FDA and NIH Win Award for IP Licensing of Meningitis Vaccine

FDA and the National Institutes of Health (NIH) are being recognized for their global partnership in developing and licensing the meningitis vaccine, MenAfriVac. The Licensing Executives Society will be bestowing the 2014 Deals of Distinction Award to FDA and the NIH for the year’s most outstanding intellectual property licensing deal, for technology transfer of the pioneering, low-cost meningitis vaccine launched in sub-Saharan Africa. The award is to be presented at the society’s 50th annual meeting, Oct. 5-8 in San Francisco.

NIH and FDA worked with Seattle-based non-profit PATH and the Serum Institute of India (SII) to develop MenAfriVac. According to NIH, the patent license granted from the NIH Office of Technology Transfer (NIH OTT) to PATH is crucial to the manufacturing process of the vaccine. SII agreed to scale up the technology in exchange for technical know-how and produced the vaccine at an affordable cost.

The technology was invented by FDA scientists at the Center for Biologics Evaluation and Research and subsequently sublicensed by PATH to SII under the Meningitis Vaccine Project, a partnership of PATH and the World Health Organization (WHO). The vaccine, which targets a common form of bacterial meningitis (serogroup A) found in sub-Saharan Africa, is ideal for remote locations because it does not require constant refrigeration and has a low production cost.

Vaccination can prevent meningococcal meningitis, a deadly bacterial infection of the brain. The technology used in the production of vaccines, however, is complex. Vaccine production can be difficult for developing countries that lack the necessary infrastructure. According to NIH, “the patent license agreement involving the FDA-developed technology and the expertise of the NIH technology transfer officers was crucial in developing and transferring the technology needed to manufacture MenAfriVac at an affordable cost for the 26 African countries where serogroup A meningitis is most common.”

“We are quite pleased about this inspired work in vaccine research as well as being able to transfer the intellectual property in a way to have such a spectacular impact on public health in this region of Africa,” said NIH Director Francis S. Collins, MD, PhD, in a press release.

“This is a compelling example of how the FDA’s unique role in regulatory science makes critical and wide-ranging contributions to public health,” said Karen Midthun, MD, director of FDA’s Center for Biologics Evaluation and Research, in the press release. “The impact of this truly global partnership has been tremendous.”

Launched in December 2010 as part of a vaccination campaign in Burkina Faso, MenAfriVac has been given to more than 150 million people in 12 African countries. No reported cases of serogroup A meningitis have been reported, to date, in vaccinated populations.

“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 OTT Director, Mark L. Rohrbaugh, PhD, JD, in the press release.

“This deal stood out because it shows the true collaboration and teamwork of all parties involved,” said Deals of Distinction Chair Thierry Musy-Verdel, in the press release. “It also demonstrates that it is possible for research organizations, such as federal laboratories, to license their technologies to organizations other than traditional pharmaceutical and biotech companies and to successfully achieve commercialization and public utilization of their research.”

Source: National Institutes of Health