Subscribe
Share
Share
Embed
The Official Podcast for the Minnesota Law Review - https://journals.law.umn.edu/mlr
Lee: Hello and welcome to the Experto Crede podcast. I�m your host, Lee Silberberg. Online editor, Volume 6: The Minnesota Law Review. Today I�m very lucky to have a special podcast episode with Mr. Jasper L. Tran, Mr. David Gindler. Jasper is an alum of the University of Minnesota; and Mr. Gindler is a very, very valuable voice in the current topic we�ll be talking about today but because that topic is a little bit out there, I�m going to give Mr. Tran and Mr. Gindler the space to talk about and kind of introduce it. So, Mr. Tran, Mr. Gindler, thank you for coming on with me today
David: It�s truly our pleasure. I was delighted when we were asked to do this podcast episode because I do have a connection to the University of Minnesota, my father is a graduate of the University of Minnesota; both as an undergraduate and from the law school. Back when he went to school, you probably could go through both undergraduate and law school in 6 years. Not that that�s terribly advisable, and I think my father would tell you that it�s not terribly advisable, but that�s what you could do back then, so I�m truly delighted to be part of this podcast.
Jasper: Yeah, I echo David, well, my father didn�t go to the University of Minnesota, but I myself went to the University of Minnesota Law School and I also served on the Minnesota Law Review, so I�m happy to be back in a different capacity and speak about exciting, IP topics and Covid.
Lee: We�re lucky to have y�all. So, to get right into it a little bit, today we�re going to be talking about, as you said, some topics related to IP and its intersection with Covid, especially relating to how the IP laws are dealing with vaccines versus small molecule pills and everything that�s going on with that. Before we get into that, I�d love to know a little bit about y�all, your practice and Milbank, since I think this is a fairly rare opportunity to talk to individuals who are practicing attorneys inside the private sector as opposed to the halls of academia.
David: Thank you for that opportunity. You know, I often say I have one of the world�s best jobs. What do I mean by that? People pay me money to learn how things work. That strikes me as a terrific job to have. So, in the role of Intellectual Property, I get to work with start-ups, large companies, Universities, non-profit institutions, all who are trying to deal with cutting edge technologies. One of the really fascinating parts of my job is: we�ll get hired to work on technologies which are going to be introduced next year or the year after. I get visibility into things that will dramatically change the way people get health care, the way people interact with technology. This is a remarkable opportunity and I�m very grateful to have that at Milbank. We�re not technology centered in any particular field here. We work in, and that�s a great benefit to my practice, everything from life sciences, pharmaceuticals, electrical engineering, computer science, wireless technologies. We�re sort of all over the map, and that makes our practice really rich and diverse. We also represent people on the plaintiff side, on the defense side; and I�m not just involved in Litigation. I get to be involved in licensing discussions off and on behalf of universities who are licensing for profit institutions on their research, which is extremely gratifying. So, this is work where I feel very privileged in many ways to be entrusted by whether it�s a university, start-up, or a well-established company to help them deal with their IP rights. IP rights truly drive innovation in ways that many people don�t see, but which I�m lucky enough to even have visibility into that. Jasper, what do you think?
Jasper: Yeah, I agree with what David is saying, I would just emphasize one thing that David mentioned; I don�t think other law firms really have this, is one of the things that differentiates us is that we represent a balanced mix of both plaintiff and defendants, and you see a lot of big firms represent mostly big corporate defendants. So that�s kind of just like, if you want to litigate from the plaintiffs� side, you have a chance to do that here and one other thing I mentioned that differentiates us from other law firms, and I say this with a slight chuckle, is that students may have heard our name being linked to certain scale related to associate compensation, and that law students may have heard Milbank is the market leader in associate compensation especially just less than a month ago � we have been the first to raise associate salary four times in the past five years. They name it the Milbank scale, and we have been quite intentional about it so maybe if we get into that a little bit, David can speak more about � from the partnership perspective that might interest the students.
