Speaker 1  0:00  
Good afternoon. Welcome to plant variety protection for sexually propagated to propagated and asexually reproduced varieties presented by Autumn. My name is Holly Lundgren. autumns online professional development manager. And I will be your staff host for today. All lines have been muted and today's session is being recorded. If you have a question, you may enter it at any time using the q&a feature. I would like to take just a brief moment to acknowledge and thank autumns 2020, online professional development sponsors. We really appreciate your ongoing support. And now I will introduce our speakers. Heidi Neville is an intellectual property attorney with over 25 years of experience obtaining patents and designing IP strategy in the areas of biotechnology, chemicals and pharmaceuticals. How do you participated in the seminal United States Supreme Court case? Pioneer vs. Je MX apply, which confirms the availability of utility patent protection for plants. Heidi enjoys being an advocate of biotechnology, speaking around the country on important issues in the field, and was recently appointed by the United States Secretary of Agriculture to serve on the USDA PvP advisory board to help shape the country's IP policy for plants. Mara Sanders joined the United States Department of Agriculture after completing her Master of Science degree from Rutgers University. At the USDA, she serves as a plant variety examiner. Mara is passionate about food security, specifically creating sustainable agriculture systems for smallholder farmers through improved seed systems by increasing access to quality germplasm resources. Mara believes that the combination of traditional farming knowledge and modern plant breeding concepts can create sustainable nutritional and inclusive food production systems. And now we will turn it over to our distinguished presenters. Welcome Heidi, welcome Mara.

Speaker 2  2:11  
Hello, and welcome to the plant variety protection office portion of the webinar. This is planned Friday protection for seed tuber and asexual reproduce varieties and I am Maura Sanders, a plant Friday examiner here with the USDA. Today I will be covering a little bit about us plant protection REITs. Preparing to apply the application process, how we examine your varieties, certificate issuance, and what happens post issuance. Those few updates from our office. We are currently opening and operating business as usual. And now GRP, where we keep our germ plasm is open and accepting seed variety germ plasm again, and we're closed shortly for a short time earlier this year for just a little update on asexually reproduced varieties, just a new addition for us from the 2018 Farm Bill. We have a germplasm delay in effect until the sixth of January 2023. And I'll talk about that a little later. We are adding new forms all the time. So if you don't see the species you need, feel free to contact us. Just a little note on our stance on essentially derived varieties. Currently, we do not make any determination on ATVs. Variety meets our requirements for protection it may be granted and determination of an EDD will depend on owner litigation. And we are currently working with you Bob on ETV guidance and more explanatory notes. So there are two main systems to protect plant varieties in the United States. The USDA plant variety protection office which offers a plant variety protection certificate for seed tuber, and asexually reproduced plants. And there's also the Patent and Trademark Office under the Department of Commerce. And they protect plants under plant patents and utility patents. We do work closely together. We're both under the UCAV 1991 convention but we don't operate together like on a day to day basis. So our examination methods are different. And some other key differences are our Applications are accepted for variety sold less than one year in the US and for years internationally. Where the Patent and Trademark Office it's one year for both domestic and international sales. We do at VDPAU allow essentially for drag varieties whereas the patent office does not. And we do not have an annual maintenance fee and the Patent and Trademark Office does for the utility patents but not with the plant patents. A little bit about our office over the last 10 years. These are our top 10 crops, with soybean and corn being almost half of our protections. Then comes wheat, potato, lettuce, cotton fields and garden beans and rye grass and fescue, and other is everything else. From ornamentals to fruit vegetables, tree varieties, we protect a little bit of everything. A couple of statistics we receive 427 applications per year, and issue an average of 325 certificates annually. Average time from application to issuance is 18 months, but this can be longer for more our high volume crops that I just showed you. Soybean corn 110 days is our fastest turnaround time. EPO has applications for 170 species currently, and we're adding more all the time. We are a member of the International Union for the protection of new varieties of plants, also known as you glove. We follow you pubs guidance for DDoS trials, meaning distinctness uniformity and stability, use their forms and cooperate between authorities. We do except some DDoS reports from other UCAV authorities for certain species, so contact us for more information if you'd like to do that. Applying with VDPAU allows applicants to claim priority and other EU Bob authorities, meaning that the first application date will be used with the second application if if it's claimed within one year of the original application date VDPAU grants protection for 20 years and 25 for trees and woody vines from the issuance date and any priority or provisional protection does not affect the length of that protection. So as you're getting ready to apply, you have to make sure that the new variety you want to protect follows the use of guidance for what is considered a new variety. So it has to be new, like I was saying before not sold commercially or sold for less than a year in the US less than for the years internationally, or less than six years for trees and woody vines. It should be distinct meaning distinguishable from any other publicly known variety uniform in that any variations are describable predictable and commercially acceptable and stable. So when it's reproduced, the characteristics that you use to protect it should remain unchanged. As you get ready for protection, you should double check that the variety falls under the variety guidance, you should have completed the DLs trials, which are where the applicant variety and the 123 most similar varieties are compared in a field setting or greenhouse. You can follow the up of test guidelines for more information for each specific crop. But this should be conducted by the applicant or breeder, the US does not conduct these trials for you. And you should choose a unique name for the variety within that crop type. And there are more regulations on that under the federal seat act. But contact us if we need more help with that. For the application process itself. Anyone who's a breeder of unique variety of a sexual sexually or to her property to plant