Médecins Sans Frontières (MSF)/Doctors without Borders India announced on October 13, 2017 that it has filed a petition before the High Court of Delhi to overturn the patent granted on the Pneumococcal Conjugate Vaccine (PCV) to the US pharmaceutical corporation Pfizer12.

Earlier this year on August 13, the Indian Patent Office dashed hopes for improved access to an affordable PCV13 when it granted a patent to Pfizer for its PCV 13 product, marketed as Prevnar13, which will expire only in 2026. MSF had challenged Pfizer's unmerited patent claims on the vaccine in India last year, to enable and accelerate the availability of more affordable versions of PCV.

Globally, pneumonia causes more than a quarter of deaths in children under the age of five – that is nearly one million young lives lost per year. India carries the world's highest burden of pneumonia, accounting for nearly 20% of these global infant pneumonia deaths. 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.

In a petition filed at the Delhi High Court, MSF India has argued that in August 2017, the Delhi Patent Office erroneously granted a patent to Pfizer by disregarding the evidence, produced by MSF, which indicated that the pharmaceutical giant's claim to a patent was spurious. MSF argued that 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 for many more years. 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 of existing medical products and restricts access to affordable medicines.

The Pneumococcal Conjugate Vaccine (PCV) is currently available from 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 (DCVM). Approximately one-third of the world's 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% of its vaccination budget on purchasing PCV13 alone and this is set to continue for another decade unless patent barriers are removed to bring in more competition.

Yuanqiong Hu, Legal & Policy Advisor, MSF Access Campaign concluded saying that "While MSF has initiated the legal process to challenge the patent, the actual revocation of an unmerited patent takes years. Looking at the urgent need for this vaccine, we really hope that the Indian Health Ministry in the meantime considers issuing a government use license, to encourage manufacturers who have been developing more affordable PCV13 vaccines to continue with phase 3 clinical trials and deliver the life-saving vaccine for the immunization program, not just in India but across the world".

Conclusion:

Pneumococcal disease is the leading cause of vaccine-preventable deaths in children under five years of age both globally and in India. India accounts for nearly 20% of global pneumonia deaths in this age group. In 2010, pneumococcal pneumonia accounted for approximately 16% of all severe pneumonia cases and 30% of pneumonia related deaths in children under five years of age in India13. Médecins Sans Frontières which has earlier also objected to the grant of the patent for this vaccine has now filed a petition before the High Court of Delhi to overturn the patent granted to the US pharmaceutical corporation Pfizer.

Footnotes

12 https://www.msfindia.in/msf-approaches-delhi-high-court-challenge-unmerited-patent-grant-pneumonia-vaccine-0

13 http://pib.nic.in/newsite/PrintRelease.aspx?relid=161763

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