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Why has MSF chosen India to challenge Pfizer's patent on a pneumonia vaccine

MSF's opposition is to stop this from happening. MSF, also known as Doctors Without Borders, has not only given a direct challenge to Pfizer, but taken a stand against the growing the big pharma lobby pressure in India.

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International not-for-profit Medecins Sans Frontieres (MSF) has taken on US pharma giant Pfizer, challenging the latter's patent for a pneumonia vaccine priced at $100 a vial, in the Indian Patent Office. If the patent is granted, Pfizer's monopoly on the drug could stop the production of generic, affordable version of the vaccine, making patients pay dearly from their pockets.

MSF's opposition is to stop this from happening. MSF, also known as Doctors Without Borders, has not only given a direct challenge to Pfizer, but taken a stand against the growing the big pharma lobby pressure in India.

A global heavyweight when it comes to public health care, MSF filed this opposition on 12 March. It's primary interest is to secure an affordable supply of pneumonia vaccines for its project across African countries. The vaccine is needed urgently there, and India is famous for manufacturing cheap generic drugs used in African Countries. Its second reason is to support the public safeguards that come with India's patent laws, so that Indian generic companies can continue producing drugs.

Pneumonia, said MSF, kills about a million children a year, making it a leading cause of childhood deaths. The supply for a pneumonia vaccine is imperative in different parts of the world, not just India.

"India is called the pharmacy of the developing world. UNICEF buys 90% of their vaccines from here," said Shailly Gupta, deputy head of MSF Access Campaign that works towards affordable medicines. "A patent to Pfizer will impact the supply of medicines to other counties with need." Already, two generic companies, Serum Institute of India Ltd and Panacea Biotec, have cheaper pneumonia vaccines in development. According to Gupta, Serum means to price its vaccine at $6. Dr. Rajeev Dhele, executive Director at Serum, told dna that the current patent laws do make it very hard for generic companies to make these drugs; they have to put in extra effort to create technology that does not infringe on the originator company's.

MSF has previously supported civil society groups and generic companies in opposition claims. One such was a successful pre-grant opposition against German pharmaceutical company Boehringer Ingelheim for nevirapine syrup, used for children with HIV/AIDS. The case was won by Positive Women's Network and the Indian Network for People Living with HIV/AIDS in 2007.

There have been pre-grant oppositions against AIDS drugs manufactured by Gilead, tenofovir, and Roche, valganciclovir.

However, the situation has changed, as Gupta explained, especially after news reports emerged of US India Business Council (USIBC) and US Chamber of Commerce having received "private assurances" from Indian officials that the government will not use 'compulsory licensing' (CL) for commercial purposes. Such licences are granted to Indian generic companies to produce medicines patented by other pharmaceuticals in either a case of national emergency, or when a generic company approaches the government, or when the government issues notifications for drugs it deems unaffordable or unavailable in India. This private assurance, on which the Indian government as a whole, and the union health ministry has so far declined to comment, would severely impact production of generic medicines.

As Gupta says, the strength of Indian companies lies in their ability to reverse engineer. Earlier, they would quickly recreate these drugs and sell them while a Western firm would apply for patents in India. Even if a firm would take the Indian company to court, judges rarely granted stays on the production of generic drugs.

"This has changed. Courts have started granting stays, and the now generic companies no longer want to challenge originator companies holding patents," said Gupta. Despite Make in India, she said, Indian generic firms no longer feel they can work in this atmosphere. Many have started tying up with originator companies, letting them fix the price, leading to fears of impacts on patients when pharmacies only have expensive drugs to offer.

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