Speaker 1  0:00  
Alright, so is that is that Michelle that we asked to change slides or who? Who's driving

Speaker 2  0:07  
I'll so Melissa is going to put up slides to start off and then and then I'll put up the slide our slides our content slides got it right

Speaker 3  0:37  
Hi everyone we'll get started in just a minute want to get a few more people in the door?

Speaker 3  1:15  
Okay, hello and welcome to today's autumn webinar, a clear and present danger understanding NIST proposed Marchin framework and its impact on innovation. My name is Melissa Weber. I'm professional development senior manager and today's staff host. All lines have been muted to ensure high quality audio and today's session is being recorded. If you have a question for our presenters, we encourage you to use the q&a feature on your zoom toolbar. Should you need closed captioning during today's what session the Zoom live transcript feature is turned on and available on your toolbar. A recording of this webinar will be made available for viewing in the autumn Learning Center later today and is included in your registration. This presentation will also be able to be found on the autumns autumn website under marchin rights. Before we begin to today's session, I'd like to acknowledge and thank autumns online professional development sponsor, Marshall Gerstein, and we appreciate their ongoing support. And now I'd like to welcome today's speakers, we've got Steve Sokka, Sheila Koura, and Mike wearing, and we look forward to learning from them today all about the margin framework.

Speaker 2  2:38  
Great, thank you, Melissa. And good to see so many colleagues on the line today, I wish this was a webinar about more happy stuff. But unfortunately, we need to talk about something that's very serious, that could affect our profession. And unfortunately, the innovation ecosystem as a whole, this is the most significant, faulty interpretation of the Bible act that we've seen in the 40 plus years of Bible act history. So I wanted to walk you through along with my colleagues, Sheila and Mike, the, what this framework says, and the impact that this is going to have as well as what you could do. So if I talk through the next couple of steps here. So I want to give you a quick overview of what these framework, the history that led up to the framework, what the framework actually says, Then Sheila is going to join us and give us an update on where things are currently with Marchin provisions, and then how they will be modified potentially, by this NIST guidance framework. Then I will provide an overview of our 14 page comment letter to NIST on this. And then finally, Mike will wrap up with what you the membership can do to make your voice heard on this really critical issue. So gonna have the first step. So again, everybody on this line knows about the by Dolac that do not need to go into that in depth. But what I wanted to highlight here, and this will become important a little later in the conversation, is, as you guys know, a vital Act was passed in 1980. What you guys also know is the majority of tech transfer offices started post 1980. So at the time of the vital act, tech transfer was not as nowhere close as prevalent as it is today. And that can actually be visualized in this graph. So you can see prior to 1980, according to one of our licensing surveys, there were about 1920 institutions that had tech transfer offices, and that really exploded in the in the coming decades. And you can see that so you can imagine the significance of the by Dole Act when there really weren't tech transfer offices. There was this need to make or there was an airbag, there was an airbag to be used if things went the wrong way, hence marchin rights. And we'll get into that in just a minute. So the other thing I wanted to highlight is, as you guys will know, marchin rights applies to things that are funded by the federal government, in whole or in part. And so here you can see on this graph, that federal funding continues to be the majority of funding that US universities receive. Now, yeah, it's dropped from the 70%, down to, you know, 60 ish percent. But again, if it's funded, federally, federally funded in whole or in part, so you can imagine that any impact to marchin rights is going to affect the vast majority of the inventions received on your campuses. Okay, so why don't we go through a little history. So as you might know, there have been eight marchin rights petitions that have been filed. Of those eight petitions, every single one of them have been denied. And they've been denied by both Democratic and Republican administrations, this is not a political thing. This is the use of marchin rights, that airbag in certain very precise specific reasoning for instituting the marchin rights, which has not occurred. So eight times it's happened, and all of them have been denied. The last one was actually just in March of 22. So March of last year, and so in March of last year, extend these petition. And in fact, this happened to be the second extending petition, there was a petition to march in Annex standy years ago under the previous Republican administration, that was denied, then nothing's changed, the facts have changed, the law hasn't changed. And under the current Democratic administration, that's a petition was also denied. However, interestingly, at the end of that particular read, letter, rejecting that petition, there was a line here, that the NIH and HHS will pursue a whole of government approach to ensure the use of marching authority is consistent with the policies and objectives of the by Dole Act. We thought that this was interesting. And of course, we wanted to have that stakeholder input. Unfortunately, this came out in the form of this draft inter agency guidance framework. So you've now seen this, this is on our website, we'll drop the link that has all the relevant documents in a minute on by the way, these slides are going to be available on that website that we're going to post. So don't worry about jotting stuff down, you'll have all this content for you. So just before the holidays, December 8, this draft in our agency guidance framework was released. And so the goal of that framework was to provide all those funding agencies clear guidance on when to use marchin rights. Now, again, we've been using it for 43 years. And it's been pretty clear. However, there was an important addition and she'll is going to describe some other changes. And one of them is if the contractor a licensee is commercialize the product, but the price or other terms at which the product is currently available to the public are not reasonable. Now, that is potentially a margin trigger. That's never before been the case. And Sheila, we'll get into more of the history on that one. So that's what happened. On December 8, they allowed a 60 day comment period for stakeholders to weigh in on this. So by February 6, and of this year, so in about a week, these comments are all due. And that's it. Interestingly, and for those of you that have posted comments on the federal register before, this is limited to 5pm on the sixth, oftentimes, it's till the end of the day. So be aware of this when you get your comments in. Currently, there are over 42,000 comments on this guidance framework. And the purpose of that framework and these comments is to help inform their decision. So again, Autumn has filed our comments, we provided them both in PDF as well as editable word form for you, if you want to take pieces of that and move on. Okay, so that's where we are today. Now, what I'd like to do is I'd like to turn it over to Sheila, who can walk us through the current marchin rights Have a procedure as well as this guidance framework, Sheila. Thanks,

