Doctors Without Borders (MSF) on Monday objected to the US government’s granting of an exclusive patent license to Sanofi Pasteur for a developing Zika vaccine, though Sanofi fired back on Tuesday explaining the risks of developing such a vaccine.
According to a Federal Register notice from 9 December, the Department of the Army of the US Department of Defense intends to grant an exclusive, royalty-bearing, revocable license on a patent entitled, ‘‘Zika Virus Vaccine and Methods of Production,’’ filed 31 May 2016, and an exclusive, royalty-bearing, revocable license to another patent application entitled, ‘‘Zika Vaccine and Methods of Preparation,’’ filed 3 August 2016, to Sanofi Pasteur.
The problem with such an exclusive license, according to MSF, the non-governmental organization Knowledge Ecology International and others, is that the US government has already dedicated more than $40 million in grant funding to Sanofi to help develop this vaccine candidate.
And if Sanofi receives approval from the US Food and Drug Administration (FDA) for the vaccine, the company could reap hundreds of millions in profits on top of the Zika vaccine sales thanks to a priority review voucher (for more on these vouchers, see the Focus explainer).
“An exclusive license will give Sanofi a monopoly in the research, manufacturing and sale of the technology and will allow Sanofi to exclude competition in the clinical development as well as in the manufacturing and pricing of this technology,” MSF explained in a comment posted Monday, adding that “it is very concerning to see the U.S. government considering locking in a development deal that will limit innovation and will not safeguard affordable access to the resulting vaccine.”
But Sanofi contends that it is still risking resources to bring this Zika vaccine through clinical development and that it is not a guarantee that it will be a success.
“We are devoting human and other resources, so even with the BARDA funding to take WRAIR’s [Walter Reed Army Institute of Research’s] Zika purified inactivated virus (ZPIV) vaccine through phase II development-- including manufacturing and characterization of the vaccine product as well as optimization of the upstream process to improve production yields--we’re still assuming financial and opportunity risks because there is no clear path to commercialization at this time, as the epidemiology of this infectious disease is still a moving target,” Susan Watkins, senior director of communications at Sanofi Pasteur, told Focus.
“We have modeled various commercial scenarios including current endemic areas, spread to other geographies and the travel market, among others,” she added. “The nature of the epidemiology and spread of the virus will impact the degree of profitability. Further, by partnering with public health agencies, we are sharing inherent risks.”