 I'm Joy Rode. I'm an assistant professor at the Ford School of Public Policy. And I'm delighted to introduce today's final event, which is the book launch, as well as a conversation, with Shobita Parthasarthi about her new book, Patent Politics, Life Forms, Markets, and the public interest in the United States and Europe, just out from University of Chicago Press. I'd first like to thank the sponsors for this event, the Ford School of Public Policy, and the Institute for Humanities here at U of M. I'd also like to thank our co-sponsors, the Science, Technology, and Society program, the Science, Technology, and Public Policy program, and Global Reach. So just to orient you towards what's going to happen over the next hour and a half, Professor Parthasarthi will first give us some of the highlights of her work, followed by a discussion with Professor Rick Hall. And we're going to reserve ample time for Q&A. So please, I encourage you to share your questions on the note cards that are circulating. If you're watching on the live stream, please tweet at either to hashtag policy talks or hashtag patent politics17. And now, here to introduce and recognize Professor Parthasarthi, please join me in welcoming Susan Collins, the Joan and Sanford Wildein of the Ford School of Public Policy. Thank you, Joy, and good afternoon to everybody. I am really delighted to be here and wish that I had been able to be part of the full, really interesting symposium today. So it really is a pleasure to see so many of you at this event, which, as Joy has just mentioned, is really the culmination of this daylong symposium on a range of important issues related to patent policy and politics. So this symposium, as you know, was hosted by the University of Michigan's Institute for the Humanities and organized by our featured speaker, the Ford School's own associate professor, Shobita Parthasarthi. And I had really wanted a moment on today's program because, for me, it really is both a pleasure and an honor to be able to introduce Shobita and to really congratulate her on her book and the outstanding work that I know has gone into it. Shobita Parthasarthi is associate professor of public policy and women's studies. And she is also director of one of the Ford School's Dynamic Research Centers, the Science, Technology, and Public Policy program. Her own research focuses on the governance of ethically and socially controversial science and technology issues. She's done very important comparative work drawing significant insights from looking at issues across national borders. Her work addresses how technological innovation and innovation systems can better achieve public interest in social justice goals. Her latest book, which we're both celebrating today and looking forward, at least I know I am, to learning much more about, was just published by the University of Chicago Press. In 2007, she published a book titled Building Genetic Medicine, Breast Cancer Technology and the Comparative Politics of Health Care from MIT Press. Findings from that book were very influential. For example, in the 2013 US Supreme Court decision that prohibited patents on isolated human genes. Shobita holds a bachelor's degree in biology from the University of Chicago and also a master's and PhD in science and technology studies from Cornell University. She recently started a new project that focuses on the geopolitics of science and technology-based efforts to alleviate policy. And that work has a focus in India. She's held in very high regard by her faculty colleagues at the Ford School for her creativity and her highly engaged scholarship work and her policy engagements more generally. So Shobita, on behalf of the faculty and of the Ford School community, you have my warmest congratulations on the publication of your new book and on the impact that that work has had and I know will continue to have. So please join me in welcoming Shobita Parthasarathi to the podium to present her new book and its implications to us. Welcome. Thank you very much, Susan, for that wonderful introduction. And thank you, Joy, for your introduction as well. Thank you also to all of the symposium participants today. It's been a really intellectually wonderful, exciting day. And I have been really honored to be a part of it and to talk to and learn from all of you. I also, as I turn to my book and I reflect on what has been many, many, many years of thinking about and worrying about the questions that it raises, I also feel that this is the best opportunity that I have to thank so many people who were instrumental in producing it. That includes family, friends, colleagues, interview subjects, the keepers of the archives, across three different continents. And so I just want to take the opportunity to thank those people. And that includes many of you in this audience. And I'm really excited to talk to you a little bit today about my book. And hopefully it lives up to all of the torture that I put you through for the last 10 years or so. So uh-oh, that was the end. It was a very short presentation. It's a very short book, too. There we go. All right, so patents are, as I said this morning at the introduction to the symposium, patents are an incredibly important part of the scaffolding of modern society. They are really important symbols of innovation. They are also really important in terms of mediating our economic relationships. And they also provide kind of a certification, an official certification that something is novel. We hear, for example, on advertisements that something has received a patent and that is supposed to change the way we think about that object. It also, patents also, as we learned about today, are really important mediators in terms of political relationships, in terms of relationships between nations, in terms of the dynamics of international politics as well. But at the same time, something has happened in the patent system over the last 40 years or so. Over the last 40 years, there have been new figures in the patent system, environmentalists, patient advocates, farmers, others, who challenge the very basis of that patent system. They're asking difficult questions of those who have populated this system for at least a couple of centuries. And they're making life pretty difficult for those who are accustomed to a very well-ordered technical and legal system. And that's what's interesting, and that's what at the beginning of thinking about this project, when it was just a kernel in the eye of it soon to be mother, I thought about how strange it was that these people that didn't really seem to fit were participating and challenging and taking to the streets to think about and to engage in such an incredibly technical and esoteric topic. And so that was sort of the beginning of my journey into the patent system. And as I scratched the surface, I began to realize that these politics weren't in any way uniform, that they looked quite different depending on where you looked. And they even looked different in two places that we tend to think of as really similar, the United States and Europe. And that is why I chose to focus my analysis there. That gets to the question of the focus of the book, which is sort of in two ways a focused analysis of this broader set of politics that have been swirling around patent systems across the world now for almost 40 years. The first is a focus on life form patents. And for those of you who haven't been at the symposium all day, life form patents are basically patents on pieces of DNA or genetically engineered microorganisms in the process of my book. I looked at genetically engineered plants and animals, human embryonic stem cells and clones, human genes and complementary DNA sequences. And the reason that I chose to focus on life form patents was because they seemed to have all of the characteristics of all of the other kinds of controversies that have swirled around intellectual property and specifically patents over the last four decades. The first was a question that arose around whether or not patents stifle innovation. The second question that arose in this context and is arising elsewhere is whether or not patents limit access to important and even lifesaving technologies. And again, for those of you who are participating in the symposium today, we