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‘Old IP’ System Stifles Biotech Innovation, Hinders Third-World Rx Access, Report Says

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Richard Gold
Associate Professor,
Center for Intellectual Property Policy
McGill University
NAME: Richard Gold
 
POSITION: Associate professor of innovation and intellectual property and director, Centre for Intellectual Property Policy, McGill University; president, The Innovation Partnership
 
BACKGROUND: Research associate, Health Law Institute, University of Alberta; fellow, Einstein Institute for Science, Health & the Courts; assistant professor, University of Western Ontario; associate, Torys LLP; clerk, Supreme Court of Canada; clerk, Ontario Court of Appeal
 
The world’s intellectual property system is broken, stifles innovation, and prevents life-saving technologies from reaching patients in developed and developing countries, according to a report released this week by an international IP coalition.
 
The report, entitled “Toward a New Era of Intellectual Property: From Confrontation to Negotiation,” was funded by the Social Sciences and Humanities Research Council of Canada, and is the result of seven years of work by McGill University professor Richard Gold and a group of experts in law, ethics, and economics called the International Expert Group on Biotechnology, Innovation, and IP.
 
In the report, the authors present findings from discussions with international policy makers, industry representatives, scientists, and academics, as well as from several biotech IP case studies from around the world.
 
According to the report, biotech policy makers, business leaders, and academics rely too heavily on an “old IP” system that encourages as much patenting as possible and is counterproductive to innovation and hinders developing nations from accessing potentially life-saving technologies.
 
Instead, the authors assert that biotech players need to adopt a “new IP” strategy that focuses on cooperation and collaboration at all levels; and they make several recommendations to government, industry, and university officials to help implement such a strategy.
 
Among these recommendations are for universities to develop clear IP-licensing principles to promote greater access to biotechnology innovations and to develop better measures of tech-transfer success based on social returns; for industry to participate in more public-private partnerships and to be transparent about their patent holdings; and for governments to take a more active role in encouraging and mediating public-private partnerships and to collect standardized patent-related information, including licensing data.
 
The full report, released at a press event this week in Ottawa, can be found on the website of The Innovation Partnership, a non-profit that will focus on addressing many of the issues raised by the research. Comprehensive data supporting the group’s report will be released on Oct. 14 at a press event in Washington, D.C.
 
This week, McGill’s Gold gave a snapshot of the report’s findings – particularly their implications for university biotech transfer – in an interview with BTW.
 

 
What was the impetus for this study and report? Who were the major players involved in its creation?
 
It started in 2001. There was a small group of experts to start with. We recognized several trends: the increased debate about technology transfer and the role of the university in tech transfer; the debate about research exceptions, particularly in the US, but not exclusively; and debates over access to medicines – so the [World Trade Organization Ministerial Conference of 1999] in Seattle had just happened, followed by the Doha Declaration [on the TRIPS Agreement and Public Health] in 2001. Following this there was … greater questioning of tech transfer, and questioning of the Bayh-Dole Act and its effectiveness in the US and other countries.
These were all trends that we were seeing all pushing toward the question: What is the role of technology transfer and innovation in biotechnology? There were also early signs that the pharmaceutical industry was seeing a declining level of innovation. There was already talk about their big blockbuster patents coming to the end, and how they would refill the medicine cabinet.
 
As these developments occurred we added depth to the team, and were funded by the Canadian government to look into these questions. Canada, after the US, is probably number two in biotech, at least per capita. The Canadian government has put a lot of investment – both at the national and provincial levels – in biotechnology, health, and agriculture. Also, [in 2003] Canada was the first country to [waive two licensing provisions of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights], and [established] the Access to Medicines Regime, so these questions were quite important to the country. As time went by our research questions became more refined, and as developments happened, the research took its present shape.
 
The research group was the International Expert Group on Biotechnology, Innovation, and Intellectual Property, right? What was the role of the non-profit The Innovation Partnership in this?
 
It was an outcome, actually, perhaps a surprising one. When we started this work, we had few preconceptions about where our research would lead. But in several instances in different areas, we noticed there was a missing actor. That actor was kind of this ‘trust builder,’ as we describe it in the report. That trust builder needed to bring together the actors to allow collaborations to happen. And governments who normally one would think would fill that role hadn’t been. We recognized that since trust was so critical to the development of these collaborations and essential to the future of biotechnology that someone had to play that role. We didn’t see many actors out there, although there were a few.
 
