Opposing Pneumonia Vaccine Patents in India
On 11 March, Doctors Without Borders (DWB) officially launched a ‘patent opposition’ in India in order to better guarantee access to pneumonia vaccines for children. Pfizer, a US pharmaceutical company, is attempting to file a patent on PCV13, so-called because the product is a pneumococcal conjugate vaccine that involves conjugating thirteen serotypes of streptococcus pneumonia into a single carrier. However, under section 25(1) of India’s Patents Act, individuals and third parties can challenge the patent application through pre-grant opposition. These challenges can be justified under a number of grounds, but DWB is claiming that the patent is too obvious and lacks a truly inventive methodology.
Ensuring widespread access to pneumonia vaccines is of particular interest to humanitarian groups such as DWB. Pneumonia is a leading case of childhood death, with almost one million children under the age of five dying each year because of the disease. Pneumonia inflames victims’ lungs, often affecting the microscopic alveoli that facilitate breathing. While the symptoms, which include coughs, fevers, and phlegm, are usually not severe, they may lead to fatal complications for very young and very old individuals. These complications include bacterial infections, lung abscesses, and fluid build-up.
Critically, pneumonia can be caused by a number of different sources, which include bacteria, viruses, parasites, and fungi. As such, treatment will differ depending on the particular kind of pneumonia, varying from antibiotics to viral inhibitors. Many of these treatments, however, are difficult to provide in low-income settings; often, the healthcare unit is incapable of providing the procedure or the patient is unable to afford it. Given these constraints, most humanitarian organizations do not focus on providing pneumonia treatments for afflicted individuals. Instead, they advocate for increasing the availability of vaccines. This emphasis on vaccines reflects a general strategy that uses preventative care, which is generally less painful and more cost-effective than relying on reactive treatments.
Pneumonia vaccines are widely implemented by many health care systems, and as such are often a large source of revenue for pharmaceutical companies. Indeed, companies like Pfizer have reported sales of up to six billion annually from these vaccines. Importantly, some organizations have noted that there are often differences in vaccine prices depending on the country. For example, according to studies by DWB, a dose of pneumococcal vaccine in France in 2014 was $58.43 USD. However, that same dose was $63.74 USD in nearby Morocco. In general, for pneumonia and other diseases, middle-income countries often had to pay more for the same medication than their high-income counterparts.
Many health organizations have criticized these disparities in vaccine prices. Firstly, they reflect an abuse of bargaining power. Often, these middle-income countries enter into price negotiations with limited information and with fewer pharmaceutical competitors to which they can turn. Secondly, given the limited health care budgets of these countries, these health care systems are forced to make difficult choices about which vaccines they should prioritize, often leaving certain vulnerable populations at risk.
The vaccine market for low-income countries is different. Gavi, a public-private global health partnership organization that subsidizes pharmaceutical companies in order to lower vaccine prices, ensures that prices in these countries are capped at around three dollars per dose. While these prices are more affordable, many of these countries still struggle with implementing vaccines while supporting other health care initiatives.
One potential solution to these health care barriers is reliance on generic vaccines rather than brand-name pharmaceuticals. Indeed, the Serum Institute in India claims that it can generate a generic version of the standard pneumococcal conjugate vaccine for two dollars per dose. The threat of other companies creating competitively priced generic vaccines poses a problem for pharmaceutical companies like Pfizer. As such, these companies often try to use patents in order to prevent other organizations from decreasing their profits.
This profit-maximizing motivation, claims DWB, is at the heart of Pfizer’s current patent application. That is, Pfizer wants a patent on its supposedly innovative version of PCV13 in order to extend their monopoly on pneumonia vaccines in India. DWB’s challenge is not without merit. The European Patent Office already revoked an equivalent patent, and another patent filed in South Korea is also facing formal challenges. If the pre-grant opposition fails, then DWB may also file a post-grant opposition application.