Vaccines

How do the patent system and the development of vaccines sit together? 

This week on Two IPs in A Pod, Anton Hutter of  Venner Shipley and Frank Tietze of Cambridge University join hosts Lee Davies and Gwilym Roberts to chat through their views on COVID 19, vaccines and the IP industry. 

Transcript

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Lee Davies  00:01

Hello, Gwilym. How are you this fine sunny morning?

Gwilym Roberts  00:04

I'm very well thank you. I've been up from a walk. I've seen some ducks. And there was mist rising off the lake in the park. It was very mangrovey

Lee Davies  00:13

Ah fabulous. It's, it's quite nice to wake up to a gorgeous, what I guess is the start of a spring morning, new hope on the horizon and all of that, do you feel full of hope?

Gwilym Roberts  00:22

I'm a little bit full of hope I'm, I've done one hopeful thing, which is to book a bottomless brunch on the 17th of April. 

Lee Davies  00:29

A what? 

Gwilym Roberts  00:30

A bottomless brunch. They do it in all the pubs around here. So you go in...

Lee Davies  00:32

Is it an eat all you like buffet kind of thing?

Gwilym Roberts  00:36

Yeah, we've replaced eat with not eat. Obviously, there's a lot of beer involved. It really appeals to the student in me. And yeah, theoretically, we would be able to sit outside again and do all that awesome stuff. So I booked it about 12 seconds after the dates came out, I thought be quick for the new people to be on that fast. So I have got a table some very, very excited about.

Introduction  00:59

Lee Davis and Gwilym Roberts are, the two eye peas in a pod. And you're listening to a podcast on intellectual property brought to you by the Chartered Institute of patent attorneys. 

Lee Davies  01:12

You say you're excited about it. But I've started to feel some sort of fear and trepidation about it. Or I don't know if I'm ready to go back to being social again.

Gwilym Roberts  01:21

I mentioned before I'm worried about my volume controlled in shops. Did I talk about that?

Lee Davies  01:26

Why, speak to people is if you're on zoom

Gwilym Roberts  01:28

Yeah, I don't know how to talk anymore to real people. So I don't know. I was shopping. I was talking really, really quietly and they couldn't hear me because I've forgotten how you speak in public. So I am yeah, I'm nervous that loads of these little things will be like baby chicks leaving the egg all over again.

Lee Davies  01:42

I'm terrified, someone's gonna thrust the handout and expect me to shake it . I didn't like shaking hands before the pandemic.  So for me, it's been a blessing relief.

Gwilym Roberts  01:50

I bumped an elbow recently. And even that was weird, 

Lee Davies  01:53

Hope it wasn't painful.  My jokes are getting a bit tamer. Great podcast lined up for today, we're going to be talking vaccines, which is a scary thing to talk about, because I guess vaccines weren't much on people's radar until COVID came along. We're talking vaccines and IP, which an even scarier thing to talk about, I think because, again, vaccines and IP weren't on people's radar until the pandemic coming on. We've got two great guests. We've got Anton Hutter and Frank Tietze with us and they are going to take us through their view their perspective on how IP and vaccines come together to make the world a better place. Anton, do you fancy introducing yourself to us? 

Anton Hutter  02:33

Thank you, Lee morning. Pleasure to be here. Thanks very much for inviting me. I'm Anton, Anton Hutter and partner in Venner Shipley's chemical and Life Sciences team. I'm a patent attorney. And I specialize in biotechnology with a lot of emphasis on immune related inventions and vaccines. And I've been working on a number of vaccines over the past nine or 10 months. And I'm based in Venner Shipley's, Guilford office in Surrey,

Lee Davies  03:00

Fabulous. Here, it's really, really great to have you on the pod. Thanks for coming. And Frank, how about you?

Frank Tietze  03:05

Thank you, Lee, and, Gwilym, it's pleasure to be here. And thanks for inviting me. I'm a lecturer at the University of Cambridge. And at the engineering department, I run a research group, which we call the innovation IP management laboratory. In our group, we actually look at the role and how IP is being used, put to use an innovation processes and more widely in innovation systems. And when came COVID came along, we started looking at the different innovation activities that we suddenly all witnessed. Whether it is the innovation, UK ventilator consultant suddenly being put together with new relationships being formed with different companies that suddenly wanted to innovate together, or whether it's actually the vaccine development. So the vaccine as such is an innovation process. So we follow that with interest over the past years. And besides that, we have various other research activities going on, looking at how different actors use IP strategically, but we're also looking in my research group at different technologies, such as AI and blockchain technologies, and how that will change the IP landscape and the IP industry in the future.