Lee: Pay scale is very important. Compensation is a very valuable part of law school experience and something that students definitely need to learn about. I know that I came in had no idea of any of it, so I think it�s very valuable. To begin a little bit, so I appreciate y�all giving an introduction about Milbank. How did you all end up in this area, in this field? Was it a direct route to this, honestly very, very technical are of the law, but probably, as Mr. Gindler pointed out, very fun and satisfying place to be?
David: Well, I owe it all to the Los Angeles Dodgers. So, what�s that connection? So, you know, I graduated from law school in 1984, just to date myself, and I was a litigator doing many different kinds of things for the first, you know, basically 12-13 years of my practice. So I�m at a Dodger game in 1998, and I�m with a law school friend who just took a job as general counsel of a non-profit research center in Southern California called �City of Hope�. And at the Dodger game, he very casually says to me: �David, can you run a conflict check and can you represent us? We may have a dispute with a big Pharma company.� And I said: �Okay, I�ll run a conflict check.� So I ran a conflict check, we didn�t have a conflict, and so, we got hired and involved in a huge patent licensing dispute, which is all a matter of public record between City of Hope and a large Biotech company called �Genentech�. That turned into a significant lawsuit which we tried and secured a very large verdict. At the time, it wound up being the largest verdict ever affirmed by the California Supreme Court, we ultimately collected over 500 million dollars for City of Hope and that got me a little bit of attention and then you get hired by other people who have technology issues. And then slowly, I got more involved in it. But I have to tell you that I was completely hooked in doing this area from the City of Hope case because I loved learning about technology, and I loved being able to talk to jurors about technology and to teach them. One of the more memorable days in court that I had was in that trial for City of Hope. I had to have a � I had one of the inventors of the patent at issue explain the technology, which involves tricking E.coli into making human proteins by changing the DNA of the E.coli. And so � the witness, whose name was Arthur Riggs, was on the stand and he had a Kleenex box, and in that Kleenex box he had unspooled reel to reel tape. And I said: �Doctor Riggs, what do you have there?� and he says: �This is E.coli� I said: �Looks like a Kleenex box� he says, �nope! This is E.coli� I said: Does it look like Kleenex box?� He said �yeah, it has a rectangular shape� I said �So, how did you actually do this little miracle of persuading E.coli to make human insulin?� which is basically what he did. He said �Well� he reaches into the Kleenex box, he pulls out a clump of the tape and says, �This is what the DNA looks like inside of E.coli. So, how do we put human DNA in here? Well we have to use a scissors, regular scissors are a little big, we use a chemical scissors and we make a snippet in just the right place, and we insert the human DNA into the E.coli DNA. There are chemical bonds we can do to repair the breaks, and then we put the E.coli back in a culture medium where it will grow and all of a sudden, now I have E.coli that will do something for me; it will make human insulin.� And the jurors were literally on the edge of their seats listening to this because it sounds like science fiction and the ability to have a scientist explain really profound discoveries and tell it to jurors and have them understand it and appreciate the impact it has on society and on their own health. I was completely hooked. And that has been the focus of my practice; a lot of my practice is in life sciences, but not all of it. You know, I can provide many other stories like that, but it really tells you sort of � how rewarding I find what I do.
Jasper: I�m a little bit different than David, I don�t have that much experience in the field yet. I�m still a seventh-year associate. I have a more traditional IP Litigation career path in the sense that I have a science background, I heard about the right of inventors and about invention in a chemistry class, which sparked my interests about IP law and led me to law school; and I pretty much focus mostly on IP classes in law school, in addition to the traditional doctrinal classes. I wrote my school papers in IP technology & law topics, I did two years of patent prosecution during law school and I�ve always been passionate about IP law and I�m what people would call a legal nerd, and I often share my thoughts on the current trend of legal scholarships and focusing on IP law and Technology law and health law. And I currently represent patent owners litigating two infringement matters against Tesla and Medtronic, both with David as lead counsel. Medtronic is headquartered in Minnesota, so law students might have heard of it.
