Indian Patent Office Delivers Major Blow to Affordable Pneumonia Vaccine Hopes

SOUTH SUDAN © Valérie Batselaere/MSF

Recent decision blocks production of affordable generic options for people and treatment providers like MSF

NEW YORK/GENEVA, AUGUST 22, 2017—Hopes for improved access to an affordable pneumococcal conjugate vaccine (PCV) that protects both children and adults from pneumonia was dealt a major blow after the Indian patent office granted a patent to the U.S. pharmaceutical corporation Pfizer.

The Pfizer product, PCV13, marketed as Prevnar13, protects against 13 types of pneumococcal bacteria. The patent blocks other manufacturers in India from making and supplying more affordable versions of the vaccine to those who need it most.

“It’s unfair and unacceptable that almost a million children die each year from pneumonia even though a lifesaving vaccine is available,” said Dr. Prince Mathew, Asia regional coordinator for Doctors Without Borders/Médecins Sans Frontières (MSF). “Children everywhere have a right to be protected from pneumonia, but many governments can’t afford the prices set by Pfizer. We urgently need additional manufacturers to rapidly introduce competition with the aim of lowering vaccine prices.”

In 2016, MSF challenged Pfizer’s unmerited patent claims in India after the same patent was revoked by the European Patent Office (EPO). The patent is also being legally challenged in South Korea and before the US Patent Trademark Appeal Board.

The Indian patent office’s decision has broader implications, as it indicates a weakening of India’s strict patentability standards, which results in granting monopolies for minor and trivial improvements of existing medical products, as allowed in some other countries. Such ever-greening practices will hamper India’s role as “pharmacy of the developing world,” supplying governments and treatment providers like MSF with affordable medicines and vaccines.

"Pfizer’s PCV 13 is too obvious to deserve a patent as per Indian patent law, and is just a way to guarantee an extended market monopoly for the corporation for many years to come,” said Leena Menghaney, South Asia head of MSF’s Access Campaign.

MSF relies heavily on affordable generic medicines to do its medical work around the world; two thirds of its medicines used to treat people with HIV, tuberculosis, and malaria are generic medicines made in India. Indian vaccine manufacturers have already announced that they can supply PCV for a much lower price. However, Pfizer’s patent allows it to continue controlling the PCV market in India until 2026 and blocks developing country vaccine manufacturers from supplying a competing version of Pfizer’s PCV.

Manufacturers will have to find new routes to develop a non-infringing PCV vaccine, which may delay the availability of competing products in the pipeline from Indian producers.

“In our work, we see many children with life-threatening respiratory infections; many deaths could be prevented if more kids were vaccinated with PCV,” said Dr. Anas Shorman, a paediatrician working for MSF in Jordan. “More than 50 countries have spoken out against high vaccine prices, and children in countries like Indonesia, Jordan, and Tunisia simply can’t wait any longer to get access to the lifesaving pneumonia vaccine.”

Each year, MSF teams vaccinate millions of people, both as outbreak response to diseases such as measles, meningitis, yellow fever, and cholera, as well as routine immunization activities in projects where it provides health care to mothers and children. MSF has purchased PCV in the past for use in its emergency operations and is scaling up its use of PCV and other vaccines with a particular focus on improving routine immunization, as well as extending the package of vaccines used in humanitarian emergencies. In 2015, MSF launched its "A FAIR SHOT” campaign to push for pharmaceutical companies Pfizer and GSK—the only two producers of the pneumonia vaccine—to reduce the price of the vaccine to $5 per child for all three doses.