Lee Davies  04:17

Wow, that sounds like we've got about 27 podcasts in there, Frank. So we may have to come back to you for some of those that sounds fantastically interesting. Well, really great to have you on as well. So let's, let's kick the show off with a very, I think sounds relatively straightforward question, but I guess it's more complex than we think. And that's Can you give us some sort of overview or understanding of the history, if you like, of the patent system as it relates to medicine, and in particular, the development of vaccines, how does the patent system and the development of vaccines sit together?

Frank Tietze  04:49

So how I see it is actually, I mean, the patent system is one of the world's oldest open data repositories. So patterns are actually publications, and they serve different purposes. And the patent system, as such has different roles to play in innovation processes and systems. One important role that the patent system has, it's actually to incentivize innovation. And to give people some kind of or inventors, those who invest in our lead, who decided to do so give them an extra incentive. And by being able to play in property rights, that doesn't say anything of how they should behave, and how they should be dealing with the property they are given in exchange for filing for investing in r&d and filing for a patent application. So to me, the patent system, particularly when it comes to COVID, and vaccine development, and all the other, as we call it, crisis particular innovations, that we have witnessed having had to be developed or where production had to be upscaled to suddenly meet the spike in demand. And such as PPU. equipment, the patent system here has the role of an incentive to maximize investments that go into innovation. And that's what we needed in this pandemic. And then at some point, the patent system is also the dissemination function, the knowledge gets put into the public domain, at least partial knowledge. That's what was written down in patent applications, and then others can build on it. So these are the two functions I think, are relevant in the context of, of the pandemic. And then there's, of course, much more to the patent system.

Lee Davies  06:28

And that second part is, for me, the fascinating part because I think that's the bit that gets overlooked is the fact that what what you have there is this repository of knowledge that people can dip into and use.

Frank Tietze  06:40

And one point where we might come back to later questions here is there is this 18 month period that typically patent applications are kept secret. And one good question  in periods of crisis, where time is really of critical importance, whether one might want to look at changing that for crisis critical patent applications as for the deadline, but we really mustn't forget that the patent system was originally put in place as an incentive for companies not to keep everything secret, but to make things publicly available. And thereby it has a knowledge transfer mechanisms into the public domain, with that limitation that the knowledge can't be used for, or at least the owner as it is, with all property rights, the owner has to be asked permission to give for the IP to be used. In the same way, without the patent system, that mechanism wouldn't be available. And if you imagine Lee buying a new house, but you wouldn't have a front door, you couldn't prevent anyone from getting in or out. So the patent system in a way gives you the way how I see it is it gives you the door. And but it's your decision whether you want to lock the door and don't let anyone in to your house to share the comfort that you have and offer a good coffee, or whether you actually leave it open and have a pretty open house policy and invites friends and families to come along.

Lee Davies  08:09

If my wife was listening to this, she tell you that often go out and forget to shut the door. So you've got me absolutely there. Anton, you want to add anything? 

Anton Hutter  08:17

Yeah, I think specifically when it comes to developing vaccines for me, there are at least three or four clear time points in the research and development where you would be thinking about filing patent applications. You've got the early r&d stage where you do the initial biology and chemistry to make your drug in your vaccine. And then you'll do some in vitro or in test tube experiments. And then some, hopefully, some experiments in some animals, maybe some pigs or rodents or monkeys to see to see if there's an immune response happening. And at that point, you will file your first patent application. And I think that's also then once that first patent application safely launched, then very often, certainly in academia, and I think many companies would also be publishing academically in journals. So although you've got your 18 month patent publication deadline, which at the moment is fixed and isn't brought forward, from what I'm seeing, although that once that patent application has been filed, then the researchers are very keen to disseminate the information on the invention and aren't waiting until the PCT is published. And then you roll out your clinical trials. And you see if in humans, you get the immune response. And again, very often that generates new exciting data, in terms of administration modes, formulation, improvements, and again, you'd file your follow on patent applications and you probably publish that again before your PCTs are published. And then you do your vaccine rollout large scale as we're currently enjoying at the moment. 20 million is it now or 19 million, which Which is terrific. And again, more intellectual property is being generated, you'll hear on the news, the difference between the timings of the first primary jab and then the second booster jab. Although I think in the clinical trials they did was it three or four weeks apart, Now, there's this delay and I heard last night that actually a delay can improve the immune response now that wasn't tested and trialed in the clinical trials, because certain types of immune cells are being triggered and the inferior ones are not being triggered, because they're dying off. So without getting the details, that's very interesting. And I think that generates tier three or phase three of intellectual property, which will be patented, and published. And then finally, once we've resolved the vaccine, and we're happy with the formulation, then it's all about manufacturing and upscaling. And improvements on thermal stability. So you see, you've got through for me three or four clear time points in the generation of the vaccine when you'd be filing patent applications, and probably publishing as well to tell people what you've done rather than wait until the PCT publication.