Lee: Awesome. Well, thank y�all so much for that, I really appreciate that background. To kind of get into it a little bit, so today we�ll be talking about open-source intellectual property and its impact on biotechnology and generally all of this intersecting with Covid. This is a technical subject very clearly, so I want to give y�all the space to kind of situate us, you know � what is this actually in layman�s terms. What�s going on? How should we understand this?
David: So, Covid is a virus. And we�ve known about viruses for quite a long time, and we learned quite a lot more of them at the turn of the century when we had the last pandemic. Viruses basically live to attach themselves to healthy cells, take them over and replicate. That�s what they do for a living. And to be able to replicate, they mutate; and that�s what they do for a living. Some viruses don�t mutate very much, in ways that they are very susceptible to vaccines. Polio is an example. You can get the same vaccine today as you got, you know � 40 / 50 years ago because it doesn�t mutate in the same kind of way. And then you have Corona Viruses, which mutate a lot. When Covid struck, the question became: �Can we reach a vaccine?�. Though the idea behind the two leading vaccines is a technology called �mRNA�. This technology didn�t come along last Thursday. It wasn�t like somebody sat around a round table in January 2019 and said �Uh, you know, what about mRNA? You think that might work as a vaccine?�. This platform had been well developed and well established and when folks saw the pandemic hit, it�s not as if people said, �What shall we do?�, No. Two different companies decided to take very similar approaches. So, okay, what is mRNA? Well, mRNA is a biproduct of DNA. We all know that DNA is the blueprint of life. DNA is in your body and it codes for proteins; that�s what the DNA does. But how does DNA create a protein? Well, it first has to be turned into what�s called Messenger RNA. Messenger RNA is the intermediate between DNA and getting the protein. And how does mRNA produce a protein? That�s the magic of cells. Cells know how to do that. But what scientists did, is they thought, �What we need to do for a vaccine is what all vaccines do. They provoke an immuno-response.� The human body is extraordinary in its ability to fight off disease. The adaptive immune system is just remarkable. And so all vaccines are premised on the idea of provoking an immune-response without harming the individual by provoking the immune-response. So what did they do? What they did was first actually sequenced the Coronavirus. That�s actually really easy to do. You can buy desktop sequencers. You know, that was not the hard part. They had that done quickly. Then they have to decide, okay, so now, what part of the Coronavirus could we actually make a little copy of that will not be harmful to people and that will provoke an immuno-response. Well the Coronavirus has a very specific structure. It has the site proteins on the top. And so they said, �here�s what we�ll do, we�ll simply create mRNA that codes for the site protein. So, you take the mRNA that�s coded for the site protein, you then put it in a little vessel, like a little nano particle, and there�s a whole different set of technologies about how to make nano particles. You put it in a nano particle, and then you inject it into a person. And then that goes into your human cell, your human cell sees the mRNA and says, �mRNA? I know what to do with that!� It turns into little copies of the site protein, which are completely harmless, but your body says, �Site proteins? Those don�t belong here. I need to mount an immune-response� And your body produces antibodies. And the same antibodies that will go and attack the site protein, will go and attack the Coronavirus if it ever enters your bloodstream. That is the magic of both the Pfizer and Moderna vaccines. Though, you know, one of the leaders in this field is a woman named Kizzmekia Corbett, who was of the national institutes of health. And, she rather matter of factly said, �You think we can manufacture an mRNA vaccine to Covid?� Her response: �Absolutely!� And she was absolutely right.
Jasper: I would emphasize what David is saying that the mRNA technology and nano particle technology � the tiny container that contains the virus the mRNA to inject into the human body, the new technology is the very first time we ever used it in a vaccine. And that�s what made it really difficult for other people to replicate, even though the patent is already public.
Lee: Kind of going off that, so that�s honestly an extraordinary story and one that I think I was � I would say I was exposed to as I�ve listened to other work that you�ve had, Mr. Gindler, but also just kind of doing the research for this podcast. I�m curious, where does the law come into this? Because clearly there is a conflict system of scientific discoveries and development that goes on, but I imagine that can�t be too separated from the kind of work that you all do.