heard a lot about, especially these first two questions, whether or not patents are being issued at two early stages of development to actually lead to more innovation. And then second, whether or not patents are actually hurting access to technology, especially, for example, to essential medicines. The third kind of question is a broader question around the increasing enclosure of the public domain. That is, are too many things being privatized? And we hear that in a lot of places. We often hear that, for example, in the case of software patents. But the version of it that moved in the life form patent discussion was one around the commodification of life and nature. And then finally, a question about whether or not exclusive rights were being awarded appropriately. And again, this issue came up earlier today in the context of patents on traditional or indigenous knowledge. As I said, I focused my book in a second way, that is focusing on the United States and Europe. And I did that for a few reasons. The first is that these are two places that we tend to think of as largely politically and economically similar. And in particular, when it comes to intellectual property and patents and trade, these are two places that tend to advocate for the international harmonization of patent laws. So one would assume that they are both advocating the international harmonization of patent law that they tend to think that there should be general agreement on the substance of those laws. Now, there has been some scholarship, legal scholarship primarily, that looks at the differences between the United States and Europe in terms of specifically even life-form patents, but even more generally, their patent systems. And legal scholars have tended to focus on the fact that the European Union and also the European Patent Office have a clause in their legislation that prohibits patents on inventions deemed contrary to public policy or morality or the order public clause. Now, I argue throughout the book that that's important, but it doesn't tell us nearly enough. And I ask, for example, why it is that there is an order public clause in the first place. I explore the idea that the order public clause is in fact morphed in its meaning quite a bit over the course of its history. And I also ask why it is that, for example, in the United States, we have something that on its face looks similar, a moral utility clause, but it hasn't had the same kind of importance in terms of defining the system. And what I hope is that by doing this kind of analysis, I've also been allowed to piece out a lot more complexity in terms of the similarities and differences between the US and European systems. And more broadly, as I'll say today, I've also, I hope, been able to provide a more deep-seated analysis of the politics, the deep politics that underlie these two patent systems and, more generally, the world of intellectual property. So I think it's worth stepping back for just a moment to give you a sense of the methodology that went into producing this book, in part because, as I've already foreshadowed, I approach the patent system pretty different than most analysts of the patent system. I am an interpretive social scientist and I use qualitative methods, including historical records, interviews, participant observation, and document analysis. And I do it in comparative perspective to identify and understand social patterns. And so my first effort was to try to understand the recent controversies. As I said, that was sort of my journey into this set of questions. And so I focused on the recent controversies around life form patents. And I began by doing that in a few ways. I looked at what are called patent prosecutions. So those are documents that are all on file but patent offices where all of the back and forth between patent applicants and challengers and the patent office are available. They tend, especially for the kinds of controversial cases that I studied to run into the thousands of pages and I suffered through all of those thousands of pages. But the beauty of documents that run into the thousands of pages is that the jewels tend to be in the middle. So for better or worse, knowing that that was probably likely to be there, I kept searching. The second thing that I did was over 100 interviews with individuals involved in the patent system in various ways. Patent office officials, government representatives, civil society groups involved in challenging patents, patent lawyers, legal scholars, as well as industry representatives who often were those who were attempting to get some of these life form patented. I did participant observation that included attending congressional and patent office hearings, meetings and conferences, and then I analyzed a lot of the documents that were generated by the actors in these controversies. As I did this, I also realized that I needed, if I was in fact going to do a broader analysis looking at the politics, I needed to develop a historical perspective. And once I did that, I decided that I would look at US congressional documents and court decisions from the 18th century to the present, as well as European documents that followed the history of the European patent system, as well as recent archives related to the European biotech patent directive, which I'll talk a little bit more about in a few minutes. So what I would like to do, just in case you all get bored by the end of this presentation, is to foreshadow what the main contributions I think the book, or at least I attempt to provide in the book. The first, as I've already suggested, is that there are deep seated differences between patent systems and patents across jurisdictions. And furthermore, I wanna, in the book, reveal the details of the political configurations that lie underneath. And to be honest, part of those political configurations involve the work that gets done to ensure that we don't think about those politics at all. That is, the idea that the patent system is technical and esoteric is in fact a political achievement. And part of what the book tries to do is to uncover both how that achievement comes to be and how those achievements are different in the United States and Europe. As I suggested, what I try to do as well is to tie these political configurations to differences in political culture, ideology, and history. And in particular, I argue throughout the book that there are fundamental differences between the US and Europe in terms of how we understand the relationship between the government and market vis-a-vis innovation. In the United States, we tend to have a market making ideology. That is that the role of the government is to create the conditions for the market and that the market will produce social and moral order. After that, the government gets out of the way. Whereas in Europe, and I realize it's a little bit controversial for me to talk about Europe as a category and I'm happy to talk about that a little bit more in the Q&A period. But across European countries and in what we have come to know as Europe, there's more of a market, what I call a market shaping ideology. That is that the government plays a much more active role in terms of shaping the market and stepping in to ensure that there is a moral order that defines the way the market works. The second contribution that I hope that the book makes is to argue that with these different political configurations of patents and patent systems come very different approaches to governance, understandings of governance and understandings of governance that I argue go beyond the patent system and shape the way we think about the governance of science and technology more broadly. We'll see, we see in the book that the US and Europe, despite their apparent similarities, define evidence and expertise for policy differently, that they understand the patent system's role differently, that they define different appropriate participants and avenues of participation and finally that they understand the public interest differently as well. And then finally, the book is part of a larger set of, larger set of scholarship that focuses on the politics, the epistemology of policy or the political epistemology of policy and in particular what the book attempts to do is to demonstrate how political