The MenAfriVac vaccine, shown being administered at its launch in Burkina Faso in 2010, has already been used to immunize more than 153 million people, and is expected to prevent more than 1 million cases of meningitis A by 2020. Photo: PATH/Gabe Bienczycki.
On a recent night in San Francisco, an elite group gathered: leaders who orchestrated one of the most creative and innovative intellectual property business transactions recognized this year. Think of it as the Oscars of intellectual licensing, where the top winners are typically titans of their industries celebrating mergers, acquisitions, and joint ventures.
So what brought PATH to the stage at this gala, alongside the likes of Google, Lenova, and ConocoPhillips?
Making a pact to save people’s lives
The event was the prestigious “2014 Deals of Distinction Award” ceremony, organized by the Licensing Executives Society (LES) Inc. As the title suggests, the recipients of these awards were honored for notable deals with their partners.
From left to right: Mark Bloom, past chair of the Industry-University-Government Interface (IUGI) Sector of LES – USA and Canada; Peter Soukas, senior licensing and patenting manager, National Institutes of Health (NIH) Office of Technology Transfer; Colleen Ottoson, deputy general counsel, PATH; F. Marc LaForce, director, Technical Services, Serum Institute of India Ltd.; Steven M. Ferguson, deputy director, Licensing and Entrepreneurship, NIH Office of Technology Transfer; Thierry Musy-Verdel, IUGI Deals of Distinction chair. Photo: Design Interface Inc.
In this case, PATH, along with the National Institutes of Health (NIH), US Food and Drug Association (FDA), and Serum Institute of India Ltd. (SIIL), were recognized for an intellectual property licensing deal and technology transfer negotiated about a decade ago. The technology? Development and manufacture of the low-cost MenAfriVac® meningitis vaccine designed for use in sub-Saharan Africa. To date, the deal has helped lead to the vaccination of more than 153 million people. By 2020, the vaccine is expected to protect more than 400 million people, preventing 1 million cases of meningitis A, 150,000 deaths, and 250,000 cases of severe disability.
What made this partnership especially unique was an early pact to make a vaccine affordable and accessible without requiring constant refrigeration. In other words, the vaccine had to have a low production cost and be able to survive hot, long-distance transportation to the remote towns and villages where it was badly needed.
As founding director of the Meningitis Vaccine Project, Dr. Marc LaForce led the successful development, licensure, and introduction of MenAfriVac®. Photo: PATH/Gabe Bienczycki.
The lifecycle gets flipped
Typically, to bring a new vaccine to market, a long set of conventional milestones are reached before a price point is even considered. These milestones include, but aren’t limited to, test trials, product design, manufacturing, shipping, and market promotion. In this model, costs can add up rapidly, and lead to vaccines being marketed at prices that put them out of reach in many economies.
When the World Health Organization (WHO) came to PATH looking for low-cost solutions to address the most common form of bacterial meningitis, serogroup A, it was clear that the traditional manufacturing process would prove challenging. Testing, licensing, and manufacturing a new vaccine with specific cost limits meant new partnerships would have to be developed. And so, the search went global.
An effective vaccine technology had been developed by Dr. Che-Hung Robert Lee and Dr. Carl Frasch of the FDA’s Center for Biologics Evaluation and Research, and through a partnership organized by PATH, the NIH Office of Technology Transfer licensed it for this project. PATH then worked with Serum Institute of India Ltd., a pharmaceutical manufacturer based in in Pune, India, that agreed to scale up the technology in exchange for the technical know-how they would gain during the process.
The result of this remarkable deal? The low-cost MenAfriVac was produced in India, making it affordable to the 26 African countries where serogroup A meningitis is most common.
This short video shows the dramatic lifesaving impact of the MenAfriVac partnership. Run time: 4:20. Copyright 2011, PATH.
Why is licensing so important?
This award calls out a rarely considered aspect of bringing critical lifesaving technologies to scale: the deals that facilitate the exchange of critical intellectual property that can unlock solutions with dramatic lifesaving impact.
“A successful collaboration requires much more than a few agreements. It requires vision, good will, aligned values, diligence, and more,” said Colleen Ottoson, deputy general counsel for Legal Affairs at PATH. “A complex, public-private partnership can only succeed if the technology licenses and related agreements set forth clear and complementary terms and objectives. Upon the achievement of these interdependent agreement objectives, the partnership will realize its larger public health goals.”
To understand the challenges facing PATH, WHO, SIIL, and other partners as they studied the best way to address the development of a new low-cost, easy-to-transport vaccine to fight meningitis in sub-Saharan Africa, it helps to understand the history of the disease.
Timeline of bacterial meningitis and the MenAfriVac vaccine against it. Click to see full-size. Illustration: PATH.
“The license and collaboration have turned out to be an interesting model for vaccine development to address public health needs in developing countries. The vaccine was tailored to a particular population, developed at a modest cost, and structured from the start with provisions to ensure sustainable access,” said NIH Office of Technology Transfer Director Mark L. Rohrbaugh.
Added IUGI Deals of Distinction Chair Thierry Musy-Verdel, “It also demonstrates that it is possible for research organizations such as federal laboratories and universities to license their technologies to organizations other than traditional pharmaceutical and biotech companies and to successfully achieve product commercialization and thus public utilization of their research.”
MenAfriVac was launched in a vaccination campaign in Burkina Faso in December 2010. To date, more than 153 million people in 12 African countries have been vaccinated.
MenAfriVac is a registered trademark of Serum Institute of India Ltd.