Speaker 1  0:00  
Good afternoon and welcome to today's webinar, IP commercialization strategies European perspectives presented by Autumn. My name is Samantha Spiegel, autumns Professional Development Manager, and I'll be your staff host for today. All lines have been muted to ensure high quality audio and today's session is being recorded. If you have questions for our panelists, we encourage you to use the q&a feature on your zoom toolbar. We will take questions throughout the presentation today, so don't forget to submit them as they come to you. You can submit a question anonymously if you would prefer or as yourself. If you have a technical question or a comment, please feel free to use the chat. Should you need closed captioning during today's session, the Zoom closed caption feature is turned on and available on your toolbar. Before we begin, I would like to take a quick moment to acknowledge and thank autumns online professional development sponsors. We appreciate your ongoing support. I now have the pleasure of introducing you to today's distinguished speakers. Their full bios will be available on the autumn Learning Center, but you get but to get to the presentations. I will briefly welcome and introduce everyone. Today's moderator is Neela Bhikkhuni who serves Baptist Health South Florida as a VP for innovation. Our panelists today include Dr. Enrico gonna do with City University of London City Law School Magalie come tardy a PhD candidate at University of El Conte and a practicing Italian attorney and cone their booth, the Head of Technology Transfer Office at the Netherlands Cancer Institute. Welcome all and I will turn it over to Neela to have us begin.

Speaker 2  1:38  
Hi, welcome to this session on IP commercialization strategies in EU perspective. I'm coming to you from Miami, Florida. And I'm excited to hear what the panel has to say. So we'll start with Enrico.

Unknown Speaker  1:57  
Thanks, thanks so much for for the invitation magalia Die, we are very happy and honored to be part of these of these events. And I am going to share my screen now. I think you're able to see it right. Let's start suddenly with the with the you know, the competition law aspect of licensing technology licensing in the European Union. Right. patent licenses know how licenses software licenses. I mean, these are very important instruments when it comes to commercializing IP. Right. So, the licensing is a strategy to extract profits plus to maximize IP to commercialize IP. But we need to be careful when we do licensing in Europe because we may end up violating a competition rules, especially this provision of the treaty for the function of the European Union, which is article 101 on restrictive agreements, agreements which restrict trade between undertakings within companies in their European internal market. Okay. As I said before, there are you know, most demand jurisdictions there are these kinds of rules in America in the US that is the Sherman Act, which prohibits restrictive agreements. So now, we are going to see how and these licensing scenario is regulated under EU law. We have a regulation in the EU, on which is called the economy, technology transfer block exemption regulation, okay. And it covers licenses and assignments of all so called the technology rights. What do we mean by technology rights, patents, know how utility models, design rights, semiconductor plant varieties and software? Software which by the way, as we know, may also be protected by copyright. Right? Is that so called technological copyright, let's say? Well, the general approach, embraced by this piece of legislation is that these licensing agreements usually improves economic efficiency and are pro competitive because they can they're able to reduce to cut, duplication of research costs and time. And they may facilitate the diffusion the dissemination of products and in general, produce market product market competition, not by creating additional revenues, or streams of revenues to recoup the investments made by by the calm My knees, which also has a macroeconomic effect now in terms of economic growth and consumers wealth. However, there is also the other side of the coin, right the European Commission which is the competition watchdog in the Europe, so, the the institution which checks whether companies violate competition rules by you know, doing cartels engaging in monopolistic behaviors and so on, so forth. So, the European Commission is very much aware that licensing transfer saw by B may also be used to block competition. Right, for example, to fix prices to limit output to segment markets in the European Union, this would be totally prohibited under EU law. Remember that the EU is made of 27 member states and in IP owner cannot use licensing strategies to segment the European market in different international markets. However, there are certain clauses in licensing agreements part and an Ohio software licenses, which are exempted from the restriction from the bank. They are allowed it's an exception misc agreements concluded between competing companies where the combined market share does not exceed 20% of the relevant market. Okay, well, these agreements cannot be considered anti competitive. So it's a quantitative threshold and the when the companies do not compete, compete directly between themselves still there are agreements that are exempted from these blacklist, where the combined market share does not exceed 30% of the market okay. Then, so, exemption are granted on the condition that the license agreement for example, do not contain does not contain certain restrictions, which are not acceptable, because they have a significant anti competitive effect. And the regulation gives a list of hardcore and excluded restrictions that are regarded anti competitive and they will not be exempted, blacklist, a sort of blacklist of a very dangerous restrictions of competition. And here I've inserted some examples. For example, when the patent owner restricts the ability of the licensee to determine prices, when you know the products are you know sold to third parties. Limitation of output the patent owner cannot unilaterally decide the output made by the licensee to be made by the licensee or where the ability of the licensee to exploit its own technology rights is curtailed by the contract that that's not possible or jurisdiction of their veto of any value any of the parties to the agreement to carry out research and development unless such lack of restriction restriction on the ability to carry out research or development is necessary absolutely necessary to prevent the disclosure of for example, they know how right when it comes to license know how license I mean the the scenario is a bit is a bit different. Okay. So, these are just a few examples of of list of behaviors that cannot be exempted that will always be banned, because they're considered very, very dangerous fixing prices and you know, limiting output. They are the most anti competitive clause in the in the market. So, I will stop now here for the moment and pass it to Magali and then I will be back okay.