culture, ideology and history shape knowledge and expertise for policy. Now we tend to think that knowledge and expertise for policy is self-evident. I of course am employed by a school that teaches its students that we are providing them with the tools to produce and evaluate that knowledge for policy, but what the book demonstrates is that the definition of appropriate knowledge and expertise for patent policy is highly political, that the knowledge that counts as appropriate and relevant knowledge, the expertise that counts as appropriate and relevant knowledge, and the methods for evaluating that knowledge and expertise are quite different in the United States and Europe. So what I'll do with the remaining time that I have today is to sort of paint you a basic picture of the book's trajectory. So as I suggested, while I started with an interest in the contemporary, I ended by starting the book with a bit of a historical grounding. And I argue in the book that while, again, we tend to think of the US and pan-European systems as being relatively similar, that in fact they start from very different places and in fact Mario mentioned this a little bit in his talk earlier today. So I argue that patents are seen and have been seen in fact in the European context as moral and socioeconomic objects as well as innovation and market drivers. And the idea that the public interest is not in fact synonymous with the inventor's interest, that there is a balancing that is to be done and that there's a role for government in performing that balancing act is evident from the earliest privileged systems. And in fact, it then gets codified into law in public order kinds of language as well as categorical exceptions to patentability and then by the late 19th century compulsory licensing legislation. And when the pan-European system is produced is created in the 1970s, it follows this approach that has been created by individual European countries slowly over the course of a number of centuries. Now the US patent system famously is embedded in our very DNA, that is our constitution. There's language in the constitution that talks about the importance of intellectual property and then there is a series of laws in the late 18th century and into the 19th century that provide a legal scaffolding for that patent system. And I argue that in those early days even though there is language about balance, that in fact there's an assumption that the public is, everyone in the public is a prospective inventor. So there's a lot of efforts to ensure that people can participate in the system, keep application fees low, make sure that everyone can get excited about technology to have public displays of patented technologies and that is in the service of inspiring innovation. And so what that does is it means that the inventor's interest and the public interest become essentially synonymous. And that idea I would argue continues to this day. There is also in the early development of our patent system in the United States a great emphasis on procedural objectivity. That is the idea that the people who should be doing the work of determining patentability should be those who have scientific training. They are the ones who can best provide the most objective analysis that they have scientific training, but also legal training so that they're objective both in terms of the kinds of decisions that they've made but the process of that decision-making. And there are in fact throughout the 18th century, sorry, throughout the 19th century and into the 20th century, there are attempts in the United States to try to ape what's happening in Europe. So there are attempts, for example, to bring compulsory licensing legislation. The response is to say no, no, if you have, we should be able to trust inventors and inventors are the ones operating in the public interest and you are bringing politics into an otherwise technical and amoral system. So the idea that the technical and the political are separate, that this is an amoral system is sort of baked in even from the system's early days. Now I'm gonna fast forward a little bit and talk about the more recent controversies that are the real main focus of the book. So in the 1970s and 1980s, as some of you probably already know, question biotechnology emerges, recombinant DNA technology emerges. There are new kinds of questions that arise for policymakers writ large. What are these new organisms? Are they new organisms? How should they be regulated? The patent systems don't escape these concerns either. They have to contend with questions about whether or not genetically engineered microorganisms, for example, are technologies or nature? Are they life or are they not life? And who should make these decisions and what the role of the patent system is in the context of science and technology policy? So it's not just questions about what patents are and what biotechnology is. It's also, these are also raising questions about what the patent system is and what science and technology policy is as well. Faced with these questions, the United States treats this as a really, really narrow question about products of nature. There's a Supreme Court case that came up earlier today called the Diamond versus Trekobrathie case. And what's interesting about this case is that it isn't so easy for the patent system to keep it narrow at the beginning because while most of the people that participate who submit amicus briefs are your usual actors in the system, universities, biotechnology companies, individual scientists, there's also an amicus brief from a civil society coalition made up of environmentalists and development organizations who ask really thorny moral questions. But the court and the other amicus briefs say, no, no, what you're talking about isn't relevant at all. The patent system is incredibly narrow and it isn't really talking about questions of life. What's interesting about this is when you look at it in comparative perspective and you see what happens in Europe. Almost immediately, while the European Commission tries to treat this question initially as a similar legal and technical question about just expanding patentability, the European parliament, European parliamentarians, not a civil society coalition initially starts to ask these kinds of questions that the civil society coalition is asking in the United States. Is it moral to allow these kinds of patents? What are the broad socioeconomic implications of these patents? To them, the questions are important and different because they are matters of life and because they are matters of life they are matters to be decided by policy makers and to go back to the conversation that we were having in the last session in fact it is seen as something that should be balanced and therefore there's a role for policy makers to play whereas in the United States there's not a question about balancing and therefore there's no role even though the civil society coalition is pushing for Congress to be the one that's making this decision that they're not seen as having a legitimate role in the discussion. Finally, after an unprecedented 10 years of debate in the European parliament, they pass a biotech patent directive that in its final formulation includes a number of concessions to these parliamentarians and of course in the course of that 10 years they've got a lot of civil society involvement as well and that those concessions run the gamut. A lot of attention as I suggested have been focused on exclusions around cloning and embryonic stem cells that are linked to this order public clause but I also want to bring in the fact that they reiterate the importance of a research exemption that there's a farmer's privilege among other things because I want to make the point that it's broader as I said than simply the existence of the order public clause and I suggest in the book that the order public clause is in fact reinterpreted in this moment to have bioethical meaning when it never had that kind of meaning before. So I don't have a lot of time but I just want to say a couple of more things about the remainder of the book which is in fact the bulk of the text. So you would think perhaps that especially given how boring, I'm sure you thought the patent system was before you walked in here, now