But we felt it was important that we create one, as well, as an outcome of our research, for a couple of reasons. One is that we had already developed the network in doing our research. The research was done in collaboration with industry, NGOs, and so on. We already had developed a certain level of trust, had a network, and had developed and developing nations involved with the project, so we were well-positioned to do it. We’re not the only ones – there are other groups that play this role, but we thought there was still a need.
 
One of the key findings in your report is the idea that academic researchers who are more likely to seek patents are less likely to collaborate with other researchers on a scientific level. Can you discuss this in a bit more detail? Do you have data backing this up?
 
Yes, the actual article that will be described in this will be put through a peer-review process. This is more of a preliminary finding, and the final report will come out after it has gone through the peer-review process. I’m fairly confident in the result, but it will come out in a purer form later with all the caveats that scientific literature would have.
 
In the past we’ve been able to measure fairly simple things about tech transfer, like its effect on publishing [of research]. But the big question is: If we are right – and I think the evidence supports that we are – that collaborations are key, then what is the effect of patents on this?
 
We’ve been getting at this backwards, in the ways we can, by using published literature – looking at the anti-commons problem, delays in publication, and so on. But so far we haven’t been able to tackle the link between patenting and commercialization behavior, and the effectiveness and desire of PIs to get involved with collaborations. If patenting runs counter to it, that’s something we ought to know. That wouldn’t mean that patenting is bad; it just means that you have to either have counter-balancing forces, or be more careful at the university level about when you would encourage and allow patenting.
 
Essentially we studied a research consortium of stem cells in Canada, but who were internationally linked. The idea was to isolate for each of those actors how much they published and who they published with. We used publication with someone else as a proxy for collaboration. And then we looked at how much they patented. There was a lot of work just getting the data and clarifying the millions of relationships, but through those analyses you can then do regression analyses and so forth, and I’m not [the] statistician on the research team – but essentially we found that there was this oppositional effect of those who patented more tended to collaborate less. Of course there are some caveats that need to be put on it, but that was the bottom-line finding.
 
It’s interesting that you used stem cells, since that area has been a lightning rod for IP controversy around the world. Do you think this finding may have been influenced by the fact that the commercial promise of stem cells is so great? Do you think your findings would have been the same if you used as a basis for this research question a vaccine for a disease that primarily affects developing nations, for example?
 
This is one of the things that we raise in the study – an absence of good empirical evidence. I think it always dangerous to extrapolate too far from one case study. Yes, I am able to say this with confidence about Canadian stem cell researchers, and I’m pretty confident about worldwide researchers because the links were international. And I think it’s probably true for other fairly early-stage technologies in biomedicine – for instance, epigenetics, nanobiotechnology.
 
As you move to technologies that are used primarily in the developing world, there are fewer commercial opportunities, so the behaviors would likely be different. The policies at the universities become different, the funders become different. How significant these differences are – I don’t know. You would have to run the same type of procedure on that. The advantage of what we’ve done is that we’ve disclosed a lot of how we’ve done it, so hopefully it will be easier for people to replicate it in stem cells and apply it to other fields, and only then will we find whether this conclusion is a general conclusion about biotech, about university research, or only about those technologies that seem to have a greater commercial value.
 
The report makes recommendations to academia, industry, and government, and the common theme is collaboration. Each of these groups has different motives when it comes to biotechnology research and commercialization, though.
 
They all have different motivations, and sometimes we look at one view and don’t look at the other. So we tried to bring a global view here, and an understanding that different actors come to biotech research and development for different reasons.
 
At the same time, we identified the common interest, and that is collaboration. It is important to understand that industry gets involved with collaborations because in the end it has to meet [its] bottom line. As they’re facing declining levels of innovation, they need to find ways to fill up the medicine cabinet. And a lot of the new technologies, like epigenetics or stem cells, are exceedingly high risk. It’s difficult for one company to take on that risk themselves, so they are going to be forced into collaborations to spread that risk, both financially and technologically. They’re pushed to collaborate because really, if they are going to take advantage of biotech, yes they can buy biotech companies like they are doing now, but at a certain point that strategy is not going to work.
 
A university is pushed to collaboration for a very different reason, which is that they want to serve the public, and they want to keep their researchers involved in the most cutting-edge research. More and more evidence is suggesting that if universities – especially in more technologically focused fields – work by themselves, they’re not going to get that. They need industrial partners. But they need to do it on the right terms … and to understand what their motivation going in is.
 