David: You�re exactly correct. So, what drives innovation? Well, many things drive innovation, but intellectual property rights are designed to drive and reward innovation; and they do so in a very interesting way. So, patents are a bargain. They�re a bargain between our society, our government, and individual innovators. And here�s the bargain: the bargain is, if you disclose every little thing about your invention, you cannot hold anything back � you have to disclose everything about it to allow every person who is skilled in your field of technology to replicate it. If you do that, and if the Patent Office decides that what you have come up with is different enough than what came in the past, we�re going to give you a patent, which is the right to exclude others from using your invention. That�s the only thing a patent does. A patent doesn�t enable a patent holder to do anything. You always have the right to engage in business to make whatever you want. A patent is the right to exclude. You get, essentially, a monopoly on the use of your invention for twenty years from the date of the application in exchange for telling the world how you did it. And why is that an important bargain? Because the other scientists can look at your work and say, �I can do better� and that is how science progresses. Everyone builds on everybody else. So how does that apply in this area? What drove the innovation behind mRNA technology? Research spurred by IP rights. That�s been true from the dawn of the technology era. What�s important to keep in mind is that biotechnology companies understand the principle. They understand that innovation not just helps them, but competition is healthy. And what I�ve seen, is that foundational patents in the biotechnology arena are not hoarded; they are broadly licensed. I can give you two examples, which are remarkable. You know, Genentech was founded as the first biotechnology company, and they came up with foundational patents about how to express human proteins in bacteria � Which they widely licensed to anybody who wanted it, or products that did not compete with a Genentech product. You wanted a license, you can have one. The same thing is true for another technology by Genentech developed, which is a special kind of genetically engineered antibody; the patents were widely utilized and licensed to anybody that wants it. As long as you�re not competing directly with another Genentech product. Everybody�s got a license. Why is this good? It�s good because it promotes the well-being of society, it�s good because it advances science. So when I hear doomsday predictions, that IP rights are going to crush innovation and are going to impair the distribution of vaccines, that�s basically not my experience in looking at the history of biotechnology. There are huge challenges to distributing a vaccine on a global basis. Huge challenges. But do you know whether patent rights have impaired that distribution mechanism? Not at all. Zero. There is no impact on patent rights in getting vaccines out. There are huge challenges in getting them out because they�re not easy to manufacture and not easy to store. The vaccines are a special kind of drug called the biologic; mRNA is biological material. That is not the same thing as making Lipitor, because Lipitor is a bunch of chemicals you put together � it�s a much different manufacturing process. There�s a lot of expertise that�s required to scale up and manufacture with essentially a biologic and then to put it into a nano particle. That�s not east stuff to do. So, it�s remarkable in my view that smart scientists were able to come up with the vaccine harnessing technology in the short period of time that they did. But a lot of this is driven by smart IP policy, which drove innovation to where it was to where we can turn around and change things. You know, that wasn�t true in 1918 when we had a worldwide pandemic which was very, very scary. And it was scary in ways that the current pandemic is not because we have the ability to prevent, and I think soon, the ability to treat.
Jasper: To sum up some of the points David is saying and to add some more colors to it, when companies license a patent, they really tried to recoup research and development they put into coming up with innovation. So that�s � and companies don�t really exclude others in the sense that they just stop them from doing a certain activity, rather than they just collect royalties when the other people do it. So that�s one distinction I think people really don�t make when they hear these patent waiver discussions. And when David talks about the distribution issue with vaccines globally, he�s talking about the manufacturing process that comes into the issue with the lack of raw materials supply chain issue that�s going on around the globe; lack of human resources in terms of skilled scientists are making mRNA vaccines; we have limited manufacturing plants around the world that are capable of making these types of mRNA vaccines and those are the kind of issues that we see in the global distribution scheme, and we think that the patent waiver conflates a lot of that, and that�s what David really means�it doesn�t really affect any of the distribution in the short term.
