Introduction A patent application is a formal form of request pending approval from the authorized…
Médecins Sans Frontières (MSF) also known as Doctors Without Borders, an international humanitarian-aid non-governmental organization, has filed a pre-grant opposition in India to prevent US pharmaceutical company “Pfizer” from getting a patent on the pneumococcal conjugate vaccine (PCV13, marketed as Prevenar 13®).
Prevenar 13® is the world’s largest selling vaccine for infants and toddlers, that helps prevent invasive disease caused by 13 types of Streptococcus pneumoniae. Prevenar 13® contains extracts from thirteen of the most common types of Streptococcus pneumoniae bacteria which are responsible for causing invasive diseases such as pneumonia, blood poisoning and meningitis. The vaccine works by preparing the body’s defences to fight the infection, without causing the disease.
The patent application (8081/DELNP/2007) filed by Pfizer, if granted, would allow the company to keep controlling the PCV 13 vaccine market until 2026 in India. Pfizer’s patent application covers a multivalent immunogenic composition comprising 13 distinct polysaccharide-protein conjugates, wherein each of the conjugates contains a capsular polysaccharide from a different serotype of Streptococcus pneumoniae conjugated to a carrier protein together with a physiologically acceptable vehicle. Pfizer claimed it should be awarded a patent because the method of conjugating 13 serotypes of streptococcus pneumonia into a single carrier is new but MSF claimed it was not inventive.
MSF said it decided to oppose Pfizer’s patent application “after years of fruitless negotiations” with Pfizer to lower the vaccine’s price for use in its projects. While Pfizer offers the pneumonia vaccine at a discounted rate for $10 per child, a vaccine producer in India, Serum Institute, has announced that it could supply the vaccine to MSF and countries in need for $6 per child.
MSF has filed a “pre-grant opposition”, an administrative process that allows third parties to formally challenge validity of pending patent applications before they are granted, arguing that Pfizer’s claimed method is too obvious to deserve a patent under Indian law, pointing out that an equivalent patent was already revoked by the European Patent Office (EPO) and the validity of South Korean equivalent is currently being challenged.
“Our pre-grant opposition shows that the method Pfizer is trying to patent is too obvious to deserve a patent under Indian law, and is just a way to guarantee a market monopoly for Pfizer for many years to come,” said Leena Menghaney, Head of MSF’s Access Campaign in South Asia. “India must rebuff demands from pharmaceutical companies, which are backed by diplomatic pressure tactics of the U.S. and other governments, that India change its patentability standards to restrict generic competition. Pfizer’s unmerited patent application on the pneumonia vaccine should be rejected, opening the door to more affordable versions of the vaccines being produced.”
“This is the first time a vaccine (biosimilar) patent has been challenged in India by a medical organisation, with the goal of millions more children being protected against deadly pneumonia”, MSF further claimed.
About the Author: Antony David, Senior Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at: [email protected].