Vaccination campaign by the Pfizer

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.

Is Pfizer just bigger or better?

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.

Office of the Controller General of Patents, Designs & Trade Marks (CGPDTM) reports to the Ministry of Commerce and Industry. The real question is: when the time comes to make a choice, would the commerce ministry be on the side of the American giant Pfizer (the one it granted the patent to) or the health ministry?

“It is queer that the controller of patents took Pfizer on its face value. EPO’s decision to revoke the patent is a substantive one,” the official told The Ken. He was referring to the patent pre-grant opposition by Panacea, which was heard on 18 March 2015. Although the patent holds because Pfizer has appealed against the revocation of the patent in Europe, it is only a procedural delay which is an opportunity for Pfizer to buy time. It should not have affected the final decision to grant a patent, he added.

Pfizer already holds the patent on PCV7 (an older vaccine protecting against 7 bacteria) and GlaxoSmithKline on PCV10 (which protects against 10 bacteria), the real question is if the PCV13 vaccine under dispute is indeed ‘novel’ to deserve the patent. Is it merely an ‘incremental’ innovation?

“It is obvious that it is an inventive step, and there are not enough questions put by the patent office to Pfizer to prove their innovation. Why did they not do a rigorous job before granting the patent?” asked the official.

The answer is not obvious. It may be increased interaction: training of Indian examiners and a fast-track examination option, between the traditionally more conservative Indian Patent Office and the liberal counterpart in the US. A trend that began with Prime Minister Modi’s first visit to the US in 2014, as evident on the Patent Office’s website.

A public health perspective is an essential bulwark for considering pharmaceutical patent applications, said Leena Menghaney, the petitioner representing MSF.


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