Indian patent for Pfizer’s pneumonia vaccine seen as a blow to aid group

The grant of an Indian patent to Pfizer’s Prevenar13, a pneumococcal conjugate vaccine, has raised the hackles of pro-health group MSF who are worried that it will hamper access to the vaccine.

“It’s unfair and unacceptable that almost a million children die each year from pneumonia, even though a life-saving vaccine is available,” said MSF’s Prince Mathew, adding that the vaccine’s prices were not affordable even to governments.

Mathew is Asia Regional Coordinator with the humanitarian organsation Médecins Sans Frontières (MSF) or “ Doctors without Borders”.

“We urgently need additional manufacturers to rapidly introduce competition with the aim of lowering vaccine prices,” he said.

The organisation’s fear is that the grant of the Indian patent will block other manufacturers in India from supplying this vaccine, which protects against 13 types of pneumococcal bacteria (PCV-13).

Quality tests Responding to a BusinessLine query on the development, Pfizer said, “We are pleased to note that the validity of the Prevenar 13 patent has now been recognised by the Indian Patent Office. Prevenar 13 provides the broadest serotype coverage of any pneumococcal conjugate vaccine available in the world today.

“Supported by extensive clinical research, each dose of PCV 13 requires 400 different raw materials, 580 manufacturing steps, 678 quality tests and two-and-a-half years to produce.” This vaccine was launched in India in 2010 and in its multi-dose vial presentation, it has been included in the expansion of India’s immunisation program in select States.

“ 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,” the company spokesperson added.

Patent questions Leena Menghaney, South Asia Head for MSF’s Access Campaign points out 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 an extended market monopoly for the corporation.”

In 2016, MSF challenged Pfizer’s “unmerited” patent claims in India, after the same patent was revoked by the European Patent Office (EPO). The patent is also being legally challenged in South Korea and before the US Patent Trademark Appeal Board.

MSF cautions that Pfizer’s patent will give it a controlling position in the PCV market in India until 2026, thereby, blocking developing country vaccine manufacturers from supplying a competing version of Pfizer’s PCV.

The patent grant to Prevnar13 also indicated a weakening of India’s strict patentability standards, which results in granting monopolies for minor and trivial improvements of existing medical products, as allowed in some other countries, MSF said.

Such ever-greening practices will hamper India’s role as ‘pharmacy of the developing world,’ supplying governments and procurers like MSF with affordable medicines and vaccines, the note added.

Pfizer’s Prevenar13 (PCV13) and GlaxoSmithKline’s Synflorix (PCV10) are priced at approximately ₹3,800/dose (approximately $59 per dose, with three doses needed for full vaccination) and ₹1,800/dose (approximately $28 per dose, with three doses needed for full vaccination), respectively, in the private market, the MSF note said.

In 2015, MSF launched its ‘A FAIR SHOT’ campaign to push for pharmaceutical companies Pfizer and GlaxoSmithKline to reduce the price of pneumonia vaccines to $5 per child for all three doses.