Government is interested for different reasons. They’re looking at social and economic development, though it will depend if you are a rich or poor country. If you are a rich country, and you have a good biotech sector, you want to maintain it; you want it to provide income; and to a certain extent, you also want it to provide needed products and services in your country, especially countries that have a public health care system – they pay for that service. If you’re a developing country, you just want access.
 
No matter who you are, you need to be involved in collaborations. But everybody needs to know why they’re involved and to understand why everybody else is involved, and I think that’s the part that has been missing. Sometimes we just look at universities and we ignore why industry is involved and to what extent. Some people might say, ‘This is publicly financed research, and therefore there should be no patents and anybody should be able to use it.’ But that doesn’t take into account how you are going to get industry to be actively involved. And sometimes industry doesn’t recognize enough why universities are involved and what’s in it for them. Part of our goal here is to explain that each one of them has a reason to collaborate, but they need to talk.
 
One specific recommendation in the report is for universities to develop clear principles for using and disseminating IP to ensure greater access. Many universities like the University of British Columbia (BTW, 6/4/2008), the University of California-Berkeley, and those involved with the Nine Points document (BTW, 3/19/2007) have begun to do this. Is this enough?
 
No. We were very pleased to see the Nine Points document, and that’s a step in the right direction. But that’s only the beginning. That’s not setting up a really collaborative research platform. It’s fine to have a university or a couple of universities involved with a couple of companies. But we’re looking at larger partnerships where data is shared more. There are fewer of those, and they will have different flavors depending on where they are in the research cycle.
 
If you’re looking at more fundamental research, like the Structural Genomics Consortium – that’s a very large platform, with funding from multiple sources, including an important investment from industry, which I think is critical. I don’t think a lot of public-private partnerships have relatively little investment by industry. And as they are moving into an epigenetics program, where the molecules that are developed will be completely in the public domain and no one will be allowed to patent or commercialize them in order to develop the basic knowledge of how epigenetics work and what its effects in humans are, you’re going to have early-stage partnerships that need to be much more broadly based than they are now. What are those open platforms that are able to attract industry and universities? There is a start, but we haven’t gone far enough. We need greater investment in these platforms, and I think that’s where the government comes in, because I think the government needs to provide greater incentives for people to create those platforms – either through funding of those models, or as a participant, as the Structural Genomics Consortium has.
 
The Nine Points document is good, and UC-Berkeley’s policies are moving in the right direction, and that’s only in the US. In Canada, it’s true that UBC has adopted global access principles, but that’s more about humanitarian clauses and starting to think about measuring social outcomes of innovation. It’s an important first step, and I congratulate them, but it’s a far cry from where we need to be in terms of really designing these consortia. I’ve been talking to biotech industry leaders in Montreal, for instance, and saying, ‘You actually should be sharing your information much more widely within the Montreal community, and find the legal structures so that one company can learn from another – otherwise you’re not going to be able to take these little atoms of knowledge and consolidate them into something new.’
 
That’s thinking they haven’t been involved with, and neither have Canada’s universities, unfortunately, for the most part. We’re about 10 years behind the US. And when you move outside the US, it’s even farther behind. Europe is behind Canada in this regard, and then when you start looking at Africa or Asia, we’re still trying to export Bayh-Dole. There is a lot of debate about how good Bayh-Dole is for the US, and clearly the jury is still out on it, but clearly it is not good for other countries. It was meant to respond to a particular structure that existed in the US where, in order for a university to get permission to transfer knowledge, they had to go through a huge bureaucracy. That doesn’t exist in other places. The funding mechanisms for universities – large private universities like Harvard and Stanford that do tons of research and public good don’t exist in most countries.
 
So Bayh-Dole doesn’t export well, yet people are still implementing it. We did a course last year in Kenya, for example, and we told them to think about tech transfer as a way to disseminate their knowledge and not to make money, but they kept coming back to, ‘How do we make money?’ And they’re not going to. There is a lot of learning that needs to be done about what tech transfer is about and what it is not. It’s not about making money, it’s about fulfilling the mission of the institution to create knowledge and disseminate it.
 
That leads to the report’s recommendation to develop new ways to measure tech-transfer success. The focus has traditionally been on number of patents, licenses executed, and licensing revenues, but groups such as the Association of University Technology Managers are trying to develop metrics that can more accurately reflect the success of tech transfer (BTW, 12/10/07 and 3/5/08). Has your group developed any ideas on how to do this?
 
