ghtech.org is proud to announce the first in a series of guest posts to the blog. Today’s post is written by Dr. Rebecca Goulding, a researcher working at the University of British Columbia in the area of intellectual property for neglected diseases. You can read her full bio at the end of the post. Look for more posts from global health leaders in the coming weeks.
by Dr. Rebecca Goulding
Given that fact that you are reading this blog, you probably already know that cheap, robust, field-appropriate health technologies that can give rapid feedback about disease states are greatly needed to improve health outcomes in developing countries. I’m not talking about CT or MRI scanners, or complex diagnostic devices that you might see at a local city hospital – but relatively simple and robust tools that can be used in a range of remote, resource-constrained areas. Examples include: risk-assessment for pre-eclampsia during child-birth, detection of infectious diseases and their drug resistant sub-types (in patients, animal hosts and the general environment), and communication devices that help community health workers and patients to interpret diagnoses or to adhere to treatment regimens. Inventing such a technology is only the first step in a long and winding road to getting it to people in need. Researchers who envisage the whole pathway – from conception of an idea through to real-world implementation – have a greater chance of achieving “access success”.
As a hypothetical exercise let’s say you are a UBC graduate student or professor with a great idea for a new Chagas disease diagnostic test that is much better than existing tools: it is tough, easy to use, gives rapid results, and best of all, it would be cheap to make. This has the potential to be a key piece of technology that could help clinicians and public health experts to decide who to treat and how to control the spread of this deadly parasitic disease. Funding from the CIHR or the NIH may help you to figure out the test’s sensitivity and specificity in the lab. It might also be possible to get funding to gather field data, for example to test whether the technology will work well under field-conditions in Bolivia, one of the countries with the highest prevalence of the disease. But what are the next steps that must be taken before this test starts being used on a much broader scale?
The process of developing your health technology into a tool that has significant impact will require significant funding. What usually happens at universities is that inventions like diagnostic tests (equipment and method) are patented. The patented invention is then often licensed, sometimes exclusively, to a third party wishing to develop the invention in exchange for a royalty payment to the inventor and the university. Any company thinking about investing the capital (often very substantial amounts of money!) to develop your diagnostic technology is likely to want you to have a strong intellectual property (IP) position (i.e. strong patent(s) protection). However, it is important to get the balance right: enough IP protection to be able to incentivize investment in development, and not too much so that others are not entirely shut out from innovating in the area.
Here exists an important stage in your products pathway to access success: will there be any interested parties willing to invest the money to develop your Chagas disease diagnostic test? There are two distinct markets for Chagas disease diagnostics: a) in developed countries (e.g. Latin American immigrant populations in California) and b) in middle-income countries (e.g. Brazil, Peru, Bolivia). Therefore it is possible that a small biotechnology company may be interested to license the IP to develop a product – but only if they can be sure to achieve a return on their investment. Some larger companies may also be willing to invest in such a project as part of their social corporate responsibility, but will still want to avoid making a loss. A product development partnership (PDP, also known as public private partnership), which funds and manages the development of technologies for neglected diseases, may also be interested in your technology. PDPs do not do in-house R&D, but instead fund development partners who do. Alternatively, it may be possible to start up your own spin-off company, by licensing the technology to a spin-off from UBC, and by securing funding for product development from other private, government or philanthropic sources.
For argument’s sake, imagine that a company is interested in licensing your Chagas disease diagnostic. What kind of things must you consider before licensing negotiations begin?
University technology transfer offices deal with the negotiations for the licensing of IP to third parties. The issue of improving access to university-discovered technologies in developing countries is increasingly on their radar, thanks to organizations such as the Bill and Melinda Gates Foundation and Universities Allied for Essential Medicines (UAEM). For example, in 2007, after discussions with UAEM and others, UBC announced it was adopting global access principles that aim to improve global economic and social impacts of UBC’s innovations and guarantee technology access to these technologies for the world’s poor. There is a range of global access licensing strategies that could potentially be used to negotiate a balanced deal that creates incentives for the company and at the same time ensures access to technologies for the people who need them the most. These include limiting field of use, including geographical restrictions, requiring at-cost production of the technology in developing countries and limiting royalty payments in exchange for other terms that promote access. While UBC and other universities are clearly on board with improving technology access, much depends on how amenable the licensee is to such concessions.
Universities may have better access success if they license such technologies to relevant PDPs who themselves have an access mandate at the very core of their business model. These PDPs have a mandate to ensure the availability and affordability of technologies and medicines, and also their adoption in developing countries (the AAA mandate). PDPs have significant funding at their disposal for product development and access to partner companies who may make in-kind contributions. Thus they have the leverage to make significant demands when negotiating licensing deals with universities and other IP holders. PDPs typically want a royalty-free exclusive license for the IP (at least for the neglected disease field of use in question), from the IP holder, which also allows them the freedom to manufacture the products in any country, presumably by any manufacturer they choose. As long as universities (and the inventor – that’s you!) are comfortable to give up the technology for free to a PDP, then this might be the most straightforward way of ensuring access success.
There are an increasing number of innovative licensing deals being made between universities and licensees – and it seems there is increasing receptivity for the goals of access. I believe it is important for university researchers at the forefront of health technology innovation, to think through what an “access success” strategy would look like, and that this needs to happen before they get to the boardroom of the licensing office to negotiate.
Dr. Rebecca Goulding is currently working as a consultant on the potential of alternative intellectual property, regulatory and financial innovation strategies to promote biomedical innovation for neglected diseases. She has worked as a postdoctoral fellow at ISIS at the Sauder School of Business (2009-2010) and with the Intellectual Property Policy and Research Group (IPPRG) at the W. Maurice Young Centre for Applied Ethics (2008-2009), where she worked on alternative intellectual property regimes and upstream genomic research. Rebecca completed her BSc in genetics and MSc in hematology/oncology at the University of Dublin, Trinity College. She continued her graduate studies at the Terry Fox Laboratory, BC Cancer Research Centre, finishing her PhD in genetics at University of British Columbia in 2008. For her thesis, Rebecca studied Ras protein signaling pathways in lymphocytes and the molecular genetics of leukemia development. During the last years of her PhD, she became involved with a student group called Universities Allied for Essential Medicines (UAEM), which inspired her interest in global health research, particularly in the area of neglected disease drug research.
Actions that will help improve R&D productivity, according to Tufts CSDD, include greater reliance on translational science to help identify the right disease targets for new molecules; greater use of partnering with external service providers to share risks, reduce cycle times, lower costs, and improve resource management; and greater use of sophisticated portfolio management techniques.”