Frank Tietze  11:13

And if I might jump in here, I think what you said at the end, the upscaling and innovations relating to that, suddenly creating these massive volume production volumes that we all need. That is an issue where I would expect at the moment innovations to happen and where we might then see later on patent applications. Of course, when when they get revealed, I think we're probably all looking forward for the actual vaccine patents to be released in a few months time to look at those. And one thing that you said, Anton, where I think it is important to mention other types of IP here is you mentioned academic publications. And that's all about copyrights, and academic publications usually get into huge publishers who put them out and too often take over the copyright and an interesting IP initiative that we've seen there is to actually make that knowledge available, and avoid that it sits behind a paywall was the Wellcome Trust pledge that they did, to invite publishers and other agencies and funding bodies to actually make these publications and data set available, open access, and there's a huge long list of publishers and other associations who have actually joined that Wellcome Trust pledge.

Gwilym Roberts  12:36

So Lee, we've got another five or six podcasts just been added to the ones that you'd identified a few moments ago, we've covered an astonishing amount of ground in the first question. Congratulations, everybody. And I think one of the really interesting points, I think, Anton, you began on this, in the sense, was looking at the two of the big reasons for the IP system. And whether I think it's been a bit of discussion around about what we know, there's a lot of anti-vax going around, there's also some anti patents going around as well, because of these concerns about exclusivity. And as you would predict, closing the front door, and so on, you do a brilliant job of reminding us all that I loved your phrase, it is the world's the world's world's earliest Open Data Repository. And I think it's always worth reflecting on the fact that if anybody ever wants to know anything has ever been done, technically, in the last 200 years, they can find it really, really quickly using a perfectly globally acceptable classification system. That's astonishing. For me, I agree, it's incredibly important reason for a patent system and indeed, don't stop me on AI, and how important is going to be to make sure that we use cases 

Lee Davies  13:44

Please don't start him with AI. 

Gwilym Roberts  13:47

How important is going to be for the patent system to be documenting some of the core technologies there anyway, let's get back to get going back to vaccines. Yeah, there has been some concern hasn't know that the patent system, or fears by maybe people that don't know quite so much about the system, that the patent system may be used to block access to the vaccines or to control the prices of vaccines and so on, too strongly. And I wonder personally, whether it's a balance at the moment between the different aspects of the patent system that needs to be struck between the incentivization of research, and in the end, that's a commercialcarrot, if you like, versus I personally feel the ability of using the patent system to make sure that people can collaborate better, and ensure a fair reward. Do you think that the balance has been struck? Do you think the government perhaps needs to step in and think about that a little bit?

Frank Tietze  14:42

What I would definitely say here is that and we've seen some empirical academic studies in what is called Open Innovation Research. So which is very much about different actors collaborating, often, companies collaborating together, and I think that is pretty relevant here. And what those studies have shown is that IP really, really has a role to play and particular patterns are really important to enable collaborations. And that has triggered a large debate in the academic circles to actually say, how should firms suddenly behave differently? And how should they treat patents differently. So there is, as I said, the evidence that IP basically builds a bridge. And it's just only by actually being able to have these property rights in place and I think we know that from very well established economic theory that for all kinds of markets, the allocation of property rights to different actors, a clear allocation of property rights is really important for markets to function. And I think the same argument goes for collaboration, that by clearly being able to allocate IP to the different parties that enables efficient contracts to be signed between the different actors. Now, it's not often that actually that easy. The challenge comes with actually specifying the background IP that different players bring into a collaboration. And that is, as I've also mentioned, copyright before. And it's not just all about patents, patents may play a key role. But there's also the trade secrets. There's other know how, someone mentioned before data, that large data sets can play quite a role, I think Anton said that when he talked about the vaccination development process. So yes, is the answer that patents and other IP rights really play a role to enable collaboration, so that different partners can can really work out the contracts and the relationships, how they work together. And then obviously,  there are the issues about the foreground IP, how do you split that up? And I think there's more research to be done and then one could really discuss that certain firms or maybe even universities have particular ideas about them owning all the foreground IP that comes out of certain research, and there might be different licensing models that we may need in the future, dealing better with future crisis.

