Pfizer has come under fire for holding exclusive patent rights that bars competition on its pneumonia vaccine worldwide, which is being challenged in patent litigations in several countries, an aid group said Monday.
Doctors Without Borders will challenge Pfizer in the High Court of Delhi in India Tuesday to overturn a patent court ruling that granted the pharmaceutical giant a “monopolistic” control over a pneumonia vaccine, Prevnar 13, it said.
“Pfizer does not deserve the patent it was granted in August on its pneumonia vaccine,” the international humanitarian group, also known as Médecins Sans Frontières (MSF), said Monday. “(Pfizer’s) unmerited patent prevents vaccine manufacturers in India from developing and marketing PCV13 until 2026, depriving countless children of the opportunity to be protected against pneumonia, which kills 2,500 kids a day.”
The aid group is asking the Indian court to overturn the August ruling on Prevnar 13 (PCV13), saying the patent doesn’t meet the standards of India’s Patent Act. It had previously filed an objection to the American pharmaceutical giant’s patent request last year.
Pfizer currently has exclusive rights to sell Prevnar 13 in India until 2026. No other companies are allowed to make cheaper copies of the vaccine.
Although India included the pneumonia vaccine in its public immunization program earlier this year, only three states had access to the vaccine due to its high price arising from the lack of competition, the group said.
Doctors Without Borders criticized Pfizer for crippling the country’s immunization budget with high drug prices. It costs 68-times more to vaccinate a child with the list of WHO-recommended vaccines now than it did in 2001, mostly because of stifled competition and high prices, the aid agency said.
Prevnar, launched in India in 2010, protects children and adults from 13 types of pneumococcal bacteria. The vaccine is one of only two pneumonia vaccines -- Pfizer’s PCV 13 and GlaxoSmithKline’s PCV 10 -- produced in the world. Pfizer and GSK have made more than $40 billion on their vaccines, the aid group said.
Pfizer said in response that it had provided more than 300 million doses of Prevnar 13 through the Global Alliance for Vaccines and Immunisation (GAVI), which is an international public-private partnership to deliver better vaccine access to developing countries.
The same patent is also currently challenged in Korea and the EU.
In Korea, the case is currently in the end stages of appeal, having won at the trial court level, with results to be announced soon. The EU patent revocation order is under suspension, the company said. The patent litigations in Japan and the U.S. have been overruled, with the courts upholding the patent on Prevnar 13, Pfizer said.
Pfizer said it advocates the importance of patents citing the complexity of manufacturing vaccines while remaining committed to the broadest deployment of the vaccine throughout the world.
“We believe patents are not a barrier to access. Pfizer believes that meaningful patent protection is vital as it encourages medical progress, further investment into discovery and development of newer and effective medicines and vaccines in India and across the world,” the company said Tuesday.
Meanwhile, the results from the High Court of Delhi is expected to have international implications, as other developing countries rely on India to create and provide cheaper generics of medical products.
“At MSF, we have watched far too many children die of pneumonia, and we’re not going to back down until the price is no longer a barrier,” the group said.
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