I know you all think it's super interesting and can't wait to buy the book. You would think that these settlements would solve the problem but in fact they fanned the flames and so in the ensuing years there were questions about the status of genetically engineered animals and the controversies that emerged involved environmental groups, farmers, religious figures in both the United States and in Europe and in the course of these there were not just debates about the status of animals as technologies but also about who could participate in patent systems and how they could do so. So I argue in the book that the United States asserts what I call expertise barriers or you could call it Goldilocks with an unhappy ending. There were rhetorical barriers that were asserted by what I call patent system insiders including decision makers and stakeholders. This happened in congressional hearings where patent office officials and patent lawyers would say to these civil society groups that they didn't understand the patent system and that the concerns that they were raising were irrelevant. To go back to our morning's discussion they challenged even the notion of short causal chains, right? They said no, patents have nothing to do with these kinds of implications that you're bringing up. They asserted legal barriers because citizens had lacked standing as we discussed this morning. The kinds of concerns that were raised were inappropriate for the venue of the courts. And then finally there were bureaucratic responses essentially saying that this is a technocratic space and there's no space here to have this kind of political conversation. By contrast, the pan-European system becomes much more open to public participation and critique. Challengers in Europe used the European patent office's opposition mechanism to challenge a patent on a mouse genetically engineered to contract cancer known as the OncoMouse lovingly put on a postcard by Greenpeace here. And they used that to challenge the patentability specifically vis-a-vis the order public clause. And while they were ultimately successful in narrowing this patent, I argue in the book that that is actually only one of the important implications of their activism. What they also did at the same time was to help create a space within the European patent office for ethical reasoning. There was also a new sense of public accountability that emerges even in the space that in the US was seen as so technocratic, the European patent office, the PTO's counterpart. And in fact throughout this period there are efforts to buy the European patent office to organizational efforts to sensitize examiners. There are seminars for example by ethicists and science and technology studies scholars and historians. There's a scenarios report where there's an attempt to do future casting that involves explicit attention to the ethical and social implications of patents. And there are also, and I find this particularly interesting in the weekly gazette that's provided to all of the examiners at the patent office. There are pictures and news reports coming from the European patent office's communication staff informing the patent examination staff of all of the controversies that are happening that are swirling around the place. And of course some of those controversies include barricades at the doors of the European patent office. So it's not like patent examiners didn't know that they exist. But I would argue that in the PTO they would say that even acknowledgement of that would be a pollution of the objectivity of the patent examiner. So again these challenges continue to intensify and the last chapters of the book talk about controversies around patents on human genes, plants, stem cells, and complementary DNA. And I'm not gonna get into the details of it because I have no more time. But I do wanna spend just a couple of extra minutes talking, sort of giving you a sense of what I argue is happening in terms of the governance and how they really diverge in the United States and in Europe. And what I argue in the book is that these categories which I mentioned at the beginning are all linked together. That is, you sort of see different pictures emerging of the worlds of these patent systems in the two places if you look beyond the law. As I've argued, patents in the US are seen as techno legal. They're seen as having very limited impact. There are, to use Susan's language, short, not even very, very limited causal chains. There's only implications for innovation and economic growth. With that, as you can imagine, there's a limited scope for relevant evidence and expertise. Evidence and expertise is focused on legal precedent, scientific prior art, market experience, and then very limited evaluation of the implications of innovation. There's also a new role for the patent system, or sorry, a maintained role for the patent system as being a very narrow bureaucratic, technocratic space that is quite far divorced from other kinds of regulatory and policy arenas. And there are even differences in terms of the acceptable terms of debate, which also then affects who is part of those political environments in the two places. In Europe, as I suggested at the outset, there's a moral and socioeconomic definition of patents which, as you could probably assume, then creates more space for a variety of different kinds of evidence and expertise. There's also a broader approach to participation. As I suggested, there's growing attention to public accountability, as well as procedural objectivity. There's a wider array of relevant publics that are seen as those who should participate in the patent system, and a broader set of acceptable questions that can be discussed in the context of intellectual property. And there's no real division seen between what the patent system is in charge of and what the other part of the regulatory apparatus for science and technology should be part of. So I've already suggested what I think the important conclusions of the book are. So I'll just finish with a couple of sentences about what I hope the broader implications might be. And I should warn you that the purpose of the book is not an explicitly normative one, but to the extent that I do think about those things in the book, I wanna suggest a couple of things. The first is opening up a space for governance-based solutions to some of the controversies that have been swirling around the patent system over the last few decades. We tend to focus on market-based solutions, but I think that some of the experimental work that's been done in the pan-European patent system provides us with some ways of thinking about how the infrastructure of the patent system, how there could be changes to organization, to practices that could actually broaden the approach to patents and in particular to address this swirling controversy. But I think even if we decide that the patent system is not the right place to adjudicate these kinds of issues, the broader point, and I say this as a scholar of science and technology policy, is that there is this growing concern about the moral and socioeconomic implications of science and technology, and that we're far past the time to find institutional spaces to address those kinds of concerns. And I argue as well that the idea that technology moves too fast doesn't really wash anymore, I think. We have lots of work, lots of scholarship and lots of cases, as well as examples, like some of what I talk about in the book that can help us think through what kinds of institutional frameworks and policy can help us develop better governance frameworks for science and technology. So I'll stop there. Thank you so much, Shobita, that was fascinating. I have like 15 questions already, but before I get to ask my questions, and we get to ask our questions, Professor Rick Hall gets to ask his questions. So you've already sat down, so I don't have to invite you to sit down. Facilitating a discussion with Shobita will be Professor Rick Hall. He's Professor of Political Science and Public Policy here at U of M, and his research focuses on American national politics. He's covered topics from participation and representation in Congress, campaign finance reform, legislative oversight. He's currently working on a really interesting project