can apply. So that can be an individual public institution or corporation. And this is kind of list of how to apply from your side the applicant side. So first, you'll need to be ie authenticated. And that's to access our ePdP online system. Then you'll then need to upload your data pay via either ePdP or pay.gov and then be available for the examiner to to answer any questions the examiner might have. Submit your germplasm, then you'll be if you're lucky, it's your certificate and then be available for a post issuance questions or needs that we have. The best way to apply is using ePdP which can be accessed anywhere in the world where there's internet. Things you can do with AB PvP are found new applications, amend your existing ones. pay your fees, check the status of the application correspond with the PvP staff, or search for other applications. To get access to ePdP. First thing you need to do is get em authenticated. And these links will be available on our website. But domestic users need level two access and international use. users only need level one access, you'll have to click on this link link and go through the process that includes creating an account. Confirm your email verifying your identity which could mean a trip to like a police station or other place to get your identity checked with your ID and then login to complete the authentication. So then you will log into the ePdP account system with that same username and password from the authentication and you will you can then create your application So we first log on to PvP, this is kind of what it's going to look like. It's going to ask for your personal information, your name contact information, and then have you associate yourself with an organization and this can either be an existing one in our database or a you can enter in a new one. And then once you create your application, the application in our office is called a SC 470. And it has different exhibits or sections involved. So the main one is the SC 470, General owner information. And then we have exhibit a variety origin and breeding history is a beast. A statement of distinctness C is the writing description information, D is where you can attach any additional information and then E is the basis of ownership. So the general SD 470 section will ask just for the name of the owner, representatives variety name in the data first sale, and the data for sales important to to just establish the newness of the variety. Just note when you are creating your application in the section that says crop kind, you will need to put in the crop kind that matches what you're trying to protect. And if it's not available, you should contact our office because the questions are very specific to each crop kind of

Speaker 2  11:23  
exhibit a variety origin and breeding history is a short description of any hybridization, mutation, genetic manipulation events, how the variety was developed, the stock plants or parent plants that were used any IP protections for those, but applicant variety or the stock or parent plants, any breeding stages, methods used and your selection criteria should also be included. I have a little example here for a seed variety. So this is a hybrid pepper. And if you can see, it includes just a very short description of parents, how it was bred how they were selected, any protections that the parents have patent or plant variety protection. And then the bottom is just like a little description of the variety, what makes it unique, is kind of a general description of it. And then this one is an asexual example. So it's opportunity variety. And you can see first it was made across and then it tells you where it took place. And then let's see things were selected and why and then how it has been reproduced since. Exhibit B the statement of distinctness will include the name of the most similar varieties up to three and the characteristics that distinguish the most similar varieties from the subject variety. So these can be quantitative or qualitative. For the quantitative ones, you should also put in statistical data to validate those differences. Exhibits C is the variety description information. So these are like main characteristics of your variety, and it is comparable to the UCAV table of characteristics for most of our most of our crop types. Each crop has its own specific Exhibit C form, so make sure that you're using the correct one for your crop. If it's not listed, contact us and make sure to fill out as much as you can because incomplete exhibit C's do prolong the examination process when we have to make a request for information to the applicant. Exhibit D is where you can attach anything additional data tables, charts, photographs, other information that you think we might need to make the distinction between your variety and other ones we have. Exhibit E is the statement of the basis of ownership. So this is where you confirm the owner's name and the country and its owner is not the original owner or breeder then the transfer process should be explained. So you should trace the ownership back to the original owner or breeder. Receipt of application will be sent in a filing date will be established for your variety. This will be sent via email so make sure that the representative or the owner listed on the application is kept up to date with our office because this provides important information on the filing date which establishes priority and provisional protection and as well as germplasm information as to where to make the deposit. So germplasm requirements for seed is 3000 seeds. Additionally, for first generation hybrids, it will be 3000 of each of the parents needed to reproduce it. And this was will be sent to the National Laboratory for Genetic Resources prevention and l GRP. As I mentioned earlier, and not to our office so NL GRP is in Fort Collins, Colorado, and our offices in Washington DC so make sure that you're sending them to Colorado sexual ones we have currently a deposit delay from January 6 2020 to January 6 2023, while we address feasibility of making and maintaining deposits. Currently, the owner or applicant can maintain them germplasm themselves or Senator repository of their choosing. But either way PPPoE needs within three months of a request. So prevent failure to provide a specimen, when requested may result in abandonment. And all the germplasm becomes public publicly available when SW expires. So we've kind of moved around our payments a little bit in the past couple years. Now instead of having a application payment and a certificate issuance payment, now it's all at the beginning so it is $5,150. All at once, when you apply. Payments can be made using the ePdP system or using pay.gov and you can use bank account Amazon account, PayPal, debit or credit card calls on the phone or you can mail us a check. So our examination process once we receive your application, it's assigned to one of our examiner's and we will check its newness distinctness uniformity and stability. First, we check for distinctness. And to do this process, the examiners will verify that everything is complete characteristic data is provided. Confirm that the most similar