Lee: So there seems to be a tension between the idea of open-source technology and patent waivers and the ability of companies to recoup the cost of development and if I�m understanding you correctly, what you�re saying is that the tension is not necessarily accurate to the way the real world is working right now that the open-source technology tension with IP rights isn�t directly in tension at all and that IP rights can be pro-competitive in many ways, as can open-source technology. Am I understanding this correctly?
David: You are, but let�s not all drink the Kool-Aid just that quickly because there is another side to this story. IP rights do promote competition and innovation but there is an illegitimate voice be heard on the subject of, well how much exclusivity should you get? Though, in the United States, if you come up with a new drug, you get certain regulatory exclusivity even if you didn�t have a patent at all. Patents sit on top of that and provide extra protection. And the question is, well how much protection? Well let me give you an example; a real-world example that raises the question of, well, can you have too much IP protection? Though the largest selling biologic product in the known universe, as far as I can tell, is a product called �Humira�, which treats certain auto-immune disease � it is quite a remarkable drug. It�s made by a company called �AbbVie�. There have been a number of companies wanting to make essentially a generic version of it. It�s called a �Biosimilar�, but it�s basically a generic. In the litigation, over the generic makers desire to enter the market, AbbVie has come up with a huge number of patents that they say protect the making of Humira. I�m talking about over 50 patents. And people have stood back and said, �Well how can that be?� You know, �a few patents covering a single product?� And that�s because you have smart patent lawyers. So, how can you get a whole bunch of patents on a single drug? Well, first you have a patent on the DNA sequence of the biologic, then you have a patent on the method of introducing the DNA sequence into a host cell, which will express the drug. Then you have a patent on the host cell of cell, then you have a patent on the method of culturing a host�s cell in a medium which will express the drug. Then you have a method of administering the drug in a certain dose to treat a certain disease. Then you have a patent of administering the drug in a different dose to treat a different disease. I think I�ve rambled off, maybe eight or nine different potential patents on a biologic. I am not making this up. This is typical for what will go on in terms of patenting. So, there�s a policy voice to be heard in terms of, well, are you simply extending that monopoly for too long, and are you getting more than your fair share of the recoupment of the investment? This is a legitimate policy discussion. For many years, there wasn�t even a generic pathway available for biologics � it didn�t even exist in the United States. If you wanted to make your own biologic, you had to start from scratch. So, that law changed actually, as part of what�s called �Obamacare�. The affordable care act actually created the generic pathway for biosimilars. These are important policy discussions and it�s important, even for people like me who are IP enthusiasts � we see the benefit that innovation provides when driven by IP rights. I also see the other side of it and understand from a policy perspective we have to have balance, because we have to have a meaningful return for investment. I believe there�s a time when your exclusivity expires and then the price goes down � and that�s how it should be.
Jasper: I agree with David. In some sense, IP does promote competition in the sense that, if you�re an inventor and it promotes, and if you have a protection on your invention then it really helps you come up with the next innovation. The same thing with your competitor. You know, if they feel as though their idea is being perfected, then it really encourages them to do more research development with more ideas. If they don�t have any protection around the ideas, they�re just going to stop innovating and they�ll just get lazy and be like �what is the point? There�s no incentive in this area� So, IP itself at the end of the day does promote competition and innovation.
Lee: Jumping off that point to something Mr. Gindler brought up which is the difference between biologics and other forms of medication via pills. I for one had no idea about all the differences that go into these two processes until I had a friend explain it to me and I listened to a prior podcast Mr. Gindler had been on � If you could please walk us through all the myriad differences in a relatively concise way so that the listener understands that these are very different, the technologies are very different and the law around them is just very different.