Yes and no. Part of this lack of a link between commercialization and networking was really part of an effort to try and answer the question: ‘How do we develop empirical methods to establish the effectiveness and impact of innovation?’ That was the aim of the project.
 
We don’t have the answers yet, and we’re trying to respond to that. And I understand why it is so hard for universities – because we haven’t invested enough in developing the statistical methods. Too few people are doing this really difficult work of figuring out how to take this data and put it in a meaningful form. It’s also that we need the data to be stored in a better form. When you have different patent offices around the world with completely different systems to search the data, with different information – it’s very difficult to compare US performance to European performance to Canadian performance.
 
We also don’t have much of a window on licensing practices, because those are mostly confidential. Unless we know what is actually happening in the license, it is very difficult. We don’t collect data on that; the Japanese are trying to, by the way. So part of the call is yes, we want AUTM and universities to have better measures, but at the same time we need governments to be involved in collecting better data. These two things evolve together. We need more investment in the statistics end to see if we can actually find patterns that indicate success; have better data collection to make that possible; and have the openness that I think AUTM is demonstrating. It’s a little bit of a chicken and egg problem right now.
 
People look to the US as an example because of the success of the biotech industry here, which is probably why other countries have sought to adopt a Bayh-Dole-like structure. But do you think that Bayh-Dole is working in the US, or that this report might be perceived as an argument that it needs to be reformed?
 
I think we’ll leave the particular law reform in the US to Americans. If you look at our research team, we’ve got people on both sides of the equation. The real answer is that you can’t look at Bay-Dole by itself. It came in at a certain time in 1980 within a patent regime that was already being modified. It’s impossible to say that Bayh-Dole was or was not responsible. Yes, there are certain small problems with the exact way it works. Does it function? It may in the US setting. If you got rid of Bayh-Dole, would all the criticisms of the Patent Act go away? Certainly not. My guess is, by just looking at the literature, that Bayh-Dole was more the tail than the dog. There were already structural changes happening in the US that better explain what happened than Bayh-Dole itself.
 
But you’ve got Bayh-Dole; it’s embedded in your legislation; it’s not going away. The better question, to me, is that given that it exists, as do march-in rights and other aspects of Bayh-Dole that haven’t been exercised as much, what can we do with the system we have? Does it need substantial modification? I think there are some positive aspects of some of the proposals put forth, but again, that’s for Americans to decide.
 
In my opinion, the US has a patent system that has the most checks and balances of any system in the world. You can isolate a couple of bad points about it, but there are a whole bunch of really positive aspects of US patent law. Unfortunately, when it is exported, we tend to only export part of it. You export the part of Bayh-Dole that says universities should commercialize. But you don’t spread the march-in rights, and the high patenting standards of the US.
 
Has your group worked to promote some of these recommendations and changes at your own academic institutions?
 
Yes, I’m on the IP committee for McGill, and we’ll soon be having a university-wide joint meeting on IP issues. I’ve been talking with the tech-transfer office. We’ll be talking at the Canadian equivalent of AUTM in the fall. And similarly, our colleagues at the University of Alberta and the Ottawa University have been working with their tech-transfer offices. I can’t say we’ve had enormous success, but it’s a process.
 
Part of the problem is that tech transfer hasn’t been seen as one of the overall missions of the university. It’s been seen as a very narrow technical area and therefore lumped into a separate department. The people that run those, for the most part, recognize the problems. The problem is they hit a ceiling where they can’t engage the senior management of universities. You get to the vice-president level of the institution, and the interest level goes down. They don’t see it as one of the essential missions of the university. What was interesting at UBC, and part of the reason they have the policy they do, is that their president decided that this was important to the university. It’s rare that senior officials at universities take this on.
 
Look at the fight that the Universities Allied for Essential Medicines had with universities like Yale, which one would expect would be a leader in this area. I realize there are differences in mandates between public and private universities, but there is a ceiling that a lot of people involved in these issues feel exist. Part of the message of this report is that this is actually essential to the well-being of the university. This is part of making the university relevant to its community; in particular, public universities, which all Canadian universities are, should be much more cognizant about not just counting patents. For example, a company moves to Montreal because they want to work with McGill researchers. That, to me, is a much better selling point for a university seeking funding from the public purse than, ‘We got 50 patents this year.’

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