variety is adequately described, we then develop an appropriate distinctive search using our database that we have and will search out other search tools as needed. And at the end, we make a examination report. So we have a database that contains all protected varieties and known varieties that are adequately described. Each search that we make is unique for that crop kind and includes qualitative and quantitative ranges. Each developed search are loaded into the application record and kept and when the search is run the parameters exclude the competing varieties and end result should be if the subject variety is either unique or not. I have a little example here of a search. So we are our subject variety is the red flower in the top right hand corner. So as you can see, we have 10 varieties in our database or hypothetical database. So that would be the first filter we put on it. The second one would be the plant type is it compact or spreading so that kicks out all the plants that are spreading. Um, then the next one is number of flower petals. Since this is quantitative, we usually put in a range, so it's from three to six petals. So that knocks out any of the flowers that have more than six petals. And then we search for leaf color, dark green, so anything that's not dark green, gets kicked out. And then the last one would be flower color red. So that's our subject variety. So our most similar variety would be the golden flower that's in the leaf color column. So our report would be something like it's distinct. And it's different from the most similar variety by flower color. If we only have 10 crops in our database or need to look other places, these are some of the search tools we would use, we would go to UCAV other authorities Aska crop signs, look in journals, and or go to grim the germplasm Resources Information Information Network. In the end, we if it passes all of our requirements, we'll make a an examination report. And this is kind of a summary of the application just for to document our process. First thing would be the eligibility information, nomination clearance, reading history statement of distinctness descriptive information basis of ownership. And then the examination search results will be at the end. After the examination report is completed, the examiner will send it to our quality assurance person who reviews it and the supporting documents, make sure that everything's okay. Then it's sent to the commissioner for the review. They mainly check the eligibility and make sure all components are there. And then it is sent up to the Secretary of Agriculture who signs them. batches are sent up to the Secretary just so that we don't overwhelm them with too many each day. So there might be a slight delay when it goes up to him just be patient. Then the sign certificates are mailed out to applicants and final reports are posted on online including all of that information So after your certificate is issued, you may have questions about the enforcement of your rights. The owners of a protective variety may bring civil action against persons infringing on their rights. Honors may also take to ask a court to issue an injunction to prevent others from further violations. Resources are available on our website. And they include the links to the seed innovation and protection lines or the farmers yield initiative. However, VDPAU will not go after or enforce anything ourselves is up to the owner. But we will provide application and evidence support. So the benefits of a PDP certificate you get provisional protection upon application, exclusive legal rights to market and exclude others from selling your protected variety priority when filing and another EU pub 40. No annual maintenance fees. And after expiration of protection, the variety will become publicly available for continued innovation. And if anyone is interested, claim credit protection office does have an advisory board as 14 members selected by the Secretary of Agriculture. And they present farmers seed industry, trade and professional associations, public and private research institutions. And they meet twice a year to advise us on issues we might be having. On a broader sense, they helped a lot with the asexual

Speaker 2  21:26  
addition to our act and regulations and help us go over any problems you may have. If you're interested in joining, please join our GovDelivery notice on our website to get updates or you can email us directly. And there's anything thank you for joining and feel free to contact us with any questions you might have.

Unknown Speaker  21:51  
I'd like to welcome everyone to the awesome presentation today. And for those of you who were there for the live version, I apologize. We had some technical difficulties. So this is the rerecord of the version that was presented earlier this morning. To begin with, I'd like to point out that I am recently begin serving on the autumn board of directors. And the opinions expressed today are only mine and do not reflect any of those of the autumn organization or its board of directors. So to begin, and I want to thank Maura for her presentation. And this will be a little bit different take on things. Part of what I would like to get into today is a little bit of case law and some guidance on what essentially derived means. We'll talk about the EU pub guidelines and their explanatory notes. This is relevant as you POB has recently opened up their their guidelines for comments. And so this is an area that is going to be having some new comments presented. After that I thought we would go into the EPO and recent case law that has come out of the EPO that has important implications for protecting plant varieties that are the result of traditional breeding as a utility patent. And finally, we'll go into a few options for protecting a sexually produced plants additional options such as utility patents, then the plant patent statute that we have here in the United States. So with that, we'll go ahead and dive in. So first of all, you pop the EU POB has presented the plan was the International Union for protection of new varieties of plants. It was based in Geneva and was established in 1961. There have been three revisions of you pop the first in 1972, the second in 1978. And finally in 1991. The EU pub guidelines were established to protect an international system to protect plants and plant varieties that are developed. Each member state or country has to enact their own you pop guidelines for plant breeders rights or here in the United States. It was for plant variety protection. So each country has a few differences in the way that they have enacted this legislation. And so every country has a little bit different laws relating to this as far as enforcement and for registration. The 1991 version is the most recent version that opened up a lot of additional protections and we'll talk a little bit about that. And the United States has a mate had had a major difference prior to the farm bill and that the United States in 1991 did not allow for or protection of asexually produced plants. That has changed with the Farm Bill. And presumably this was because we had the plant patent statute here in