David: Well you can think of the world of medications as falling into two broad groups. I�m over-simplifying, but not by that much. For one group we�ll call small molecule drugs, think of those as pills. Though it�s everything from Lipitor to any other medication that�s just a bunch of chemicals which are put together into a pill form. They�re called small molecules because they�re small and they have a certain pathway for approval. There is a second class of drugs, which are called biologics. Now, those drugs didn�t even exist until the 1980�s � that�s what we mean by biotechnology. Biologics are drugs which are made from biological material, and they are created by biological material; let me give you a good example. So, one kind of biologic is called a recombinant antibody. That is a genetically engineered antibody that is designed to treat a certain disease � the antibody does not exist in nature. Scientists try to come up with an antibody that will attack the root cause or something that promotes a new disease state � they try to cure the disease state. So, what�s an example? So an antibody that�s specially created, goes with the following process: First you come up with a DNA sequence for the antibody. Then you introduce that DNA sequence into a host cell. This may come across as sort of bizarre, but the host cell of choice are Chinese hamster ovary cells. They just work really, really well. You introduce this DNA sequence through a structure called a vector, it�s actually typically a piece of bacteria, into your host cell, often a Chinese hamster ovary cell. The cell that incorporates that DNA into its own DNA, and what do cells do for a living? They read the DNA and they produce what the DNA codes for. And now you�ve coded for your antibody, which doesn�t exist in nature. And now you have a treatment for a disease that, using the antibody that didn�t previously exist anywhere. What�s an example? So, there�s a drug of biologic called �Herceptin� Herceptin treats a certain kind of breast cancer which is called HER2+ breast cancer. Some women who have breast cancer overexpress a hormone called HER 2, H-E-R-2 � that is very bad because what happens is that the hormone causes the cancer to multiply at an exponential rate and it makes the cancer very deadly. What does Herceptin do? It basically hamper down the production of HER2, so it gives other cancer patients the opportunity to work. Herceptin was literally a game changer for women who had HER2+ breast cancer. That diagnosis before Herceptin was awful. It was awful. Today, Herceptin prolongs the life significantly, of women who have HER2+ breast cancer. That�s an example of a biologic, a specially engineered antibody that�s targeted to treat a specific aspect of a disease. There are many other examples � Humira is another example of a specially designed antibody. Biologics are different, not just because they are biological material, they�re really, really hard to make and let me tell you what I mean by that. An antibody actually has a three-dimensional structure, it actually looks � it�s drawn in a cartoon like a �Y�. So it sort of looks a bit like a Y, but it actually has a three-dimensional structure, it�s a thing that exists in your body. And it�s not just getting the DNA sequence right. It�s a matter of having the antibody actually be expressed and folded in a certain way so that it can be effective. And there are companies which have tried and failed to make a generic version of an antibody that�s been on the market for a really long time. Let me give you an example, there is another game changing medication that is called �Rituxan� it�s used to treat non-Hodgkin lymphoma and other diseases. Before Rituxan, getting a diagnosis of non-Hodgkin lymphoma, that was really bad. Rituxan can be in many cases, a cure. Rituxan has been on the market for a really long time and a number of companies applied to make a biosimilar version of it, a generic. One is a well-known, large, very sophisticated company based in Germany called �Boehringer Ingelheim� They are the top of their game. And in order to get approval, you would actually have to put your generic through clinical trials to show that it works just as well. It failed. They gave up. They just packed up their bags and said �we can�t get them to work as well as a Rituxan made by Genentech� it�s that hard. So, just because you want to make one, doesn�t mean you can make one. So the science and the technology behind making a biologic is much harder. That ties into why there�s such challenges in making sure you can scale up manufacturing of the vaccines. These are not little pills. It�s mRNA, it�s the building block of life and so you�re taking biological material, you have to store it at a certain temperature, it�s got to be maintained in all the nanoparticle and then it gets injected. So, that gives you some visibility to just how complicated the processes are. This is why, for example, the price of a small molecule plummets the day the generic comes on the market � and I mean plummets like by 99%. It drops down that fast. So, biosimilars, the price goes down, but not by as much because it�s really hard to make; it�s not the same technology. It�s not like just gearing up your factory to make, no this chemical compound and that chemical compound. I�ll tell you one of the things though, that�s very very promising about covid cures, is that Pfizer has developed a pill, and that�s the beauty of it, it�s a pill. It�s a small molecule that you can take that has tremendous efficacy for preventing severe disease. This has not been heralded like it should because this can be a game changer, because you don�t have to store it at anything. If this can get widely distributed, such that, if people get Covid they can get this pill quickly, this can also be a path out. Though, that�s another remarkable innovation and it shows how if it�s a small molecule drug, that is a whole different world of distribution and manufacturing than in a mRNA vaccine.