about the role that lobbying and money plays in national policymaking. Who knew that happened? So I'll turn it over to you, Rick. Thank you. I'm gonna start first with a comment rather than a question, and it's that this book is not boring. It's very interesting, and I think it's interesting to me, I'm not a student or certainly of patents or policy or politics, but I really think it should be of interest to most anyone who's interested in policy and politics. Beyond that, I think it's rich empirically, it's clever conceptually, it's intellectually challenging. I think, in other words, I think it's a really terrific book, and I too have lots of questions that I would like Shobita to talk more about, but I'm gonna focus on a few. I am a political scientist. I've sought rehabilitation, but it's hard to treat. So most of my questions are gonna be about the sort of political lessons from this study. And in reading this book, I was at first reminded of an old political science literature on iron triangles or sub-governments, sort of a cousin, political science cousin to regulatory capture. The iron triangles are where you have some regulated industry colluding with the agencies that have jurisdiction over that agency and colluding with the congressional committees that have jurisdiction over the agencies. But this doesn't really look like that. It's, in some ways, the industry didn't need to capture the patent office, right? Congress did not collude, it sort of abdicated, right? You give the sort of historical development that helps us understand this, but are there any other examples like this in American bureaucratic politics? I think part of what it has to do with is, and I'd be curious, you are the student of political science, so you may. I don't know a thing. But I guess what I think about is the fact, and this is something that also came up a little bit sort of implicitly throughout the day, or at least I was thinking about, is that in part the patent system in the US is able to, has positioned itself this way and plays this game in part because it constructs itself primarily as a legal domain. It rejects the idea that it's a policy domain. And I think that because it rejects that idea that it's a policy domain, it can then reject the idea that there's a balancing to be done, right? It's there theoretically, but it's not there really in practice. And that's why this sort of, as I was saying, the public interest kind of gets subsumed in the inventor's interest. So I think this, the idea that Congress doesn't need to be captured, that the patent office doesn't need to be captured, either all of this is sort of happening without any idea that there's any other public to be considered is because there isn't in fact this idea that you need, that there are opposing views because the idea is that if you have a good working procedurally objective patent system, then good will result, right? So I think the place maybe to look would be to other domains where the law, where it's seen as a legal space and not a policy space. I mean, in fact, there are these fascinating debates, not even debates, right? So it's fascinating attempts. I mean, it's very interesting at the throughout the symposium today. I noticed, I'm not entirely surprised, of course, that the folks that I invited to the symposium today used the word regulation a lot. But of course, suggesting that the patent system is a regulatory domain is one that most insiders in the patent system would reject. I mean, they do reject. And there are these interesting moments as well that where even, at least I like to think very wistfully about the Obama administration. But in 2000, as recently as sort of October, I think, they responded to a UN report about access to essential medicines by saying, it's unfortunate that the UN wrote this report. Patents have nothing to do. Patents are by themselves promoting human rights. This is not the kind of, there's no way in which patents are not promoting human rights. The second thing that I'll say and I talk about a little bit in the book is that at some point in the controversy over human gene patents, the patent and trademark office is required to do this review of whether or not gene patents hurt research or healthcare. And the patent office isn't particularly happy about this. And so they have these hearings and at the beginning of the hearings each time the commissioner talks about how, the sort of fact that we have to do this at all betrays a misunderstanding of the system, right? But what's interesting is that to me when I was sort of doing the research was that I realized that they had a public comment mechanism and that public comment mechanism divided the categories of publics as companies and individuals. And I think there may have been a third category. There was no sort of category like civil society group or public interest group, for example. And I think that's a very conventional notice and comment. Not at all. It's the same published in the federal registers, right? I believe it was published in the federal register. They have had a number of things published in the federal register. But like I then out of curiosity went to the food and drug administration and looked at something on e-cigarettes and they have 30 different categories of the ways you could define yourself as a comp. If you submitted a public comment, international public citizen, things like that. And even that sort of very basic kind of difference constructs publics, right? In really interesting ways. Yeah, so that helps me understand sort of why it was that this patent office and this patent system became this entity that wasn't responsive to broader publics. It would make it really hard for civil society groups to challenge it. But they didn't try very much, right? I mean, that's what really surprises me that there weren't challenges to the system. I mean, they've sort of, I mean, even in the early going that led to the, what's the Chakraborty case? That amicus brief, there was one amicus brief, right? And it was mainly Jeremy Rifkin and a small group of others. And that was it. And nothing bubbles up. Now, I can understand why because of the nature of the patent system, it's really impenetrable. But Congress is a relatively porous institution, right? And we've got in all kinds of areas we've got. And it's not only industry groups, it's public interest groups that try to challenge the system. And yet, it didn't bubble up there, right? Why do you think that was? So this is something that I have wondered about. And in fact, sort of as part of my investigations, I looked, I say this in the book, that I looked back at the amicus briefs that had been filed throughout the history, at patent cases, and there hadn't been any. They don't have standing. Yeah, they don't have standing. So they can't sue. Right, right. And they get challenged. But you're right to say, they could have gone into Congress. One is to think about the history of the kinds of groups that might challenge. That's a relatively recent phenomenon, let's say 1970s forward. But it is true that I would argue that it is very, very recent. And I would argue that even in the span of my own identity as an academic, that that has changed. And I say that because when I was doing research on my first book, and it was also comparative, and was sort of tied to the questions around human gene patents, when I started doing the research, and I was doing it also in Britain, and questions were arising about human genome patents in Britain, when I would speak to healthcare professionals, genetic counselors, patient advocates, in the United States, they largely would say to me, but that's just the system. And this is the price we pay for innovation. So in the late 1990s and the early 2000s, that was the logic that the patent, and they had bought into that logic of the patent system, right? And so in part, perhaps because of the human gene patent case, in part because of Monsanto's misdeeds and bad press, in part because of the controversy around HIV, I think that's changing a little bit. I think that the patent system remains impenetrable, but as I say in the book, Neil Young now has a song called the Monsanto Years, where he's railing against the patent system. So something has, something is changing, but that doesn't