the United States. So in the United States, our version of the EU POV guidelines and the EU pa protections is it seven USC 2321 and 2582. So the plant breeders rights and you POV allowed for the discoverer of a plant to take to have protection for propagating material for that variety for a period of 15 years. It's a little bit different for woody plants and some other plant types. It does not cover harvested material. Thus it did not cover originally asexually produced plants 1991, the POB was guidelines were revised. And this is where they gave the farmers exemption which allows a farmer to save seed equal to that amount that they purchased and originally planted. They also provided a breeders exemption which is very important and allows the owner of the purchaser of a PvP protected variety to breed with that variety and to create new varieties and even perhaps subsequently to PvP that new variety so that breeders exemption is really important and what came about in in the case that the JM case that we were originally involved in, it also expanded the protection of plant varieties certificates and plant breeders rights to include essentially derived varieties and this is where this language came from. It also extend extended protection to hybrids and expanded protection for most crops up to 20 years. So it was the 1991 version where essentially derived varieties came into being. So let's see, if you look at the first thing to discuss when looking at enforcing a PBR or in fact trying to register a PBR is which version of the EU pop guidelines was enacted in your particular country. And so this is a list of various countries that are that are plant important countries, and in my opinion and which ones they have. So, the the concept of whether an essentially derived variety may be protected under a PBR or a PvP depends on which version of the convention the legislation is following. So for example, several winter nursery countries like Argentina, Chile, Colombia, and Mexico are currently under the 1978 version and thus do not extend protection to essentially derived plants and do not protect asexually derived plants and plant varieties. So it's important to know which one which we're operating under the US is operating under the 1991 version. So I've always used to do these presentations and say there's no definition of essentially derived anywhere, and nobody really knows what it means. That is clearly not the case. Now, and there has been some case law that has happened that has eventually come into account that gives us some guidance on on what this means. I'm currently involved in litigation here in the United States to enforce a PvP against a putative essentially derived variety. So, maybe there will be some case law here in the United States, hopefully not and we can get this matter resolved for my client. The guidelines on essentially derived from you POB say that an essentially derived variety is per Manam predominantly derived from another variety or that is predominantly derived from the initial variety, while retaining is expression of the essential characteristics that result in the genotype or combination of genotypes of the variety. So when we look at predominantly derived and retains essential characteristics, the second part is clearly distinguishable from the initial variety. And finally, except for the differences that result from the act of derivation conforms to the initial variety and expression of these essential characteristics. So this is a little bit like stereo instructions, but if we piece it out and go through it, I think you'll get some real guidance and it will become a little bit more clear. So the scope of production of the PvP provides equally to any variety that is essentially derived from a protected variety unless the protected variety is Self and essentially derived variety. So, when we look at that got a little cartoon here that might be a bit helpful. So, if we look at this cartoon we have first the initial derive a variety than the actions of a plant breeder. Now, we have essentially derived variety one actions of a plant breeder again from the essentially derived variety to essentially derived variety to. So, now we have these essentially derived varieties essentially derived variety one and two, may be infringing the initial variety, so that can be those can be an infringing acts on the initial variety ADV to however, as it was developed from another essentially derived variety is not infringing on EDB one, so the breeder now, so that it doesn't continue on in succession. To the end of time, there is a limit on how much how far and essentially derived variety can go. The breeder, however, may be able to PvP and Edie v one or E DV two. So with that alphabet soup, maybe that's a little bit clearer.

Unknown Speaker  31:16  
So what does what do the terms predominant derivation and essential characteristics actually mean? Generally, predominant derivation is talking about genetic origin. And as I think about this, I tend to think about that in terms of copyright law, you need to prove access, or that somebody started with the original original initial variety that was subject of the PvP or the PBR application. So essentially, it's access that you started with that variety, and then essential characteristics, which is the degree of genetic, I would say, or morphologic similarity, both the genetic origin and the genetic similarity are going to require looking at the genotype and the phenotype of the putative, essentially derived variety. We don't know what level of phenotypic or genotypic similarity is, is necessary that 95% genetic identity 78% We don't, there are no hard and fast rules with that, it's going to be largely up to the courts to interpret that. And of course, in in a case or of enforcement, we're going to be looking for expert testimony that's going to look going to give us some help with guidelines for what that may be things like genetic markers, and AFLP data. So what are the essential characteristics of a particular variety or crop things that the producer the seller, the buyer would find important and valuable about that crop. And of course, this is very crop specific, if I'm looking at a rose, maybe an essential feature is the color of the rose or the color of the petals if I'm looking at something like rice, an essential feature is going to be yield. So they very they're very crop specific as to what is an essential characteristic and so, we need you need to take that into account when when looking at enforcing these. The one thing one source of information for determining what is an essential characteristics of course, is the Exhibit C form. The forms that the PBR and the PvP provide for us to fill out in order to gain protection for them. For example, on if you are going to file a PvP on wheat, there are 27 different morphological traits that you report in obtaining your pbpc certificate. Obviously, those are traits which are considered important for wheat length of the ear density of the ear presence or absence of ons. So these are obviously very important traits and would be likely evidence that a court would consider as what is an essential characteristic.

