Pneumococcal disease is a serious infection caused by a bacteria.
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Prevnar 13®”- Pfizer’s pneumococcal conjugate vaccine (PCV) Patent in India Case Study

Prevnar 13®”- Pfizer’s pneumococcal conjugate vaccine (PCV) Patent in India Case Study

Pneumonia is an acute respiratory infection which affects the lungs. It causes difficulty in breathing and limits oxygen intake. It can be caused by bacteria, fungi or viruses and is a contagious disease. Symptoms of pneumonia include cough, difficulty in breathing, fast breathing or wheezing. Infants may experience an inability to feed or drink, unconsciousness or convulsions, or worse. It is the biggest cause of death among infants in India due to infectious diseases accounting for nearly 20% of global infant pneumonia deaths.

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PFIZER is viewed as one of the “World’s biggest pharmaceutical companies”. The company creates and delivers medicines and vaccines for a wide range of restorative orders, including immunology, oncology, cardiology, endocrinology, and neurology.

Pfizer scientists have produced innovative breakthroughs in a wide range of research areas, including depression, high cholesterol, HIV infection, hypertension, bacterial infections and systemic fungal infections, cancer, arthritis, and osteoporosis.

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Indian Patent Office has granted Pfizer Inc. a patent for its powerful pneumonia vaccine“Prevnar 13® ” barring other companies from making affordable copies of the vaccine, giving Pfizer the exclusive right to sell it in India until 2026.

Prevnar 13® is a vaccine indicated for active immunization for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F.

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The grant of patent to Pfizer Inc.’s pneumonia vaccine, Prevnar 13® was opposed by Indian vaccine maker Panacea Biotec Ltd and MSF (Médecins Sans Frontières) India stating that this would make this vaccine out of reach of thousands in poor nations as several poor nations depend on India’s strong drug industry to supply cheaper copies of medicines and vaccines. The grant of patent for the pneumococcal conjugate vaccine (PCV)- Prevnar 13® means Indian companies won’t be able to make the vaccine for in-house use, or exports.

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Panacea Biotec Ltd has filed a review petition with the Controller of Patents seeking the cancellation of the decision of the patent. According to Panacea Biotec, Pfizer’s vaccine does not qualify as an invention as defined under the Indian Patents Act, 1970, and is, therefore, non patentable. Panacea Biotec is developing its own more affordable version of the pneumococcal conjugate vaccine (PCV). It is currently undergoing clinical trials.

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MSF(Médecins Sans Frontières) India approached the Delhi high court to revoke the patent. Leena Menghaney, the petitioner who is representing MSF (Médecins Sans Frontières) India said “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”.

Tech Corp International Strategist (TCIS, India)

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