Gwilym Roberts  17:20

Thank you. So Anton, this question about whether the patent system is getting a slightly bad press at the moment. People are concerned about the possibility it can be used to change the pricing of vaccines or reduce access, obviously, like you I'm a patent attorney, and we tend to look more on the the patent owner side. And we tell our clients are all patent owners. Do you find there's a sensitivity and awareness amongst your your clients that they're aware that they need to look at the public mood in this area? 

Anton Hutter  17:51

Yeah, I think from the clients that I'm working for, in particularly in the COVID area, which is detection, everybody wants to have a new diagnostic, a home mobile phone related app diagnostic to vaccines, people realize that for the greater good it shouldn't be all about making money. And there is an element of altruism here as well, which is very refreshing. We know that in the press, at least three or four of the approved vaccines are being sold at nothing more than cost. There's quite a variety in costs, because some of them are done one, for example, the messenger RNA vaccine was very expensive to make is very complicated and so I think there's about $20, but those, the Oxford and the Pfizer vaccines are just small number of pounds. So if this were blockbuster drugs, these would be costing significantly more. So I think it's good to see that the pricing at the moment, at least for this phase of COVID-19. We're not seeing large prices being put on the gaps.

Frank Tietze  19:03

So I think I mean, if I could go back here to one of my earlier points that I said about the kind of alternative to patents. And one of the reasons why the patent system was originally put in place is to incentivize sharing. And the fallback option here is that without patents, you can go back to trade secrets or companies go back to trade secrets. And we mustn't forget that and the reason why I'm emphasizing that is because I think there's still in various communities, a lack of understanding what the patent really is. And as I said before, it is essentially at the beginning, only an allocation of ownership rights. So someone gets an ownership title for something they have invented. And your point Gwilym was about the kind of bad press that might be around patents in the when it comes to vaccines, but maybe why the medical or maybe even in the humanitarian communities, I think the misperception here is, maybe that will be a bit of a job for CIPA as well, would be to really clarify that to certain communities, that it is more about the behavior of the owners of these patents, that maybe has a kind of negative impact. And that has created the negative perception of patterns in certain context. So the allocation of ownership rights, but just giving someone a title does not mean others are not able to use it, but they just have to ask permission. And then it's up to the behavior of that owner of that IP. And things have somehow gone wrong, maybe in the past by some of the actors, large scale patent portfolio owners having adopted certain strategies that may have shaped negative perception here, and it comes down to clarifying that, and, and correcting the, the kind of, let's say, the negative connotation that a patent may have for certain communities. And very sadly, we have for one of our other research projects, where we look into the relationship between IP and sustainable impact, environmental, but also social impact that it can create, and how IP is being used. We did a recent interview with a French company and what we heard in that interview made me almost a bit sad. But that story was exactly the company used patents and it was criticized for using patents and then it reverted back to stop filing patents and keeping things more secret. And that actually doesn't help anyone. 

Gwilym Roberts  21:44

No, it's a catastrophe. Which is why as I say, I'm worried about the AI side of things. By the same token, it's quite interesting. Lee,

Lee Davies  21:51

I've got friends Gwilym, you, I know you might find this difficult to believe, but I -

Gwilym Roberts  21:54

Stop there, stop there.

Lee Davies  21:57

And occasionally I have conversations with them. And that's another that's equally as scary, unbelievable. And but they sort of know what I do, but they don't really understand. I don't come from the IP world I come from the board of education and professional associations, and I've, over the last 10 years, I've learned a huge amount about the IP space. So they asked me questions in in kind of real laypersons terms. So one of the questions I was asked, I'd like Anton and Frank's perspective on this is, I think people are used to the fact that it takes a long, long time to get medicines, particularly to market. Lots of research, lots of development. And I've heard people say that, you know, it's the patent system that slows things down. It's a barrier to rapid innovation. We've not seen that, in terms of the development of all of the COVID vaccines. So why was it different this time? Or is the perception wrong?

