 |
| The vaccine protects children and adults from 13 types of pneumococcal bacteria, and a full vaccination course costs about $170 |
India has granted Pfizer Inc a patent for its powerful pneumonia vaccine Prevenar 13, in a blow to some health groups that said this would put the treatment out of reach of thousands in poorer nations.
The decision by Indiaโs patent office bars other companies from making cheaper copies of the vaccine and allows Pfizer to exclusively sell it in India until 2026.
Itโs a big victory for the U.S. drugmaker in a market that has the worldโs largest number of pneumonia cases, a lung disease that kills nearly a million children a year globally.
The decision also has international implications, as several poorer nations rely on Indiaโs robust drugs industry to supply cheaper copies of medicines and vaccines.
It also comes at a time of ongoing U.S. pressure on India to tighten its patent laws. The United States Trade Representative expressed concerns about Indiaโs intellectual property laws in a report in June, and listed it among countries whose IP laws unfairly favour local companies.
Pfizerโs vaccine protects children and adults from 13 types of pneumococcal bacteria, and a full vaccination course costs about $170 on Indiaโs private market.
India started giving out the vaccine for free under its national immunisation program earlier this year, but the rollout like that of most vaccines in the program, is in phases, so only about 2.1 million of the 25 million eligible people in the country will get it this year.
The patent grant means Indian companies wonโt be able to make the vaccine for domestic use, or exports.
โManufacturers will have to find new routes to develop a non-infringing (pneumonia) vaccine, which may delay the availability of competing products in the pipeline from Indian producers,โ the medical charity Medecins Sans Frontieres (MSF) said in a statement. (http://bit.ly/2vU4rUk)
MSF filed an objection to Pfizerโs patent request last year on the grounds that a patent would deprive many developing nations of cheaper copies. (http://reut.rs/1QJEdXq)
At least one Indian company, Panacea Biotec Ltd, is developing a cheaper form of the vaccine, and had also filed an opposition to Pfizerโs patent request last year.
A source familiar with the matter said Panacea is considering filing a post-grant opposition. Separately, MSF said it was reviewing its legal options in the matter.
Pfizerโs patent on the same vaccine was revoked by the European Patent Office last year, and is being challenged in South Korea and the United States, MSF said.
The pharmaceutical giant has made the vaccine available at discounted prices under the Global Alliance for Vaccines and Immunisation (GAVI) โ an international public-private partnership to improve access to vaccines in the worldโs poorest countries. More than 50 countries are eligible to procure the vaccine through GAVI, according to the organizationโs website.
Following criticism over the high price of Prevenar 13, Pfizer reduced the vaccine price to non-governmental organisations last November, seeking to protect vulnerable people from illness in humanitarian crises.
Pfizer welcomed the granting of the patent, saying each dose of Prevenar 13 takes two-and-a-half years to produce, and the vaccine was launched in India in 2010.
โPfizer remains committed towards further enhancing access of this vaccine in India, both in the market as well as through partnership with the Government to expand introduction in the public program,โ a spokeswoman in India said.