Unknown Speaker  34:23  
So what is the degree of conformity of the essential characteristics? So what what level of difference is allowed? It's not defined in you pop up of states that it is essentially derived if it retains virtually the whole genotype of the other variety. So the whole genotype. So looking to us case law, as I indicated earlier, there is no reported case in the US on udv predominant derivation or essential characteristics. So and looking at enforcing against putative essentially derived variety. We're looking at some international case law that might be helpful, but it's not necessarily dispositive. The first case that we'll look at from Europe is a case law out of the Netherlands it's Van Zandt and plants, and this dealt with a freesia variety. In looking at the court, they found that the defendants variety was essentially derived and therefore infringed. The plaintiffs P PB are out applicant PBR plant breeders rights certificate. The evidence presented at the trial showed no genetic difference between the two. The evidence was a DNA test or DNA marker profile, or microsatellite markers and an AFLP profile. AFLP profile is digestion of the genes with restriction enzymes. And then you sort of measure the size of the pieces of the digestion. Both of those tests showed no genetic difference than the phenotypic differences. They went into that analysis and 38 out of 39, important morphological characteristics were found to be identical. The other thing the defendant offered up no explanation for why there was such high genetic similarity. So I I would put, I would posture that this was a pretty slam dunk case. There doesn't seem to be much in question here on this case. The next case is sort of considered the seminal case in essentially derived varieties and that is Danziger versus Asti. This involved baby's breath if the plant that's this what I've always used, heard it called, and when you got used to get roses, they used to always include baby's breath with. So in this case, each party presented its own AFLP evidence of differing similarities. And the court was not real impressed with the AFLP data. You know, 91 might have found 96% identity, the other one found 92% identity, the court sort of said, I don't know what is enough. And there's always the question of whether the markers or any AFLP restriction enzymes are evenly distributed throughout the genome. So, they tended to get away from that genetic evidence and instead went on to find the morphological differences and looked at the morphological differences in the plants. And here there was found to be no essentially derived variety. They the court held that one or a few inheritable characteristics are greater than one or a few are required for essential derivation. So it needs to be more than just one or two essential characteristics to establish the central derivation. Then we look at the case that was litigated in Germany, this case the parties settled, but it's a little bit I think it helps because this case they used the court appointed an expert to use microsatellite markers and to an analyze each of the two varieties. And the court appointed expert came back with a finding that there was 90% identity between the two varieties. And the court found that that was enough to consider an adv. So here we're looking at a court that works primarily with the genetic information, a court appointed expert to provide that genetic information. The defendant appealed, saying you can't you cannot just consider the genetic information, you need to consider phenotypes and morphological traits and that that and requested that the decision be vacated on that premise. We don't know how that's going to turn out because the parties ultimately settled the case. But it does show that some courts are going to use exclusively genetic well as other courts might find that phenotypes more persuasive and it's really not settled. Then we found to have a case out of Italy that where it was found to be an essentially derived variety and this involved rice. So again, here we see that the court appointed an expert to determine a genetic analysis, and the expert came back and said that 21 out of 25 genetic markers were inherited directly from the initial variety So a crop like rice that has been completely sequenced i This information is certainly more telling than something a less a less sequenced crop where we don't have the markers evenly distributed throughout the genome. The court then went on and considered the relevant essential characteristics for rice, what are the essential characteristics that make a rice plant valuable Grain Type, vegetative cycle, productive capacity yield, of course, and herbicide resistance, they found that all of these essential characteristics were present in the initial variety and in the essentially derived variety. And Italy found that this was sufficient to call the the the putative essentially derived variety infringing. So as we looked at the case law that is evolved from Europe, the takeaways are that phenotype data alone can be the basis for a decision, we saw that in the earlier case, there can only be a few phenotypic differences between the varieties or one to be an ADV of the other. And what is considered important phenotypic characteristics overlap. And a good source of finding what is an essential phenotypic characteristic is perhaps the forms that are used when you fill out and filed for a plant breeders right or a plant variety protection certificate. Then we went we have some case law that has also evolved out of Israel. This is the same two parties that were sued each other in the Netherlands over the baby's breath varieties, Danziger and Asti. So here Israel had a very different, different statutory regime for infringement of a PBR. And the burden of proof lies with the defendant to establish that their variety is distinct from the initial variety, if the plane of first establishes evidence of genetic conformity. So first, we're going to look at genetic conformity as a plaintiff, I'm going to put that in my initial papers, then the burden shifts for the defendant to say, there's a there is not essentially there is not genetic conformity, or there is not it's not an EDP. The court a rejected the argument that only morphological traits should be characterized. And the plaintiff presented AFLP evidence. That was the court accepted to establish that there was genetic conformity, now the burden shifted to the defendants. Here, they said that the threshold is not limited to one trait, or a small number of morphological traits. And now in this case, they the same variety was found not to be an essentially derived variety, because the burden was shifted to the defendant, and the defendant was able to establish that there are enough differences in morphological traits to show that it was not essentially derived. Oh, I apologize. I apologize, there were enough, the data was enough to establish that it was essentially derived. It was the opposite of the earlier holding. So the here who who has the burden of truth can prove can be decisive. Once the burden shifted to the defendant, the defendant was really unable to come up with anything to show that it was not essentially derived.