Anton Hutter  22:53

To in less than a year, we've now got four approved vaccines and more in the pipeline. I think it's important to realize that it's not as if the research started from scratch last January or February, Oxford, Pfizer, Moderna, they've all been working on vaccines for years, way before the coronavirus outbreak, and I think the great thing about molecular biology biotech now is  that all you need is a genomic sequence, a protein sequence, and that's what they got in the middle of January. I think the genome for this current COVID-19 Coronavirus, was released, all of the researchers grabbed it and very, very quickly in a small number of days, I think 10 days, you can then immediately create what is your initial vaccine, you just need the sequence. They generated the sequence to the spike protein that's the bit on the outside of the protein that hits and targets the cell, the host cell on a certain receptor. And so they thought, well, that's the bit that we need to be targeting for an immune response. That's the important part of the virus. And so using essentially I'm simplifying it but essentially a plug and play system, all of these different vaccine approaches, you've got the DNA, adeno virus Oxford approach, and then the mRNA approach that Moderna and AstraZeneca are using, all you need is a string of letters from the protein sequence and then you can very rapidly convert that into a nucleotide, which then becomes your vaccine, and then can be injected into the rodents as I said a few minutes ago, and then eventually if you get the immune response in rodents, and that looks promising, then you can roll that out as we did very quickly, assuming it's the toxicity is low or zero, then that can be rolled out into the human preliminary preclinical trials. So yes, we have vaccines in less than a year, which is fantastic. But I think it's really a testament to how advanced biochemistry and the biotech industry has got over over the last two or three years.

Gwilym Roberts  25:13

I've got a theory about crises such as the one that we're in, which is that I think everyone knows the crisis drives innovation. But I've kind of vaguely researched theory that it doesn't create new innovation so much as finds a home for existing innovation. An example I use is from the Second World War, where they've been loads and loads of work prior to the second world war on radar. But it wasn't important. It was just the long term thinking and suddenly became incredibly important and as we all know, now we have microwave ovens as a direct consequence of that amazingly! Anyway, I'm looking at this aspect here. I'm going to go completely out of my technical zone here. I heard a little bit about the use of I think mRNA, I think that's it for me and biotech. But I gather that we might been quite seen quite an acceleration of the technology there to maybe use that for some of the vaccines. Is that right?

Anton Hutter  26:10

Two of the vaccines are messenger RNA. That's what the M stands for. Yeah. So as opposed to DNA, which is what the the Oxford vaccine uses, messenger RNA is the encoded transcripts. So it's sort of halfway between the genome, the DNA, and the protein, messenger RNA, is that messenger.

Gwilym Roberts  26:30

And was that was that is that quite a new technology? Or a new use of that technology? 

Anton Hutter  26:33

It is, yes.

Gwilym Roberts  26:35

Yeah so my theories right?. Whoo. 

Frank Tietze  26:38

I think, to your point about whether we really see, like radically new innovations being developed in crisis, and I think the question that Lee posed about whether there are delays, because of the patent system, when it comes to vaccine development, I think the important academic concept that I can chuck in here is called cumulative innovation or innovation trajectory. So we have to look at those. And there are certain fields, where, let's say the IP landscapes or patent landscapes are really fragmented. And then again, it comes down to really difficult, fragmented ownership situations, which come with certain problems to actually make things work. And if you have accumulated innovations that happened, let's say, in the electronics space, where you have various different owners owning different bits and pieces, and it gets really complicated, then we might have some, let's say, deteriorating, slowing down effects of the patent system. But in other areas where there are fewer actors and where IP  rights are fairly and clearly allocated to the different actors, and if then there is the willingness to collaborate and make things work and I think that's what we've seen, in at least certain sectors related to the current pandemic, is that there was really a willingness to work together and a willingness to collaborate together, and then things can make work and then there's more than just IP that to make that collaborations work. And over time, a number of incremental innovations stacked on top of each other can be leading to quite some radical different changes. But again, we shouldn't also be forgetting, as Anton has pointed out, that the mRNA technology was actually also developed for a long time, before the actual COVID pandemic has happened.

Lee Davies  28:42

Can I um, keep us on the sort of heavy science side for a bit if that's okay. I won't pretend for one moment that I understand oh, I won't. I've heard phrases like spiky protein, I thought that was some kind of milk drink, but the one thing I do understand, I think is that this thing is not going to be over quickly. We're hearing in the news all the time that probably we're going to end up in a similar situation to other things such as influenza, so annual boosters, we might see new strains of Coronavirus that will require either modified or new approaches to vaccination. What are the IP implications there?

