Hyderabad: Médecins Sans Frontières (MSF)/Doctors Without Borders, a Paris-based international humanitarian-aid non-governmental organisation, on Friday said it has filed a ‘patent opposition’ in India to prevent US pharmaceutical company Pfizer Inc. from getting a patent on the pneumococcal conjugate vaccine (PCV13), so more affordable versions can become available to developing countries and humanitarian organisations.

This is the first time a vaccine (biosimilar) patent has been challenged in India by a medical organisation, with the goal of protecting millions more children against deadly pneumonia, MSF said in a statement.

“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 US and other governments, that India change its patentability standards to restrict generic competition," Menghaney added.

After years of fruitless negotiations with Pfizer to lower the vaccine’s price for use in its projects, MSF is challenging this patent application in India to ensure that manufacturers who are planning to produce the pneumonia vaccine do not face key patent barriers at the time of launching a more affordable version, the agency said.

The Indian government allows for pre-grant opposition—a form of citizen review at the patent examination stage before the patent office to show that claims that cover a certain aspect of a drug or vaccine do not merit patenting under India’s Patents Act.

An equivalent patent to the one opposed today in India was already revoked by the European Patent Office (EPO) and is currently being challenged in South Korea. Pfizer’s patent application involves the methods of conjugating 13 serotypes of streptococcus pneumonia into a single carrier.

Three Indian companies are engaged in development of pneumococcal vaccine including Pune-based Serum Institute of India Ltd, New Delhi-based Panacea Biotec Ltd and Aurobindo Pharma Ltd’s subsidiary Tergene Biotech Pvt. Ltd. The pneumococcal vaccine of Serum and Panacea are in the end stages of phase-1 clinical trials; Tergene’s vaccine is expected to enter phase-1 in the next two months.

Pneumonia is the leading cause of childhood death, killing almost one million children each year.

Currently, pharmaceutical companies Pfizer and GlaxoSmithKline (GSK) are the only two manufacturers of the vaccine, which could prevent a large number of these deaths.

Pfizer has priced PCV13 (marketed as Prevenar) out of reach of many developing countries and humanitarian organisations.

The pneumonia vaccine accounts for almost half the price of vaccinating a child in the poorest countries.

“The pneumonia vaccine is the world’s best-selling vaccine, and last year alone, Pfizer brought in more than US$6 billion in sales just for this product—meanwhile many developing countries, where millions of children risk getting pneumonia, simply can’t afford it," said Manica Balasegaram, executive director of MSF’s Access Campaign.

“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," Balasegaram said.

Subscribe to Mint Newsletters * Enter a valid email * Thank you for subscribing to our newsletter.

Share Via