Speaker 1  10:04  
Steve. So as Steve was talking about margin, it's kind of an airbag for the vital act. So vital covers a lot of things. We're focusing on margin today, for the reasons that Steve outlined. But the idea is that under certain limited and outlined circumstances, the government can come in and exercise its marchin rights to require somebody who's received federal funding to create technology that was a contractor, or a university like us, and assignees. The government can require that party to license to a third party or the government can do it itself. So that's what is meant by marchin rights. And there, there are four specific circumstances that are outlined in the statute, and you can go ahead and put those on the state that will focus on the first two today. But the first one is, the federal government determined or the agency that have been petitioned determined that action is necessary because the contractor or the the assignee, again, that's the person who received the federal funding that could be the university has not taken or it's not expected to take within a reasonable time steps to achieve a practical application of the subject invention in its field of use. So that's one circumstance and that that is directed again only to the person who's receiving the federal funding, but the contractor or the assignees. The second circumstance is an action if necessary to alleviate some sort of health or safety need, that's not being reasonably satisfied by the contractor, the assignee or the licensees of the technology. So again, we'll focus on those first two. But there are two other things that are outlined and specifically enumerated and vital that would give the federal government the ability to march in. The third one is that there's a public use need that's been specified by federal regulations. And that's not being satisfied by the contractor or the assignee or the licensee. And the fourth one has to do with the domestic manufacturer requirements and vital. And so with that, you can go ahead and go on to the next slide, Steve. Though, sometimes, and to the lawyers on the line, if you've ever been tasked with kind of going and trying to find the intent of Congress based on legislative history for a bill, that can be a daunting task. This is a unique circumstances or senators, by indole, were very clear about what they thought about pricing as a prerequisite or a rationale for using margin. And so this was through an article that they published in The Washington Post called our law helps patients get new drugs sooner. And the Senator said we did not intend the vital act did not intend that the government would be able to set prices on products that result from research that was done, at least in part with federal funding. The law doesn't talk about pricing, when you looked at those four criteria in the earlier slide that said nothing about pricing. And the senators go on and say that's not because we didn't think about it, but not because we forgot about it. We knew about pride thing, and we intentionally did not put it in as a rationale for March. And here, again, they they iterate or reiterate that the whole point is to get the public and private sector working together to help develop federally funded intervention. So they go on to say, the ability of the government to take out to take back a license or grant a new life. And that's not going to be contingent on what is the price of the resulting product that came out of that research. And the only way that the federal government should be exercising its marchin rights if the private industry collaborator is not commercializing the product, the ability is there. There's there is a product that can be commercialized and made available, but the private industry collaborator isn't doing it. That's what Marchant was created, or according to senators by unknown. And then when we think about like how these petitions have worked, so Steve mentioned earlier that there have been eight petitions, and they've all been to the NIH, you can go to the next slide. Thank you. They've all been to the NIH. And each time the NIH has declined to grant the margin. And the NIH has specifically considered pricing as one rationale for the government's marching on several occasions, and has repeatedly said this is not an NIH problem to solve. And this is not what march in is supposed to be used for under the vital lot. So we have a couple of examples on this slide. As Steve mentioned, the autumn comments are available and the slides were will be available so you don't have to jot these down. And in the autumn comments, you will also find links to the original sources so you can go back and take a look at these things on your own. But here the point is that over and over again, the NIH has said Marchin is not an appropriate way to control the prices of products. That is something that Congress could do. and should do, because often these things can have global implications or they can have more general economic implications. So that that is an area for Congress not where the NIH exercise. In the in the second example, here, again, the extraordinary remedy of Marchin, not an appropriate means of controlling prices when the product is broadly available to people on the market. And then again, as recently as 2017. And there are probably other statements, but I tried to pick some of the stronger ones here, the broader issue of drug pricing would be best addressed through the legislature. So that's what the NIH has told us over and over again. And that matches what we've heard from Senator Sian dole, and that matches the actual explicit language in the vital act. So you can go to the next slide speed. So when we think about why the NIH may not want to be thinking about drug pricing, we can look at an experiment that the NIH actually did for us. So again, we have you know, what, what did the vital act say about pricing? Why doesn't it say anything about pricing, we know it's intentional. And then on top of that, we can actually look and see that the NIH did a little bit of an experiment with reasonable pricing times and licenses to show us what might happen to technology transfer it, this was imposed on all types of licensing for federally funded work. And so in 1990, the NIH imposed some reasonable pricing terms and requirements in its greatest so it included terms that required reasonable writing on the back end. Ultimately, the NIH found that those terms were driving industry away and making industry not want to work with the NIH to help develop federally funded technologies, and determined that's exactly the opposite of what vital was intended to do. So they said this was a bad idea. They repealed that practice, and then ultimately saw the number of Kratos that they were able to enter, go up after they repeal that, that reasonable pricing requirements. So kind of went with that history, though, again, not not expressly in the statute. We know what senators by and dole thought about it. We know what the NIH thinks about right thing in terms of marching. And we have some idea as to why the NIH might think this is a problem that are addressed by Congress and not something that we would deal with in the tech transfer space, though. So why are we talking about this today, what happened, such that now pricing might be part of this expanded mechanism for markets that we can go to the next slide to get a little bit of insight into that. So again, these are this is just a repeat of the four specific circumstances that are outlined in the vital act for when March and might be appropriate. And NIS has focused on the first two of these. So the first one talks about when the contractor or the upside eat has not taken, or it's not expected to take action to achieve a practical application of the subject invention. And when we look at what practical application means, in terms of by goal, it's situations where the contractor or the assignee is licensing the technology, it's in a way that is reasonable. And so one of the examples that that Steve uses to explain this is you can't at the university, go to your licensee and say yes, please help me develop this federally funded technology. But in order to do that, you have to fund a building on my campus, or you have to find a program on my campus. That's not making those rights available on a reasonable basis on reasonable terms. And that term is used in the definition of practical application. So how then do we get from practical application to pricing, and that's what happened, then what the mystic guidance. So if you can go then to the next slide, please. So what NIST has done is they've rewritten what practical application means and criterion one. And Steve mentioned that slide earlier. So under the expanded view of what is a practical application, According to NIST, march in might be available if the contractor or the licensee has commercialize the product, but the price or some other term

