India grants Pfizer patent for blockbuster brand Prevenar 13

NEW DELHI: India has granted US drug giant Pfizer a patent for its blockbuster vaccine, Prevenar 13, used to protect children against life threatening pneumococcal diseases. The approval comes over a decade after the company applied for the patent in the country.

Pneumonia is one of the leading cause of deaths of children under five years of age. India has seven pneumonia related deaths per 1,000 live births, according to the 2016 Pneumonia and Diarrhea Progress Report by John Hopkins Bloomberg School of Public Health.

Prevenar 13 is approved to prevent pneumococcal pneumonia and invasive pneumococcal diseases caused by 13 strains of streptococcus pneumonia, according to Pfizer. The vaccine provides the “broadest” serotype coverage of any pneumococcal conjugate vaccine available in the world today, the company’s spokesperson told ET.

Pfizer subsidiary Wyeth’s application for grant of Prevenar 13’s patent “entered national phase” in October 2007, according to the Indian Patent Office’s document that granted the approval. Over the years, this patent application has been opposed by Indian vaccine maker Panacea Biotec and global medical humanitarian organisation Médecins Sans Frontières (MSF).

According to those opposing the application, Pfizer’s vaccine lacked the novelty for it to be considered for a patent but the patent office, in its approval on August 11, dismissed these arguments.



According to the office, Pfizer has demonstrated “surprising effects” that have to be considered as establishing that the vaccine is inventive.

“We are pleased to note that the validity of the Prevenar 13 patent has now been recognized by the Indian Patent Office,” a Pfizer spokesperson told ET.

“Supported by extensive clinical research and real-world experience, each dose of PCV 13 requires 400 different raw materials, 580 manufacturing steps, 678 quality tests and two and a half years to produce…Pfizer 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.”

Prevenar 13 was launched in India in 2010, according to the spokesperson.

The vaccine has consistently been one of Pfizer’s strongest performing brands, experiencing year-on-year growth in the “mid double digits” and capturing 18% of the Indian vaccine market, according to Pfizer’s 2016 annual report.

This March, the Indian government introduced Pfizer’s PCV 13 vaccine into its national immunisation program through a program funded by Gavi, the Vaccine Alliance. Around five states (approximately 5.15 million babies) are expected to be covered in the first phase.