Pfizer secures Indian patent for its pneumonia vaccine

23 Aug 2017


US pharmaceutical giant Pfizer has secured an Indian patent for its pneumonia vaccine, Prevnar 13, despite opposition from the health group Médecins Sans Frontières (MSF) and rival Indian  drugmaker Panacea.

The non-profit group had filed a ''patent opposition'' to prevent Pfizer from getting a patent on its pneumococcal conjugate vaccine (PCV 13), which, it said, would bar poor patients access to the vaccine.

While the approval comes almost a decade after Pfizer subsidiary Wyeth applied for a patent for Prevnar 13, the decision by the patent office effectively bars other companies from making cheaper versions of the vaccine and allows Pfizer to exclusively sell it in India until 2026.

MSF has warned that grant of the patent would block other manufacturers in India from supplying the vaccine, which protects against 13 types of pneumococcal bacteria, to those who need it most.

According to Leena Menghaney, South Asia head of MSF's Access Campaign, ''The method Pfizer is trying to patent is too obvious to deserve a patent under Indian law, and is just a way to guarantee an extended market monopoly for the corporation for many years to come.''

India has the world's highest number of pneumonia and diarrhoea deaths among children. Pneumonia and diarrhoea claimed more than 300,000 children in 2013 in India, according to a 2014 report by Unicef.

It's a big victory for the US drugmaker, but a great loss for patients, especially children, in India and other poorer countries where access to cheaper vaccines is key to making healthcare affordable.

For several poorer nations that rely on India's robust drugs industry to supply cheaper copies of medicines and vaccines, the decision comes as a big blow.

Pfizer's vaccine that offers protects against 13 types of pneumococcal bacteria costs over Rs10,000 ($170) for a full vaccination course in private hospitals.

The vaccine is given free under a national immunisation program that the Indian government started in March, but the rollout is restricted, so only about 2.1 million of the 25 million eligible people in the country will get it this year.

The government, however, did not give reasons for the phased rollout.

"Manufacturers will have to find new routes to develop a non-infringing (pneumonia) vaccine, which may delay the availability of competing products in the pipeline from Indian producers," MSF said in a statement.

Pfizer's patent on the same vaccine was revoked by the European Patent Office last year, and is being challenged in South Korea and the United States, MSF said.

The pharmaceutical giant has made the vaccine available at discounted prices under the Global Alliance for Vaccines and Immunisation (GAVI) - an international public-private partnership to improve access to vaccines in the world's poorest countries. More than 50 countries are eligible to procure the vaccine through GAVI, according to the organization's website.

Following criticism over the high price of Prevenar 13, Pfizer reduced the vaccine price to non-governmental organizations last November, seeking to protect vulnerable people from illness in humanitarian crises.

Pfizer welcomed the granting of the patent, saying Prevenar 13 took two-and-a-half years to produce, and was launched in India in 2010.

''In its multi-dose vial presentation, this vaccine has been included in the expansion of India's public immunization programme in select states under the GAVI-funded platform. Supported by extensive clinical research and real-world experience, each dose of PCV-13 requires 400 different raw materials, 580 manufacturing steps, 678 quality tests and two and a half years to produce. Pfizer remains committed towards further enhancing access of this vaccine in India, both in the market as well as through partnership with the government to expand introduction in the public program,'' added the Pfizer spokesperson.

This means the government's funds for immunisation programme will increasingly flow more into Pfizer's kitty while enhancing access of this vaccine in India through partnership.

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