Doctors Without Borders/Médecins Sans Frontières (MSF) is challenging a recent Indian court decision to give U.S. pharmaceutical corporation Pfizer a patent it doesn't deserve on its pneumonia vaccine Prevnar13 (PCV13). This decision solidifies Pfizer's monopoly across the globe and prevents vaccine manufacturers in India from making and selling more affordable versions of PCV13 for people in India and other countries where the patent exists until 2026. High pneumonia vaccine prices—largely due to the lack of competition from affordable manufacturers—are a primary reason approximately one-third of countries have not been able to introduce pneumonia vaccines in their standard vaccination programs.

Latest Updates:

Next Steps:

  • South Korea is expected to make a decision before the end of the year on whether or not to uphold Pfizer’s patent on PCV13.
     
  • MSF will urge India at a court hearing in February 2018 to overturn the patent they recently granted to Pfizer.

 

What is this patent decision in India all about?

The Indian Patent Office’s August decision to grant Pfizer a patent on its lifesaving pneumonia vaccine PCV13 is the latest example of how patent offices have been bowing more and more to pharmaceutical corporation pressure and putting companies before their citizens.

Pfizer claims they should get a patent for the method of conjugating 13 serotypes of streptococcus pneumonia into a single carrier even though it does not involve an inventive step and the technology used to combine the serotypes is not new. The patent is a mere addition of serotypes to the already established 7-valent vaccine and is too obvious to deserve a patent.

The decision to grant a patent means Pfizer is the only company that can make and sell the 13-valent pneumococcal conjugate vaccine PCV13 in India until March 2026.

Why does it matter for children everywhere?

Globally, pneumonia kills almost one million children every year or 2,500 kids per day. Vaccines exist that can prevent a lot of these deaths, but monopolies keep the prices out of reach for many countries that therefore cannot afford to purchase them to protect their children. In fact, the cost of the pneumonia vaccine 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.

Granting a patent to Pfizer in India—“the pharmacy of the developing world”—solidifies that monopoly and means companies in that country won’t be able to make and sell cheaper versions of PCV13 for people living there or in other countries for nearly a decade.

At MSF, we see children dying each and every day of pneumonia—countless deaths that could be prevented if only PCV wasn’t priced out of reach of many parents and governments. MSF itself relies heavily on affordable vaccines and medicines from India to do its medical work around the world; two-thirds of its medicines used to treat people with HIV, tuberculosis, and malaria are generic medicines made in India.

Why is Pfizer trying so hard to maintain its PCV13 monopoly?

PCV13 makes the company a lot of money and is the world’s best-selling vaccine. In fact, Pfizer has sold more than $36 billion of PCV since 2009, and last year this vaccine alone accounted for $6.2 billion worth of all the company’s sales.

Could other drugmakers really sell this product for less?

Yes, manufacturers in India have already said they could start supplying a pneumonia vaccine at nearly a 50-percent price reduction (from the current lowest global prices) in the next few years, which would be a gamechanger for health ministries across the globe.

How does MSF typically fight unmerited patents?

Periodically over the past 15 years, when certain patents were considered a barrier to generic supplies of tuberculosis, HIV and hepatitis C drugs, MSF has conducted searches for patent applications, provided technical support to civil society organizations challenging the grant of evergreening patents (when companies get additional patents on a product for minor or trivial changes), and filed an opposition under its own name.

How has MSF supported increasing access to PCV in the past?

After years of fruitless negotiations with Pfizer and GSK for an affordable price, MSF launched A Fair Shot, a public campaign calling for a reduction of the price of PCV. Since then, more than 415,000 people have joined our call and asked Pfizer and GSK to reduce the price of the pneumonia vaccine to $5 per child (for all three doses) in developing countries and for humanitarian organizations. While Pfizer and GSK and have lowered the price for organizations like MSF, this is not enough. These companies must stop standing in the way of other developers that want to provide more affordable options for everyone.

Why doesn’t Pfizer deserve a patent on PCV13?

Under Indian patent law, the method used to combine these serotypes is not deserving of a patent on the basis of being “too obvious” to deserve a patent.

An equivalent patent application was already revoked by the European Patent Office (EPO) judging it to be non-inventive. The patent is also being legally challenged before the U.S. Patent Trademark Appeal Board and in South Korea.

Are there any other ways to increase access apart from getting India to annul Pfizer’s PCV patent?

Yes, in the meantime, the Indian Health Ministry and other governments unable to access pneumonia vaccines due to the unaffordable price should consider issuing a government use license, which is a legal step a country can take to introduce competition for a particular medical product for the sake of public health. This would encourage manufacturers who have been developing more affordable PCV13 vaccines to continue with clinical trials and registration to deliver this lifesaving vaccine in India and across the world.

News and stories from around the world