New Delhi: The grant of a patent to Pfizer Inc.’s pneumonia vaccine Prevenar 13 has been opposed by Indian vaccine maker Panacea Biotec Ltd and MSF (Médecins Sans Frontières) India, the local unit of Paris-based humanitarian aid organization.
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.
In August this year, India’s patent office granted the patent to Pfizer for Prevenar 13, barring other companies from making cheaper copies of the vaccine and allowing Pfizer the exclusive right to sell it in India until 2026.
According to people privy to the development, 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.
Both Panacea Biotec and MSF India had opposed Pfizer’s application for an Indian patent for the pneumonia vaccine last year, to enable and accelerate availability of more affordable versions of PCV. However, the patent office approved the patent in August, a decade after the company applied for it.
Arguing that the Delhi patent office “erroneously" granted the patent to Pfizer by “disregarding" evidence indicating that the pharmaceutical giant’s claim to a patent was spurious, MSF India 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.
“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 MSF India.
“MSF has appealed to the court to annul the decision to grant the patent and the patent office to hear the matter afresh," she added.
“We are not aware of any proceedings filed. However, meaningful patent protection is vital as it encourages medical progress, further investment into discovery and development of newer and effective medicines and vaccines that address unmet medical needs of patients in India," said a Pfizer spokesperson.
Globally, pneumonia causes more than a quarter of deaths in children under the age of five. India carries the world’s highest burden, accounting for nearly 20% of these global infant pneumonia deaths.
PCV 13, which safeguards against 13 types of pneumococcal bacteria, also lowers the likelihood of antimicrobial resistance by significantly reducing common childhood infections and decreasing the need for antibiotic use among infants and children.
According to MSF India, approximately one-third of the world’s countries have not been able to introduce PCV, largely because of high prices. Those that have introduced the vaccine are struggling with its costs. South Africa spends more than 50% of its vaccination budget on purchasing PCV 13 alone and this is set to continue for another decade unless patent barriers are removed to bring in more competition.