Using IP to accelerate product development and ensure access
A guest blog post by Margaret McGlynn, President and CEO of the International AIDS Vaccine Initiative
The value of intellectual property (IP) and patents–long a hotly debated issue in global health policy circles–heated up again among delegates and advocates at the United Nations summit on non-communicable diseases last month. While everybody understands that patents are of critical importance to the participation of the private sector in drug and vaccine development, intellectual property rights can also be used to erect barriers to equitable access. This is particularly true in the developing world, where many essential medicines and vaccines have been out of reach for millions of the most vulnerable people even when lower prices are available via tiered pricing policies.
This discourse misses the mark if it paints the IP issue as a black-and-white tradeoff between access to essential medicines for the poor on one side and innovation, corporations, and profit on the other. IP can—and, I believe, should—facilitate equitable access while simultaneously driving innovation and investment in new biomedical products. Managing IP rights to achieve both of these objectives is critical to the success of public-private product development partnerships (PDPs).
PDPs are structured to remedy a market failure: products to prevent or treat diseases that predominantly afflict the poor in developing countries offer such insufficient commercial returns that private companies are hard pressed to justify the long years and enormous sums needed to develop them. But much of the knowhow needed for viable drug and vaccine development resides in the private sector, and its contributions are essential to creating many products of vital importance to global health. PDPs redress this market failure by assuming much of the early-stage risk of investing in research and development, as well as by contributing scientific, technical and clinical assets, thus engaging the private sector into what would ordinarily be prohibitively costly and risky product development projects.
Like many other PDPs, IAVI, the organization dedicated to supporting AIDS vaccine development that I recently joined as CEO, is a creative manager of the IP rights associated with such product development. IAVI works simultaneously to use IP to draw in the expertise of the private sector and to ensure that we can influence access strategically to honor our commitment to make any future AIDS vaccine available to the people who need them most, wherever they may reside.
IAVI has long enlisted biotechnology companies and vaccine manufacturers as partners throughout the AIDS vaccine development process. It also has methodically cultivated its own capabilities in translational research—the conversion of scientific concepts into viable candidate products—and shared that expertise with academic researchers around the world who are designing AIDS vaccines. IAVI thus seeks to bridge the gulf between academia and the private sector, tapping the unique strengths of each. We link, in a sense, the best scientific minds and ideas out there with the unparalleled practical capabilities of vaccine manufacturers and the cutting-edge technologies of biotechs to accelerate progress toward an AIDS vaccine.
In doing so, we pay close attention to the formulation of our IP agreements, making sure that both scientists and companies with which we partner are adequately incentivized. By filing patents, IAVI also ensures that we have the freedom to operate and the ability to ensure that products developed through IAVI funding (and by extension our donors) are brought to market in accordance with the public health imperative behind our mission. This allows IAVI to ensure that any vaccine stemming from work it has supported can be swiftly made available to people everywhere and sold at a price that is affordable — and, under some agreements, to regain control over shared tools and technologies if a partner fails to meet those conditions.
Once those basic requirements are met, IAVI is amenable to a variety of licensing arrangements. The types of arrangements depend on the development phase of a particular product or product component, and the respective capabilities and contributions of IAVI and its partner. For example, IAVI might retain rights to a potential product in the initial phase of the development, while planning to transfer development rights to a partner once a product reaches its proof of concept. The transfer of rights could provide the partner with the rights to manufacture and distribute a potential product in developed countries, whereas IAVI would retain these rights for developing countries. Alternatively, a partner might be granted exclusive or non-exclusive rights to manufacture and develop for a specific region or worldwide, provided they commit to distribute the vaccine at accessible prices in developing countries.
The possibility of commercial returns in these collaborations is one mechanism to attract private-sector participation in AIDS vaccine development. Another is the ability of PDPs to assume financial risk for R&D by directly financing biotech and pharma projects to tap the sector’s unique skills. For example, in partnership with the Bill & Melinda Gates Foundation, IAVI has established an Innovation Fund that supports the unconventional application of new or existing technologies to AIDS vaccine design and development.
The Innovation Fund has so far issued 14 grants to biotech companies and academic researchers, and has already achieved a notable win: a U.S.-based biotech supported by the fund, Theraclone Sciences, played a central role in an IAVI-led partnership’s recent isolation of potent antibodies that neutralize a variety of circulating HIV subtypes. These antibodies are thought to hold important clues to the design of effective AIDS vaccines, and IAVI has retained rights to any preventive vaccine derived from their work. But Theraclone too stands to gain from the discovery: the company retains rights to any therapies that might stem from these discoveries. Furthermore, by careful formulation of its IP agreement, IAVI has protected its commitment to share information and reagents with others in the AIDS vaccine field. The first antibodies isolated through this project have already been sent to more than 30 other laboratories involved in AIDS vaccine design.
The Innovation Fund is one example of how PDPs engage partners in the development of biomedical products to address diseases of poverty and epidemics that primarily afflict developing countries. Indeed, in the past decade, PDPs have proven their substantial innovation power in fighting diseases, especially those for which there is no market for the necessary drugs, vaccines or diagnostic tools. PDPs redress this market failure by investing in R&D by contributing valuable scientific, technical and clinical assets, and by bringing together partners from various sectors in the global North and South to drive product development forward. Today, they have ushered more than a dozen new products to market—including malaria drugs and vaccines against cholera and meningococcal disease. They collectively account for at least 150 biomedical products under development. Such numbers are testament not just to the value of the PDP model, but also to the thoughtful pragmatism and creative engagement across sectors by those dedicated to developing new products to stop the world’s top killers and delivering them into the hands of those who need them most.