Session Notes: Workshop 3: Long-Term ROI – Leveraging Portfolio Development and Patent Protection

Apr 22, 2026
Long-Term ROI: Leveraging the combination of Portfolio Development and Patent Protection - Transcript
00:00:00
 
 : It's quite Uh there's going to be space for you here to have your uh okay computer and Maybe maybe we can I still need to check with the organizer, but maybe we can still move the tables a bit or this table a bit. Yeah, just so you're it's possibly easier. Yeah, I'm just gonna Yeah. From Slovak background. Yeah. Okay. Yeah, it is very I'm by heritage but I he is German actually. So he has to say like I also speak German. Your German is certainly better than my father. Can you speak quite well? That's beautiful. That's the most important thing. I just learned about it. But you have the joining information. join. Yes. Yes. Sorry. You will find No person anything. I wanted something else. Raphael is your guy to your can happen like equivalent soul says talking to each other. One of the three cups, right?
 
 
00:05:02
 
 : I grab my computer and see if I can connect the computer. Wait. Uh is where is his is he going to be here with his computer? Um actually he's going to grab his computer. So we'll see. And I'll I will give you my laps or whatever you I'm already in the office. So I can just I'll just sit on the side. Uh yeah, but all good. It's a bit unconventional, but it whatever gets the job done. I mean, it's a first. The base plan was to have that call so everybody have doesn't share the screen. But I didn't know that we would have two screens. Actually I just found out like few days ago on proper yeah you know that's the thing that I think this is a so so it is conventional to you everybody satisfied yeah where do you want to position here there as if people here then as close as possible to the as possible to be here but the HDM HDMI is here.
 
 
00:06:19
 
 : So, is it how does long how long does it reach? I'm not even sure if I have this HDMI or I have this. So, I have a lot of different stuff and it connects with my computer. You can do any of these three then it good. Good. Uh what what is the time? 35. Okay. That's true. The one ask we have a doctor next to HDMI because you have something like this but for can you ask the free workshops? Oh yeah. Yeah. I look myself something like this. One moment. Let's Yeah, because you know you know why we need it so people can can see where you're sitting. Yes. With me. Maybe just a little bit. It's quite dim. I should turn the light a little bit so it's to show the slide. Yes, it was on the screen already a minute ago. So there should be we tried our best actually but there is a problem.
 
 
00:15:29
 
 : So multiple like different kind of presentation setups. So if you can uh we could do that with with a full ID that you can see the presentation. Yeah, you're you're smart. I can do that additionally. But for those who would like to see more can also do this. So we have both options. Can you this on my computer? Do you have to And you have one hour, right? You probably have 60 minutes. You probably give a signal. No pictures. No pictures. One, two, three. Yeah, I can see. Yes, if you don't from phone some of the details may also be a bit small on your screen but maybe you just need to all mute so it's Is the presentation on live? But you still will see the slides. I don't mute myself so I can record. So is it that you have you have not yet opened the zoom project or I have Yeah, that was 397. Yeah, I think we are.
 
 
00:18:21
 
 : Okay. The screen all the time. Yeah. Thank you. I will start as a backup. It's a difficult question. Um, so we can work on things together. Thank you very much for your interest in this. I always I've often made the experience that patents is often something not of particular interest to nonpatter people and at the same time as patents are linked to it's something important for the informal value proposition. I will say a few words about myself and where I come from. I'm a European patent attorney and work at a small biotech company very small company that's 50 people at a very large company in terms of patent protection own more than 500 patents uh in Europe US and the rest of the world do as a company by companies to bring general data acid assets into the clinic. So um the first medicine on was developed with our technology. Mona recently took a life of COVID vaccine which is based on naked nanop particle technology and um so on the one hand we have a foot on the ground on on the on the basic research and on the other hand we collaborated.
 
 
00:20:00
 
 : um patterns do play a huge role also for us as a biotech company in our monetization. uh we have a research center in in Canada and is otherwise based in just a few footsteps from here and what I've often experienced in patterns is that particularly for those who don't work with patents every day there are some conceptions and some ideas like I believe is probably that way and sometimes it's that way and sometimes it's not quite that way so for us to warm us up a little. I just prepared a couple of key slides about some myths and or facts. And I'd appreciate if you're not shy, you're just a group among us. So this is not in no no school uh no uh marks awarded nor class. And so please when you when you that looks weird to me or that that rings the bell or you have an idea about something just um just uh speak up and before we do this also for you to understand the audience um maybe we can quickly raise hand to see how we distributed.
 
 
00:21:21
 
 : Who of us works at large pharma? Who of us has something to do with exclusivities of pharmaceuticals? In a wider country, okay, that gives us a good idea some of an idea who comes from uh the biotech world companies that don't currently have a product on the market and the three of you have not raised your hand in any of the three questions you have. Yeah. Yes. The middle size of the company. Okay. And I do software development. Oh wow. Service provider for clinical trial expanded access. So I do have to deal with large farming small. So do I. Wonderful. So I have a I have a vague idea and if you feel like completely up to you whenever you raise your voice and you haven't had the opportunity to introduce yourself and your background yet, feel free to say I'm uh the name and possibly background comes from with or without as you feel comfortable. So, um I'm I'm just going to put a few hypotheses on and then we'll do a real uh work on a real case a hypothetical case but with a lot of resemblance to to uh real cases um and also organized of course um in the media names of the gist of questions being respond.
 
