Indian Patent Office granted patent to Pfizer’s pneumonia vaccine PCV13 marketed as Prevnar13.

The patent granted to Pfizer on August 11 came into the public eye today. It involves the method of conjugating (assembling) together serotypes of streptococcus pneumonia into a single carrier.

The approval comes over a decade after the company applied for the patent in the country.

Prevenar 13 is approved to prevent pneumococcal pneumonia and invasive pneumococcal diseases caused by 13 strains of streptococcus pneumonia, according to Pfizer.

The vaccine is also the costliest pediatric vaccine provides the “broadest” serotype coverage of any pneumonia”.

The blockbuster vaccine contributes about USD 6 billion to Pfizer.

Pfizer application for patent was met with opposition from Indian vaccine maker Panacea Biotec and Medicines Sans Frontieres (MSF), a Paris-based international humanitarian-aid non-governmental organization on grounds that Pfizer is seeking patent for mere addition of serotypes to the already established 7 valent vaccine and does not meet the inventive step requirement.

Panacea Biotech is developing its own version of pneumococcal conjugate vaccine (PCV) which is currently under clinical trials.

MSF said it filed a pre-grant opposition so more affordable versions can become available to developing countries and humanitarian organisations.

MSF criticised Indian government's decision to grant patent to Pfizer’s pneumonia vaccine.

“It’s unfair and unacceptable that almost a million children die each year from pneumonia, even though a life-saving vaccine is available. Children everywhere have a right to be protected from pneumonia, but many governments can’t afford the prices set by Pfizer,” said Dr Prince Mathew, Asia Regional Coordinator for MSF.

“We urgently need additional manufacturers to rapidly introduce competition with the aim of lowering vaccine prices.”

The granting of this patent would block other manufacturers in India from supplying this vaccine - which protects against 13 types of pneumococcal bacteria (PCV-13) - to those who need it most.

According to Leena Menghaney, South Asia Head for MSF’s Access Campaign, “The 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.”

In 2016, MSF challenged Pfizer’s patent claims in India, after the same patent was revoked by the European Patent Office (EPO). The patent is also being legally challenged in South Korea and before the US Patent Trademark Appeal Board.

India has the world’s highest burden of pneumonia, accounting for nearly 20 percent of global pneumonia deaths in children under the age of five.

In India, PCV had until recently been available solely in the private market with out-of-pocket price tags beyond the reach of not only vulnerable children and impoverished parents but also the Health Ministry.

At present, only two pneumococcal conjugate vaccines are registered by CDSCO and imported into India: Pfizer’s Prevnar13 (PCV13) and GSK’s Synflorix (PCV10) which are very expensively priced at approximately INR 3,800/dose (approximately USD 59 per dose, with three doses needed for full vaccination) and Rs 1,800/dose (approximately USD 28 per dose, with three doses needed for full vaccination) respectively in the private market.

No pneumococcal vaccine has been registered from an Indian manufacturer and made available to provide competition to Pfizer and GSK who currently dominate the market internationally and India.

The pneumonia vaccine is now being introduced into India’s Universal Immunization Program (UIP) with support from Gavi, the Vaccine Alliance. Yet, at more than USD 9 per child, or USD 3 per dose for each of the three doses needed for full vaccination. The high price of the vaccine forced the government to do limited roll-outs of the PCV vaccine in Himachal Pradesh, Bihar and Uttar Pradesh.