Friday, March 11, 2016 —
PCV 13 PATENT OPPOSITION | QUESTIONS & ANSWERS
Q: What is this patent application about?
A: A key pending patent application (8081/DELNP/2007 in India) filed by Pfizer, would allow the company to keep controlling the pneumococcal conjugate vaccine (called PCV13) market until 2025.
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.
MSF considers this patent as a barrier to accessing an affordable vaccine - that protects against 13 types of pneumococcal bacteria (PCV 13) - from manufacturers in India and other countries. Competition from emerging manufacturers could be delayed if the claims are granted.
Q: What is the problem with access to the pneumonia vaccine?
A: We are seeing children dying everyday of pneumonia. Globally pneumonia kills almost one million children every year. The PCV13 is a vaccine to prevent pneumonia, but it is priced out of reach of many parents and governments.
Pfizer has charged inflated prices for the pneumonia vaccine for years. The pneumonia vaccine is the world’s best-selling vaccine. Pfizer has sold more than $26 billion dollars of pneumonia vaccine since 2009, and last year accounted for $6.2 billion dollars’ worth of sales alone.
In the poorest countries, this vaccine costs 70 times more than the measles vaccine. MSF has tried to negotiate with Pfizer a lower price for its own medical projects for years, but never succeeded. After years of fruitless negotiations with Pfizer and GSK for an affordable price, last year MSF launched – A Fair Shot – a public campaign calling for a reduction of the price of the pneumonia vaccine. Since then, almost 200 000 people have joined our call and asked Pfizer and GSK to reduce the price of the pneumonia vaccine to 5 dollars per child (for all three doses) in developing countries.
One long term solution is competition which could introduce more suppliers of affordable PCV13. Manufacturers in India could start supplying the vaccine at nearly a 50% price reduction in the next few years. This would be a game changer that increases competition and reduces the price.
Why is MSF filing this patent opposition in India?
Robust competition from India has consistently proven to result in dramatic price reductions for medicines and vaccines. The cost of first generation HIV treatment dropped from over $10,000 per patient per year in 2000 to $350 by 2001 thanks to generic competition from India.
The recombinant Hepatitis B vaccine is another clear example. Large multinational pharmaceutical companies held monopolies on the vaccine and kept prices high. At prices as high as USD$23 a dose, the vaccine was out of reach for most people and treatment providers in developing countries. An Indian manufacturer, in the absence of patent barriers, developed a Hepatitis B vaccine that led to dramatic price reductions. The current price is less than $1/dose. This enabled low-cost mass vaccination globally through organizations such as UNICEF.
Indian manufacturers could be a source of affordable pneumonia vaccines to the rest of the world. Indian manufacturers have already announced that they could produce the pneumococcal vaccine for a fraction of the current price. However, if Pfizer’s application for the patent on PCV13 is granted, it will not expire until 2026, creating a chilling effect on Indian suppliers who will not want to face expensive litigation in courts on grounds of patent infringement. This means they will have to find new routes to develop a non-infringing PCV vaccine which will delay the availability of the product from Indian producers. We simply can’t wait any longer and need to boost competition.
Q: What does MSF expect from this patent opposition?
A: Ever-greening’ or ‘secondary’ patents are routinely granted in the United States, but India chose to prioritise public health over multinational pharmaceutical industry interests when it revised its patent law in 2005. This public health approach to setting strict patent standards is in line with international trade rules and encourages timely entry of competition from other manufacturers into the market, thereby driving prices down.
The patent opposition mechanism in India — which provides a right to stakeholders to provide technical input regarding the validity of patent claims – provides MSF with an opportunity to counter the anti - competitive effects of Pfizer’s frivolous patent application while it is being examined. We hope that Pfizer’s secondary patent application will be rejected in India and that Indian manufacturers can start supplying the vaccine for a fraction of the current price.
The equivalent patent application was already rejected by the European Patent Office (EPO) and is currently being challenged in South Korea.
The patent claims do not involve a technical advancement and instead is just a way to preserve a monopoly for Pfizer for many more years. Our patent opposition is aimed at strengthening the strict examination of these frivolous patent claims and also to ensure that the Indian Patent Office - often pressured by the US government, companies and their law firms - can issue an independent decision rejecting the application.
Q: Has MSF supported other patent oppositions in the past?
A: As mentioned above, ‘ever-greening’ or ‘secondary’ patents are routinely a barrier for access to affordable vaccines and medicines.
Periodically over the past 15 years, when certain patents were considered a barrier to generic supplies of TB, HIV and HCV drugs, MSF has conducted searches for patent applications, provided technical support to civil society organizations challenging the grant of ever-greening patents, and filed an opposition under its own name.
In 2006, MSF first supported Indian Networks of People Living with HIV in filing an opposition to the grant of a patent to GSK on the formulation of HIV medicines. The patent claim was withdrawn by GSK after the patent challenge successfully highlighted that the claims were not related to a ‘new invention’ but simply the fixed dose combination of two existing drugs: Zidovudine and Lamivudine (AZT/3TC). In the past decade, several secondary patent applications on HIV medicines have been rejected by the Indian patent office after PLHIV networks, legal aid groups and MSF worked together for more than a decade to file patent oppositions in India. This has contributed to protecting competition from Indian manufacturers who today supply HIV treatment programmes, saving millions of lives in the developing world.
 For an average price of US$0.30 cents per dose (UNICEF/Gavi) for the measles vaccine and US $21 for the three doses of PCV at Gavi price (including AMC subsidies).
Chakma, Justin et al. “Indian Vaccine Innovation: The Case of ShanthaBiotechnics.” Globalization and Health 7 (2011): 9. PMC.Web. 12 Oct. 2015.