 
00:23:37
 
 : So that that should be um running the hypothesis. I'm not sure what happened, but we lost the slides. That's That's too bad. Okay, that's too bad. That should be You can see them here by my side, but not everyone can see them. So, we will go quickly through those slides. No. Yes. Good. So what would you say without any exclusivity at least for a certain time developing drugs would be economically not interesting. speaking this way. We will we will look at two different systems or at different systems towards the end of the workshop. Not all systems are as patenting friendly as for example Europe and the US. Um but um it's a as you know also from your clinical trial expert experience a lot of pre-investment goes into developing a pharmaceutical either no or also into further developing exploring your patient population developing a new dosage form and that research is always costly. So um question can arise how much would investment would still happen in into the pharmaceutical um sector if whoever develops the drug could not profit from exclusivity to that drug at least for a certain while the current You can't believe Very very good point.
 
 
00:26:22
 
 : Very good point. Not sure how that system. So what I will do is I will hypothesis there is no right or wrong and there are some there are systems that do for example that are much less generous on exclusivity including cut exclusivities and um they're very strong for example in the generic industry um so there is there there is no no um um right or wrong related question patterns are important for exclusivity Right or wrong? I don't right or wrong. I would say I can't say then I would say okay. Yeah, that could be facial exclusivity like you're three participants on the market but you have such a good relationship with the competitor cannot effectively sell the drug even though you have no legal exclusive new. Yeah. One way we could say patent in in in some situations still the the processes for production are exclusive either by trade secrets or by by by separate that happen. One way I could say that are supposed to be but they're not the only Yes.
 
 
00:28:28
 
 : Yes. And we will see in the practical work that we do also how it can interplay with other measures of uh exclusivity. There is another hypothesis whether there is a patent or not question of luck or the question of politics. How good is the team that does? Yes. Yes. So there are certain criteria for patent and larely one can say an an invention needs to be. So whatever is being protected by the patent needs to solve the technical problem. So just a workshop variant of something that already exists for example a field already on the market as a white screen and someone added to it and makes it a pink field that doesn't technical problem. So um if the person with a pick still doesn't get a patent that's not because he was lucky it's just that um so normally it's not a question of luck but it can be a question of strategy because patents are national rights and road has 200 countries and most patent applicants will take a decision at some stage.
 
 
00:29:57
 
 : Okay, these are our major markets. We fight for patent protection there. We may not for protection for example in South Africa and there is no patent in South Africa but luck related question. How long a patent runs depending on how good the lawyer is that takes care of it. Yeah. Well, but I think there is some standard in term of timing that the team is going to make the difference for the prolongation. Okay. Yeah. Or the protection then I think this is where the team make but I do hope that everyone in our country that the same rules for everything. Yes. And then it's the team the legal team behind that actually is going to protect it longer. You're you're you're essentially on the right track. I don't there there is an international convention uh uh which most countries of the world are member now the US was one of the last going and according to that 20 years from the date was all patents it doesn't matter what is the product what is the invention well that's easy to remember I thought it was only pharma 20 what what need to be done patent be granted the patent needs to be used because a patent gives exclusivity.
 
 
00:31:35
 
 : I own a patent and I want to exclude all of the comp that invention that's patented. um then that should have a certain value depending on the company for example $2,000 for so the patent after it's grant it needs to be renewed every year if I don't pay the renewal fee then it runs if I have a big pocket and I'm willing to pay a lot of rene pattern all patterns from 20 years. So also for rare diseases but the rare disease question is an excellent question. There are additional incentives for rare diseases and I'd like to come back to that toward the end. There are also regulatory um incentives uh for rare diseases and some situations they can buy. It's an excellent question and um and and we'll come to it and then as every patent expires after 20 years um when when one comes to the end of the 20 years does that mean exclusivity is over and suddenly there is no exclusivity for being able to do different things like a teacher to like like a subcutaneous version itself.
 
 
00:33:04
 
 : Yeah. Dominic, you looking at not at this workshop before because I've never done it before. Oh, no. I haven't been very experienced in the same big farm. I mean, I was in BMS. There was a full team. It was like those two. Yeah. Yeah. So the two things come together. Yes. Each patent run only 20 years but sometimes the follow up. Yes. Each patent runs 20 years and yes each patent leaves an invention behind to be patentable. So making an existing drug is not an invention but making something innovative with an existing drug for example solving a tolerability. Um let's say today therefore after 20 years from when the drug was invented exclusively to the to the drug as such expires the drug pattern is over. active in season over but the specific formulation that subject can can still enjoy exclusivity for the additional season because those began running and we visualize it in a bit in a practical example get you an additional three you get 20 days of your invention and in the third experiment that I did I said your invention is okay So the contract is 20 years from the first invention, 20 years from the second invention and then
 