Jasper: I think David gave a very good overview of the difference between a vaccine and a pill and as to how you make it. I do want to emphasize something because it is a practical consequence of this. So the know how�s of how to make a biologic or vaccines are very difficult. And that�s just kind of why the patent waiver discussion really doesn�t really matter in the grand scheme of things. The know-how of how to make the small molecules of pills is much easier. So companies really aren�t concerned about patent waivers when it comes to making COVID pills because the moment they waive pills, generic companies can just copy it. And that�s why you don�t see the patent waiver discussion when it comes to COVID pills even though these are fairly newer. So I think they�re just focusing on the raw product.
Lee: On the point of patent waivers, so for some background about me, I actually take a biologic for migraines, and it was a life changing medication for me. I went from having many many migraines a week to maybe two or three a month, just absolutely changed how life works for me. So I get the idea that this is life changing because it really can be. In terms of patent waiver, how does that fit in the mix between the creation of COVID pills and the biologic that I think everyone has kind of gotten used to in America as the way that we deal with COVID-19.
David: Patent waivers are a very important topic. And I think they are an important topic for the following reason: I don�t think COVID�s going anywhere. We�re going to get past the pandemic phase but then we�re going to be in an endemic phase and it�s not going to be for like the next three years. It�s going to be around. And it�s going to mutate, but hopefully not in a way that is deadly. Though, vaccines are going to be important for preventing outbreaks and keeping people out of the hospital for I think many many years. I think as a matter of policy, it will be important for patents not to stand in the way. And I think it would be very hard for large pharma to take any sort of position that would impair the distribution of vaccines for global health because I think there will be a blowback on a monumental scale. And I don�t think you�ve heard a lot of hesitancy from large companies like Pfizer in terms of not having patens stand in the way. The question is: How do you go about doing that? And there are different schools of thought about how to do that. There is one school of thought that just wants to have an outright waiver. You just don�t get to force your patent rights at all, period. That�s one school of thought � it�s a respectable school of thought. There are other schools of thought which is �Well, maybe patents should be put into a patent pool and licensed on commercially reasonable terms� No one�s trying to make a lot of money off of this, but there has to be a fair return. And then there are other proposals. I cant tell you which one is the best from a policy perspective, I might have my own personal views on that but that�s more of a policy issue than I think it is an IP issue. What I can tell you though is, I�m pretty confident that no matter which side of the policy spectrum that you live in, that large pharmaceutical companies are not going to let patents get in the way of vaccinating the world. I think everyone wants to vaccinate the world. I think large pharma companies operated in responsible ways in developing a vaccine, ensuring that it was safe and ensuring that it was effective; I think Pfizer has demonstrated that it�s very important for the vaccine to be not just safe but efficacious. You�ve probably read recently, that they withdrew their current application for their vaccine to be administered to children under five. So why is that? Is it unsafe for children under five? Nope. That�s not what the data shows. The data showed not a significant benefit for the dosing; they weren�t getting a better outcome. So they said we need more and better data before we decide on dosing for children under five. Now if big pharma�s wanted to make a bunch of money, they would�ve just said �you know what, we�ve got some pretty good data, let�s go forward� but it wasn�t good enough data, so they voluntarily pulled it back and said, �we need some more time; different dosing regimen� So, I�m pretty confident that we�re going to get through this. I�m pretty confident that we�re going to get through it because of smart scientists like Kizzy Corbett, who�s sort of my hero, who can really get us through to the other side.
Jasper: I agree with David in what�s going on in the patent world. I think there is a sense that there is a weakening of patent rights in the past few decades, and patents should be stronger to encourage innovation in this new Covid / mRNA and nanotechnology. So, not only that we get through this pandemic, but when the next pandemic hits, we already have the technology available and are making the vaccines, making the pills and we just stop protecting innovations and inventors� rights, which is why I went to law school in the first place.