Speaker 1  19:20  
at which the product is being offered to the public is reasonable. So they're working in price under that, that reasonable and practical application. It's interesting here to note that again, that first criterion is directed to the contractor or the assignee. And as we know, the person who's initially licensing the technology have very little input on what a price to an end user would be. Though it is a difficult, I think construction to get pricing into the kind of practical application framework on that first criterion, though, another way and This is just another line. So they go on to say that the agency, the NIH, whoever is receiving a petition, can look at factors that unreasonably limit the availability of the invention to the public, including the reasonableness of the price and other terms at which the product is made available to end users. So again, working in that's price to end users in a factor that really is only supposed to be thinking about how the technology was licensed by the entity that received the federal funding. And then nest also addresses pricing to some extent in the second criterion. So that's on the next slide. So this looks at that second criterion, which deals with the health or safety needs, and queries what it means to be reasonably satisfied. So this goes on to say, one of the questions that the agency considering the petition can ask is, is the contractor or the licensee exploiting a health or safety need in order to find a product, right, that is extreme and unjustified, given the totality of circumstances. So again, now working in price under this health and safety prong, and let's provide provide some examples. So it says, you know, one way that we might be able to tell that someone is exploiting a health or safety need is because a needs manifests itself, all of a sudden, there's a new virus or something circulating and prices drastically go up. But this goes on to say the agency is not limited to looking at those circumstances where prices go up or fluctuate in ways that don't make sense with the market. They can also consider the initial price upon which that product was made available to the public and determine whether that is extreme, unjustified or exploitative by health or safety need. And so that's how that's how now we're looking at that expanded use of margin that now includes, according to this NIST framework, guidance, a pricing component. And so with that, I'll turn it back over to Steve to talk about autumns views on this. Great,