Unknown Speaker  10:05  
So I'm going to share my screen

Unknown Speaker  10:25  
so now you should see it in big. Okay. So before, what I'm going to try to do in this presentation is to give an Italian perspective of the rules that govern ownership on inventorship. When it comes to the individualization of intellectual property rights and a little of the, what are the consequences in rotation, pi path. So basically, the structure is like this, we will first try to understand why I'm wearing Italian lone mothers, how it is regulated under Italian law. And what I'm, which are the intellectual property rights are applicable applicable to these rules. So starting with me with the why, as you know, in Europe, the path to getting a patent is very different from us, because we had the, of course, a national patent application, would we that would give us an Italian patent, when we have the original patent path and say, the European patent convention, we don't have yet a unitary title, we have a bundle of patterns we send, and they are effective in the designated country. So that's why some chance Italian law comes into play, because of this difference, because it's regulated under as it were Italian law. So going to the European patent convention, if we have a look, it makes a distinct difference between inventor and the owner. It says on merely that we have to indicate who is the inventor, and then inventor is the one that has the right insight to explore the path. And this is quite striking just a former requirements I but it's not so strive for one as in the end, then when the applicant and the owner, they don't concede, let's say there needs to be filed the justification for these substantive rights to be entitled to the pattern. And this is the issue that is predominant under national law. And the same goes with the pattern I serve as an object of property when we are transferring, right, when do we have license? And these are the rules are these rules, the rules or gov under the National Law of the pattern, where is its efficacy. So this will necessarily differ in each European country. So we had the first point that I want to make the take home point is that when do we have an element of connection? First of all, we have to have a loop to the substantive relation between the inventor and the owner. So I'm not going to enter in the detail of, you know, even international product law when it comes through to groups and inventors and owners around different countries. But the most important point is that, first of all, we have to have a look to how this contractor relationship is dropped rotten drafting. And it is important to make it clear. When it comes to regulating this round, we have to make another preliminary distinction between moral grounds and economic rights, because the moral right is substantially the right to be recognized as an inventor, and this is a person has brought that cannot be assigned. Whereas the economic right is indeed the right to exploit the patent just throw the invention and this is what can be assigned. And by default, as we saw in the patent conventional also in Ditalion. To him independent intellectual property code. The owner is pursued the inventor but for this we have extensions. And exceptions go different when it comes to private or public entities. Let's have a look to the private side that is called the employee inventions. In Italy. We have three types of employee inventions. The service invention is the one in any case, of course, the moral rise as I said, it always stays with the with the inventor in the service invention, it's related to those inventions that are contemplated in it contract if we go and see the contractor relationship between the parties, the employee has been hired specifically to reach that invention and he receives a specific remuneration for that. So it's very clear. And that's why we say the economic rights are belong to the to the employer. Instead, the company invention is in between situation and say, because the employee, it's working for the company, he's doing some activities, but he's he has not been specifically hired to to reach that inventive activity. So, in that and is not specifically remunerated for for that activity. But the in that case, the economic rights still belong to the to the employer, but the employee has is entitled to have a fair price and I will come back to what does it mean. And finally, we have the occasional invention, that is in those cases in which the activity there is no commercial relation between the activity, the inventive activity of the of the employee and the invention that has been reached. And in that case, they're the ones are always with the with the employee, but if the invention has some relation with a false beeping or can be useful for the employer, he has the possibility to opt for acquire or use in this right in time limit of three months. This is correlated with a duty of the employee to inform the employer about filing having filing the patent application. As I said before, in the case of company invention, there is the employees entitled to a fair play fair price consideration. What does he mean is basically an extraordinary compensation for an extraordinary activity, invented activity of the inventor. So in those cases in which there is this counseling, and the employee was not specifically remunerated, but according to case law, sometimes not even adequately remunerated, he has, he's entitled to have this fair price. It's kind of funny indemnity. So it's not that he would become it in installments, it's like kind of a lump sum. And to determine it's very difficult, actually, courts are always trying to determine the amount of this fair price. But there are a kind of criteria, basically, the Italian courts follow the what is called in German formula, which is a crusade and lay down in German law, but with some, let's say amendments, which is I mean, own interpretation. Sorry. So, it's one of the criteria is important of dimension, but this is mainly taken aside from this German cook formula, then the talent course on that you have to consider what is the level of autonomy of the employee, whatever the hell they kind of had that he got from the from the employer, they were gonna ration the contribution in overall of the organisation and some other criteria. As I said, this has been quiet or still very controversial in case law. One of the first things that arise is when I mean, they are always discussing whether an employee has a right or not, to the fair, the fair price, I mean, the line to draw the line between what is service invention and company invention is not very easy. But normally, let's say courts tend to recognize the fair price where this there is no there's no provision of the invention activity or where the even the remuneration is not in accordance outside to the invention that has been obtained. Also another question that are asked what happens if the inventor simplifies the the party in in Italy, but then it gets an extension, I mean, in the framework, for example, of European patent. In that case, the court says that the the fair price is not for each part and cannot cannot be calculated for each button, but for the invention activity, so the reward is to the invention, not to the patent. And another thing that now it's less important because it has changed the last some years and now you know, Italian courts are not very fast, but until very recently, we had this discussion is that