necessarily, but the patent system's barriers still remain quite impenetrable. Yeah, I mean, the Parisian I first thought of was, the FDA and the drug approval process, but Dan Carpenter's history of the FDA shows how deeply political that was and how hard the FDA had to develop its reputation for expertise and had to engage in a lot of coalition building activity in order to develop its autonomy, but that autonomy's always been politically up for grabs to some degree in a way that this office wasn't. So yeah, I'd be interested to know if there are other cases like that, like the patent office. So let me ask a little bit of a different question. I think one of the real achievements of this book is that it sort of brings conceptual order to a really immensely complex politics, the politics of patents. And you move in the book across levels of analysis, from individual actions and incentives to groups and organizations, to nation-states, to pan-national organizations. And you analyze this changes over time. And the organizations you study, there's lots of them, there's different ones, right? There's patent office, there's agencies, there's legal institutions, right? Universities, industry groups, and it's an ungodly amount of research. It sure felt that way, yes. So I'd like to ask you a question about how do you pull this together? That is, you said you were an interpretive social scientist. So could you say a little bit about your method, because in the end you come up with a fairly economical argument, right? That ideology and culture, and you give pretty specific definitions of what those mean, that those really drive the nature of patent politics in the United States versus Europe. Like, how do you advise a graduate student how to go about this kind of work? They need to be masochists. I guess there's a lot of disciplining. It's a long process and it requires a lot of disciplining and a lot of immersion and obviously a lot of patience. But what I tried to do was to allow myself to fall down rabbit holes a lot and take them where they led me and to keep asking questions and to not prejudge what the answers would be and to not be particularly nice to myself. So I'm sort of serious about the masochism part. But I think that that is one of the challenges of this kind of interpretive social science is that you do have to kind of be relentless and keep looking for the connections. Because in fact, as I said earlier, I started without really even thinking about this as being a historical project. And then I realized that if I actually wanted to understand what was happening, it would be malpractice to not look at the history. And so I think that a part of this method is, and what I do say to graduate students, which they don't always like, is that they can't accept easy answers and they have to keep asking questions. And if things don't make sense, that there's something that they haven't looked for yet and they haven't figured out yet. And that's something that I think, I hope, I've gotten a little bit better at from book one to book two, which is that in part I have the luxury of tenure the other thing I should say is that this kind of work doesn't distinguish between data collection, data analysis, and writing, right? So you have to write and then you go back to the data collection because something doesn't quite make sense and then you have to do analysis and then you have to, you know, so that is also very much a very much a difficult process and one that requires a lot of iteration and a lot of people, many of whom are in this room, who are lovely humans, but who I asked to read the book because I knew they would be honest with me in saying this can, you know, you haven't really identified the relationship here, but then at some point, and I think that this is the challenge is to, you know, you sort of have this data, you kind of have made intermediate linkages and you sort of have some conceptual order, but where I think I particularly struggled sort of the big draft one to sort of the big draft two, which is sort of closer approximation to this book was sort of I wrote it out and I had kind of micro to medium level stories, but then I set it aside and I was like, what, you know, what's actually happening here? What can I actually say with all of this stuff that has been partially digested? And then I went back and rewrote the whole thing. And then rewrote it a little bit more, but that was sort of the basic process. So part of it's this iterative method. Very much so. You're immersing yourself in the history, the archives, the interviews, right? You sort of develop some connections, you sort of try to generalize, things don't completely make sense when you do that, you have to go back and so you're going, which I think is the way most of us do social science actually, I mean. Well, I'm glad. I think many of us sort of theorize abstractly, come up with a hypothesis and go out and test that. I think we're always going back and forth between theory and the world, but. Which raises interesting questions about how we talk about the simplicity of what we do and the answers that we come up with is the actual process, right? How much, where are we for time? Three more minutes. You said that the purpose of the book is not specifically normative, but how much of this book is a critique of capitalism? Or more specifically, market ideology, right? Yeah, okay, I'll accept that. Yeah, I will accept that. Or at least, yeah, and I mean, I want to complicate the critique a little bit. I mean, these are both capitalist places, right? So this is different imaginations of capitalism and different instantiations of capitalism. But, yeah, I mean, I would accept that. I mean, I guess I shrink from normativity partially because I don't think I'm expert at or want to necessarily say this is how this situation is really messed up and here's how I think it should change. But, yeah, I'll accept that it's normative in that way. Well, you know, I mean, that's true, they are capitalist, but I noticed that one of the key players in the European system was this fellow, Willie Rothke, who's a German socialist, right? Who really starts to introduce these moral and ethical considerations and socioeconomic considerations in the debate. So it's sort of like, you know, European system has a socialist tradition in a way that we don't and, you know, that, you know, I mean, there was a kind of, you know, critique of capitalism that gave rise to it. That's true. And to go back to the question that you started with, I mean, you know, there's something very interesting about I, again, because of where I started my first, my dissertation, in fact, I started my dissertation when civil society groups, after the director had just passed the biotech patent directive. And so my knowledge of it was there had been this controversy. And so when I went back into the archives and realized that, in fact, it was parliamentarians who were asking these questions way before the civil society groups got involved, you realize that, in fact, that's a big difference between the kinds of debates that were happening and that have happened over time from the US Congress, right? They're not asking those questions and they're not, in fact, there's, you know, as I talk about in the book, even anything that has a whiff of that question gets immediately rebuked, right, as socialism. Not Germany. Right? Oh, that, yes, yes. Are you, you know, there's this moment where some, you know, are you saying you're against profits? You know, I mean, and that is the, has a chilling kind of effect on the debate. Well, I was kind of wondering whether or not, you know, we were gonna start more morphing and more to industry capture, you know, as civil society groups start challenging the system more. Lurking in the background, right, is Genentech, which spends five to eight million dollars, I'll look this up. Five to eight million dollars a year on lobbying. Bio, the biotechnology industry organization, spends 10. Pharma, which doesn't really represent the same interest, 18 million. And the biotech companies that have registered lobbyists, I mean, you have to scroll down through several pages. And these numbers don't even reflect what they're spending, you know, for their legal teams, right? So it's sort of like, well, you