- The government of India has granted Pfizer, Inc. a patent for its top-selling pneumonia vaccine Prevnar 13, giving the drugmaker market exclusivity in a decision that aid groups say could limit access to the life-saving drug.
- Medecins Sans Frontieres (MSF), a vocal critic of Pfizer's pricing of Prevnar, argues the patent grant will block developing country manufacturers from making cheaper versions of a pneumococcal conjugate vaccine.
- Pfizer launched the vaccine in India in 2010, and last fall lowered the price of Prevnar in humanitarian emergency settings. The patent, though, will allow Pfizer to control the market for pneumococcal conjugate vaccines in India through 2026.
Pfizer and GlaxoSmithKline plc are the two major providers of pneumonia vaccines worldwide. Due to the high incidence of pneumonia, price and access have been hot-button issues especially in emerging markets like India or developing countries.
MSF contends that Pfizer's price for Prevnar puts it out of reach for poorer countries and fought to block the grant of a patent in India so other manufacturers could make cheaper copies of the vaccine.
"We urgently need additional manufacturers to rapidly introduce competition with the aim of lowering vaccine prices," said Prince Mathew, Asia Regional Coordinator for MSF, in a statement.
Pfizer has expanded its humanitarian assistance program for the drug and also works with the Global Alliance for Vaccines and Immunisation (GAVI) to expand access.
Last year, Pfizer said it would lower the price of Prevnar in emergency humanitarian settings to the lowest prevailing global price — now currently $3.05 per dose. In its assistance program, Pfizer has made Prevnar available in a four-dose vial.
"In its multi-dose vial presentation, this vaccine has been included in the expansion of India’s public immunization program in select states under the GAVI funded platform," Pfizer said in a statement. "Pfizer remains committed towards further enhancing access of this vaccine in India, both in the market as well as through partnership with the Government to expand introduction in the public program."
MSF has an ongoing campaign to push both Pfizer and GlaxoSmithKline to lower the cost of their pneumonia vaccines to below $5 per child for three doses.
Globally, Prevnar 13 is one of the company's best-selling products, pulling in $1.15 billion in the second quarter of this year. Roughly a quarter of those sales come from emerging markets, according to company reports.
MSF had previously challenged Pfizer's attempt to patent Prevnar in India, filing a so-called "pre-grant" patent opposition with the government last year.
"The manufacturing method Pfizer is trying to patent is too obvious to deserve a patent under Indian law, and is just a way to guarantee an extended market monopoly for the corporation for many years to come," said Leena Menghaney, South Asia head for MSF's Access campaign, in a statement this week on news of the patent grant.
MSF has accused Pfizer of "ever-greening," a practice where drugmakers patent incremental improvements to extend market exclusivity. The group also expressed concern that India's granting of a patent indicates a weakening of the country's patentability standards.
Sometimes called the "pharmacy of the world," India is particularly important country in the global supply chain for medicines and vaccines. Many of the world's generic manufacturers are located in the country and will now be blocked from producing competing versions of Pfizer's conjugate vaccine.
Note: This article has been updated to reflect the price of Prevnar 13 in emergency humanitarian settings.