In India Patent Pfizer’s Pneumonia Vaccine Challenges

Pfizer’s pneumonia vaccine patent has come under legal challenge in India. India’s High Court in Delhi has moved to February 2018 the final decision on enabling Pfizer to be the only pharmaceutical company selling pneumococcal conjugate vaccine (PCV 13) to the Indian government, and plan that was contested by a worldwide humanitarian group providing the medical guide.

The PCV 13 is planned for India’s universal immunization program for children. Last August, the court held that Pfizer could have patent rights in India for the vaccine, barring local manufacturers from selling less expensive versions of PCV 13, marketed as Prenevar 13.

In November, Médecins Sans Frontières (MSF) or Doctors without Borders acquired the deferment by arguing in court that the patent does not meet the standards laid out by India’s laws.

As per Leena Menghaney, leader of MSF’s Access Campaign in South Asia, the patent based on a mere addition of serotypes to the effectively established multivalent vaccine and fails to meet the inventiveness criteria. She says that in 2014, the European Patent Office had revoked comparable patents granted to Pfizer for being non- inventive.

“We hope to get the patent revoked in India since it ensures Pfizer a monopoly on the pneumonia vaccine until the point when 2026, by which time local manufacturers with far less expensive versions of the vaccine would have dropped out,” Menghaney says.

MSF says in an announcement 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 children for every day.”

According to MSF, countries that purchase PCV 13 are struggling with high, on-patent costs. South Africa, for instance, spends more than 30 percent of its vaccination budget on buying PCV 13. In India, the government has possessed the capacity to introduce PCV 13 in just three areas Bihar, Himachal Pradesh and Uttar Pradesh as a result of the expenses.

“The plan is to add six new areas to the program each year,” Neena Gupta, director general of the state family welfare department, told the Indian Express newspaper on June 9. The Indian program, 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 keeping up the value, evaluations show that the Indian government will think that it’s difficult to sustain the program.

“At more than US$9 dollars per child, for the three dosages required for full vaccination, the value stays high, constraining the government to do limited roll-outs of the PCV vaccine,” says Menghaney, including that the patent will also hamper India’s part as pharmacy of the developing world’ by making it harder to get to the vaccine.

“From Pfizer, countries like South Korea and India producing the patent monopoly in key affects all countries that are procuring PCV 13,” says Menghaney.


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