Anton Hutter  29:20

And so I think every year we will see new outbreaks and new variants. And some of these variants will be protected by existing vaccines but for me, it's inevitable that the evolution of the virus - viruses are clever little things you have to have a certain amount of admiration for them afraid to say because they are so simple and all they want to do is is breed and they need a host to be able to do that. Unfortunately we are the host. So they will evolve with only one MO and that is to improve its chances of infecting a different host and or improving it's its rate of division, it's not in its interest, evolutionary speaking to kill its host. So I think that's something that you have to bear in mind. Obviously, the numbers not good at the moment, but I think it will evolve. And in a few years time, and I can't say if it's next year or the year after, but today's vaccines will not vaccinate us, as well as they are today. I mean, the numbers that we're seeing on efficacy are fantastic 85, 90, 95% these are unheard of if you think that the current influenza vaccine is only about 50 or 60% efficacious. But that said, I think in a few years time, we will have to have a new vaccine, I think we will need annual jobs or perhaps jobs every two years, as we do influenza. And the future virus that we really immunizing against will not be the same virus that we're immunizing against today, the spike protein will have changed in some way. And so I think new patent applications will be filed to these new variants, whether or not they're novel and inventive criteria for patentability remains to be seen, but I think the innovators will have new products, new vaccines, new formulations, new methods of manufacturing these new vaccines. So there's a whole host of potential intellectual property there that may well be protected.

Frank Tietze  31:27

And I mean, I've mentioned this academic concept of cumulative innovation. Now there's another one, which is called continuous innovation, right. And that's what we need, we will, in order to cover the new variants with vaccines, they will have to be developed further. So there needs to be further investments need to be channeled into research to understand also, maybe not just to be reactive to the changing different types of the spike protein, but to understand how that process works, and there will be more research being funneled into. And then again, we we have that dilemma, which it comes down to that we have to maximize investments. And that's where patents are one of the mechanisms to do that. But at the same time, we have to make it available as a tool to the public. And there's the big debate about access to medicine. And somehow the original mechanism of the patent system to get maximum 20 years kind of protection, that can be debated. Obviously, if we wait for them for 20 years for the new technologies to be available, then the virus will be up and away and massively in front of us. So we will have to maybe think more about how, whether there are any new mechanisms that we can really develop, that we maintain the incentive mechanism of patterns to maximize investments in continuous investments to address the changes of COVID virus. And that at the same time, we have to think about the way we've maintained that investment incentive how we could still come up with ways to share that IP. And there are existing mechanisms, as you all aware that compulsory licensing is one of them, but that has never really been triggered because it comes with severe implications on the kind of market. And as we all know, trust plays a big role in industry. So we may have to think about other mechanisms there to kind of get hold of that dilemma that we have to maximize investments where patterns play a good role, but also making this available and maybe some softer forms of these kind of compulsory licensing regimes with also patent pools. But we also know from the past that setting up patent pools are extremely difficult. It often takes a good amount of negotiations between different partners and that could be a lengthy process. So maybe that's also  not a perfect tool in a pandemic, where time is short. Right? 

Gwilym Roberts  34:16

We saw things like the open COVID pledge, didn't we as well. So that was some collaboration levels there. 

Frank Tietze  34:23

Yeah, of course. I mean, I could talk more about that, as I've been involved in that one. And, I think the open COVID pledge is one example, but actually, there are other types of pledges. I've mentioned the Wellcome Trust, an initiative to kind of temporarily pledge Copyright by making publications and data set available for the time of the pandemic, that's a pledge to copyrights and I do think that the pledge mechanism is interesting. And we could for instance, think about funding contracts, government funding contracts for r&d investments, and including some form of pledge clause potentially in the future. And that could also be an instrument that could be used in in government procurement contracts or vaccines. But that comes down to, again, in comparing pledges to patent pools and compulsory licensing regimes, pledges are fairly young instrument, and they are not so well understood. I don't know, to what extent really, policymakers have really heard about patent pledges and if they understand what it means, but that temporary self executing mechanism, linking a pledge to an organization such as the WHO, announcing a global pandemic and then ending a global pandemic, there are really good mechanisms that can be used to design clever pledges. And I think that's an instrument that we should be looking more at to help with future crisis,

Lee Davies  36:07

Sticking with the pharmaceutical companies as businesses model. I know businesses need to be profitable to survive, that would have presumably factored into the approach to developing vaccines. But I also know that governments around the world and charitable foundations and even private individuals have put money into the development of vaccines. Probably an unfair question, because it's maybe off of our collective radars. But are there strings attached in relation to ownership of IP rights when you've got this multiplicity of funding streams?