Unknown Speaker  43:57  
So if we move on to Australia, Australia, again, has the statute that says essential characteristics, traits that contribute to principle features. And EDB does not exhibit any important as distinct from cosmetic features that differentiated so now in Australia they're looking at are the differences purely cosmetic, or are they important? This involved two species of grass varieties, presumably for astroturf, for turf, for greens and things like that involves Sir Walter versus B. 12. B 12, was found not to be an essentially derived variety. There were two characteristics that were found to be different, the color and the length between the stock and the leaves or the internode length. So the shortened internode was an important distinction from B 12 to Sir Walter and that shortened internode length increased says were tolerance and was a feature desirable for commercial use. So, here b 12 was found to differ in an important feature and that be the internode length. Therefore, not an adv. Then we had another case for out of Australia, where kings pride was accused of being an ADV of Sir Walter. Here there was DNA evidence that was used by the court that showed that King's pride was closer in genetic identity to the parent of Sir Walter then it was to Sir Walter. So the court found that Sir Walter was not an essentially derived variety from Kings pride. Kings pride was also shown to have stronger plant vigor, longer internode length and longer stolen length than Sir Walter and therefore these were important traits that were considered and thus not to be an essentially derived variety. Stolen length was in was considered important, or be allowing for density so that the crop the grass would be grown closer together and stronger. So, the takeaway difference in Australia is that one trait, if it's an important trait, may be enough to carry the day on a morphological basis. So there are some systems that have been developed to help for enforcement of Ed B's against ATVs. And the international seed Federation system has put these together for certain crops. It involves guidelines for arbitration, and mediation of essentially derived variety disputes. It provides methodologies and action thresholds to determine the outcome of controversy. This is based upon industry agreement. And thus far there have only been however six crops that they have gone through this whole system for to put these guidelines together. And that is maize, cotton, lettuce, oilseed rape potato and perennial ryegrass. So for crops other than those, this this option is not available. Here under these international secede Federation guidelines, a putative EDP needs to prove where he was derived from. So we need that initial derivation thing, component there, again, that access. And then there are specific genetic markers that are identified for each of these crops and in a test that will, will happen based upon these genetic markers. And if there's a certain threshold depending on the crop, it is automatically found to be essentially derived. So the EU POB has over the years offered up so much guidance to try and help us figure out what essentially derived means. There were explanatory notes in 2009. Again in 2017, and recently at the meeting in October 2019, the EU prob administrative and legal committee agreed to open the EDB explanatory notes from 2017 for comment. So a lot of organizations are publishing their proposed comments to that for comments from the industry. Asda for example is about in the process. I'm on the committee, the the patent intellectual property committee for Asda, and we have been reviewing their proposed state statement to submit to you pub that will be published fairly soon for comments. So I would encourage everyone to, to watch for that to see if what Asda is going to offer up to try to help this and there are other seed organizations that are also getting involved in providing comments, as well. So that will be something to watch in the next few years. Next, I'd like to shift to an important case that came out of Europe and now we're going to shift over to protecting SEC utility patent protection for plant varieties that are the result of traditional breeding, and what what is available under the utility patent statutes. The EPO, patent statute has a provision article 53 that prohibits the patenting of quote an essentially biological process. Now, what is considered an essentially biological process according in 2010, the enlarged board of appeal. And this has been going on for a good 10 years of litigation. The broccoli one and the tomato one case, confirmed that article 53 does exclude plants and animals obtained through traditional breeding from utility patent protection. So in their mind the recombining of the genetic material of the two parents is an essentially biological process, I would submit that to making a cross that might not have otherwise occurred is not an essentially biological process. And it should fall outside of that. But that is not what the Court held, the Court held that this sort of recombining of the genetics is not anything that you have control over. And therefore it is an essentially biological process. There's no utility patents for plant varieties through obtained through traditional breeding. In 2015, the board reconsidered this decision and held gave a glimmer of light that we were all were very excited about back in the day that said, it may be possible. It's not a whole black and white thing, there may be a situation where plants or plant material through derived through traditional breeding could be patentable subject matter, and that the issue was more one of enablement, the question of was your seed deposit enough to protect him to enable that variety. So there may have been some very limited scope available through through the seed deposit, and that was enabled and for utility patents. Then 2017, the European Union union set out a bio patent directive to specifically reinforce article 53 saying, and it was rule of implementation 28 Two that says that European patent shall not be granted in respect to plants or animals exclusively obtained by an essentially biological process. So effectively trying to legislatively shut that door and reverse the board decision under broccoli one and broccoli two. In 2018, the technical board of beared board of appeal declared that the EPA owes practice under Rule 28. Two was invalid for plant and animal patents, and was found to have no impact on the 2015 decision. So now 2018, after the directive, we're sad. Now we're back to 2018, where they're saying that this this directive is invalid and doesn't have any effect on the 2015. So potentially, plants and animals may be patentable. Following the 28, two guideline, the board reversed the decision of Syngenta patenting of chili pepper plants, holding that it had been it was invalid under Rule 28. Two