Speaker 2  22:03  
thank you, Sheila, appreciate that. Great, well, so as you're watching this, and you're listening to Sheila give the history of how marchin rights has been used, and now how it's being reinterpreted, you can imagine the impact that that is going to have on the innovation ecosystem. And to be very, very clear, Autumn does not support hydrant prices, we do not support high prices of any kind. All we care about is getting those innovations out of those labs, into the hands of companies to create the products and services of tomorrow, that can be priced downstream. As you guys well know, you do not have pricing provisions in your license agreements, you're and nor would a company agree to those even if you have them in there. Instead, we want to get those inventions that are funded by taxpayers, into the hands of companies to develop into those products and services that are going to positively changed the world. So how did we respond to these pretty drastic reinterpretation of what the Bible says. So we're going to drop into the chat in a second, the link that's at the bottom and again, you'll see these slides, so you have the link yourself. But if you want to look at it a little quicker. We'll drop that in. But basically, in our 14 page comment letter, written by Sheila Mike and some excellent members of the audit community, we came up with three major points. And I'll get into each in a little more detail in a second. The first as Sheila Welch pointed out, the draft guidelines do not align at all with the letter nor the intent of the viola act, that was not at all what the vital Act was meant to do. And so if I go back to this idea of the vital Act came into effect before there were tech transfer offices, that again, that airbag was there, because these were brand new tech transfer offices, clearly, very professional, well run organizations now, and and are continuing to grow. But you can imagine the concern back then, was maybe we needed to deploy that arabesque clearly, that's that's not been the case, according to the history of Marchin petitions. So that's number one, do not align with the letter nor the intent of the viola. The second implementation of the draft guidelines will do little to anything to actually reduce drug costs. And in fact, it will have likely have the opposite effect in that there will be a limitation of additional competing products downstream. One of the things I want to mention that's really important here is these marching guidelines apply to any type of field. This is not limited to medicine. This is not limited to drugs. This cover Whereas anything, anything, AI photovoltaics, you name it, medical devices, you name it. So be aware of that. So you know, it's not going to have any, it's gonna have very limited effect on drug costs, which appears to be the goal here. And instead, it's going to have the opposite effect. I'll give you a little more detail on that in a second. The third point, and this is the most important of the three is this will chill investment in federally funded technologies. And we are really concerned about that part, as you probably are, you can imagine your conversations with your potential licensees now. Now imagine that, hey, just to let you know, if that technology is not reasonably priced, when you put it on the market, two years, five years, 10 years from now, the government can march and take it away from you and give it to somebody else. Okay, what's reasonable? Yeah, I don't know. Okay, is there some way to determine this? Nope. You can imagine the uncertainty that this just provides to the entire innovation ecosystem. And you guys know how difficult it is to get those innovations into the hands of companies to advance them. We're just adding uncertainty to a level never ever before seen. I say never before seen since the by Dole Act, I probably should say, some of you might be aware, prior to 1980. There was this concept of being contaminated by federal funding. That is when companies wanted to license intellectual property that might be developed at a university, they asked, Hey, was this funded by the federal government? And if the answer was yes, they said, Oh, nevermind, then, and then moved on to something else, the barriers to licensing intellectual property that was federally funded, was too challenging. And these, these inventions were just contaminated by federal funding, and people moved elsewhere, really concerned that that might be the future of federally funded inventions, if these guidelines are to take effect. So that's kind of the general overview if I dig into a couple of these. And again, Sheila did a fantastic job of walking through why it doesn't align with the letter nor the intent. So I'm gonna skip over that, since we talked about that are ready. The second is, it will actually do little to nothing to affect, or to reduce drug costs. And so let me give you an example of this. And so we'll drop it into the chat in a second. There is a recent report by vital transformations that looked at 361 FDA approved drugs. That was somewhere in the neighborhood of 2011 to 2020. They looked at the 361 new drugs. And they said, All right, what's the percentage of these that were funded? With or had a government interest in one of those drugs? Do you know wild guess what that number might be? Turns out, it's 8% 8% of the 361 FDA approved drugs, had government interest noted on for those drugs, so 8% had any government interest? Now they dug a little deeper? And they said, All right, well, as you know, many drugs in this case are covered by multiple patents. So if there's one federally funded patent, and then there are other patents that are not federally funded, that could provide a challenge to the federal government, should they use their Marchin provisions? Well, how often does that happen? Well, it turns out that of the 361, FDA approved drugs 2011 2020 of the 361. There are a total of five, five drugs in which the composition of matter and the meth mechanism of action patents are our government interest, tats. That's it, five, five out of 361. You can imagine that, again, the and that's data. That's the data that if you instituted marchin rights today in the in the way proposed, you're going to have an effect on five, five. So that wanted to get that across. Now, the other really important aspect and of course, the one that we dive into is the chilling of the investment into those federally funded innovations. Again, we're going to go back slide back into contaminated by federal research funding. And again, this is not something that is is a mystery, and we're not sure it's going to happen. And you know, we know this for certain there have been there's a National Academies of study a report in 2018 years ago, that said marching in, if implemented would chill for many years, perhaps for decades, the inclination to invest in research and development and to create new biotechnology companies. Again, that's just one you can imagine and you sitting in the seats you sit and you could see the impact that this is going to have. Now fortunately, stakeholders from the NVCA and others are weighing in on the impact that this is going to have on that innovation ecosystem.

Speaker 2  30:36  
All right. Um, so I wanted to quickly summarize some of our comments that we made. And so as, as you might know, having read the Federal Register, notice, they NIST asked, Hey, we've got five questions to help us tailor our framework, our marching guideline framework, we explicitly said, Look, given your underlying premise that this is legal, and will lower drug prices without harming American innovation, all of which is incorrect. We will not even attempt to approve, improve the fatally flawed process. And we just flat out said that, look, there's there's no coming back from this. Instead, what we said is we said, Look, can you fully engage stakeholders outside of a 60 day comment period over the holidays, where you lose a couple of weeks, and commissioned a study on the impact of these draft guidelines before you implement them? You've got 43 years of great examples of success COVID being just one of them. Why don't you at least do a study before you go against the intent, the meaning of by Dole Act, and create uncertainty in the ecosystem that will then National Academies of Science that will endure for years, if not decades. In addition, so So that's one approach, hey, do a study on this and actually see if this is going to have impact and better engage the stakeholders across the innovation ecosystem. The other thing that we're doing is we're also signing on to a higher ed coalition letter. And in that letter, we're actually saying just rescind the guidelines, just just get rid of them completely, there is no hope for them. So that letter, once it's public, we will be posting that as well on that same website. So with that, I want to turn it over to Mike. As you can see, this is a substantial issue covering innovation and technology transfer. And so I want to turn it over to Mike now to let you know what you can do to help and Mike a gleam. I saw a question in there about the 42,000 comments, and kind of you know where they list it. So Mike, let me turn it over to you. Yes,