Frank Tietze  36:43

It kind of links back to my answers I gave just a second ago. Obviously, I don't know that for sure. Obviously, lots of these contracts are kept confidential. But if I think about some kind of grants, governmental funding grants that I had, for my research, there's typically not much IP related to it. So it comes down to the university IP policies to decide which way they want to go. But that's why I think, as I mentioned just a second ago, a pledge, maybe not as a separate entity, like the open COVID pledge, but a pledge clause could find its way in the future, maybe in governmental funding contracts. So to give you an analogy here, and what the research councils in the UK are now doing, they are pushing really, for research results that come out of Research Council funded projects to be made available open access, right. And that's a kind of requirements to make the published IP, or copyrights available to the public and don't put it behind the paywall. In the future, we might not see that same with potentially patentable research results, I would not advocate for that. But what could still say that in these contracts, there should be like an emergency clause for pandemics or global crisis, that wouldn't prevent the universities for instance, to file patents and go for spinouts. Because we all know that investors really are interested in the founders being able to say we have a patent, and that helps them to attract investments again. But there could be that emergency clause in these funding contracts, which basically says, you can do whatever you want, you can go for your startup, you can start a company, but in terms of a global pandemic, you will have to make the patentable IP available for the duration of the dynamic. But then again, we shouldn't forget that there's more than just the patterns. It's often the complimentary know how that we need to actually enable the large scale production facilities to scale up vaccine production as what we are needing now at the moment.

Lee Davies  39:14

It's an extraordinary sort of scale up problem, isn't it? That this must be something that we've never faced before in terms of the physical volume of medicines that we're needing to produce.

Frank Tietze  39:25

But to your point, I think there are these two challenges, the one that Anton mentioned, there's continuous research that has to go into the kind of further development and adjustments of the vaccine so that it maintains effective against future mutations and variants. At the same time, the production scale up but also then the global logistics to actually ship it around the world. So that is a challenge we haven't really discussed today and subject to completely another story. But I think IP really plays a role in both of those. But again, patents are only part of that puzzle. And if we ask, for instance, there's this case that Sanofi is also now producing the Pfizer vaccine, and Anton, you may know more about that, but I think they have come to an arrangement there to make this work at the moment. And that, again, shows that if there's a willingness of the actors, then that can all be sorted. Patents again, as I mentioned, at the beginning, they allocate ownership rights, which is important to attract investments and be able to make certain decisions but in a pandemic, there's much more that is needed in terms of collaboration, goodwill, and the willingness to engage and share and jointly innovate.

Anton Hutter  40:55

The other thing to bear in mind is patent applications, if the patent attorneys doing his job properly, it won't be specifically protecting only the COVID-19 that we're having to deal with today. So, patent applications for detection of the virus for treatment for vaccines for drugs, and so on, you would hope that the claims of those patent applications are covering not just COVID-19, but other viruses and future pandemics and so on, or non pandemics and so to uncouple, the pandemic and pressing urgent needs today, and ownership of those IP rights from less pressing, still obviously important, because you're saving people's lives, but I mean, how many patents are there on heart disease, and no one has a problem with those, or cancer, for that matter how many patients are unfortunately dying every year, it's just because there's a lot of emotion, and I can understand it, but it's very emotive, this pandemic, for good reason, but I think we need to just separate the emotion and think about the reasons for the patent system that you alluded to a while ago and make sure that we don't then dilute those reasons for the patent system, and ownership and enforcement's and so on, for something that is, as I say, we're dealing with right now, but hopefully, in six months and a year, it will be the norm. I mean, I think we will have to have annual or biannual jobs and we'll look back on this and think, oh, well, we got through it and the patent system did work and it actually fostered and stimulated the innovation and that's why we've got four vaccines today. I think if we didn't have the vaccine patent system, we probably wouldn't be here having a nice choice on which vaccine we want to have put into our arm. So, we have to be careful, I think.

Lee Davies  42:54

It's been a brilliant podcast, and thanks, guys for the opportunity to talk to you. For me, there's been some ups and downs, there's been some kind of hope for the future but also there's been some talk that perhaps, still lets us know that we've got a long way to go. Let's finish on the positives. So, Anton first and then Frank, what are your big take outs from the last year or so, what have you learned, either from the kind of vaccine side of things, or the patents are the things that you're going to take with you in and onto the future?

Anton Hutter  43:25

Well, I can be quite philosophical, if you like, and I think we do live in a capitalist society and as long as we live in a capitalist society, we do need intellectual property to protect and encourage R&D. And I've seen that, I've been very busy because of some terrific R&D that has come out because of the knowledge that it will be protected by intellectual property. And I expect humanity will move beyond money and the capitalist society at some point. If a virus hasn't wiped us out beforehand.

