Interview: Erik Iverson of the Bill & Melinda Gates Foundation

Erik Iverson

Erik Iverson is Associate General Counsel with the Bill & Melinda Gates Foundation, working exclusively with Foundation’s Global Health initiate. Mr. Iverson works with grantees in the development of intellectual property management plans, collaboration agreements and global access strategies with respect to the health solutions being funded by the Foundation. On Thursday, April 14, 2011, he will be the keynote speaker at the BIO IP Counsels Committee Conference, which will be held in Seattle, Washington from April 13-15, 2011. Mr. Iverson’s presentation at the BIO Conference is titled: “The Business Case for International Humanitarian Approaches to IP Management and Collaborations.” Several of my contacts at the Biotechnology Industry Organization (BIO) graciously put me in touch with Inverson and facilitated the coordination of an interview.  The transcript of part 1 of the interview appears below.

In a nutshell, the Bill & Melinda Gates Foundation is dedicated to bringing innovations in health, development, and learning to the global community. According to the Gates Foundation Global Health Program webpage the Global Health Program “harnesses advances in science and technology to save lives in poor countries.”  The page goes on to explain: ” Where proven tools exist, we support sustainable ways to improve their delivery.  Where they don’t, we invest in research and development of new interventions, such as vaccines, drugs, and diagnostics.”  During our conversation Iverson and I talked about how the Gates Foundation seeks to incentivize innovators, as well as foster and respect intellectual property rights while at the same time engaging in what by its very nature is a humanitarian effort.

Without further ado, my part 1 of my interview with Erik Iverson.

[Bio-Pharma]

QUINN: I really appreciate your taking the time to chat with me today and one of the reasons that we are having this conversation is I know you’re going to be speaking at the BIO IP Council meeting in Seattle in the middle of April. So I thought it might be interesting to talk to you about Intellectual Property in general. Maybe we can touch on some of things that you might tell the BIO group without stealing your thunder and also perhaps give you an opportunity to tell us a little bit more about what it is that you do at the Bill and Melinda Gates foundation. I know that’s a lot to cover so I will just let you start where you’d like to start and then we can go from there.

IVERSON: Sure where I intend to start as I do with most talks along these lines is to give an overview of how the foundation approaches intellectual property and quite frankly more importantly the management of those rights and the underlying technologies for purposes of insuring the furtherance of the foundations mission. That is making sure that drugs and vaccines and diagnostics are available to the people most in need in developing countries.

The basis on which we approach these issues at the foundation is we apply what we refer to as our global access policy and that is a policy based on 2 pillars; one being the broad and prompt dissemination of information arising out of the funded projects and secondly ensuring that the funded, intended product will be made accessible in terms of price and quantity and usability into developing countries of the world for use by the people most in need. The big question lies in how are those two pillars applied most notably to the technologies that are the subject matter of the grants. And then what I will do in my talk is give some examples of how we apply those and how we work with companies; the academics, the governments, multi-laterals, NGOs and others in trying to arrange and have the parties arrange strategies, global access strategies to reflect how they intend to approach those issues.

I also have to be clear with everybody that a fundamental premise at the foundation is that we absolutely respect intellectual property rights. We recognize their importance and we certainly recognize the importance of companies and their involvement in developing products and having them commercialized both in developed and developing countries.

QUINN: I’m glad that you brought that up because one of the things that a lot of the time when people hear of efforts to help primarily the third worlds when you are doing it in a humanitarian way is that intellectual property rights, a lot of the time, get pushed to the back burner. Some may even say that they get trampled down. That is not what I understand that you guys do. You have a far more progressive way of handling intellectual property, is that fair to say?

IVERSON: It certainly is in global health, I think unlike perhaps if you are doing a purely developed country deal. What you see in the global health sector, which is quite complex, is people on the far sides of the spectrum, those who really believe that patents are a true hindrance to having products be made available in developing countries and on the other side of the spectrum, people who are just absolutely staunch in needing to patent everything that comes out of the work. What we do is to we recognize the entire continuum of that spectrum and work with our partners to try and figure out where should we fall and of the technologies that are at play and being developed and ultimately products that being made available, what should happen? And we don’t take a prescribed approach in regard to any technologies as to where people need to fall on that spectrum

QUINN: When you’re approaching these negotiations with individuals, is this on a one off basis? Are you trying to establish more of general guiding principles that move the foundation in a direction to deal with all different types of negotiations? How do you approach it?

IVERSON: The guiding principles are the two pillars of our global access policy that I stated before but our approach for any given circumstance we believe requires tailoring and consideration on its own merits so that your approach for example with a malaria vaccine or a pneumococcal vaccine is going to be very different as to how you approach it in terms of development and global access strategy than it is for example if you are doing a visceral leishmaniasis drug.

QUINN: Can you explain a little bit about that? Why is it a different approach?

IVERSON: The difference of approach arises because you certainly have different markets that come to bear, where there are some products, pneumococcal products, for example pneumococcal vaccines will have different market applicability where companies will want to commercialize it in developed countries, but there is obviously a huge demand to make sure those products are available in developing countries. But when it comes to, for example, the leishmaniasis drugs, there really is no developed country markets. So the question is where do you want to get each of those products manufactured, how is it going to be distributed, what might be a revenue model to ensure a sustainable product? And each one is so dramatically different that warrants its own consideration.

