October 13, 2017

NEW YORK/NEW DELHI, OCTOBER 13, 2017—The international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières(MSF) filed a petition before the High Court of Delhi today to overturn a patent granted to Pfizer pharmaceutical corporation on the pneumococcal conjugate vaccine (PCV).

The patent—granted in August by the Indian Patent Office for Pfizer’s PCV13 product, marketed as Prevnar13—will prevent other companies from manufacturing cheaper, generic versions of the lifesaving vaccine until 2026. MSF had challenged Pfizer’s attempt to patent this vaccine in India. The decision also has broader implications, as it indicates a weakening of India’s strict patentability standards, which results in granting monopolies for minor and trivial improvements to existing medical products and restricts access to affordable medicines for people most in need.

“A public health perspective for scrutinizing pharmaceutical patent applications is necessary to ensure wider access to essential medicines and vaccines,” said Leena Menghaney, the petitioner who is representing the medical aid organization in court. “Examiners in the Indian Patent Office must be aware that the decision they take to grant a patent can directly affect access to lifesaving medicines and vaccines in India and across the developing world. MSF is appealing to the court to annul the decision to grant the patent and the patent office to hear the matter afresh.”

In the petition filed on Friday, MSF India argues that the Delhi Patent Office disregarded MSF’s evidence indicating that the pharmaceutical giant’s claim to a patent was spurious. The mere addition of serotypes to the already established 7-valent vaccine did not involve a technical advancement—it was merely a tactic to preserve Pfizer’s monopoly, said MSF.

Globally, pneumonia causes more than a quarter of deaths in children under the age of five—nearly one million young lives lost per year. The PCV13, which safeguards against 13 types of pneumococcal bacteria, also lowers the likelihood of antimicrobial resistance (AMR) by significantly reducing common childhood infections and decreasing the need for antibiotic use among infants and children.

“Millions of babies and young kids around the world are left unprotected against pneumonia as many governments cannot afford the high price of PCV set by pharmaceutical corporations,” said Dr. Greg Elder, medical coordinator for MSF’s Access Campaign. “As doctors who have watched far too many children die of pneumonia, we’re not going to back down until we know that all countries can afford this vaccine.”

The PCV is currently sold by only two pharmaceutical corporations: Pfizer and GlaxoSmithKline (GSK). Unfortunately, this vaccine is priced out of reach of many parents, governments, and treatment providers, due to a duopoly market and a lack of sufficient competition from developing country vaccine manufacturers. Approximately one-third of countries have not been able to introduce PCV, largely because of high prices. Those who have introduced the vaccine are struggling with its costs. South Africa spends more than 50 percent of its vaccination budget on purchasing PCV13 alone, and this is set to continue for another decade unless patent barriers are removed to accelerate competition.

“While MSF has initiated the legal process to challenge the patent, the actual revocation of an unmerited patent takes years,” said Yuanqiong Hu, legal and policy advisor for MSF’s Access Campaign. “Looking at the urgent need for this vaccine, we really hope that the Indian Health Ministry considers issuing a government use license in the meantime. This would encourage manufacturers who have been developing more affordable PCV13 vaccines to continue with phase III clinical trials to deliver this lifesaving vaccine, not just in India but across the world.” 

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