MSF challenges Pfizer’s pneumonia vaccine patent in India
pharmafile | March 11, 2016 | News story | Medical Communications, Research and Development, Sales and Marketing | GSK, Pfizer, Prevnar 13, pneumonia vaccine
The charity Médecins Sans Frontières (MSF) has formally opposed Pfizer’s bid to obtain a patent for the pneumonia vaccine PCV13, in a bid to protect affordability for developing countries and humanitarian organisations.
Prevnar 13 is an update to the original 7-valent formulation, and protects against six additional strains of the pneumonia virus. It was approved by the US FDA in 2010 and is the world’s bestselling vaccine, bringing Pfizer more than $6 billion in global sales.
MSF also known as Doctors without Borders, says if Pfizer was to obtain a patent for PCV13 in India, which the US company markets as Prevnar 13, Indian generics companies would be unable to produce affordable unbranded versions for use domestically or in other countries. The charity says its action is aimed at protecting millions of children against deadly pneumonia – the leading cause of child mortality in India – which kills around one million children each year worldwide.
Pfizer and GSK are the only two manufacturers of the vaccine, which MSF says could prevent a large number of these deaths. The charity says “Pfizer has priced PCV13 out of reach of many developing countries and humanitarian organisations,” noting that the cost of vaccinating a child has risen 68-fold since 2001.
“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 can’t afford it,” says 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, the Serum Institute, 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.
Pfizer does offer the vaccine at a discounted rate through the Vaccine Alliance Gavi, for $10 per child. India is one of the 58 countries able to procure the product through GAVI, but has not exercised this option.
MSF countered Pfizer’s plan by filing a pre-grant opposition – a form of citizen review at the patent examination stage – which brings to the Patent Office’s attention reasons why a drug or vaccine should not merit a patent. The method Pfizer is trying to patent is the process by which all 13 serotypes of the streptococcus pneumonia virus are put into a single carrier. The charity argues that this method is too obvious to warrant a patent in itself, pointing out that an equivalent patent 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,” says 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 U.S. 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.”
MSF says it has engaged in “years of fruitless negotiations with Pfizer to lower the vaccine’s price for use in its projects,” and had decided to take action to ensure that manufacturers planning to produce affordable unbranded versions of the pneumonia vaccine are not blocked from doing so.
“Pneumonia kills a child every 35 seconds,” concludes Dr Balasegaram. “As doctors who have watched far too many children die of pneumonia, we’re not going to back down until we know that all countries can afford this vaccine.”
Joel Levy
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