know, if all of a sudden this legal technical definition, what patents are about breaks down, well, we've got this in reserve, which allows us to still puts us in a pretty good position. Yeah, yeah, I think that's right, I think that's right. Thank you so much, Rick, for those questions and comments. Let's thank Professor Hall. And now it's our turn. And if you're concerned that we won't get to your question, don't worry, because Shobita will be answering the questions we don't get to on Twitter this week. Her hashtag is at Shobita P, her handle, and she'll be tweeting from the hashtag patent politics17. So keep your questions coming. I'm gonna start with one, I think you've answered a bit of the beginning of this question, but not the second part. So what has allowed each of these patent regimes in the US and the EU to maintain their characters? So what keeps the US patent system technical? You've spoken to that a bit. There are many ways to use Congress, for example, to pressure the bureaucracy to change. And in parallel, why has the EPO not yet been captured or not been captured by this technical approach and sort of reinterpreted the order public clause in a narrow way? And if you could speak into the other microphone, just because it's picking up the sound better for the feed. Yeah, so I think that's a really great question and I think that that's why, that's sort of what motivated me to think more deeply about what was doing this work, right? If it was just about the immediate political environment, then one could imagine that the European context could shift or that the US context should shift. And I should say something that perhaps I haven't said clearly enough, partially in the interest of time, but one thing that I think is important in this is that I said that you sort of see the historical antecedents of what we see today in the European system. But what I didn't say explicitly is that in fact, throughout the 20th century, there have been, there were moves in the European context to become more like the US system. And in fact, there are efforts, for example, there are multiple informal and formal efforts to make sure that the US and Europe are making the same patent decisions. They have a trilateral patent cooperation, for example, where they send examiners sample applications and they make sure that they're doing very similar work. So that's in some ways, to me, even more interesting and curious because at one level, one would argue, and often they do, that in fact, they are very similar and they have converged. And I think you could argue that maybe there were 10 to 20 years where they had converged, or one could argue that they've converged in certain spaces, but that they were always, what I argue in the book is that there were always these differences bubbling underneath, they weren't necessarily obvious because until the 1990s, nobody had challenged patents in the European context. So the question of whether average citizens had a role to play had never, there was a space in the European Patent Convention that was in 1973 that said that any third party could challenge, but nobody had actually used that. So once those kinds of things started to get tested, then you see that these kinds of differences that are bubbling underneath start to have a little bit more traction, right? So the idea that the question of is an average citizen, does an average citizen participate in patent decision making in this bureaucracy, right? One could imagine that the European Patent Office could have said no third party, we define it this way and that doesn't include you, or we could say, we mean that you can challenge on the grounds of its issue, but we don't mean what you're talking about, this weird definition of order public, or there are a variety of different things that they could have done, which they didn't do, and they sort of take these decisions over and over again that suggest that there's something very deep-seated in the political culture that allows for the system to kind of perpetuate that way, and now what I think is that over the last few decades, because the system has kind of diverged, in fact, I would argue, from the US system in these important ways, there's sort of some strength in that divergence. There are these institutional mechanisms, like every application in biotechnology is slapped with a sticker that requires it to go through a sensitive cases review. Now, even whether or not that changes the review of the patent application, it's a reminder to the examiner that there's such a thing as a sensitive case and we have to think about it, right? So those kinds of even organizational differences are now embedded in the system in ways that ensure that these kinds of things are more at the surface. These cultural differences are more at the surface than they used to be. All right, another one, kind of shifting gears a bit towards methodology. So what are the benefits and or the limitations of comparing Europe to the US, these particular regions, rather than examining differences between very different political systems or differences between, say, low and high income countries? Yeah, that's a really great question and something that I've been thinking about. So I think that I, as a comparativist and someone who's just starting to do research in India, I think that there is a space for potentially doing those kinds of comparisons, but I think they would likely yield very different results because there are such, you know, the sort of the kinds of things that one can hold basically constant, there are fewer of those. So that then means that you have to think, okay, these are sort of really fundamentally different. So what allows, what creates the comparative logic between these two places? How do I make these things two comparable objects? And that I think when you're putting a lower income country next to a higher income country becomes more challenging. But one could imagine, and this gets to the first part of the question, that comparing the US and Europe could also be seen as challenging. And I still kind of sometimes see it as challenging because, you know, hopefully it was at least clear enough in what I've said today. But, you know, the European Pound Office is a bit of a weird organization. It's technically not tied to any government. It's technically not part of the European Union. You know, someone could say, well, you're comparing a country, you know, to a region and a region that is sort of kind of, you know, unclear about whether it's, you know, about the sanctity of said region. And so, you know, the reason why I chose those two places as comparable is not only because, as I suggested earlier, that they had these fundamental political and economic similarities that they both, that they are the active players, that there's a pan-European system and a US patent system that see themselves as equivalent for the purpose of patent discussion, but also because the challengers saw them as equivalent as well. So it's not like challengers were really, except in one of the cases that I look like, there's not a lot of pressure directly at national patent offices in Europe. The kinds of pressure that we're talking about here was happening at both the US office and the European office, and that's what allows them. And so, you know, and that's, yeah, so that's basically sort of how I would think about that. Okay, so here's a question that comes up a lot actually when in science and technology policy context, we talk about democratizing policy processes. And so someone writes, it seems like the European models openness would make the closure of conflict much more difficult. So is this a problem? And if so, how are Europeans addressing it? Right. So the question, of course, is a problem for whom and how, and why do we tend to assume that it is a problem, right? Because we certainly accept certain kinds of messy, very messy democratic procedures as being legitimate and important, even if we deeply hate the outcome, right? And apparently, even if you win, then you can challenge the legitimacy of that democratic procedure. But, you know, sorry, it's implicit in my mind at the moment. But, you know, but I think it's interesting, it's interesting to me anyway to think about the places where we think are legitimate