Mike Waring  33:02  
thank you very much, Steve. And Sheila, thanks for the opportunity to participate here today. I think the issue here today for tech transfer is what are we going to do about this situation? We've been talking about it for weeks, we've been encouraging people to work on their comments. There was an insight column at the beginning of January that laid out a whole to do list for folks. We've been reiterating that in podcasts and other kinds of communications. This web webinar is another example of that. Your Federal Relations, people have heard lots about this from their associations as well, as well as your medical school people. So they're all aware of the situation. So this should not come as any surprise to folks on your campus who are involved in this process. But what can universities what can autumn members do to make a difference here on this whole situation, and of course, the obvious one, number one is make sure you file your comments. By next Tuesday at five o'clock, we have not gotten any extension, there's been a request for an extension for up to 90 days, we could still hear about an extension between now and next Tuesday, excuse me, but operating under the assumption that we will not get an extension. It's really important that if you want to make comments, if you want to weigh in on this, you need to do it over the next eight days. Look at the comments that were sent to you by Autumn, all of you have a copy of that you're free to use any or all of that. But I would really also encourage you to add local examples or stories from your own campus or institution. The more regional the more local you can make it, the better it will resonate with people in your area. And I'll talk more about that in a minute. And the link to actually file the comments is included in the NIST comments that Autumn sent around, there's a link to simply go in there, you cut and paste your comments into the link, you hit, hit send and they're done. And that's all it takes. It's very simple. So please get your comments and they can be one page. They can be 1000 pages. You could even take autumns comments and put a cover page on yours and say we at the University of X totally support the autumn comments and why Make sure you know that. So that's another way to very quickly make sure your voice is heard on this. Another thing to do is, once you've sent your comments in or you've got your comments together, please, please, please get together with your Federal Relations team on your campus, your Government Relations folks, make sure you share your comments with them and encourage them to then share them with your congressional delegation from your state or region. And you can also share it with your governor, your mayor, other people in the local community we want is we want to try to use our comments to lever leverage other people's concerns about this as well. We're already doing that here in Washington, a number of members of Congress are now speaking out against these proposed guidelines they have already we're going to hopefully see some letters from Congress to the Hill, there's other kinds of communications from the hill to agencies about this and to the White House, encourage them not to do this. So that's the kind of pressure you want to continue to put on people. So taking your comments and saying congressman or senator, these are really important to us, here's why we need you to go to bat for us in Washington as well on this, let them know how this plan could could affect your ability to create all kinds of technologies, not just drugs, this affects everything that you do. It could be clean energy, it could be agriculture, it could be all kinds of inventions that your your true campus is working on. And being able now to then find people willing to invest in those technologies, with the possibility that someday down the road, the price may or may not meet some kind of vague, reasonable, this definition is going to be problematic. And I think as you explain that to people start out by explaining how we do innovation on our campuses, and then get into the specifics about why this idea is not a good idea to pursue. There's also some other things that you can do as well. Obviously, you want to make sure other people on your own campus understand why your institution is making comments. I'm hopeful that your senior administrators and your university president are already aware of this, I know that the presidential associations have been reaching out to VP ers and the Presidents about this. You want to make sure your Board of Regents is involved in this. A lot of those people are business people in your state in your region, powerful alumni, they have a voice, they may want to communicate with people in Washington about this issue. And then a number of you live in areas where there are regional research and economic development collaborations. I know I used to work at the University of Michigan, there's a university research quarter there, which involves Michigan, Michigan State and Wayne State, I believe they're going to be finding comments on behalf of those institutions. So it has a regional effect. It's not just universities that are going to suffer here. It's the whole environment around those. So anybody to do business with, let them know what's going on and see if they will also weigh in on this. And finally, I would also say that even after the filing date next Tuesday, that we don't know when any decisions will be made on this set of this framework. So we have additional time, and we need to use that time to keep up the pressure on NIST not to include this reasonable pricing proviso and its marching guidelines. One of the things you could do, again, with your president or maybe somebody in your campus is do an op ed, get it placed in the local paper, talk to the local TV stations and have them understand how this is going. And obviously copying all these things with policymakers, particularly at the federal level where this decision is being made. The argument that we've made before to we make it at the end of our comments is that this government wants to deal with drug pricing. There are ways to do that, besides turning the Baidoa law on its head, we've already seen last year, there was a cap put on insulin prices per month. There's also a requirement now that drug companies and Medicare can negotiate prices for drugs that Medicare buys for senior citizens, whether you like or don't like those particular responses, those are direct things that Congress or the administration can do that have nothing to do with the IP that's related to those issues. And that will directly have an effect on drug pricing. So whether those are good or bad is a secondary issue. There are other ways to address this issue than going through this very convoluted set of framework that the NIST is trying to create here. That is going to basically turn the by though law on its head, I think the three points, I hope you'll all make the three points that automates, but you may think of others yourself is that this goes way beyond what the law allows, that is not going to solve the problem that the administration or that needs is trying to solve here and that it's going to cause huge collateral damage to the other kinds of technologies that we work on every day, the majority of what we do every day. So it's not an idea that it's being pursued without really being thoughtful about the impact it's going to have beyond the drug pricing issue, which seems to be getting most of the attention from the folks who are pushing this so I'll stop there happy to answer your question, Steve. I'm happy to respond this first question which is, do we know how many of these comments are in favor of these marchin rights changes? I think the vast majority them are. But if you go look at them, and you certainly can, by going to the website, most of them are two or three sentences from people saying, Oh, I'm so glad you're doing this, this is going to reduce the cost of my drugs, which is fine. That's that's one person's opinion. But it's not an accurate position. It's easily to be ginned up by people on a grassroots basis, it's not going to really, hopefully, it will not be carry as much weight. She's me, as a thoughtful of comments that Autumn and a number of our allies are making in this process. And we're getting I should mention, too, that we're getting lots of comments from groups that aren't necessarily involved in universities. But they're also involved in the innovation pipeline. And they see this as being a very negative kind of thing that we're talking about here. There's all kinds of groups, all kinds of businesses that are weighing in on our behalf, because they see this as a challenge, not only to this drug issue, but also all across the board on these sorts of things. So let me stop there happy to answer any of the questions, Steve, and Sheila.

