires more planning and expense than preparing and sending seeds.

A few PBR systems require direct submission of the witness plants to the PBR office itself. Most, instead, require the applicant to certify that the plants

have duly arrived in the country by a given deadline, with proper phytosanitary certification;
have cleared any required quarantines;
are under the care of a designated nursery at a specified location; and
are available for inspection by the PBR authority upon request (or some variation on that general set of requirements).

There are even a few countries that will waive any requirement of local witness plants in lieu of certified DUS tests from another UPOV member country whose testing standards it recognizes as being trustworthy.

I will provide another, more-detailed post with some rookie mistakes, horror stories, lessons learned, etc., on adventures with clonally-propagated witness plants around the world. Having “ridden herd” on thousands of witness plants making their way to dozens of countries over a couple of decades, I think I’ll be able to come up with some DO and DON’T material. In the meantime, though, on to the rest of the PBR process:

For seed-propagated cultivars, in many countries the seed deposit you will be required to make is simply held in reserve by the PBR office, and you are still required to provide a place where plants grown from another batch of your seeds will be examined. So, in this way, the seed-grown plants are essentially the same as the witness plants discussed above — they are just a lot easier to get to the right place and get started growing, especially if they are crossing international borders and long distances and, perhaps, waiting until the next growing season to be tested.

The Forms – Not Too Bad, But Watch the International Details

For the most part, a PBR application is a series of forms. There are some general questions about the applicant, the applicant’s representative, the botanical name of the variety, the denomination (variety name), the breeder, prior commercial activity involving the variety, the origin and breeding history and ancestry of the variety, a statement about the uniformity and stability, and a statement about the distinctness from other known varieties. Depending on the species, there also can be much more detailed descriptive forms that ask about certain morphological or functional characteristics that are important or useful in distinguishing among members of a given species.

There can be some major hiccups at the form stage — serious problems with providing the right documents to establish that the applicant has the proper authority to apply for the rights. This can happen especially if there is an earlier application in another country that is providing a priority date for the later application. Without going into too much detail, there are many international documentation hoops that one must jump through, in some countries, to get this part of the process out of the way; some things are similar from country-to-country, and some things are unique in each country. It can be a serious headache if you haven’t handled it before, so I definitely recommend experienced, professional help for this part of the process.

Provisional Acceptance, Public Comment, and Examination

Once the forms are filled out, reviewed, accepted as being complete, and the deposit of seeds or plant material is received and verified, the application is “provisionally accepted,” published, and moves on to examination. In Canada, the details of the application are published in the quarterly Plant Varieties Journal. An application cannot be eligible for grant until at least six months after it was published, thus giving the public six months to object to anything in the published application.

DUS testing usually begins after the application formalities are complete and the application is published. For DUS testing, an examiner may choose to make one or multiple visits to the designated site where the seeds have been planted or the witness plants are being grown. In any case, the examiner will examine the plants in detail to compare them with reference varieties (to verify distinctness) and will examine individuals within a population of plants of the cultivar, to verify their uniformity. The examiner will also assess the stability of the cultivar, either by making multiple visits to check different crops or cycles or by assessing stability within a population in a single cycle, if such a determination seems feasible under the circumstances.

One PBR Granted, Now Take On the World

If the cultivar is found to have the requisite distinctness, uniformity, and stability, and the application has been published at least six months, it can move on to being granted. There are some other formalities required before the Canadian PBR can be granted. One interesting requirement is a statement confirming that no Canadian trademark or similar indication has been, or will be, applied for or received for the denomination (cultivar name). If this seems odd, you should read this post.

There are many more things to consider when developing an international strategy for protecting a valuable seed bank or collection of genetics or clones, of whatever kind of plant with which you work. This is a brief (and simplified) overview of one country, using Canada as an example. As soon as your business expands to two countries, things become more complex; it becomes essential to track the first date of commercialization in each country where there is any commercialization, and to be aware of every country in which you’re operating or may want to operate. And you need to track and plan commercial activity not only in terms of propagating and growing, but also in terms of potentially selling harvested material and making products from harvested material. Very quickly there are numerous moving parts; watch for more blog posts to follow addressing some of them. In the meantime, you can click here to contact the author.

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.

My thanks to Eric Lundgren, JD, for helpful input on this post.

November 26, 2018/2 Comments/by Dale Hunt

Strain? Variety? Cultivar? Which is Which?

Copyrights, Genetics, Grow Your Business, Hemp, International Commerce, Interview, Marketing, Naming, Plant Breeding, Plant Patents, Plant Propagation

Although I have degrees in botany and plant genetics and have worked with plant breeders for 20+ years, I recently learned that I have been sloppy in my use of plant-breeding terminology. Part of that comes from the fact that the truly geeky among us (the professors who make the rules) sometimes change the rules without telling the rest of us. Part of it just comes from learning by hearing, rather than digging-in and looking up the actual rules. Which, being a lawyer, is something I would never do in other parts of my job. So this post is my effort to clean up my act as far as terminology goes, and to provide an update to anyone else who has questions about these things.

