The international medical humanitarian organisation Médecins Sans Frontières (MSF) has filed a 'patent opposition' in India to prevent US pharmaceutical company Pfizer from getting a patent for the pneumococcal conjugate vaccine (PCV13), so that more affordable versions can become available to developing countries and humanitarian organisations. This is the first time a vaccine patent has been challenged in India by a medical organisation, with the goal of millions more children being protected against deadly pneumonia.

This pending patent application (8081/DELNP/2007 in India) filed by Pfizer would allow the company to keep controlling the pneumococcal conjugate vaccine market until 2026. This patent involves the method of conjugating (assembling) together the 13 serotypes of streptococcus pneumonia into a single carrier. The method that Pfizer seeks to patent is essential for any PCV-13 developer. The method is deemed as too obvious to deserve a patent.

An equivalent patent application was already revoked by the European Patent Office (EPO) and is currently being challenged in South Korea.

“Our pre-grant  opposition shows that the method Pfizer is trying to patent is too obvious to deserve a patent under Indian law, and is just a way to guarantee a market monopoly for Pfizer for many years to come,” said Leena Menghaney, head of MSF's Access Campaign in South Asia. “India must rebuff demands from pharmaceutical companies, which are backed by diplomatic pressure tactics of the US and other governments, that India change its patentability standards to restrict generic competition. Pfizer's unmerited patent application on the pneumonia vaccine should be rejected, opening the door to more affordable versions of the vaccines being produced.”

After years of fruitless negotiations with Pfizer to lower the vaccine's price for use in its projects, MSF is challenging this patent application in India to ensure that manufacturers who are planning to produce the pneumonia vaccine do not face key patent barriers at the time of launching a more affordable version.

In the poorest countries, this vaccine costs 70 times more than the measles vaccine.

“The pneumonia vaccine is the world's best-selling vaccine, and last year alone, Pfizer brought in more than US$6 billion dollars in sales just for this product. Meanwhile many developing countries, where millions of children risk getting pneumonia, simply cannot afford it,” said Dr Manica Balasegaram, executive director of MSF's Access Campaign. “To make sure children everywhere can be protected from deadly pneumonia, other companies need to enter the market to supply this vaccine for a much lower price than what Pfizer charges.”

One vaccine producer in India has already announced that it could supply the pneumonia vaccine for $6 dollars per child (for all three doses) to public health programmes and humanitarian organisations like MSF. This is almost half the current lowest global price of $10 dollars per child, which is only available to a limited number of developing countries via donor funding through Gavi, the Vaccine Alliance.

Pneumonia is the leading cause of childhood death, killing almost one million children each year. Currently, Pfizer and GlaxoSmithKline (GSK) are the only two manufacturers of the vaccine, which could prevent a large number of these deaths. Pfizer has priced PCV13 (marketed as Prevenar) out of reach of many developing countries and humanitarian organisations. It is now 68 times more expensive to vaccinate a child than in 2001, according to a 2015 MSF report, The Right Shot: Bringing down Barriers to Affordable and Adapted Vaccines. The pneumonia vaccine accounts for almost half the price of vaccinating a child in the poorest countries.

In 2015, all 193 countries at the World Health Assembly passed a landmark resolution demanding more affordable vaccines and increased transparency around vaccine prices. “Last year, more than 50 countries spoke out against high vaccine prices and about the difficulties of introducing new vaccines, including Indonesia, Jordan and Tunisia. We cannot wait any longer for all countries to be able to afford this vaccine,”said Balasegaram.

The pre-grant opposition-- a form of citizen review at the patent examination stage--submits technical grounds before the patent office to show that claims that cover a certain aspect of a drug or vaccine do not merit patenting under India's Patents Act.