Unknown Speaker  19:58  
it was very common Let's say that the employer was challenging the validity of the party because the previous law said we had connected, let's say, the grant of the patent with a fair price. So, so it was challenging during the prosecution, the validity of the pattern just to avoid paying the fair price. So, this is not possible to do. And finally, to calculate this fair price, you have to take them the most important criteria is what is the potential economic of elimination, non economic success. And this is very important, especially when it comes to the effective interventions, because I mean, it, the overall amount cannot be superior than say, to the full amount of the invention. But still, you have to calculate the contribution of each member of the team. So, as I said before, here, I just want to highlight because of time, that it's very difficult to draw a line between service invention and the company invention in this one is the one that the results have been gone to belong to the employer and is one to the, it has a fair price. So that's why it's very important to have in the contract clauses that define very clearly what are the activities that the employees going to fulfill, or to carry on what is the price and he that he specifically paid to it to certain results. If we move now to the university inventions, and as it's always saying, in Italy, we have the so called called Professor privilege. That means that when researchers are conducting their work in the framework of institution that they are dedicated also to research, the results deals belong to the researcher. Of course, there is no doubt about more than brands, but it also refers to the economic exploitation of the result. But this is true when it comes through research that is found by internal researchers of the university on resources that are from the Mueller in Italy, that is the ministry of international university. But still a tie these in Italy is temporality, this general principle, because first of all the university can regulate and how licensing. Normally the university draw their own regulation. But in that sense, they call establish that at least 50% has to be recognized to the mentor and the power to the university. Also, there is another kind of safeguard through the university. That means that when the pattern or after five years or the pattern has been granted, then the the inventor or the owner, the researcher inside does not exploit the pattern, the university automatically acquire like a free license. And with the faculty, let's say to sub license. And the mayor and say, temper of this principle is that, as I said before, this applies only to research satisfied by internal resources. But when these results apply, let's say is funded by third parties, then the result of this is belongs to different the the party that has financed the research. So that's why I mean, it is true that if compared to other European countries that they had an institutional ownership in Italy there is yes, there is a professor reveal Punchbowl, but it's tempered with other roles. So still, this is not really straightforward to apply these, because in Italy, I mean, first of all, one of the issues that arise is what does it mean researcher? I mean, does it apply just to the ordinary professor, it applies also for PhD student applies for any other kind of researcher that are kind of para subordinated but they are not still in the organic of the university. So again, normally it's important, I mean, the universities throw their revelation and try to clarify this. But before embarking and saying joint project, it's very important to check that. The second thing is what happens when there is four party lower party that is finding funding the research, I mean, then the private body is not the direct limb by finding the result who is going to to have the will be entitled to the results. This is something important also to clarify. If there is any fair price in case of third party research invention, for instance, as I said before, when the research is found by third parties, can we interpret that as the researcher is inside the university or He's kind of employee of the of the party that is the private party that is found in the research. Or even in the case of what happened if the researchers decided not to patent invention, as we saw before, the safe words comes from the university when there is a patent granted, but what happens if there is no pattern? So, of course, these are all things that we can clarify contractually. And it's good advice to do so. And the last but not least is what happened with other intellectual property that may emerge from this research.

Speaker 2  25:39  
Mowgli, can we leave that to a question later?

Unknown Speaker  25:44  
Oh, two quarters. Yes, I have a thesis on and I was finishing actually. Oh, go ahead. Go ahead. Yes. Not that that as I said before them the rules that we saw, they applied for patents, but what happened you know, that research is kind of a Pandora's box, there could be trademarks, that could be copyrights and other intellectual property rights. So, what do we do? How do we regulate that we have some insights for software as a copyright and industrial design, because when there is a clear contract or that defines a word relationship, it can then the consequence belongs to the employer, but still some other interpretive issues arise as there are like, what I mentioned before about the Okay, how much has to be regulated? It has to be specifically or can be also an occasional invention, and that creation and that will be