If you already know this, please skip to any other blog post on this site. This is going to be way too basic for you. But since I’m quite fascinated by how much sense this terminology makes, and also by the fact that I didn’t fully appreciate it until now, I’m going to “geek out” on it here. So read on, or click back to more interesting topics, as you will.

Cultivar is Most Correct, but Why?

Let’s start with the “right” word: cultivar. It is a portmanteau or, as my kids would call it, a mashup, of the words “cultivated variety.” A cultivar is a group of cultivated plants that all share the same character or characters that are consistently inherited within the group. This means that the cultivar is defined by the phenotype, and not specifically by the genotype. In other words,

a cultivar is a sort of functional grouping of plants based upon the fact that they fit a certain criterion—the trait or traits the breeder was looking for in selecting the cultivar in the first place.

To obtain and stably maintain important traits in some plants, it is necessary to identify a single plant with those traits and then make exact genetic copies, via cloning. In such cases, the cultivar can only be one that is genotypically uniform. All members of the cultivar are genetically identical. This is the case with cultivars or “varieties” of grapevines and fruit trees, for example. They are asexually propagated and, to put them into the context of other posts on this site, are protected by plant patents. To read more about plant patents, click here.

However, in other plants, the traits that matter in defining the cultivated variety—the cultivar—can be heritable via sexual reproduction. In those cases, essentially all of the seeds produced by a certain event, whether that event is a self-pollination, an open pollination, an F1 hybridization of specific parents, etc., produce plants that display the cultivar-defining traits.

Of course, this makes sense because it is utterly impractical to propagate some plants asexually, and yet these seed-propagated plants are bred, selected, and cultivated to obtain certain desirable traits. Familiar examples of seed-propagated plants are the grains like wheat and rice. IP protection for most seed-propagated plants is available in the U.S. through the USDA Plant Variety Protection (PVP) system. While USDA PVP protection is not currently available for Cannabis cultivars, this post explains what can be done to protect seed-propagated cultivars, cost-effectively, with U.S. patents.

Some plants, like Cannabis and turfgrasses, are propagated both via seeds and by cloning. For example, some Cannabis cultivars have traits that are uniform enough to be seed-propagated and other Cannabis cultivars require clonal propagation to maintain their key traits. This fact demonstrates why it was important to come up with a an inclusive term, like cultivar, that would cover both situations—cultivated varieties phenotypically “uniform enough” for commercial purposes, whether those varieties happened to be genotypically uniform or not. However the cultivation and selection is done, and whatever traits collectively are important enough to define the cultivated variety, that set of traits, uniformly inherited, defines the cultivar.

Varieties Can Be Naturally-Occurring

Now on to the term “variety,” which is conceptually part of the more preferred term “cultivar.” Variety is just a less-specific term, because there can be naturally-occurring varieties as well as cultivated varieties. Nonetheless, it is often used interchangeably with cultivar, probably because in the context of commercial plants and plant breeding, it is implicit that a variety under discussion would be a cultivated one. Even official legislative documents like the Plant Variety Protection Act use the term. So it’s not an incorrect term, just more inclusive than would be ideal, inasmuch as it brings in certain varieties that were of natural origin and, therefore, should not be the subject of intellectual-property protection. The plant varieties produced by nature are and always should remain part of the public domain.

Strain Has No Accepted Meaning

What about the term “strain,” and where does it fit? The term strain appears to be used most often and most correctly in connection with microbes and viruses, and more informally in reference to plants and rodents. In plants it has no official meaning but generally applies to the group of offspring that are descended from a modified plant. I think the main reason people tend to use the term in some situations is because they may receive a sample—some seeds or an individual plant—from someone else. They maintain it through some generations and may keep using the same name as the strain they were given. Or they may give it a new name to reflect any changes that they selected for or that they may just have observed while in their care. Since there is either no need or no formal process for naming or registering this particular genetic line, the strain name they give it is enough. So they refer to it as a strain, just to avoid appearing to elevate the name to some higher level of official evaluation or importance. It seems to be essentially a default status. Kind of a common-law variety or cultivar, so to speak.

This usage appears much more common in Cannabis than in other plants I have worked with. My guess is that this is because Cannabis breeders have not been as involved in the out-in-the-open cultivar development and naming and intellectual-property protection process as breeders of other plants. So maybe it will take a while for the Cannabis community to move from “strain” to “cultivar,” or maybe it will remain a part of the idiom of the industry.