Lee: To cap this off, I really appreciate all the learning I�ve been able to do throughout this podcast, I have learned so much about the topic just throughout this period of time. I�m curious in the future, Mr. Gindler and Mr. Tran, you both mentioned that we�re going to get through this, but of course Covid is going to become possibly endemic or likely endemic and we need to cope with it as the world changes to accommodate this new version of the world that we�re living in. How do you see the law accommodating that and where do you see the law going, specifically related to the treatment of Covid and the efficacy that comes with it?
David: If I had that kind of a crystal ball, I would be in a different business, but I can make some predictions which is that the law will have to accommodate it. But it�s not an �if�, it�s just a �how?� So how are we going to ensure that we can have broad distribution at reasonable prices or at no price where the government provides the subsidy, as we have for Covid. There will have to be compromises that are made in the IP world in order to ensure that you have the incentives for innovation and that the incentives for innovation do not stand in the way of public health. That�s going to be a very important conversation that�s going to take place between democrats, between republicans, and the one thing that I think democrats and republicans probably can agree upon, is that drug prices need to be reasonable. People need to be able to have access to important medications for vaccines and otherwise and there is going to be policy discussion about the best way to get there. So, I�ve given some examples of ways in which you could accommodate the global need for vaccine distribution, and I can�t tell you which way the policy debate is going to come out. I don�t think patents are going to go away, they�re important to drive innovation. But, as I said, patents cannot stand in the way of public health. So there is going to be a policy resolution to this. How that plays out, I�m not 100% sure, except I think it�s going to be a very interesting discussion and it�s one that we haven�t had in this sort of way because we haven�t had this sort of global pandemic in like 100 years. Now we got lucky this time because we had a lot of tools in our tool kit this time to sort of cut this off at the path. This wasn�t true in 1918, I was reading a book about the 1918 Influenza � it really hit in two stages. It started in the March / April time frame in 1918 and it was called the three-day flu because it was a big sort of nothing; it was everywhere, but people got the flu for three days and then they were all fine. And then it was fine until it wasn�t. And then in September of 1918, basically all hell broke loose because it changed. And the influenza was virulent in ways that Covid is not. It killed. It killed aggressively. It killed people by causing them to bleed out. It killed them by compromising their lungs so they couldn�t breathe, and they die of pneumonia. Most of the people who died in the 1918 pandemic, died in a 24-week period starting in September of 1918. Half of those people died in a three-month period. That tells you what happens when science is not on your side. They just didn�t have the toolkit then. We have the toolkit now and I�m pretty sure that wise public health officials and wise legislators will make sure that we get to use the toolkits in responsible ways to promote public health.
Jasper: I agree with David on two points he mentioned is that it�s really hard to predict the future and drug prices in the near term is going to be the debate to make it more reasonable not just Covid but for other kind of drug prices involved too; there�s no reason that it�s limited in the Covid debate. And other Covid-related topics that is going to be among the discussion is the Supreme Court reversal of the Biden Administration�s vaccine mandate for federal employees that came down last year. I think that�s still going to be an ongoing debate for a while. And whether schools should require vaccinations, the same as private employers, which are currently slipped due to vaccine mandates � and when I say vaccine mandates, I mean including the booster and there is a lot of vaccine hesitancy when it comes to that, especially when it comes to the booster; I believe the stats are like a third of people are vaccinated with the booster. The mask mandate is still ongoing. There is still if people should be wearing masks or not and there is going to be a soon to be debate about pills mandates when it comes to Covid pills and should the employer require employees to take Covid pills when they get sick.
Lee: I am hopeful that our society will be able to overcome all those points and I really appreciate you all coming on today with me, this was incredibly informative. Thank you so much.
David: It�s truly our pleasure, thank you for having us.
Jasper: Thank you, it was a pleasure � happy to be here.