Unknown Speaker  26:49  
incubated very much Enrico Yes. I'm going to share again my, my screen one second. Okay. Okay, go to two. I think Magali you need to stop sharing otherwise I cannot. Perfect, that's perfect. Thank you, okay. Just wanted to you know, say something on how you know, IP is commercialized that university especially British university, and I will use my my own university as a case study. So, there are two ways I mean, other universities in the UK and in other parts of Europe, they have a similar structure, I will say there are two ways to commercialize IP at universities either to license out their IP, which is created in house licensing out to external companies, independent companies, and already established or creating a spin out company, right. These are the two options. And the choices between these two options depend on various factors, the kind of market we're talking about the level of interest, now, the IP which is created has generated amongst the investors or possible potential licensees, when the decision on if the decision or to create a spin out company stake and which are the factor that are taken into account to decide whether to create a spin out company the overall benefits to the university, the IP which is going to be incorporated in the spin out company, if there is a good sound business plan and the potential risks financially especially right and then that the company has an appropriate and adequate insurance Koba. They availability to have a good reliable management team with good administrators, good managers, and the end other factors. One important aspect to be taken into account is the risk of conflict of a conflict of interests. Especially inventors, who might receive shares in the spin out companies cannot benefit personally from revenues received by university from the spin out as shareholder right. So from dividends, Shane saying some shares or even royalty payments. In this way the risk of conflict of interest is is minimized, right. Inventors may also be managers of the spin out companies. However, again here we need to Taking into account a possible conflict of interest. Because the inventor is a is a researcher is a professor of university, right? And then when the inventor becomes a manager of the spin out company, well, there might be other priorities. So for example, if an invasion is reached, right, by the spin out company under the supervision of the inventors slash manager, here, there might be some, you know, issues for example, they invent or as inventor might want to publish the results of the research straightaway in an important prestigious journal, because he is a researcher or she is reserved. So, you know, the first inputs, the first photo would be, let's publish it, but now, this cannot be done until a patent application is has been filed. Obviously, otherwise, they risk to lose novelty of the invasion. So, you can see that inventors managers, they have two hats, they have to wear two hats, and sometimes it's difficult, I mean, we need the proper conflict of interest checks here, right? Because there are two different jobs. One is the inventor and one is the management of the of the of the spin out companies, when these roles overlap, you know, conflict of interest might might arise. What about the cake to be shared to be divided? The revenues, the profits, stemming from academic IP? How can such profits be shared? Well, at my university until a few, I think a few months ago, we have these kinds of skills, okay. So, for example, if they benefits from the invention or any other technology could be a software is up to 5000 pounds. So, very low, the inventor gets 100% the school from which the inventor comes gets deal, and the Central University gets zero. If the revenues generated are between 5050 1000 The inventor gets 70% the school which the inventor belongs 50%, and the center inventor 50%, from 50,000 to 100,000, the inventor gets 50,000 the school 25 And the center the rest of the five, if it is over 100,000 pounds, it's kind of you know 4343 43 Right. So, the important thing, this was a scheme adopted until a few months ago, they have slightly changed now, but the what is what has remained and it's a very important principle in my opinion is the total PhD students are eligible to these to these percentages. So, we don't discriminate between the Emeritus Professor reaches the invasion and the young PhD student who reached an invasion right. Then there might be cases where the invention is reached by a team and then therefore, there are other criteria to share okay. And then we have some phases sorry, some phases. So, now, I cannot go in detail on each of these cases, but you know, when, when a researcher fields at the universities that he or she has reached invention, the first thing she needs to do is to go to the TT office of the university and sign feel and sign the disclosure form. Right. This is the way you preserve nobility of the invasions. So, the to assess the invasion, including potential offers strong IP protection and commercial opportunities. Then if the initial search phase two leads to a recommendation to exploit the IP, the inventor researcher fee assigns the confirmatory deed of assignment, right? We do each the rights over the invention are transferred to the University. Okay? Because the university will be the owner of the possible path. But if the university decides that they don't want to push you that route, well, it may offer to assign the ownership to the IP creators and therefore the researcher, the the professor, they might want to exploit it himself or herself outside the university, okay. But if the university decides to commercialize, of course, you need to take steps, the PTO and the boards they need to take step to taking to enter in contact with a patent attorney. So my universities they have, you know, external partners Dardanus they assess the you know, the patentability of the invention. And there is also an assessment of the commercialization opportunity now by the CTO. So they may decide, okay, let's keep it in house and the license the patent the future pattern to an external company, or let's create a spin out company. These decisions are taken at this stage with the final approval by the IP commercialization commercialization board of the university, which approved this scheme. Now the commercialization strategy. Well, we plan to do these all these the procedure within six months, starting from the disclosure for being signed, sometimes it takes longer, because, you know, the procedure might be more difficult, but this is the the average. Let's see, having said that, I want to conclude just Do I still have some minutes Neela I think so, right? I think three four minutes are enough. For example, I want to give example of the of some, you know, spinouts created by other university in Britain, for example, nanopore nanopore technology created by the spin out company, nanopore technologies creative at the University of Oxford in 2005. Well, it produces and sells nanopore sequencing products with the company's value recently reaching 1.5 billion bounce it's a lot. Then you have congenic, another spin out created by the rest of Cambridge, which launched a platform that highlights genetic disorders, and very rare disease.

