The PCV 13 is intended for India’s universal immunisation programme for children. Last August, the court held that Pfizer could have patent rights in India for the vaccine, barring local manufacturers from selling cheaper versions of PCV 13, marketed as Prenevar 13. In November, Médecins Sans Frontières (MSF) or Doctors without Borders obtained the deferment by arguing in court that the patent does not meet the standards laid out by India’s laws.
According to Leena Menghaney, head of MSF’s Access Campaign in South Asia, the patent is based on a mere addition of serotypes to the already established multivalent vaccine and fails to meet the inventiveness criteria. She says that in 2014, the European Patent Office had revoked similar patents granted to Pfizer for being non-inventive.
“We hope to get the patent revoked in India because it guarantees Pfizer a monopoly on the pneumonia vaccine until 2026, by which time local manufacturers with far cheaper versions of the vaccine would have dropped out”
“We hope to get the patent revoked in India because it guarantees Pfizer a monopoly on the pneumonia vaccine until 2026, by which time local manufacturers with far cheaper versions of the vaccine would have dropped out,” Menghaney says.
MSF says in a statement that the “US-based drug corporation’s unmerited patent prevents vaccine manufacturers in India from developing and marketing PCV 13 until 2026, depriving countless children of the opportunity to be protected against pneumonia, which kills 2,500 kids per day.”
According to MSF, countries that buy PCV 13 are struggling with high, on-patent prices. South Africa, for example, spends more than 30 per cent of its vaccination budget on purchasing PCV 13.
In India, the government has been able to introduce PCV 13 in only three provinces — Bihar, Himachal Pradesh and Uttar Pradesh — because of the costs. “The plan is to add six new districts to the programme every year,” Neena Gupta, director-general of the state family welfare department, told the Indian Express newspaper on June 9.
The Indian programme, costing slightly more than US$9 dollars per child, is supported by a grant from the vaccine alliance GAVI, which runs until 2020. While Pfizer is committed to maintain the price, assessments indicate that the Indian government will find it hard to sustain the programme.
“At more than US$9 dollars per child, for the three doses needed for full vaccination, the price remains high, forcing the government to do limited roll-outs of the PCV vaccine,” says Menghaney, adding that the patent will also hamper India’s role as ‘pharmacy of the developing world’ by making it harder to access the vaccine.
“The patent monopoly in key producing countries like India and South Korea affects all countries that are procuring PCV 13 from Pfizer,” says Menghaney. Martin Friede of WHO’s Initiative for Vaccine Research tells the Development Today portal that MSF has taken a “perfectly valid legal approach” and that they “appear to have good grounds to think that their opposition will be successful.”
A Pfizer spokesperson says the company’s “tiered pricing approach for the vaccine is carefully calibrated to help ensure countries can have access to our vaccines now and in the future.”
The spokesperson said that each dose of PCV 13 requires two-and-a-half years to manufacture with 400 different raw materials, 580 manufacturing steps, and 678 quality tests.
According to the spokesperson, the vaccine is already available in more than 115 countries through their national immunisation programmes. Pneumonia accounts for more than a quarter of deaths in children under the age of five, or nearly one million children per year.
This piece was produced by SciDev.Net’s Asia & Pacific desk.