Regardless of whether there is ever a uniform adoption of the term “cultivar” in the Cannabis industry, it’s at least interesting (well, maybe only to me) to understand the extent to which the terms “cultivar,” “variety,” and “strain” overlap, how their usage may have originated, and why the usage might persist. And, now that you have read all the way to end of this post, welcome to the terminology-geek club.

Special thanks to TeePublic.com for use of the image at the top of this post.

November 18, 2018/6 Comments/by Dale Hunt

IP Strategies for Your Plant-Breeding Program

Genetics, Grow Your Business, Plant Breeding, Plant Patents, Utility Patents

As a plant breeder, you know that not every cultivar you select will have equal commercial potential. And yet it would be nice to have a plan for appropriate intellectual-property protection of all, or at least most, of your cultivars with any commercially potential. So let’s start by classifying the cultivars you may develop into three general groups.

Perhaps a certain selection will be just successful and special enough to be cloned, further propagated, named and “become” a cultivar, so to speak. You may sell some clones for a season or two, but that cultivar may never be quite great enough for anyone to really bother to try to steal from you, illicitly propagate, and turn into their own business that is based on some form of (at least) unethical misappropriation of your work. However, it just might get some traction in the market — you can’t be sure; it could have some potential. (Maybe your cultivars are always better and more successful than this, but I’m creating this as one end of the theoretical spectrum, just for purposes of completeness.)
In the middle of the spectrum is a cultivar that you know is pretty special. You think it’s quite possible that it would have demand for several years, at least, and that some nurseries would want to propagate and sell it. They might even like it enough to sell it at a premium price.
At the high end of the spectrum is a truly great cultivar that you believe will stay in demand for a long time — maybe for decades. People would go to some lengths, if they could, to get their hands on it, propagate it, even “reverse counterfeit” it by mislabeling it as something else. If possible, they might try to make their own business out of it, illegally transport it to other markets, maybe use it to breed other cultivars. This is what anyone would recognize as truly valuable genetics.

There are certainly plant cultivars on the

market that fall into all three classes, and there is a rational, cost-effective approach to IP protection for any of the three.

For the low-end cultivars, you can either just acknowledge that some good ones will slip away as diamonds in the rough, but that you can’t patent them all. So you try to sell to people you trust, and you have either a standing, relationship-based agreement or a written agreement that if they propagate more than a certain number of any one of your unpatented but still “exclusive” cultivars, they agree to pay you a certain per-plant propagation royalty. To keep things simple, you might do the enforcement/accounting on some sort of honor system, but you let them know that only your preferred relationship nurseries get your exclusive cultivars and, if you were to learn that they broke your honor code, they would lose their status as a preferred nursery.

This approach is based upon the fact that you have developed, or are developing, a reputation as someone who generates good genetics — you’re someone to whose cultivars people want access. So part of the value in this transaction is the current cultivar you’re transferring, but part of it is the relationship and your ability to deliver, or withhold, access to future cultivars.

Depending upon your relationship with other breeders in the area or in the state/region, you may be able to establish a breeders’ association that abides by certain standards and that endorses certain nurseries as being ethical and honorable. Then those nurseries would have special access to the best unpatented genetics from the breeders’ association, and/or special royalty rates for patented genetics. If there is enough collegiality among breeders, this could be done. It has certainly been done in many ag industries and in several states. You can consult with people who work with other crops, or people experienced in advising with them, to get ideas about how to structure such an association. You can also click here.

Still on the topic of the low-end cultivars, if you are about to release a cultivar for commercial sale and you’re uncertain whether it might have some potential — it’s “on the bubble” — you could file a simple provisional patent application. The filing fee is minimal — $140 for a small entity — and preparing the application would not need to cost a lot, because it is possible to file a plant patent application with a relatively limited disclosure and then file the rest later (for more information, click here.

In the case of a provisional that is intended to keep your options open at minimal cost, you wouldn’t even have to add the rest of the disclosure until after deciding whether to file the full plant patent application a year after filing the provisional. This means that, for a very modest cost, you could preserve your right (delaying your decision) to seek a patent on a cultivar for a year, to see how it does commercially, and then decide whether to live with the honor system and/or some agreements, or to “level up” to real plant patent protection.

For the second type of cultivar, the one that you know will have some persistent market value, you would definitely want plant patent protection. You can still start in a way that is cheap, quick and simple — with a provisional — while knowing that you will eventually file the full plant patent. Or you can file the plant patent application directly, right from the start.

Filing the provisional first is simple and delays some of the costs for a year, and the provisional year does not count against the 20-year patent term. So the plant patent would expire a year later than otherwise. On the other hand, your enforceable, issued patent will also grant a year later; so, if you’re worried about anyone actually infringing, your ability to take them to court and make them stop would be delayed. However, the situations in which it becomes necessary to actually enforce a plant patent seem to be quite rare. For the most part, people tend to leave patented cultivars alone, or infringers become licensees when they are threatened with litigation.