Unknown Speaker  53:06  
then the decision got referred to the enlarged board of appeal. So this is the takeaway from this if you don't want to follow all of the everything that has been going on the back and forth between the EU and the EPO, and then Board of Appeals is that the large board of appeal on May 19 of 2020 rejected the earlier broccoli and tomato rulings finding that that plant varieties are considered essentially derived and thus not available for utility patent protection. So this is the complete opposite result of our highest court, the US United States Supreme Court and the case that I was involved in with je m versus pioneer. And that case, the Supreme Court of the United States held that patent plant varieties that are the result of traditional plant breeding are in fact patent eligible subject matter. So instead of the directive that the EPO has rules, I think it was 53 article 53. We have 35 USC Section 101 which defines any new composition of matter and so on that defines what is patent eligible and under that and further. There was the ARBs. Our case was teed up also, not only under 101, which was fairly well decided by Chakrabarti, but we also had the plant patent statute, and we have the PvP and so there was a statutory construction element to the J. E. M decision in what did Congress intend did Congress intend for those to be the exclusive form of protection for plant varieties from traditional breeding, or by passing these additional regulations that we did not intend for that to expand to the role have utility patents and protecting these, the court found that multiple regimes to protect a single plant variety are fine, which is a tenant of intellectual property law. For many years copyrights, you can have copyrights and trademarks and patents to the very same sort of Article of manufacture. So that is that is fully ingrained in our United States intellectual property. So this case, the pioneer, JM case was decided in 2001. And since then, there are utility patents available here in the US for plant varieties. And I would submit also, this applies equally as well to a sexually produced varieties, which we'll talk about here in a little bit. So getting back to the EPO case, there was at least one little glimmer of light in that the Board held that European patents granted before July 1 2017, or pending as of that time, that that ruling did not affect them. So there is a possibility for utility patent protection for cases that we're pending before that time. So those of us who know that have been trying to prosecute any kind of plant application in Europe, they have been since 2017 been staying any case that had a claim to a plant, even a transgenic plant. So I don't think there is much argument that a transgenic plant is not an essentially biological process. But everything has been staged. So now with this decision in 2021, all of those applications will now be examined and examined under the two Pip 2015, broccoli one and broccoli and tomato one ruling and are potentially patentable.

Unknown Speaker  57:04  
So I wanted to get into in sort of following up with the PvPs that have recently been allowed for a sexually produced plants, the other types of intellectual property regimes that are available for a sexually produced plants here in the United States. So we have in the United States now as of 2018, farmers bill, plant variety protection, which is the equivalent of plant breeders rights in international countries. We have utility patents for a sexually produced plants that are an option. We have plant patents under the plant patent statute, which are an option. And of course, we have contracts and material transfer agreements, and of course, trademarks, trademarks in the area of plant varieties is a very specific area of law, because the actual name of a variety is cannot be the subject of a trademark, and contracts. Enforcement of a contract requires privity of contract between the parties. So both people have must have signed the contract in order to enforce the contract and other against another party. So each each type of regime has its benefits and has its limitation. So it's important when you're trying to look at protecting these varieties, different layers of protection to make sure that we have the best coverage possible. So interestingly, with the passage of the Farm Bill, there are more options to protect an asexually produced plant than a sexually produced plant. And a sexually reproduce plant can be protected by a PvP of the variety of PBR internationally of the variety, a plant patent under the 1930 plants patent statute and a utility patent. A sexually reproduce plant has PBR available that's international pBPs, if you will, a PvP of the variety and here a utility patent to the variety. So looking at it plant patents a bit this, the plant patent statute was enacted in 1930. And the concept behind it was that plant breeders should be able to have some sort of protection for the efforts of their labor. And they there was an initial thinking that a utility patent was not available to plants because of the varying nature of the seeds and the segregation of the seeds from the parental varieties. But you can so what they did for the plant patent statute is they relaxed the enablement requirement and said that it doesn't have to necessarily have to be enabled by the filing and allowed for a sexually produced plant. So if you think about it, if you're worried about the variability, a sexually asexually reproduced plant and cuttings or things like that are not going to vary from the original parental line. So we know what that plant looks like and what an infringing plant looks like. So, when you file your application enablement is simply by providing photographs of the plant, the protection lasts for 20 years, same protections as available for utility. There are no maintenance fees, there was severe the biggest limitation of the plant Patent Act is that there is one claim available for it a strawberry variety whatever or insert crop as shown and described here in so you have a series of morphological traits and then you have some pictures. Importantly, when you look at enforcing a plant patent, there is not an opportunity to have additional claims say to plant parts or to plant seeds or to methods of using the variety in breeding to develop further varieties. So that is a significant limitation. So the USPTO and following, as as issued hundreds of utility patents for plant lines and plant varieties. The end it the number is about 1600 as of 2001 when we when we litigated the JTM case. I know this because I was fairly young attorney at the time and one of my roles on writing and preparing the brief was to figure out how many plant patents the utility plant