SF Challenge Pfizer in Delhi HC Over Pneumonia Vaccine Patent
Indian vaccine maker Panacea Biotec Ltd and MSF (Médecins Sans Frontières) India, have opposed the grant of a patent to Pfizer Inc.’s pneumonia vaccine Prevenar 13.
Earlier this year, on August 13, the Indian Patent Office granted a patent to Pfizer for its PCV 13 product, marketed as Prevnar13, which will expire in 2026. The grant of patent will make the vaccine unaffordable for millions across the world, and block the entry of cheaper generic versions, health activists feel.
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.
“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, MSF 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.
”While Panacea Biotec has filed a review petition with the controller of patents seeking revocation of the patent, MSF India on Friday approached the Delhi high court to overturn the patent.
A petition was filed late last week in the Delhi High Court challenging the patent granted to US pharmaceutical company Pfizer for pneumococcal conjugate vaccine (PCV) used to protect infants, young children and adults from pneumoniae bacteria.
Panacea Biotec filed its review petition on 28 September, alleging that Pfizer’s vaccine does not amount to an invention as defined under the Indian Patents Act, 1970, and is, therefore, not patentable. Panacea Biotec is developing its own version of the pneumococcal conjugate vaccine (PCV), which is currently undergoing clinical trials.
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 restrict access to affordable medicines.
“A public health perspective used for scrutinizing pharmaceutical patent applications is an essential bulwark to ensure wider access to essential medicines and vaccines. Examiners in the Indian Patent Office must be aware that the decision they take to grant a patent can directly affect access to life-saving medicines and vaccines in India and across the developing world,” said Leena Menghaney, the petitioner who is representing the medical aid organization in court. “MSF is appealing to the court to annul the decision to grant the patent and the patent office to hear the matter afresh.”
The pneumococcal conjugate vaccine (PCV) is currently available from only two pharmaceutical corporations – Pfizer and GlaxoSmithKline (GSK).
Until recently, in India, the vaccine was available in private market for Rs 10,000. It has now been introduced in India’s Universal Immunization Programme in Himachal Pradesh, Uttar Pradesh and Bihar with the help of international funding.
Pfizer and GSK face criticism by health activists for pricing out their vaccines 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.