 
00:34:58
 
 : arbitrary. Are you sure? Yes, that's that's very closely related to for example. for the deformationation for example so or to put it in more general terms let's say typically the first thing that is the active pharmaceutical but I found a new molecule that particularly involas that general at that stage typically no formulation ready for patient is available We know that's not there indefining. I mean four examples of the process of production. Four examples um reformulation. So patent from their respective filing date the first patent to expire is the patent directed to the active pharmaceutical ingredient. Um the patent protect formulation is the only formul actually. So in some situations the pattern directed at active phos is important is key in some situation that have been buffered out by other patterns that that expire in but the general uh message. Um there can be situations where different inventions are made around one particular ingredient itself which is typically the first invention or other inventions directed at particular aspect of historic.
 
 
00:37:44
 
 : Last one. Um would you say um as we are in one world, one exclusivity strategy um is a good strategy for the entire world. like it start in certain countries I don't know more than a dozen or is that not really ah yeah so that is a very good question in simple terms no in in in more detail um sometimes yes but the effect is still kind of yes because there is a global um there is a global concept across all countries that for an invention named application it needs to be noble. cannot be known at the date that's known from any written aurora publication I'd like your own public therefore typically that pattern in all caps at the same final date and therefore and because of the convention of the 20 years they all countries absolutely renewal is one aspect then in And there you mentioned that for example in the US run for five years in other countries run either either shorter or longer. We'll come to the regulatory exclusivity of the slide.
 
 
00:39:54
 
 : So what now we'll now um um dive into and what we will see in in the in the case that we'll dive into that we have an interplay between eight others that are typically 20 years per invention b regulatory exclusivities to which we will come that are not internationally normalized at all and um yeah these these these are the key players and then there are some additional uh incentives to which we will come. Yeah, I have a question. You mentioned about noility and about makeation public. Yes, I think yeah it would be interested to learn a bit more about that because I always know that before we publish anything what I've done then we always reach out to our to be sure that's you know say just happy to learn about that say what is that new data that you generate with your drug as a no okay I'd like to take the question in two steps And I'll take the first step right now and the next step in five minutes if I don't forget and otherwise remind me for the whole interactive because I have no question.
 
 
00:41:51
 
 : Wonderful. Okay. Thank you for the very good. Thank you. Good. So what typically happens uh I will I now work at small biotics. I work many years as a farmer and it's been my experience that what often happens when one works on a project together on my day one on a project that is not the day one of the project that is like today is our round table day one in a project. We still have a patent um that runs that protects the active pharmaceutical ingredient and that um patent expires 2031. But that's our our base case and there is also an authorized um use of that active pharmaceutical um ingredient in the form of an introvenous formulation 1 milligram to treat the liver. That's our basic and you build that up with um with the traditional um stuff. And in that case based on what we have learned on patents what we see on screen is that the timeline beginning 2021 that every patent runs 20 years and this expires 2031 left more to the left side of the screen and we have been trying um based on what we have learned of patterns and we will now have a look at the European Union perspective um and we will begin additional addition patterns uh each building block are not the only building the other block.
 
 
00:43:44
 
 : So um if you just see this listen to the last 30 minutes and have no experience. Okay. Good. Then then you would think exclusivity expires with expiry of the right. And what this is the scenario um at the shown at the bottom that just from this information from what we've listened to we would think you would have but the European Union has created a second incentive for pharmaceutical companies and that is also why the concept of systems and and u political motivation incentives play a role many nonpublic are not harmonized. The European Union for new um active ingredient for new um molecules um has also introduced the system of regulatory exclusivity. So from the moment of the first authorization of that molecule there is a factual 10 year exclusivity based on the regulatory file and and while patterns are something that universally applies for water chips molecules and everything. Um the regulatory exclusivity is something that the legislature have created specifically for pharma because other than an inventor of the motor, an inventor of the medicine cannot begin selling his medicine on day one afteration was made.
 
 
00:45:24
 
 : But firstly he to cumbersome and very expensive regulatory process. loed many years of therefore in regular test said that um from the first authorization of a new molecule in the 10 years actually that is called 8 plus 2 exclusivity in the first eight years no one can even see the regulatory um um data and in the last two years generics can already make the filer but you cannot begin saying they need to wait for the expiry of 10 years. And so the factual expiry of exclusivity is at whichever expires first the patent or the regulatory. In the example we will you see now the regulatory exclusivity actuallyire. Now, we're going to make the case a little more complicated because as you have said, correct? Sometimes I see your name and sometimes I don't. But you guys don't mind. Um in many situations um pharmaceutical companies make follow-up inventions for example a particular useful and what sometimes happen with small molecules they can form crystals. And so we will see examples now that are useful and also examples that maybe are not so useful.
 
 
00:46:58
 
 : That also sometimes sometimes one there is a pattern and the pattern like nice pattern is happy not just your ego. Um so um as as uh you will know um many small molecules forming crystals and for some uh for some molecules different crystal forms they also new crystal form a new that crystal form was there four. But the question here in ou

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