Unknown Speaker  36:51  
They got funds, they got funds from genomics England and our 2 million pounds. Li Kotek. Again, another spin out company from the Cambria of Cambridge, a biotech biotech company which produces an anti aging chocolate bar. I might need to try this soon these these anti aging chocolate bar, see how it works. And then we have bio nano consulting created by UCL at Imperial College both in 2015. It developed a 10 pounds device so quite cheap that monitors a kidney disease spiral agenda created by UCL in London, many years ago 20 years ago, which develops antibody drug technology aimed at treating cancer then the spin out company was bought, then eight years ago by AstraZeneca in a for under $40 million deal. Then we have a C 40x discovery from the University of Manchester, which developed the technology producing 3d structures of drug molecules. Now, for the development of you know, rapid safe and cost effective development of a variety of drugs, it has been valued at the London Stock Exchange for 150 1 million pounds. Then from Waves Cardiff ultravision, Alessi surgical, created the by these Institute for minimal access therapy at the University of Cardiff it develops a device capable of handling the smoke during a very important crucial surgery in the abdominal. It is distributed in many countries 25 And you know it has been it has been supported with fans and so on so forth. Scotland, no can die you're met created by the University of Edinburgh in the 2008. And it produces cancer therapies basically a new generation of anti cancer therapies. Again, they secured a 676 7 million pounds, investment in venture capital financing, and other Scottish one. Clyde Biosciences created in 2012 by newest of Glasgow, and it developed innovative technologies to assess drug toxicity were important for claim, preclinical trials and so on and so forth. It got investment to be an investment by then other venture capital funds. And lastly from the University of Dundee Excel experiencia, which uses artificial intelligence to discover effective drugs more effective drugs. Again, these finance companies partnered with a private company cell Jen, which contributor with lots of billion upfront investments. So you can see that these are success stories, right? Success stories where the universities have created value A spin out company which have partnered with private actors. So what can we learn from these success stories then there are several others in continental Europe of course, but I mean universities they have a public mission and public interest mission right to the same to create and disseminate knowledge, scientific knowledge, they do that, but having such public interest mission does not prevent them from being actors and players in the market. Of course, the secret is the profits, which is the profits, which are made through spin out companies, of course, they are not, they are not shared by the Chancellor or professors. I mean, the profits are reinvested for further research. And this is the virtual, the veal twos series circle, which should be you know, admired and should be encouraged. There is nothing wrong in universities being the players in the market, as long as the profits are then used for further research. I mean, the private, let's say involvement or university is used to enhance the public interest mission of the universities themselves. I mean, in the US, you also have, of course, many success stories in this specific regard, right. So this is what they can feel, right. Commercialization of IP at university, does produce, may produce and does produce tangible results. And which strengthens at the end of the day, the university mission public interest mission by partnering with the private sector.

Speaker 2  41:52  
Thank you and Rico were, we enjoyed this segment, and we're ready for Cohn to if you will let him take over.