For any cultivar you select and believe you may want to patent, it is important to keep good records and give it a “selection name” that is generic and not the same as your trade name. For more on the importance of properly naming cultivars that you may want to patent, click here.

When you have a patented cultivar, you can commercialize it in a few ways.

You can hire nurseries to propagate for you, for a fee, and you remain the owner of all the clones, then you sell all the clones under your own trademark as the breeder and also under the tradename of that cultivar. In doing that, you can eventually develop strong recognition and respect for the overall quality of your line of genetics, as well as brand recognition for your cultivar. Both of those can be very valuable after the patent expires, because people will still want the “original” right from the source — that is what brand recognition does, and the time to build brand recognition is while you have patent exclusivity and are the only one who can sell the product/cultivar. For more on developing IP or other legal rights that outlast patent rights, click here.

Alternatively, you can sell starter clones to nurseries with licenses to propagate and sell plants for a propagation and/or sales royalty. Some nurseries prefer to sell only wholesale, while others sell retail or both wholesale and retail. Royalty rates may differ and take into account the different sales models. There are numerous approaches to plant patent/propagation royalty agreements; someone with experience in this area can help you implement the model you decide is best for you. They can also talk you through the pros and cons of the different models.

In any case, you will want the plants that end up in the retail sales setting to be marked with a patent notice that 1) lists the patent number and the cultivar name, 2) indicates that propagation is prohibited by the patent, and 3) indicates that new plants can only be obtained from an authorized source. That might seem extremely overbearing, but it is routine in the ornamental plant industry and actually adds prestige to the cultivars that are patented. For more on commercialization strategies for patented plants, click here.

Let’s move on to that very special third kind of cultivar – the one you know is going to be in demand even after the patent has expired. This might be unusual in the Cannabis industry, but it certainly has occurred in other crops. When this happens, some companies, of course, start by getting a plant patent — but they do not stop there.

In some cases, they want to also be able to prevent sexual breeding with the cultivar, control the sale of progeny and/or products made from the cultivar, etc. To do this, they file for utility-patent protection on the cultivar/cultivar. Utility patents are more costly and complicated than plant patents, but they also have more flexibility and breadth in what they can cover. It’s beyond the scope of this blog to go into utility patents in depth; but I will say that if you have a cultivar/cultivar that is extremely valuable, it may be worth protecting it via a plant patent AND a utility patent. For more on protecting plant cultivars, or families of plant cultivars, with utility patents, click here.

But what about protecting the cultivar even after any patent(s) have expired? The lucky breeders/owners who have a cultivar worth protecting for that long do not want the expiration of the patent to be the end of the story, and they do not want to have the value of the cultivar leaked away in countries without strong IP protection. For this kind of plant, where possible and feasible, it can be worth the extra effort to commercialize it in a very different way. So here is something you might consider if you end up with a cultivar of that third type:

You could exercise permanent, complete ownership of the genetics, worldwide. You may propagate (or have propagated for you) vast numbers of plants, but you never sell or give away a single meristem. Nothing. You maintain the purity of the statement, “I have never sold or given away any propagating material of this cultivar to anyone. Every plant of this cultivar, anywhere in the world, is my (or my company’s) literal physical property. These are our proprietary genetics, and no other party has ever had any form of ownership over them.”

So how do you commercialize all over the world while retaining ownership over every single plant? One approach is to LEASE the plants to the growers. They sell the harvested material only and, from the proceeds, they pay you a lease on the plants — but you own every plant. And part of the lease agreement is a ban on any sort of propagation. If a plant dies, you replace it; they do not. Propagation is done by a service nursery for a fee. You retain control and ownership of the genetics at all times.

Meanwhile, as discussed above, you are building the strongest brand recognition possible. Trademarks do not expire like patents do, so associating a strong brand with this cultivar — and with your company — will still be a beneficial aspect of an IP strategy with or without patent protection and after the patent protection has expired.

While this sounds like a challenging and possibly expensive undertaking, it has some obvious advantages. This approach to commercialization can work in a country with NO IP system, as long as it has some kind of legal system. If anyone ever is found to have plants of your cultivar, the plants are clearly stolen property. In many countries there is criminal recourse, which is more swift, persuasive, and less expensive than IP enforcement. And there is no expiration. There are complications related to this approach, to be sure. It is not necessarily a good idea for just anything; but the cultivars that are exceedingly special and are likely to have a lasting place in the market.

September 21, 2018/0 Comments/by Dale Hunt

Protecting Your Cannabis Genetics in Canada and Internationally

Strain? Variety? Cultivar? Which is Which?

IP Strategies for Your Plant-Breeding Program

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