Speaker 2  41:00  
Great. Thanks, Mike. Yeah, and so thank you, for those of you that have dropped some questions into the q&a. And if you can put them there, and we'll go through them one at a time here. So let me stop my share, and we will look at each other. Alright. So, Mike, maybe first question for you here. So, so we mentioned 40,000 comments mentioned, many of them are two sentences. And so for those of you that might not have posted on the federal register before, here's how it works. There is a textbox, you can just type in a couple of sentences and hit send and you're done. That's one way to do it the way autumn does it. And the other people do as well, is they will put together a separate PDF or you know, their comments. And then you know, in that textbox say, please see attached for the comments. And so we insert our comments that way, one thing that this group could do, should they be interested is maybe use that textbox and say something like we support the autumn comments, please find them attached. So again, this is this is easy for you to make your voice heard. So Mike, I guess the question for you is if there 42,000 comments, and you know, we've got a couple of 100 universities across the nation, those really don't balance out. Is there any other ways that we can help get our voice heard?

Mike Waring  42:23  
Well, I think finding comments of substance is really helpful, which is why I think a lot of these other comments are very short and sweet kind of throwaway lines that are being ginned up by various groups that want to support this effort. But that's why I keep going back to the notion of getting your congressional delegation involved in Washington, and letting them know this is a serious matter, and they shouldn't be weighing in. And frankly, they can even weigh in with NIST and the administration even after the February 6 deadline, as far as that goes, because the Congress has a very powerful voice. Remember, the Congress appropriates money for every agency in the federal government. So when Congress speaks, agencies listen. And if NIS gets an earful from a number of members of Congress who say, this is a terrible idea, why are you doing this? That will be very helpful. So we really want to engage people, even outside the political process, whether it's members of Congress, whether it's industry in your town, it's your governor, your mayors, your economic development, people, all those folks can have an impact here, because they speak to the whole innovation ecosystem in which tech transfer resides.

Speaker 2  43:28  
Right. Thanks, Mike. Sheila, I'm gonna turn over a question to you in just a second. But I wanted to hit a comment first. So question I'm going to have you answer Sheila is bipedal is governed by legislative power? Where does NIST have the authority to propose and implement these changes? It seems unlikely that Congress would approve such a change. So maybe you could just kind of walk us through what might happen in this case. But there's another question in here that I just wanted to address quickly. And that is, you might want to remind everyone that the proposed guidance would affect companies receiving SBIR STTR funds, which will also have a chilling effect on innovation. I note from the participants here, we've got some people from the NSF. And so recognize also that something like this will have a negative effect on federally funding of, say tips and other programs that are federally funded, this is actually going to have a boomerang effect, in that we won't be able to commercialize at the same rate and the same efficiency in the past. So again, this is not just a tech transfer thing. So it's not just an autumn thing. This is throughout the entire ecosystem. So back to you, Sheila can let me read that one more time. So BD is vital is governed by legislative power. Where does NIST have the authority to propose and implement these changes? And then it seems unlikely that Congress would approve such a change. to maybe just kind of walk us through what would happen,

Speaker 1  45:03  
or so. So that is correct. NIST has authority granted to it to interpret and practically apply the vital statute, it does not have authority to change the law or to write new laws. That kind of that line between what is just implicating a law that's been passed by Congress versus what is pushing it too far. And actually, creating new locks is something that that people fight about a lot. And cases are popping up all over the place on this and other areas of the law, and may very well pop up in this area as well, where people challenge whether NIST had the authority to do this. I'll add that that also, just because this administration thinks that NIST may have the authority to make this this what we think is an expansion of the margin provisions of the vital Act. The next administration may completely disagree and revoke it, though. And that is another reason that Otto believes that this is something for Congress to address so that it can be addressed in a more democratic and more hopefully certain and less unpredictable kind of way. So lawsuits. That's one way that this might be addressed. It's also something that that Congress could take on its own to say this is not an appropriate interpretation of the statute that we have.

Speaker 2  46:23  
Great. Thanks, Julie, you knocked out two different questions there in terms of administration. So you're exactly right. A different administration, or a NIST under a different administration could perceive it a different way. And you guys recognize that having this boomerang back and forth, your innovations aren't turned into products in a four year term, perhaps maybe not even an eight year term, you can imagine, again, the deleterious effect of this approach. Let's see, I had a question in here. Do we know of other organizations like Le s or submitted comments? And the answer is, yes. So we're in touch with with all of our stakeholder groups, we're hearing from the higher ed groups you're hearing from LCS. I mentioned the National Venture Capital Association weighed in a U RP. They're just a number of different organizations, all of which are going to be negatively impacted by this erroneous interpretation of the by Dole Act.

Mike Waring  47:22  
There's a couple of a couple of major business groups that are also taking our position. One is the US Chamber of Commerce. Another is the National Association manufacturers, because they both see this as a nightmare, interfering with their abilities for their members to take advantage of the research that it's done on university campuses and nonprofit institutions around the country. They are very aggressive on this. And so it's not just the higher ed community, it's not just the medical community that's getting engaged. It's the business community writ large. And I think that's very, that's very important to understand that, that even the people involved in the back end of this, understand the implications of this another group that's being very vocal, as filed very strong comments against this as the National Venture Capital Association. These are the people upon whose investments we rely to get those innovations out to somebody who can actually then license those and take them to the next level. And I think that's going to be a very powerful message, that if you're going to make it less likely people are going to invest in these things. What is the point?