But also what people need to recognize is that the way that you get products procured and distributed very differently and quite dramatically depending upon if you’re dealing with vaccine verses drugs and verses diagnostics.

QUINN: As I am sitting here listening to you talk about all of this, I am just thinking about the nightmare of issues that come up on the Intellectual Property end. And for folks who may be at first blush hesitant to try to engage in working with the Gates Foundation for fear of loosing their intellectual property, what do you say to them and how do you approach that?

IVERSON: Our response to that is — its more important to design a rational plan around managing your intellectual property than it is to decide whether you should have it or shouldn’t. In other words, if a grantee elects to put everything in the public domain, we’re OK with that approach but it would be good to understand how they can incentivize industry to get involved if that is in fact a factor. Like wise if a company or a grantee says, “we’re going to patent everything.” Our response is that’s fine but you have to commit and design a plan whereby you manage those technologies, that intellectual property to ensure its accessibility as well. And so I think to us the existence or non-existence of intellectual property is not the issue. The issue is how do you manage the technologies to ensure the projects success.

QUINN: It almost sounds like to me, what I am hearing you talking about, is a one off kind of way, trying to figure out for a defined project or for a desired outcome how do you approach things to strike the appropriate balance between providing incentive to get it done and on the other hand providing protection while not so much protection that others cannot actually benefit from the vaccine or the drug or what have you.

IVERSON: That’s right. There are certainly experiences where if we take a given approach and demand that it is consistently applied across global health we will inevitably take the wrong approach many times. For example to remove all intellectual property “barriers” what you’re risking is dis-incentivising industry from getting involved in those activities and whether its industry that are multinationals or developing country manufacturers for example. They very much need that exclusivity in order to become involved and to create a sustainable solution. So you’re right in stating that what we have to take into account, very much so in the equation are the incentives that are needed in order to get all sorts of folks involved. Not just industry but there are incentives that come to play with respect to the governments who ultimately are going to be the recipients of the products or the procurement agencies or multi laterals as well as the academics and NGO community.

QUINN: Can you give us an example of some of the types of work that you guys have going on right now and maybe that way we can put some meat on the bones with a real life example?

IVERSON: Some of the examples range from early stage discovery work and translational work where we are helping to build a program whereby multiple companies, big pharma companies and smaller pharma will enter into principles and given activities with academics and non profit research institutions to provide approaches whereby their compound libraries will be made available to conduct screening activities in hopes of identifying hits for new tuberculosis therapies for example. One concern of theirs is if we provide our compound libraries to these various academic and non-profit research institutions, “What’s going to happen to our intellectual property rights to those compounds, which is quite frankly the basis for their pipeline in the future. They are quite concerned about that. We have to balance those needs.

We have a significant effort on later stage development of TB therapeutics where the companies are working together to design a compound therapy and working closely with the FDA and we’ve helped foster that relationship with the regulators to come up with, as I mentioned, a compound therapy. The interesting aspect is that none of the underlying compounds have been licensed. So it is a novel approach, certainly regularity to achieve an end but also multiple companies working together and balancing each other’s needs along with the academics. Those are just a couple examples of very complex arrangements where we need to balance all of the incentives, needs and obligations of everybody at the table.

QUINN: So would it be fair to say then that what you do and what the Gates foundation does more generally speaking is facilitate and to some extent fund joint ventures between companies, universities, research facilities, governments and others to try and really provide benefit on the global health scene?

IVERSON: I would say we facilitate and challenge. Facilitate in a sense of how you’ve described it, we really work hard to convene and develop relationships and collaborations to develop new products. But we also challenge everybody to think about how they conduct business in hopes of changing the paradigm of how science is being done. And what I mean by that is business as usual in product development is not necessarily satisfactory in order to accomplish monumental tasks facing the global health community.

QUINN: And I use joint venture maybe not in the traditional sense but because it seems that another issue you would probably have to navigate at some point is as particularly companies are opening up their portfolios for research institutions, I can only imagine that there will be a host of things that down stream could be protected so there’s probably got to be a lot of discussion of that. I’m wondering if I am also hearing you talk about an open source of maybe a crowd sourced way to approach innovation.

IVERSON: Crowd sourced, that’s an interesting term, and honestly we are open to the spectrum of approaches. In other words we are not demanding that open source be utilized and we are not demanding that absolute exclusivity be utilized. We are looking at each situation and working with the partners to come up with a schematic that they agree works for the situation and there are a number of initiatives out there along the lines of making intellectual property available whether its pooling mechanisms or humanitarian licensing initiatives. And there’s a number of these efforts underway, half a dozen or 8 of them, in addition to what the foundation trying to achieve and I think that there is a need in our community as a whole to get our hands around what these are because there’s a lot of tension or pressures on the companies as well as the funders and the academic researchers to figure out how these all work together. Because at the end of the day I think we are all on the same page as to what we want to achieve. There’s just a difference of opinion as to how they can be achieved. And there’s a bit of a lack of coordination among all of us I think.

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