Pfizer does not deserve the patent it was granted in August on its pneumonia vaccine Prevnar13 (PCV13), said the international medical humanitarian organization Doctors Without Borders (MSF). MSF is set to argue tomorrow in the High Court of Delhi that it should be overturned because the patent doesn’t meet the standards laid out in India’s Patents Act. The U.S.-based drug corporation’s unmerited patent prevents vaccine manufacturers in India from developing and marketing PCV13 until 2026, depriving countless children of the opportunity to be protected against pneumonia, which kills 2,500 kids per day.
“At MSF, we have watched far too many children die of pneumonia, and we’re not going to back down until price is no longer a barrier,” said Kate Elder, vaccines policy advisor for MSF’s Access Campaign. “The decision to give Pfizer a patent in India for this vaccine is unmerited and just a way for them to remain the only game in town by blocking more affordable pneumonia vaccines.”
There are currently only two companies that make a pneumonia vaccine, Pfizer (PCV13) and GlaxoSmithKline (PCV10). These companies have already made more than $40 billion on their vaccines and have consistently fought to prevent others from entering the market with lower-price versions.
This lack of competition has resulted in high pneumonia vaccine prices, which is largely the reason approximately one-third of countries have not been able to introduce pneumonia vaccines in their standard vaccination package. In fact, the cost of a vaccine against pneumonia is a significant part of why it is now 68 times more expensive to vaccinate a child with the full package of WHO-recommended vaccines than in 2001.
Countries that have decided to buy these vaccines for their children are struggling with the high, on-patent prices. South Africa, for example, spends more than 30 percent of its vaccination budget on purchasing PCV13 alone—just one vaccine in the package of 11 vaccines supplied to people nationally. In India, the government only recently began to roll out PCV13 and has, so far, only been able to introduce it in three states: Himachal Pradesh, Bihar, and Uttar Pradesh, due to its high price and the fact it can’t be produced and sold by other companies for cheaper.
“The price of this one vaccine, Pfizer’s PCV13, is crippling the government’s immunization budget,” said Claire Waterhouse, advocacy advisor for MSF’s Access Campaign in South Africa. “While the government is looking for solutions to lower the price, the real gamechanger will be when competitor products enter the market and countries like South Africa have more affordable options.”
The Indian patent office’s August decision has even broader implications as it indicates a weakening of India’s strict patentability standards and public health safeguards. Making it easier for companies to get or extend their existing patents when they make minor and trivial improvements to an existing medical product will hamper India’s role as “pharmacy of the developing world” and make it harder for countries and treatment providers like MSF to secure affordable medicines and vaccines for patients.
In 2013—in a case with a similar potential global impact—India upheld public health safeguards enshrined in its patent law and ruled against Swiss pharmaceutical company Novartis, rejecting claims that the company deserved a patent for a new form of a known medicine.
“There are safeguards in India’s patent law for a reason, and we’ve seen the government of India make the right decision before and uphold its strict patentability standards in the case of Novartis’ cancer drug imatinib,” said Leena Menghaney, head of MSF’s Access Campaign in South Asia. “The Indian patent office has got to stop letting pharmaceutical corporations change the rules and must be aware that the patents they grant directly affect people’s access to lifesaving medicines and vaccines across the developing world.”
Pfizer’s patent on PCV13 in also being challenged in South Korea.