There’s a clash looming between Moderna, on the one side, and the South African government and the World Health Organization (WHO) on the other, over patent claims that could threaten Africaʼs access to COVID-19 vaccines, writes Bloomberg.
Health and relief groups, like Doctors Without Borders (MSF) have appealed to the vaccine-maker to abandon three patent applications filed years ago in SA, saying they could impede a WHO-backed effort to make messenger RNA shots for low-income countries at a hub in Cape Town.
The patents give Moderna the right to stop anyone from making or selling an mRNA vaccine in SA, said Charles Gore, the director of the Medicines Patent Pool, which is helping the WHO establish the mRNA hub.
Bloomberg reports that Moderna has already rebuffed Afrigen Biologics & Vaccines, part of the mRNA hub, when it asked for assistance to produce a low-cost version of the vaccine for distribution in poor nations. While Afrigen now says it can make the shot based on publicly available information, Modernaʼs patent filings in SA hang over the humanitarian effort.
The drug-maker had originally said it would not enforce its patents during the pandemic, and that it was “committed to continuing to be part of the solution in terms of the equitable access” to COVID-19 vaccines, and its intellectual property (IP) would not “create a barrier to equitable mRNA COVID vaccine access in those countries most in need”.
But vaccine advocates say Moderna can decide on its own when it sees the pandemic as having ended, at which point it could potentially try to legally block copycat vaccines. It might then ask Afrigen to pay for a commercial licence, hiking the cost of the shots for some of the worldʼs poorest nations.
“Our preference is a royalty-free voluntary licence for low- and middle- income countries or a revocation of that claim,” said Afrigen MD Petro Terblanche.
SAʼs patent office is at the root of the problem, as it accepts applications without scrutiny as long as the paperwork is in order and the fees are paid, said Jetane Charsley, a director of regulatory and compliance affairs at the governmentʼs National Intellectual Property Management Office. In most other countries patent are examined and rejected when they are too broad.
Modernaʼs patents, which will start expiring in 2034, cover the method of production of an mRNA vaccine and gene sequences used in that vaccine.
Nicholas Crisp, deputy director-general in the SA Health Department, said if no solution is found, the government might try to revoke the patents or issue a compulsory licence, allowing the hub to produce an mRNA vaccine. Both could lead to long, expensive procedures.
Bloomberg article – Moderna, WHO Set for Vaccine Clash as Patents Threaten mRNA Use (Open access)
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MSF and SA’s People’s Health Movement call for patent law reform
Afrigen’s Cape Town bid to reverse engineer Moderna’s vaccine
WHO chief calls for Trips waiver and praises SA’s vaccine development project
Africa’s first COVID-19 vaccine technology transfer hub