Unknown Speaker  42:03  
Okay, super. So Sammy, if you could certainly share my slides. So thank you very much for being asked to present here. I'm going to share with you some recent developments in the Netherlands that impact the licensing activities of all the public sector universities and research institutes. So next slide, please. So what's the trigger for the whole socially responsible licensing policy there's now in place was well, a the fact that the cost of health care and I think this is not particularly to the Netherlands, I think is this is going on worldwide, the cost of healthcare is rising rapidly year on year rate so And out of all those costs a year expensive new drugs, such as new oncology drugs, immuno oncology drugs that can cost up to 100 200,000 euros per patient per year, take a lot of attention. And there was a sense developed, I think, in the popular press in in, in chat shows on television, that's as a country where we're paying twice we're paying for the fundamental research to get done and out of that follow inventions that can be the basis for the development of new drugs. But then we pay a second time we pay the you know, the top price when the drug comes to market. And this ended up in the Dutch Parliament's there were some parliamentarians that demanded action from the Minister for Health. And he threatened at that point to legislate meaning that it would become law that universities public research institutes would have to demand the the licensing of their technologies against, you know, very minimum cost, I think that will go contrary to to the rules of the US Embassy, as was just explained by Eriko. But that's that's a matter perhaps, for discussion. But to prevent legislation from, you know, tying our hands in licensing negotiations, the universities of the university medical centers in the Netherlands, they stepped in and talking to the Minister for Health saying, Look, here we can we can we can regulate this ourselves, please don't legislate, let us come up with a solution to this problem. So that was the whole backdrop to what ultimately led to this set of socially responsible licensing principles. Next slide, please. So how did the universities and the University Medical Center go about the process? Well, we invited all stakeholders to a consultation. And the stakeholders we have in the those includes pharmaceutical industry, biotech, Companies venture capital investors on the one hand, but universities themselves, of course, funding bodies, all the way down to NGOs and other ideal driven organizations that are pushing for better access to medicine, not just in the developing the developing world, but also in the developed world. We had various consultation rounds, everybody knows at some point, we had draft texts that everybody could comment on. And ultimately, we set up a compromise proposal, including 10 principles. And this compromise ended up suiting neither end of the single spectrum, right. So the for industry by tech for venture capital, the proposal went too far, for NGOs, the proposals didn't go anywhere, near far enough. Anyway, so that was 10 principles were underwritten by all Dutch universities, University Medical Centers, also by my own institution, we're not a unit, we're not affiliated with the university. But essentially all the major research organizations in the biomedical field signed on to this, we presented the principles to government to the Minister for Health, and he was happy to be able to present those principles to parliament's and I think that as at least for the time being, stop the discussion about this, this this topic. Now, you can have a set of principles, but then the question becomes how do you apply those principles. And for this, a toolkit was developed, which includes a license agreement with all kinds of options, and whistles and bells, that contain incorporate these principles. And so that is what what is available for us to use in our in our daily practice. And the scope of all these principles is applies to technologies that enable the development of novel medicines. So that's the that's, that's the remit of that. Next slide, please. So I'm gonna go very briefly through these principles. In places I have put autumn in brackets, and that is because ultimate self has what it called and nine points to consider in licensing. So there's nine points. And there's a bit of an overlap between the socially responsible licensing principles and these autumn nine points to consider. And so where appropriate, I've put the ultim, the relevant autumn point to consider in brackets. So the first principle is that and I think that's a bit of an open door that academic research organizations need to strike that's that their results, research results contribute to society, either through economic development or otherwise. Of course, the second one, also embedded in the autumn principles is that we retain the right to use our own research results and IP and work on their IP rights. If we follow on with academic research ourselves. The third principle is one and that's also listed in the autumn licensing principles is that we only partner and license to parties that are capable, both capable and committed to further the development of the technology that we that we license. This is amongst others to prevent us from licensing to what they call patent trolls, who don't have a commitment to further development technology, but they simply want to monetize the rights that aid that they license. The fourth point is that we don't want the license to party with conflicting societal objectives. So you might read tobacco companies here in the case of my own institution, the Netherlands Cancer Institute, that is certainly a group of companies that have conflicting objectives to the objectives that we that we strive for. And then the fifth principle is that we this is referring to the Nagoya protocol that we don't license traditional indigenous knowledge or inventions based on its without having entered into appropriate agreements with the rights holders. Then, next slide, please. Principles six through nine are going to go briefly through use as well the licensees shall take parties that are directly concerned by the licensing to accomplish on ensuring that these parties are adequately informed in the this is for instance, the funding bodies that have contributed to the to the research that ultimately led to the technology and led to the license. But you might also read, for instance, patients out of advocacy groups here. So we are bound to, you know, taking these parties into accounts and keeping them informed and keeping ourselves informed of what these parties wants. Principle number seven is that licensing must not conflict with a legal task or societal mandate of academic institutions. think is a bit in line with the DOS license to, to to, you know, tobacco companies, if you like, the eight points is that we are asked to consider both the commercial interests of the current partner, partner and any future applications. And this place to not this is a bit of a Goldilocks principle, you don't want to offer a two to narrow rates. But you also don't want to offer an unrestricted exclusive license to just any application knowing that the licensee will only develop one or two out of the potential applications that are out there. The ninth principle is that we want to how do you say this promotes space or encourage licensees? Tu, Tu, Tu, Tu, Tu, to develop their products for certain countries? I think this is this is a this is a principle that that refers to I think, licensing for the developing worlds where you want to have, you know, you're not going to get the prices for your products, at least not in the in the biomedical fields, that you may get in the developed world. But that we we do want to make sure that these countries are also able to access these these products. Next slide, please. And then the final principle number 10. I've put this on a separate slide. Because this is the one principle that is I think very different from any other principles sets of principles I've seen before. It's also the one that creates a lot of a lot of discussion with licensees. So it's,

Unknown Speaker  51:47  
it's it says that we need to ensure that price setting of final products and our services does not endanger accessibility, and accessibility that is accessibility of for instance, patients to get the correct treatments. Now, next slide, please. How do we implement that this principle? 10? Well, we, we chose to take the carrot rather than the stick approach, right? So instead of saying we're gonna, we're gonna know the license, or refer to a non exclusive license or whatever, we're gonna, we're saying, Look, if you do this, you're gonna get a discount on the royalty even you can even you know, we don't even want a royalty from you. If if this if you implement this principle, and the way we formulate this, and this is also in the the toolkit, and I have a link to that toolkit in the presentation later on, is that you make available within you know, you pick your territory, I think the standard is European Union, all the licensed products and processes at prices that would allow rapid uptake by appropriate reimbursement schemes, and that would not constitute an obstacle for patients to have access to the therapy. Next slide, please. Okay, so over two years now, since the adoption of the principles, and one year since released the toolkit, so how are we doing? So I put out a mini questionnaire to my to my fellow were kto. Directors, I got a response for from just a handful. So what I have is a really small snapshot of what is out there. But it was supposed to be quite mixed. I was a bit surprised to learn to be honest. We have there's a total of just under 20 licenses that we've we've looked at. And the these principles have been in flight have been applied in full in about just over a third of all these licenses since last year. So that's not a whole lot. But it's always about principle 10, the pricing principle that discussions arise, most licenses, if not all, incorporate nine the first nine principles, but that's the 10th principle that is leaving that is leading to discussions. And that in some cases, is emitted from from license license agreements or is significantly watered down. And I think that in discussions with my colleagues, that the questions are most often with parties that need to sell their license at some points in the future to a third party that they don't know yet who that is. So they're very reluctant to sign up to terms that they don't know they will be able to sell on to a third party. I don't think there's many examples in the set that I've I've have have access to but it would be really interesting to see how far you would be able to go with this if he were talking to the party that is actually going to put that product on the market itself. So that with that. Next slide, please. I've got a couple of things for you if you want to reverse searches any further it's all in English. So the 10 principles are can be found with that link in the toolkit including this draft license. Three minutes following the other link, and I'd be happy to answer any questions that you might have.

