Did a conflict over intellectual property delay the Ebola vaccine?

Friday, October 3, 2014: A CBC headline read, “Could Ebola vaccine delay be due to an intellectual property spat?” By the next morning a colleague, Richard Gold of McGill, and I had figured out that the “IP” (intellectual property) was in fact a non-story. Whatever was delaying the start of a research trial to test the vaccine in question—known as “VSV-EBOV”—it wasn’t the IP. What should be a story is what this example reveals about commercializing research more generally…

The original news story published by ScienceInsider suggested that “negotiations” with the US company NewLink Genetics, which “holds the license for commercialization of the vaccine” were slowing the start of the trial. The CBC story chased that angle: the government told CBC “the contracts are confidential” but emphasized that it still owned the patent (one form of IP) and had “retained rights related to research and emergency response.”

Richard and I wondered: what were the precise terms of the deal?

Finding the actual deal wasn’t exactly straightforward. As the government officials had indicated these deals are typically kept confidential. But if you know where to look, in some cases, the deal, or parts of it, can be found.

We were able to find the deal through the US Securities and Exchange Commission’s “EDGAR” database. As a publicly traded company, NewLink has to disclose information about its assets, including IP-related deals such as this one (which the Canadian government originally entered into with another company, Bioprotection Systems Corp., in 2010).

Parts of the deal aren’t transparent. For example, the entire deal is predicated on “licensed rights” to patented technology described in “Appendix A”. But Appendix A simply lists three patents—all with the same title—so it’s impossible to tell what those patents cover, whether they are actually in force (agreements like this are often executed while patents are pending), and in what parts of the world.

Again, though, with a little targeted searching some of that information can sometimes be found. Using a free patent database called “CAMBIA Lens” we determined that the Canadian government filed an international patent application covering the VSV vaccine in 2003. Three jurisdictions—Europe (2010), the US (2011), and Canada (2013)—have since granted the patent. But to the best of our knowledge the patent is not in force in any other country. It’s possible the patent is still pending elsewhere because other countries (including Liberia and Sierra Leone, two of the three West African countries currently afflicted with Ebola) were “designated” for patent protection through the international patent filing. But whether the Canadian government is still trying to obtain patents in other countries is difficult to tell. Indeed, the status of pending patent applications in low and middle-income countries is notoriously difficult to figure out. In theory, though, unless and until the patent is actually granted by other countries, vaccine manufacturers outside Europe, the US, and Canada are free to make the VSV vaccine as described in the patent and/or published literature. A growing network of developing country vaccine manufacturers in fact already exists.

Of course, apart from NewLink, the Canadian government lab may be best positioned to produce such an experimental vaccine. Yet, according to the terms of the deal, the Canadian government is obliged not to compete with NewLink. It gave the company a “sole, worldwide” license to “commercialize” the technology.

But that’s only under ordinary circumstances. Critically, the deal also “carves out” Canada’s ability to “make, have made, manufacturer, use, license, sell and distribute and to administer (directly or through health care providers)” the vaccine to Canadians in the context of a public health emergency in Canada (clause 2.2.4), or, to people outside of Canada “for compassionate care purposes” where the company is not able to satisfy demand (clause 2.2.6). Given these flexibilities, the delay in shipping the promised 800-1000 doses of the vaccine to West Africa and starting a trial more likely stems from factors other than the IP deal itself. The Canadian government has the right to make the vaccine available for experimental study.

It’s nevertheless important, even in the midst of an increasingly terrifying epidemic, to reflect on what this case reveals about the commercialization of research more generally.

Commercialization related IP deals between governments or government funded researchers and private companies are now commonplace. There can be good reasons to enter into them; governments, let alone academic labs, seldom have the expertise required to scale up production of a product like a vaccine—companies do. But what the terms of those arrangements look like is often impossible to determine because the norm is to cloak them in confidence. Unless, as in the above case, the deal involves a publicly traded company, it’s unlikely to be found even by IP experts. Thankfully, the deal between the Government of Canada and NewLink gives the government ample room to manufacture and distribute the vaccine in the context of an epidemic. But is that usually the case? Are other important flexibilities (e.g. ensuring access for research purposes by other publicly funded researchers) and considerations (e.g. reflecting taxpayers’ contribution in the price of any resulting products) typically incorporated? To systematically evaluate whether all these commercialization deals between publicly funded institutions and the private sector are resulting in improved outcomes, a whole lot more transparency about the terms and trade-offs involved is needed. That’s not happening. Meanwhile, the Canadian government, funding agencies, and academic institutions are putting an increasing premium on commercialization, as presently practiced.

That hits on another troubling blind spot. Imagine for a minute that we’re not in the middle of an Ebola epidemic and two researchers were seeking funds to support their work. One researcher is in the early stages of studying “viral hemorrhagic fevers” like Ebola, with an eye to vaccine development down the road. The other, in contrast, does infectious disease related “disaster research.” Specifically, the second researcher studies how institutions decide to allocate limited health care resources in resource-poor, disease ravaged disaster areas. Which researcher do you think would be more likely to get funding? Would you be comfortable picking one—and only one—research project for funding? Experts are beginning to say that only a vaccine will stop the current Ebola epidemic. But while the requisite clinical trials are designed, debated, and eventually carried out, surely knowledge about how best to allocate finite resources would help.

If you are at all uncomfortable with choosing one type of research at the expense of the other, then you should be concerned about the direction of research funding in Canada.

Canada’s federal and provincial governments, research funding councils, and academic institutions have, over several years, increasingly prioritized commercially oriented research. Frequently, that kind of research leads to IP. Why? IP is useful to companies competing in the marketplace. If a company can exclude others from using knowledge, then they can also charge money for permission to use it. Industry systematically prefers knowledge that can be captured as some form of IP.

The problem is that some knowledge can’t easily be captured as IP. It’s really hard to stop others from using it and therefore harder to extract money from those users. Think of a “checklist” that reduces rates of infection during surgery; information showing one drug works better than another; or, to use the above example, of knowledge about how to allocate resources during an epidemic. To effectively capture these kinds of knowledge (and charge money for them) you’d essentially need to track how people think, which is impractical. And yet these kinds of knowledge can have an enormous impact on public health. In other words, there is no necessary relationship between what knowledge can most readily be appropriated as IP and that knowledge’s impact upon social welfare.

When those who fund research increasingly choose to fund one kind of research—research that’s more IP-amenable—we should worry that other knowledge that might be more immediately helpful in the middle of an epidemic, might not get the support it needs. Yes, vaccines can be enormously beneficial and IP, responsibly used, can play an important role in steering their development (assuming the IP doesn’t preclude the end product from actually reaching those in need). But sometimes we’re left waiting for vaccines to be developed, tested, produced, and/or distributed. That’s why we need knowledge about how to ethically allocate resources in the midst of a disaster. If we give undue focus to research that can be readily commercialized, we might never get it.

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