Pharmabiz
 

PATENT FOR PCV 13!

P A FrancisWednesday, October 25, 2017, 08:00 Hrs  [IST]

Two weeks ago MSF filed a petition before Delhi high court challenging the grant of a patent to Pfizer in last August for a pneumonia vaccine, PCV 13. In the petition MSF India argued that, the Delhi Patent Office erroneously granted the patent to Pfizer by disregarding the evidence MSF produced indicating that Pfizer’s claim to this patent was spurious and goes against the spirit of Indian Patent Act. It argued that the mere modification of an existing molecule did not involve a technical advancement and it is only an attempt by Pfizer to preserve the monopoly on the vaccine for many more years. The Section 3(d) was incorporated in the Patent Act with the objective of blocking the pharmaceutical companies’ attempt to claim patent right for incremental innovation involving new forms of a known molecule with no significantly enhanced efficacy. And MNCs have been trying to circumvent this provision ever since the Patent Act was amended in 2005. The government does not want pharmaceutical companies to unjustifiably profiteer from a product without incurring any significant research costs. Granting patent protection for pharmaceutical substances involving only incremental innovation is against the public interest as such research does not involve any huge expenditure or timeline unlike in the case of a new molecule. Considering the increasing number of objections to grant of patents and patent related litigations in various courts, it is important for the Patent Office to be extremely vigilant about judging such innovations so that attempts of evergreening are effectively prevented.

India perhaps has the world's highest burden of pneumonia, accounting for nearly 20 per cent of global infant pneumonia deaths. The PCV 13, which is expected to safeguard against 13 types of pneumococcal bacteria, also lowers the likelihood of antimicrobial resistance by significantly reducing common childhood infections and reducing the need for antibiotic use among infants. The vaccine is already included in India’s Universal Immunisation Programme and the government gets some international funding for the same. Currently, the government’s pneumonia vaccine programme is being funded by the Global Alliance of Vaccines and Immunisation or GAVI, an international organisation created to increase access to vaccines for children. GAVI may continue its financial support of the pneumonia programme for the next three years. But, Pfizer’s patent, which is expected to last till 2026, gives the company exclusive rights to sell the vaccine at a price that it determines in the years to come. This could make the vaccine unaffordable to the government as it may have to procure it from the market without financial assistance from 2019.The Union Health Ministry has already rolled out the vaccine in three states. The vaccine is currently being administered to approximately 21 lakh children in Himachal Pradesh, in 17 districts of Bihar and six districts of Uttar Pradesh. Next year, the government plans to start administering the vaccine in Madhya Pradesh and Rajasthan and will also expand the programme to the rest of the country.

 
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