In a single stroke, the Indian Patent Office set the dominoes falling on 11 August when it granted $53-billion pharma major Pfizer a patent for a vaccine that can prevent pneumonia. On 28 September, Panacea Biotec was the first to cry foul. After working for over a decade, it was close to a breakthrough, planning to launch its own Pneumococcal Conjugate Vaccine (PCV) by 2020. It was relying on the government to buy its affordable version over Pfizer’s expensive one.
Pneumonia and such influenza infections lead to 5% of all deaths in India.
Delhi-headquartered Panacea, which grossed Rs 555 crore ($85 million) in revenue in FY17, is not the only one. Serum Institute in Pune and Aurobindo Pharma in Hyderabad are feeling the pinch, too. After all, who doesn’t want a piece of the Rs 3,500 crore ($537 million) estimated budget for the national immunisation programme growing every year. In May, when the Minister of Health JP Nadda included PCV in the government-funded programme, he had said: “No child should die in the country from Vaccine-Preventable Diseases”.
The dominoes do not stop falling at Indian companies’ disappointment for losing the revenue government tenders would have brought if Pfizer had not secured the patent. The potential sellers are nervous, and so are the ultimate users of the vaccine. The international humanitarian not-for-profit Médecins Sans Frontières (MSF) moved the Delhi High Court to set aside the patent in October. It spoke for the ultimate user—millions of Indian children, who will likely get the vaccine only if their government can afford it.
Both Panacea and MSF right now have the power to do just that. Their respective businesses and public health interests aside, they are standing their ground that the patent itself is undeserved. And they are not the only ones to object to the patent. The European Patent Office (EPO) in 2014 revoked the patent for Pfizer’s vaccine which sells under the brand name Prevnar 13. (The number 13 stands for the number of pneumococcal bacteria that the vaccine protects against.) The patent is disputed in South Korea and the United States as well.
While MSF and Panacea are girding up for a legal battle against the Indian patent office and Pfizer, the Indian ministry of health holds a trump card. It has its first real opportunity to bring the MNC to its knees and use a compulsory licence—a World Trade Organisation (WTO) provision to override a patent to secure affordable vaccines. As it is the only time the large-scale public health relevance of the vaccine was proven when it was included in the government programme early this year, said an official in the know who requested to not be named.