Speaker 2  55:09  
So at this point, let's open the floor to any questions that might that anyone might have.

Speaker 2  55:21  
One question that I have actually is, how much do you see inventor ship and creation of IP that leads to commercialization that's joint between different institutions in different jurisdictions. So perhaps an Italian inventor with a UK inventor or a Dutch inventor, especially for those of you that work in the research establishments.

Unknown Speaker  55:55  
Happy to give it a go. I think that happens quite often. Because research is very international. And we do collaborate with parties all over the globe. And you end up with joint ventures with we have examples of invents co inventors in the US in Denmark in Germany. So yeah, we do a lot with that. And then we tried to get to some kind of a joint ownership agreements. And we pick one party that is in the lead for commercialization. And you know, parties is the, you know, the silent partner, if you like and gets a revenue share.

Unknown Speaker  56:31  
Usually, if I may stipend usually, when agreements between different university in different jurisdictions are signed the agreements they have, you know, they have clauses, articles, which govern the IP, how the IP will be managed, probably a consortium and a joint venture. So the contracts usually be the research contract between the different universities regulate these aspects, which does not mean that, you know, some cross jurisdictional issues may arise, of course, think about moral rights, right? moral rights, in copyright, or in software of moral rights are as protected in very different ways, different jurisdictions, in Comala, jurisdiction you the automated way, he's able to waive the moral rights, while in continental Europe, moral rights around waivable. So, the fact that there is a contract does not, you know, does not guarantee that, you know, there will be no issue. I mean, issues may always arise, but usually, also, from my experience, I have an event, I have made research with other universities from, you know, other countries, and these contracts are quite specific when it comes to governing IP ownership and licensing.

Unknown Speaker  58:02  
Yeah, maybe what I wanted to share in immune related to this, there are this commission recommendation on the management of intellectual property rights, that are very useful when they are our partnership between universities. They are not mandatory, so they don't have any binding effect. But in the framework of the horizon 2020 research program that are found that the European Commission is let's say, they appear several times and and the parties that are partnering, they voluntary, let's say commit to to implement these rules. When I say as I said, is not mandatory, but having a structure program or or rules on, who is the party that is going to manage and who is going the party that is and how the result is going to be explored is very important, because then in a subsequent retire application, the effective management of the intellectual property, right, they play an important role.

Speaker 2  59:18  
And I recall two different issues with the United States because we have provisional filings in making sure that the intellectual property gets protected appropriately so that there's no issues with publication before because of some of the different issues

Unknown Speaker  59:45  
if I may, I step in. I know that is something that happens very internationally for I do practice. And when you have these, first of all international results, and especially then when you want to maybe fall apart another thing that arises that maybe in the United States, you can polish or you have the grace period, and you don't have that in Italy, or in most European countries, there are some inside sometimes, you know, you cannot avoid that. Or you just come with the with the issue, let's say when it's already done. There are some alternative routes that you can consider, of course, I mean, it's not so effective as a pattern, but you have activity models that you can use is not the same. I mean, the protection, but also it's not harmonized in in European countries, but it can be an option. And in some countries, for instance, in Germany, you have six months grace period for that. In Italy, no, we don't have it. Another is in Italy, you can consider somebody you know, somebody you know, you have a six month grace period. And then you can convert it into a I mean, there is kind of an agreement, and you can just jump to it. And there are some some ways out, but it's it's a very common issue.

Speaker 2  1:01:16  
I can encourage you that are participants to add your questions in the q&a. And then we can see them.

Speaker 2  1:01:36  
Does the panel have any questions for each other?

Unknown Speaker  1:01:41  
Yeah, I have a question for Rico and Rico, you mentioned that it is forbidden to to restrict the ability of the licensee to set prices. How do you think those that those are are socially responsible licensing principles? How do they sit with that principle? Essentially, we are asking the licensee to be reasonable. And not to set prices at a level where you know, you first have to have negotiations on a national level about the pricing and reimbursement and only after this negotiations, you can actually get get on the market with your new drug. Would that be what would that fall foul of this, these restrictions that are that are there in Europe?