Lee Davies  44:00

I said keep it upbeat Anton!

Anton Hutter  44:05

But I don't think any of us are going to be around to see that day. So the system that we have works and the naysayers, I think we have to explain to them why the IP is very important in medicine and as I say, it's an emotive time because of what's going on globally but let's just think about other conditions where people are unfortunately dying as well and the patent system is fostering - we have terrific anti-cancer drugs and other diseases being treated - so I think that's what the last eight nine months has made me realize

Lee Davies

Fantastic, how about you Frank?

Frank Tietze  44:45

Maybe just to pick up one of I mean, Anton mentioned different types of drugs and there are difficult questions around the pattern system and I agree with you Anton that all the good drugs we have that save lives every day - also to mention HIV drugs - it's very difficult to really establish whether we wouldn't have them without a patent system. That is a counterfactual question and extremely difficult to even empirically to get your head around that. But the point is, we have them. And the patent system has played a role there. And I would go along the lines of what you've said, that probably we have them, because the patent system provides extra incentives that helps to maximize investments that go into the development of the drugs and that helps accelerate that process. So, one of the really big learnings for me, has been we haven't looked into pandemics before, but that has been really, really interesting to look at the pandemic, as an innovation system or innovation process and I think one of the really big learnings is for us is to see there are different phases along the pandemic. And when it comes to vaccine development, we have that R&D phase, including the scale up when we have to maximize investments that flow into that phase. And then at some point, the narrative changes and we all know that we can only end that pandemic, if it's not just the UK or Europe or Western countries that are vaccinated, but it has to be a global vaccination campaign. So, we have to make that knowledge transfer. And that's where we may have to think about new instruments and new mechanisms that are maybe not as strict as the compulsory licensing regimes or crown use, but some other forms of mechanism that really can better combine these two massive purposes that we have, and they can appear as a dilemma. So there's a need to build bridges between these two different phases in the pandemic. And as I mentioned before, some mechanisms that could be borrowed, for instance, from the open COVID pledge, or from some kind of licensing constructs that could be for instance, put into funding contracts could maybe help with that. And we need more research to really figure out how we can better handle that potential dilemma in the future.

Lee Davies  47:19

Thank you. Gwilym, it’s been a long time since I've asked you if you've learned anything recently. Have you learnt anything?

Gwilym Roberts  47:24

I've mentioned breadmaking? Haven't I?

Lee Davies 47:29

I know, you can't do breadmaking? 

Gwilym Roberts 47:31

No, I'm sure I've said this before, I think I'm continuing Anton's philosophical trend, but maybe broadening it even further. I think it's been quite amazing and heartening to see people aren't as bad as we sometimes make out. Not answering about Frank. He’s great. I mean, humanely. The jury's out on you Lee, you know I mean humanity at large. You know, we've seen amazing collaborative efforts. We have seen, I think used with altruism Anton, I think that's exactly what we've seen. We've seen huge collaboration, we've seen huge sympathy, we've seen misbehavior, as well. And I think I've also mentioned that you're seeing huge, great leadership to every level, and everyone has stepped up and dealt with all of these issues, has shown leadership in a personal or professional or whatever capacity. So there's a lot of positives, actually, it's been a tough, tough time for so many people. But it's kind of reaffirmed a few of the things I hoped were there. And I guess that's what crisis does. What about you Lee?

Lee Davies  48:31

Yeah, I was thinking about that. So aside from the conspiracy theorists who can kind of run off and live in their own world, I think the thing that I've lost much learn, but it's been good to see return is the place of the expert. Because, you know, five, six years ago, we were being told the world was fed up with experts. I know, that was largely rhetoric from a certain quarter. But that did that did start to bite and people did start to sort of distrust experts. So for me, the big thing has been, we needed expertise to get us through this. And we have to trust people to get it right. And look, they've got it right. And that's, that's been a brilliant thing. So for me, the biggest has been the return of the trust in experts. Well, Frank, Anton, it's been absolutely great having you on the podcast so thank you very much for sharing your time with us. Gwilym its all right to have you here but I might need to start to look for someone else!

Gwilym Roberts  49:28

You've got to go and have conversations with all those friends now haven’t you.

Lee Davies  49:33

Yeah, well, you know, actually made them up.

Gwilym Roberts  49:36

We know!

Lee Davies  49:38

Well, we’ll say goodbye, and as long as you don't get wiped out by some great cataclysmic event between now and then. I'll see you next week.

Gwilym Roberts 49:47

is a good one.

Frank Tietze 49:48

All right, everyone.