By Nachiket Kondhalkar
The Indian Patent Office has granted US pharmaceutical company Pfizer Inc. a patent for its pneumonia vaccine, Prevnar 13. This despite opposition from the Médecins Sans Frontières (MSF) or Doctors Without Borders. The MSF has filed a patent opposition to prevent Pfizer from getting a patent on its pneumococcal conjugate vaccine (PCV 13).
Patents, and how they work
Patents are meant to protect intellectual properties such as innovations and ideas. They were established on a simple premise: An inventor who came up with an invention would receive a specific amount of time depending on their patent. During this time, only the inventor could make money by selling their invention.
After the time period lapses, anyone can start selling the invention on their own without the inventor’s permission. Until then, the inventor has sole rights to that invention. This allowed the inventor to earn money for future research and created an environment of competition in research.
Pharmacological companies have huge R&D divisions that lead the edge of pharmaceutical research. As soon as they discover or develop a new drug, they file a patent. This allows the company a monopoly in manufacturing that drug for a specific amount of time in the country they have filed that patent in.
National and international implications
India started giving out the vaccine for free under its national immunisation programme, earlier this year. However, the distribution of most vaccines in the programme happens in phases. Thus, only about 2.1 million of the 25 million eligible people in the country will get it this year.
Pfizers vaccine protects children and adults from thirteen types of pneumococcal bacteria. A full vaccination course costs about Rs 10,887 in Indias private market.
The decision by Indias patent office bars other companies from making cheaper copies of the vaccine or exporting them. It also allows Pfizer to exclusively sell it in India until 2026. The decision also has international implications. Several poorer nations rely on India’s robust drugs industry to supply cheaper copies of medicines and vaccines.
This grant comes at a time of ongoing U.S. pressure on India to alter its patent laws. The U.S. Trade Representative expressed concerns about Indias intellectual property laws in a report. They listed India among countries whose IP laws unfairly favour local companies.
MSF’s opposes the monopoly
Manufacturers will have to find new routes to develop a non-infringing (pneumonia) vaccine, the MSF said in a statement.
According to Leena Menghaney, South Asia head of MSFs Access Campaign, The method Pfizer is trying to patent is too obvious to deserve a patent under Indian (patent) law. It is just a way to guarantee an extended market monopoly for the corporation for many years to come.
Each year, MSF teams vaccinate millions of people; both as outbreak response to diseases like measles, meningitis, yellow fever and cholera and routine immunisation projects for women and children. In 2015 alone, MSF delivered about 5.3 million doses of vaccines in more than 30 countries. They are scaling up their use of vaccines with a particular focus on improving routine immunisations. They are also extending the package of vaccines used in humanitarian emergencies. MSF has vaccinated children caught in emergencies with PCV in Central African Republic, Ethiopia, South Sudan, Syria and Uganda, among others.
300,000 lives at stake
Prevnar 13 is used for the prevention of pneumonia caused by 13 Streptococcus pneumoniae strains.
India has the worlds highest number of pneumonia and diarrhoea deaths among children. More than 300,000 children in India were diagnosed with pneumonia and diarrhoea in 2016, according to a report by UNICEF.
The MSF relies heavily on affordable generic medicines to help people around the world. Two-thirds of its medicines, used to treat people with HIV, TB and malaria, are generic medicines made in India. Indian vaccine manufacturers have already announced that they can supply PCV for a much lower price. However, Pfizers patent blocks Indian vaccine manufacturers from supplying versions competing with Pfizers PCV.
Last year, Pfizer’s patent on the same vaccine was revoked by the European Patent Office. It is also being challenged in South Korea and the United States.
Following criticism over the high price of Prevnar 13, Pfizer reduced the vaccine’s price last November.
India’s weakening patent policy
The Indian patent offices decision also has broader implications. It indicates a weakening of Indias previously strict patentability standards. This results in granting monopolies for minor and trivial improvements in existing medical products.
Such practices will hamper Indias role as pharmacy of the developing world. It will also make it difficult to supply governments and NGOs like MSF with affordable medicines and vaccines.
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