Unknown Speaker  1:02:29  
You mean? You mean a scenario where the licensee is choosing is a practice and the price which makes the whole, you know, activity unprofitable, or that makes the license? Meaningless? Let's say so that they have the license or patent owner a power to influence that? Is that the question? Well, yeah,

Unknown Speaker  1:03:01  
so So we're saying don't set the price too high, you can still set it at a at a profitable level, but we don't want you to maximize profits by setting it you know, as high as you can, and then you know, and then negotiate your way from there, I think

Unknown Speaker  1:03:17  
there might be some recommendations, some ranges, but you know, these is perceived by the Commission as as as as an interference, right, you know, licensees must be left free to practice their own price, but of course, then they have some, you know, obligations to to, to comply with in terms of quality of the product types of channels of distribution. So I must say that the, they are on the same side of the of the of the battle right licensee, so they're not see their competitor, but they're collaborating. So, they the licensee is encouraged to, to set prices to manage license in a way, which benefits the licensee, but at the same time there is so it's a win win situation, right? And therefore, the price which is if the licensee gets profits, this is good for the lesson. So, so it's kind of linked the two the two, the two outcomes, the two deaths in the two fates are linked, right. So if the licensor gives freedom to Lesson C to do the, you know, to say the price, of course, the licensee will set the price which is in line with the needs of the licensee, but these these things will be the same as the license. So right now Yep,

Unknown Speaker  1:05:02  
Yes, yep, please? Well, I was just gonna mention if perhaps the licensor isn't really much interested in, in the royalty, so he's as per se aligned with the licensee, but does want to have to have the does want the adventure to have a maximal impact

Unknown Speaker  1:05:18  
what that is are other ways to do that by you know, by agreeing on certain channels of distribution or quality requirements in order to, you know, to, to make the invention being perceived as valuable by by, by by the market by competitors or by the users I mean, but when it comes to prices, the EU institutions are really, really strict price fixing, I guess, in America as well price fixing, which could also be made through a verbal agreement, you know, to be to be to be written. But this is this is this is this is also true of other kinds of dealings, outside IP distribution, any kind of concerted practices, which aim at align prices, you know, is really condemned by with with fines with lots of, you know, very high fines. So, Dubai understand your point. Okay, thank you.

Unknown Speaker  1:06:33  
I have a question for you, for me. Sorry, if I didn't get this part, but are these principle binding or just recommendation? And if there is any case, how they are considered in before called Netherlands? I mean, do they take into account these principles?

Unknown Speaker  1:06:55  
Well, we don't have any any experience in in core to answer lots of questions, I wouldn't know what what that is. So we've all signed on to these principles, meaning that we apply them. And if we do not apply them, we need to explain why we don't apply them. So we are supposed to report on these in our annual reports. And then say we did this license with Company X. But you know, we didn't fully apply the principles for reason XYZ. And we did a license agreement earlier in the year where at the, you know, it really came down to, you know, the last part of the negotiation was this pricing thing. This was a US company as small biotech wanting to, you know, at some point license their their technology on to a third party, and they just could not agree to signing up to these principles. And at the end of the day, we did encompass the the pricing principle, but we coupled that to a definition of reasonable efforts, that was very broad. And thereby we sort of watered down that that principle. So we didn't fully apply it. And that's, you know, that's where it is. And we can we, you know, we agreed to doing this, because the alternative would have been that we would not have licensed this to any company, and that there would be no development at all. And that is something I cannot explain to patients, advocacy groups, etc. So that's why we that's why we decided in the end, after having pushed the envelope that to accept that watering down.

Speaker 2  1:08:31  
So there is a question here that says, What is your advice for sources of summary information for us based technology transfer professionals to stay up on European patenting and licensing law and procedure changes?

Unknown Speaker  1:08:49  
I'm not much of an expert in that area, to be honest, I wouldn't be able to point them to the, to the right resources.

Unknown Speaker  1:08:57  
I would say starting for in which European country because again, I think that the take home point here is that, you know, you know, it's your body's not so uniform.

Speaker 2  1:09:09  
I can tell you, I've had a couple of issues when I was in the US, and we're dealing with different European countries. And in that particular case, we had to look at the type of intellectual property and in the particular law of that state, and honestly, it was just easier for us to read, to hire patent counsel or contract counsel in that country to aid us with some of those things. So in particular, in France, we had something with CNRS, and it was just easier to manage just like we would for any other IP counsel.

Speaker 1  1:10:00  
Great, everyone. It looks like we had all the questions submitted answered. If all of you do not have other questions for each other, or any closing parts, I'm happy to closing thoughts. I'm happy to wrap us up. But I wanted to check in make sure there's no final words of wisdom that any of you wanted to share before we before we wrap this up. Great. Well, on behalf of autumn, I'd like to call on where you're gonna share.

Unknown Speaker  1:10:29  
I was just gonna say, I wouldn't presume I wouldn't be so presumptuous as to think I have words of wisdom to share.

Speaker 1  1:10:39  
Now, we've all been great words of wisdom from all of you. And I'd like to thank each of you, Neela, and Rico, Mowgli and Cohn for this informative discussion and shedding some light on these European practices. And thank all of our attendees for joining us today. As a reminder recording of the webinar will be available on the autumn Learning Center within a few days of the session and is included in your registration fee. And we will have handout PDFs of the presentations available on the autumn Learning Center as well. And please remember to complete the webinar evaluation which will open when you close out of this webinar and will be sent in an email as a follow up tomorrow. This helps us to serve your needs in the future and is super brief, I promise. So thank you again for joining us today. And thank you all again for being with us here. I hope you have a great rest of your morning, afternoon or evening wherever you may be located. And we look forward to seeing you on a future webinar soon.

Transcribed by https://otter.ai