Speaker 2  48:24  
Great comment, Mike. Great. So I see a comment here. It's a good one. It's actually kind of a two parter. And that is some schools are reluctant to stick their necks out, commenting on something that might not be inside the core mission of the university. And how do we convince senior administration? It's a big deal. So I wanted to kind of answer that on two different levels. So number one, yes, it would be great if your institution weighed in. That doesn't however, preclude you personally from weighing in, just like these, you know, 40,000 comments weighed in you, as a tech transfer professional, unconcerned with this approach. So again, that's a potential Avenue. I know, I personally, am going to be filing comments in addition to the autumn institution comments that we have. So in terms of kind of getting the word out there. But the the more important aspect of of your comment there is how do we convince senior administration this is important. And so Mike, I don't know if you want to talk about higher ed and how we've engaged with them. Yes. Well, we've

Mike Waring  49:29  
talked about mentioned both the Presidential associations who are mostly involved in this effort, AAU, the Association of American Universities, which represents the 69 largest research universities in the country by volume, as well as the Association of Public and Land Grant Universities, which represents over 250 universities, many of those AAA schools, but also a number of others around the country. They're in every state of the country, and they are all urging their members to participate. They've been communicating with presidents and vice presidents of research. They are encouraging their members to file comments They're going to file their own comments that will be part of this joint comments, they're going to be filed on behalf of the broader higher ed coalition. So there's lots of pressure or suggestions to schools that they get involved in this, the medical colleges are reaching out to their campuses to encourage them to speak out here. So there's lots of efforts by the associations to engage their membership. And different schools will take different positions on this. But I don't see any downside for anybody to weigh in on this issue. I don't think there's going to be any kind of ramifications for anybody that does that. So I don't think schools should be afraid to engage in this issue. And maybe it's not the number one issue on a campuses radar screen. But that doesn't mean it doesn't need to be supported. This is why we've been encouraging you over the past few years to develop those relationships yourself with people on your own campus, and particularly your people in your Government Relations office, because they are sort of a crossroads on your campus between the President and the research people and the different schools and colleges and the science folks. And if you can get those people engaged, they can they'll pull together people from different parts of your campus, who can then carry out a thoughtful discussion about this. When I was at Michigan a number of years ago, I sat down with our medical lobbyist. And she and I worked out a sort of a general principles about how we would view sort of this whole discussion, I found that Doheny, very helpful in sort of saying this is where the university is, the university is not for drug prices, there will be biologic drugs, and for hospitals, we pay for a lot of drug benefits for our employees. But by the same token, we're trying to create the next great drug, and we don't want to do things that are going to interfere with that. And that has to be kind of our position. And I think that's been useful. And I think as schools have used that approach, they can then find a place where they can come down on this and say, this is a problem. And especially when you think about this going way beyond the drug pricing issue, because the real damage that's going to be done here is for all these other emerging technologies, where you're going to now have maybe big companies coming in at a small company gets a little startup going and saying, wait a minute, they want to charge this, we could do that same job, for half the price, let's go march and take away their patent, give it to us, and we'll do a better job of it. Think about the consequences that might have on your own campus with people that you are working with to try to create next great invention, whether it's whether it's weather, whatever it is, in science.

Speaker 2  52:21  
Great. Thanks, Mike. And so so we've mentioned, you know, a number of other stakeholder groups, higher ed and VCA. Others that have Chamber of Commerce, Nam. But there's two questions actually, about bio and bio stance on this one. And so they came out with a quite a statement, and so, uh, read it quickly. So in a nutshell, yes, they agree with our approach, which is, or our sentiment on this, which is this is going to have a terrible effect on the innovation ecosystem. So here's just a couple of phrases they used. Using the vitals marching process as a mechanism to control prices is a dangerous precedent to set, the move would create yet another element of uncertainty within the biotech industry, this type of policy would discourage the exact type of public sector private public sector partnerships that the vital Act was designed to encourage, and it would undermine a valuable piece of the drug discovery product process. So again, just another echo of what we're hearing across the entire innovation ecosystem.

Mike Waring  53:30  
Steve, let me add one more thing here. You know, when we get into this whole discussion about whatever the invention is, what what is a reasonable price for that invention? Who will be making that determination? Who in these agencies is qualified to make that determination in some kind of consistent way across different agencies using different kinds of technologies? What kind of economic data will they have to use? How will these things be adjudicated internally? Well, there'll be hearings and processes where people have to go. In some ways, those of you who have not understood the problems we've had with the patent trade and appeals board, where people go to P tab to block inventions they don't like or to tie them up in the patent office, this is a very similar kind of version, a company could do this sort of thing. And then stall or disrupt inventions for competing technologies or other kinds of things. Who in these agencies has that kind of expertise to make the determination of what reasonable is, and that's not spelled out on any of these guidelines, and there's not any way to spell it out. Which is why by and old never went down this road because they knew there was no answer to that question.

Speaker 2  54:43  
Excellent point. Thanks, Mike. Um, let's see. And Sheila, maybe I'll direct this one to you. So that two questions here. I'm just gonna give you the first one. And so it's a good statement. It sounds like everyone, perhaps with the exception of NIST thinks this is a bad idea. What is the feeling on the success of this change being adopted by the current and then coming administration's?