places where we can have public participation and where we tend to be reticent to have that kind of public participation because we tend to assume that it's a technical space. And so it would be, you know, kind of that there has to be some fundamental problem. I think the point that I would make is that there are fundamental problems with public participation, but there are fundamental problems with not having public participation. And that when we think about how we do governance in democratic context, that we have to think seriously about public participation. But secondarily, what I would also say is that, you know, what you see when you look at the US and European systems is two things. One is, one could argue that, you know, the OnkoMaus case started in the 1980s. The final disposition was in 2004. So, you know, not particularly efficient, a long time towards closure, right? But, you know, one of the things that's different between the US and European patent systems is that in the European system, a lot of that debate happens inside of the patent bureaucracy, whereas in the US context, it happens in the courts. So the patent gets issued and then it gets litigated and that litigation could take, you know, 20 years as well. So that's one thing I think that's important to think about. The second thing to think about is, what are our values when we think about the kinds of patent decisions that we want to make and that goes back to sort of where I started, about sort of what do we think about democracy and governance, which is that, you know, you could argue that there's a loss of efficiency by some definition in the European context, but that's a calculation that they've said, no, you know, it's important to demonstrate, I'm not saying they're perfect by any stretch of the imagination, but that there's a value in public responsiveness that we have to take into account and that needs to shape our decision making and so that kind of efficiency is not necessarily the value that we're gonna maximize first. Okay, this is one that I think is kind of a hard one for you and it builds on what Rick was saying about sort of the normative, the rest of your book. Okay, so this one comes from Twitter and it says, so it sounds like you think that the EU gets the life science patents right and the US gets them wrong. So is there any benefit to the US system? Yes, there is and I, right, so yes, it's hard for me because I reject the idea that I think that the European system gets it right and the US system gets it wrong. I think, you know, right, I shirk away from that, but I guess what I do think is that, you know, we have this set, and this is where I ended, which is that we have this set of dilemmas and around science, technology, and its implications and I don't think that the kind of head in the sand approach that the US patent system tends to take is the best. That I think I will say, I wouldn't, however, say that the European system is the best either, so that's important to say, but I do think that there is an efficiency to the processes of the patent office that is overall fairly good but as I said, that doesn't get at the court system and I agree, I would also agree that, you know, the messiness that comes, I'm certainly not someone that doesn't understand that public participation and public engagement or engagement of variety of voices isn't an incredibly messy and difficult process. I guess I just think, as I said before, that if we are truly a democratic context, first of all, we need to dispense with the fiction that the patent system is this amoral technical domain outside of politics or for that matter, and I'm on my soapbox, I might as well say it, that any domain, you know, that there's any space outside of politics and in particular, what I hope that my book does is to suggest that especially when it comes to highly technical domains, we need to dispense with the idea that there's some apolitical space where evidence and expertise can be identified easily and evaluated clearly, so from there, then it seems to me the question is, how do you engage in democracy? How do you engage, I mean, how do you engage with the fact that this is actually political? How do you think about democracy in that context? And I think that there are probably a variety of ways to do it and, you know, I understand where the US system comes from. It comes from a place that assumes that procedural objectivity is the way to achieve democratic objectives, right? I mean, that's the history of that idea and it's not just the patent system and there's a lot of work in STS that talks about, you know, how this is clear and risk regulation, right? The way we think about risk regulation. This is fundamentally a part of American political culture. The problem, I think, and I'm not the only scholar to say this, is that in an era where there are all of these people banging at the doors of these highly technical policy domains, reasserting procedural objectivity and technocratic decision making as the avenue to, you know, as the way to engage in democratic governance not only doesn't work, it doesn't, I think, bode well for the future of the patent system. So what you just described about, you know, technocratic ideal, it comes right out of the progressive period, right? Which gave rise to things like public policy schools. Right. And it also was a reaction to the ugliness of politics, right? That it was highly partisan. It was corrupt, you know, as I polarized. So, you know, you're moving, so. Right, yeah. So we move from one to the other, right? I mean, we're gonna react now to sort of bring politics back in, but we're also gonna do it at a time when it's highly polarized. You know, you've got an interest group system that's, you know, rife with big money, playing a role. So, I mean, we're getting at something that I think is really interesting and I've been wrestling with over the last four months or so, and that is how to, right, exactly. You know, sort of how does one acknowledge the politics of evidence and expertise in this kind of environment? And maybe this is an idealistic solution, but maybe this is an idealistic way of thinking about it. But I actually think that we could go a long way if we are transparent about the institutions and the structures that produce scientific knowledge and expertise. So, and I think that that's actually where we've lost out a little bit, that we, you know, part of where the crisis of knowledge and the, you know, sort of the epithets of alternative facts comes from, I think, is that we don't teach people enough about the scaffolding of science and where it comes from. And that it's in fact, that it's not, that politics is not polluting, right? It just is, it's just, you know, these are, that science is a social institution, social science is a social and political institution. If we understand that they are loaded in these ways, then in fact we might be able to do a better job of evaluating it. Instead, we end up with these idealized notions of evidence for policy and then they can get ripped apart because someone, you know, manufactured data or chose to present their graph, you know, if you think about the climate-gate scandal, they chose to present their graph in a particular way. And so that then gets the whole, you know, entirety of climate science is tarred because of something that's entirely understandable to anyone who's an academic, which is of course you're gonna present the graph in the way that, you know, showcases the data best. But I think, you know, when people talk about science literacy, I actually, and I say this as an STS scholar, so, you know, that's what I'm gonna say. But I think it's a lack of literacy in the social institutions of science. I like how you put that. We are unfortunately out of time. As I mentioned, Shobita will respond to the remaining questions and if there are any more out in the audience, drop them off with me on your way out. There's some good social justice ones tying to the panels earlier today. So I just want to thank everyone for coming. Thank you, Shobita. Thank you, Rick. Please join us for a reception and a book signing just outside the room. Nicola's books is providing copies of the book for you to purchase. And thank you so much for being here. Thank you all for coming.