Managing director, University-Industry Liaison Office
University of British Columbia
NAME: Angus Livingstone
POSITION: Managing director, University-Industry Liaison Office, University of British Columbia; President, UBC Research Enterprises; Chair, Alliance for the Commercialization of Canadian Technology
BACKGROUND: Various positions, UBC-UILO, since 1988
Following the World Health Assembly’s adoption last week of a resolution on global access to health-related innovations and intellectual property, universities and non-profit research institutes are now considering how to implement “socially responsible” licensing practices perhaps more than ever.
Many schools have been practicing negotiating global access language into their licensing deals with industry on a case-by-case basis, but few have adopted a standard, universal protocol.
The University of British Columbia, one of the top life sciences research universities in Canada, took steps last year to adopt global access principles in light of the actions of peer institutions and dialogue with student-run and other advocacy groups such as Universities Allied for Essential Medicines.
Spearheaded by a group that included Barbara Campbell, former associate director at UBC’s University Industry Liaison Office; UBC president and vice chancellor Stephen Toope; and UBC UILO managing director Angus Livingstone, UBC published the principles late last year to help guide its faculty and administration, as well as other interested academic institutions.
Last month, UBC signed its first technology licensing agreement using the new principles as a guide. The agreement will allow Vancouver-based iCo Therapeutics to commercialize an oral formulation of the drug amphotericin B, which was developed at UBC.
In return for the worldwide right to develop and sell oral amp B in the developed world as a treatment for blood-borne fungal infections, iCo will also ensure availability to a suitable formulation to countries in the developing world for treating leishmaniasis through subsidized pricing.
This week, Livingstone discussed the evolution of these global access principles and the reality of implementing them in an interview with BTW.
So-called ‘socially responsible’ licensing and global access to innovations has been top of mind for many research universities over the past few years. What spurred UBC to move forward with a structured plan to adopt global access principles?
We had been working in the global access area for a number of years with individual licensing programs that included some terms. This was really reflected in a couple of ways. For instance, one technology dealt with accessing sea sponges from Papua New Guinea, and then isolating potential therapeutic compounds from those sea sponges, and returning [them] back to the country of origin.
We [also] won a fairly large [Grand Challenges in Global Health] grant, $7 million-plus, from the Gates Foundation, where we’re the lead institution for several institutions around the world. [The focus of that grant was to develop new medicines to boost the body's ability to fight infections such as malaria, typhoid fever, E. coli, and tuberculosis that are prevalent in developing countries. — Ed]. In the context of that we had to work on what our licensing strategy would be to preserve rights for third-world countries and global access.
While we were working in this area, along came a student group called Universities Allied for Essential Medicines. They were very keen, given work that had happened at Yale and some things that had been going on at the University of California-Berkeley, in having UBC adopt standard language.
We were a little bit reticent to jump into it sort of holus-bolus like that. We ended up having a series of meeting with them that included the vice president for research and the president of the university. The new president, Stephen Toope, is very interested in building up the university’s role and reputation as a global citizen. We met a number of times and essentially decided it was way too early to be adopting specific language and inserting it into all of our licensing agreements, and that this was really going to need to be a journey of discovery.
But we did think we could establish some principles, and if we did that, we’d at least be calling the question on every technology we looked at, and seeing what really made sense. Was there something we could be including in the terms, and could we do this in a way that respected and dealt with the issues that pharmaceutical and biotech companies have, because that’s very real. It would be just as damaging to what we are trying to do if we lost first-world access to some of these new therapies in light of trying to gain it for the third world.
With that we produced the principles. They went up on our website for a month or so, and got comments from people all around the world — student populations, academia, industry — and we incorporated comments into a revised version, which has been up and approved by our board of governors since November.
UAEM has been very critical recently of universities and other non-profit entities to take steps to influence global access. Have they been pushing for standard global access language in all health-related licensing agreements?
Yes, there is something called the Philadelphia [Consensus Statement], which they wanted us to adopt. It had a lot of detailed language in it, and we looked at it and said, “That doesn’t make a lot of sense.”
Did UBC look to other institutions or examples such as those provided by UARM when it drew up its global access principles?
We looked at it from a couple of points of view. The Yale model was a single licensing transaction; UC-Berkeley had more of a statement of principles; the Philadelphia Protocol had detailed language. So when we looked to form this, we though the work that had been done at Berkeley was probably most appropriate. Then, when we started to look at content, we took a look at what had come from Berkeley and from some of the general statements around the Philadelphia Protocol. So we were informed by some of the work of UAEM.