Speaker 1  55:08  
I'm gonna pitch that back to Mike. I think, God, I

Mike Waring  55:13  
think I think this is something that they want to do. I think I think that they have. And the motivations here are irrelevant. Some people have tried to ascribe political motivations to all this. And maybe there are some, it doesn't really matter. From our perspective, it's a bad idea, we need to block it, stop it, or try to get it diverted in some way. So the chance of it being adopted is there is that potential, and then clearly, they would like to do this, I think what we want to say is, this is the wrong policy, it's ill conceived, if you don't have the authority to do this, if we that's why I think getting members of Congress, their voice carries even more weight, frankly, than ours. Even though we're on the frontlines. They're the ones in the political process that can speak to agencies that can speak to people in the White House and say, You guys are on the wrong track here. This is not something you want to pursue, you haven't thought this really well out. So I think that that's really important. So that's why we are encouraging you to get with your congressional delegations, get your comments, share those with those people tell them to go to NIST and say NIST, you guys have gotten this all wrong. And I think this is a terrible idea. And we are not in support of this. And the more members of Congress and others, thought leaders, industry leaders who make that connection with people in the administration and in the White House, the better off we're going to be. And we'll see where the chips fall.

Speaker 1  56:31  
And I can take it back for just a second to say I think that there is this sort of groundswell belief that our pharmaceutical companies are making way too much money off of taxpayer funded innovation. I think I think that it is something that that people just think is going on. And that's why you might be seeing some of these very simple comments like, yes, obviously, if there's less patent, that's one less barrier to a generic that will make my drug prices go down. I think our message is that we're for various reasons, including the study that that Steve cited, that's not actually going to happen with these marchin rights. But I do think that that belief is generally out there. And that has probably led to this increase in attack on patents, which is ultimately led to this potential use behind margin. So that's why if this goes through, I think, I think why it can happen.

Speaker 2  57:27  
Yeah, and actually, you covered kind of the second question, which was, you know, what are the arguments for the guidance? And so I think you just hit that, you know, the, the expectation is, oh, well, this will drive down drug prices. And again, not even looking at the collateral damage. And again, just data driven, it's not going to have an effect, again, five out of 361. So the data is there for everybody to see. And know we're

Mike Waring  57:54  
getting an amen on that. And we talked about how few drugs are going to be impacted by this. So some people, some people on the other side, I said, Well, if that's the case, why are you so worried about this? It's not gonna affect that many of you? Well, the bottom line is, is going to affect everything that we do. And frankly, let's go beyond the drug issue. Put that aside. What about all these other technologies we're involved in, we're we're we're competing with China and with Europe and with other countries, and we're trying to develop the best clean energy, the best agricultural developments, the best new computer technologies, I mean, those things are right in front of us that affect our national security, that affect our ability to feed the world. And, and now we're going to expose all of that to some kind of review, based on price by some bureaucrat in Washington with all due respect, that has no idea about the implications of all that this is this is this is this is trying to kill a gnat with a hammer. And we've already talked about if there's an issue with drug prices deal with that directly. Let's not turn over the entire ecosystem that we invent things the United States for, and I will tell you that our other countries, I mean, if you're China, you got to be loving this watching all this internal debate in the United States about what are what can or can't be invented, what can or can't be invested in. The only reason we're ahead of those people is because we've allowed these 1000s of flowers to bloom with the support of investments by people from the venture and angel capital community and by people's great ideas. If people are going to be inhibited from getting that from the lab, the marketplace, the American taxpayer will be the loser in all that.

Speaker 2  59:24  
Yeah, and actually, and Melissa, I'll turn it over to you. I know we're getting just about a time but I want to quickly answer this last question. So there's a question here. And so you mentioned the impact of perhaps other countries on on American innovation. Of course, Autumn supports robust innovation ecosystems across the globe. But is there any standing to file a marchin rights petition and Sheila, I don't know if you are Mike want to weigh in on that, but you could imagine there could be an impact of non state or non US entities filing those petitions. So thoughts,

Mike Waring  1:00:04  
there is no standing, anybody can file a marching petition. And that's part of the problem is that it can be anybody under any, any rubric that they want to do. This is not a legal process. This is an administrative process. And so that's that that is. The other thing is that it can be done by anybody, for any reason at any time. And, you know, I think that's, that's, that's another issue that we have to deal with here, in some sense, is we're having the same fight with about P tab who can who can initiate a challenge of patents at the patent office, but through the beat tap process, who has standing to do that. So it's the same kind of fight. So all these things are working against intellectual property, which is the linchpin of technology transfer. And if we're, if we're going to do that, we're going to have ourselves a whole lot of problems that go on beyond trying to fix a few drug prices.

Speaker 2  1:00:54  
Right, fantastic. All right, well, let me just kind of reiterate the important points here, we've got a website that has all the information you need to make your voice heard. This is pretty influential in terms of our profession, we think it is wrong. And we'd love for you to weigh in on this, we hopefully gave you the materials and resources to be successful. So thank you, everybody. And feel free to reach out to us with any additional questions. Sorry, we couldn't get to all of them. Melissa, back to you. All

Speaker 3  1:01:24  
right. On behalf of autumn I'd like to thank Steve, Sheila and Mike for their informative presentation today. Lots of good questions and definitely a need for action to be taken. As a reminder, please complete the webinar evaluation following this session. It'll open when you sign off this, this session it that's going to help us plan better content for you in the future. Thanks again for joining us and have a great rest of your day.

Transcribed by https://otter.ai