The answer may also not be relevant anymore.
“The damage was done when the patent was granted to PCV13, ” said a senior executive of one of the three Indian vaccine manufacturers developing the pneumococcal conjugate vaccines. And how? The legal proceedings challenging the patent can go on for an indefinite amount of time.
While they go on, the courts may or may not put a stay on the existing patent. Either way, the ambiguity makes it difficult to decide if the Indian vaccine manufacturers should continue developing the vaccine. The delay works in Pfizer’s favour right now, and in the scenario that patent is revoked, Pfizer can appeal against the decision like EU and buy more time, he added.
Aurobindo Pharma, which refused to answer how Pfizer’s patent will affect its vaccine development, was the last one among the three to invest in PCV. In 2015, it bought 60% shares in Tergene Biotech in Hyderabad and formed a joint venture with an aim to develop the vaccine.
Panacea and Serum have been in the race much longer; both have received funding from Bill and Melinda Gates Foundation since they were chosen for Advanced Market Commitment (AMC) by Gavi, the international vaccine alliance, in September 2009. Boston Consulting Group, in a report published in December 2015, noted that of all the vaccine manufacturers chosen by Gavi, ‘Serum and Panacea are the most serious candidates for Gavi markets in the near term’. They still have the opportunity to export the vaccine at more affordable rates to other countries, just not in India.
Might is always right
“It is a neat strategy that Pfizer has adopted. First, offer the government vaccine at fairly low rates, then get a patent to monopolize the market for 10 long years. When the government is thinking of universal immunisation, the cost of this patent is huge, right when we are on the anvil of introducing the product,” said an upset senior executive of Panacea on the condition of anonymity as the matter is sub-judice.
Panacea has already developed a PCV10 and gotten it approved for Phase III clinical studies by the drug controller of India and is working on a 13/15-valent vaccine. It has not yet shared the tentative price of the final product, unlike Serum Institute which has pledged to price its vaccine at $2 a dose for government programmes.
A senior executive of Serum, which grossed Rs 4000 crore ($614 million) in revenue in FY17, said the company is not affected by Pfizer’s patent for PCV13, as their product would be different. However, since Pfizer still has more patent applications in the pipeline around the pneumonia vaccine, Serum continues to be vulnerable to infringement suits.
All Indian companies are up against two patented pneumonia vaccines in the international market—Pfizer’s Prevnar 13 and GSK’s Synflorix. In the Indian market, the former is priced at $65.38 per dose and the latter at $34.38 per dose. Consider this, even if preposterous. When the government expands its programme to provide three doses to every Indian child, Prevnar 13 alone at its market price would cost over $5 billion ($196 X 26 million birth cohort), while the entire vaccination budget for the current year is about $537 million.
Why then did it decide to become a mass buyer of Prevnar 13?
The answer lies in the $500-million aid that Geneva-based public-private body Gavi is giving to India’s immunisation programme (between 2016 and 2021).
When the government entered this partnership, its plan was simple—buy affordable and locally manufactured vaccine once the Gavi funding ends in 2021. Since now Pfizer has patented PCV13, the government has only one option, which is anything but simple.
The last resort
Pfizer is currently offering each dose at less than $3.30 to Gavi-supported countries like India. This will be provided to 5.15 million babies in the first phase—20% of around 26 million children of India’s birth cohort whom the programme plans to cover eventually.
There is already some insecurity about the vaccine as it is dependent on donation right now, said Menghaney. Once the donations end, either the government will have to buy the vaccine from Pfizer itself to scale up to cover every Indian child (as it has now become the first patented vaccine which is part of the government programme) or it will have to secure a compulsory license.