Dive Brief:
- Doctors Without Borders (MSF) on Friday legally challenged Pfizer's attempts to patent its pneumonia vaccine in India, citing the need for more affordable access. Pfizer currently markets the Prevnar 13 vaccine elsewhere, earning over $6 billion in 2015 sales.
- MSF's patent opposition was filed "pre-grant," meaning India's Patent Office will consider the humanitarian organization's objections as it examines Pfizer's patent application.
- A similar patent was previously rejected by the European Patent Office, and another is being challenged in South Korea, MSF said.
Dive Insight:
This is the first time a vaccine patent has been challenged in India by a medical organization, according to MSF. The group is also supporting an ongoing patent opposition case filed against Gilead's patent on Sovaldi in India, although that is for an existing patent.
For its part, Pfizer argues their Prevnar vaccine combines 13 different strains of streptococcus pneumonia into a single vaccine in a novel way. Prevnar is the pharma giant's most lucrative vaccine and global sales spiked 40% in 2015, compared to a year earlier. However, much of those sales come from the U.S. and other developed markets.
MSF argues Pfizer's patent is "too obvious" to deserve an award under Indian law. "To make sure children everywhere can be protected from deadly pneumonia, other companies need to enter the market to supply this vaccine for a much lower price than what Pfizer charges," said Dr. Manica Balasegaram, executive director of MSF's access campaign.
Pneumonia kills almost one million children annually, yet only two companies manufacture the vaccine.
The challenge also fits into the larger picture of India's role as drug producer. India manufactures many of the world's generic drugs and has a stricter interpretation of patent law than other emerging countries. MSF considers having affordable access to the vaccine essential for its global health work.
Pfizer has made the vaccine available at lower prices through the Global Alliance for Vaccines and Immunisation (GAVI), but India has not bought it from the alliance, Reuters reports.