and utility patents the patent office had issued. Since 1985, there was a board of appeals decision ex parte Hibbard in 1985. That said that plants can be the subject of utility patents. So that that was the practice of the patent office from 1985 forward until our case found its way to the Supreme Court. And the issue of statutory construction came up and was considered. Other areas of course, for protection, utility, patent protection for a sexually produced plants are plants, genes, proteins, molecular markers, all of these and there is no distinction here between sexually or asexually produced plants. Some of the reasons that I think utility patent protection is incredibly important for an asexually produced plants is the variety of claims that you can prosecute, as opposed to the one single claim that you can get under a plant, dairy plant patent and the earlier statute. So for example, you can get claims to the plants and to the seeds, and the plant and the plant parts. So if you are if you're making for example, a strawberry and you sell that strawberry at the store for fruits, those seeds are in that strawberry under a plant patent, that those seeds are going to be variable and are not going to reproduce the variety as shown and disclosed in the plant patent. However, in a utility patent, my coverage now extends to the seed as a plant, part of that original variety. Very important coverage. Also, you can do audios tissue cultures, which was how you would enable a you a a sexually produced plants, and the plants that are the result at least two generations out from breeding. Also, rarely importantly, you can have methods of plant breeding with the plant variety and methods of using the plant variety. Now, these method claims are also incredibly important because that allows you to take advantage of 35 USC Section 271 G. This provision allows you to prohibit importing into the United States a product that was made outside of the United States by a method that if made in the United States would infringe a method patent. So my method claims are not enforceable in Europe. However, under 271 G, if I'm going to import the results of the practice of those method claims in Europe or wherever Mexico, I can stop the product of the result of that method from being imported into the United States. Very, very valuable protection. Also, I wanted to talk a little bit about some new developments through the 2018 Farm Bill Of course, which allows cannabis to be not only the subject of patent variety protection but also with our hemp. We can use deposits for enablement for hemp. So now Under the 2018 Farm Bill, there's you can have utility patents for cannabis and we can deposit here in the United States because that hemp has been sort of decriminalized, if you will. When I a few years ago I filed for utility patent protection for a hemp client of mine. And our deposit this was for sexually reproduce sexually produced hemp. We had to go to Belgium because no depository in the United States was was accepting or allowing seeds from hemp as as a deposit. Cannabis is produced both ways. A sexually and sexually so you can get plant patents obviously for cannabis and PvPs for sexually produced cannibal cannabis were started being accepted by the USDA in April 2019. Currently, there's a deposit waiver as there was uncertainty as to which depositories are going are going to be able to accept seeds for the sexually produced or tissue cultures for the asexually produced that and that deposit waiver is in effect until 2023. As it stands right now. Other utility patent protections that are available for a sexually produced plants of course, and sexually produced plants include a wide variety of plant traits, a trait that was enveloped, developed by the inventors say through use of a chemical mutagen methods of breeding or gene editing, transformation, all of those kinds of traits that an underlying genetics, producing a new product that maybe never existed before a high oleic oil content, something like that. Markers and selection protocols also all patentable characterization of how the marker profile also patentable.

Unknown Speaker  1:07:01  
So some examples of patent claims that are available, a trait such as a carrot having increased lycopene content. So here they've got a, like a peat, high lycopene that was gotten through traditional plant breeding, presumably quantitative trait. And so now we've got a claim to that trait. This is obviously very, very broad coverage because it covers the trait irrespective of any variety. We can also patent something like breaking the linkage. So for example, if there is a beneficial traits such as high sweetness, a high Brix content of a produce from the plant, and maybe that has been linked in the past with another trait of low vegetative growth, something that is undesirable. Through breeding, we are able to break that linkage so that you can get the best of both traits that had never existed together before because they were so closely linked, one good and one bad. If I can get both good traits together through traditional breeding, I can get a claim to that with both traits present.

Unknown Speaker  1:08:22  
recombined introgression claim that's also available. And that would include a whole entire chromosomal segment that we might want to have in a deposited variety and use of that segment in breeding and selection to be present in subsequent varieties. newly identified quantitative trait loci to be used in so marker assisted selection breeding, those are also patent eligible subject matter in the United States. Finally, something that is really become very popular as far as utility patents go is the look is since the marketplace has been slow to accept end user traits through genetic manipulation to avoid the whole GMO thing. Maybe you can find that same trait in a naturally occurring plant, that naturally occurring plant might not be agronomically very desirable. It might you know, have bad plant vigor be the RB only be adapted to a very, very small growth area region. So the idea of taking that trait from that plant and crossing it with an agriculturally or agronomically elite line. So now we've got a new trait that was never in any agriculturally elite germ plasm that is something that is patentable and that allows us to have that trait in an in a high producing elite variety and allows you to patent that trait as present in elite variety and it's not limited to your specific one variety that you've developed, it's to that in any commercially viable or commercially producible variety. So that is all I had today. And I want to thank you for your participation. And again, my apologies to those who attended the live version with the poor audio. Hopefully this was a little bit better. So thank you so much.

Transcribed by https://otter.ai