I should note that a lot of student groups can be labeled radical, or at least overly idealistic, but at least the folks we’ve been dealing with here at UBC have been very rational. They’ve been keen, and very determined, but they are not so idealistic that they think we can just snap our fingers and make this happen. So their support in coming up with a workable solution with them has been tremendous.
We also did a lot of thinking ourselves, and in fact we looked at broadening this to be greater than just global access to human therapeutics, which is really the raison d’etre of UAEM; to issues of environmental technologies, security – other things that would also be advantageous for considering global access, and we put some language around that ourselves.
There was no single group out there that made us think, ‘Hey, these guys have got it right, and this is what we want to be like.’ We saw a lot of different people moving in the area, and we consolidated the information to meet our own needs.
What are the difficulties in balancing the desire to increase global access of health-related inventions and the realities of working with industry to commercialize these inventions? Is there a big gap there?
I think there is – not when you take it at the principles level. But when you start to put it in detailed language, you’re often forcing a structure around it that in reality isn’t going to work. You really need to take a look at the specifics and say, ‘In this particular case, we can achieve the same goal by the following method,’ and then convert that into language. That is sort of the approach that we have taken. Taking specific language and using it in all agreements — we just anticipate that it will receive so much pushback from industry. And it’s tough enough — people don’t really understand how difficult it is to license technologies as they are without hampering them with a lot of additional obligations that are not yet tried and true.
We’ve been working with the phrase ‘journey of discovery’ because in each file, you learn something a little bit different, and you take a look at options that may or may not work in that particular situation.
If there was a direct line to developing nations, then we would be happy to go down that. But often the way to make it available to developing nations is to have it developed in the first world. How can you craft something that allows that to happen, and provides the returns that are required to make that happen in the first world, yet still make access available in the third world?
In Canada, the policy for ownership of university-developed IP differs from institution to institution, as opposed to the Bayh-Dole-dictated structure in the US. What is the policy at UBC?
UBC’s policy is very similar to Bayh-Dole in that if you desire to commercialize a technology, you have to disclose and assign it to the university. The university then manages it on your behalf, and you get 50 percent of the proceeds.
Is it easier or harder to adopt global access standards depending on the IP ownership policy that is used?
I think it would make a difference. Certainly when you have fewer rules you have more freedom to operate, which is often what you need in these cases. When you start to talk about global access principles in the US, you start wondering about the impact of export controls, and how you might have to address that in your agreements. There could be the march-in rights for the government, [which might] impose a different restriction on how you might implement something.
Those are questions that I don’t have to try to address. They may be something that is very easily manageable, but then again, they may not be.
Even on a case-by-case basis, trying to incorporate global access principles into licensing agreements must be difficult. What are the difficulties there? Is the recent licensing agreement UBC signed with iCo Therapeutics a good example?
The iCo Therapeutics deal was really an ideal case from our point of view. It was using the same technology to address two different therapeutic needs. In the first world, it dealt with an affliction that was already treatable, but that involved a really nasty regime – IV treatment four hours a day for two weeks. There is a 100 percent success rate, so you don’t have to worry about getting better, but you’ve got a nasty two weeks to deal with.
So the oral formulation is really quite attractive from the perspective of patient care and cost control. The nice thing is that in the third-world application, it is a different oral formulation of amphotericin B that can be used for leishmaniasis, and there really isn’t an effective way in the third world to deal with that.
Now you’re dealing with figuring out how to manage this huge human health burden in developing countries, yet at the same time you can go straight down the path of first-world development. That is a nice little overlap where they are not directly competing. It would be a lot more difficult if we had the same indication in the first and third worlds, and the issues that would arise in dealing with that.
Now that you have announced the iCo deal as the first under these new global access principles, will it be status quo moving forward to consider global access in every licensing deal that UBC does?
It definitely will. With every invention disclosure that comes in now, we’re asking the question of whether this is appropriate for a global access strategy, and what that would look like. It’s not going to be an afterthought of the person doing the licensing deal; it will be right up front. And after we’ve identified the ones that we think would be appropriate, we’ll at least put in our initial term sheets that this would be an expectation of the deal.
We’re hoping that over time, both through our own practice and through other universities’ practices, we’ll be able to identify different models that apply for different types of technologies. Let’s take, for instance, a therapeutic is available for cancer — which is certainly a first-world disease but is emerging as a third-world disease, as well — the approach for managing that might be completely different from the way we would manage something in, say, infectious diseases, which might only have third-world applications. The question is: What kind of protocols can we look toward to address the issues in these different classes of technology?