Drug Deals

How big pharma and the Indian government are letting millions of patients down

Sofosbuvir, a drug manufactured by the US pharmaceutical company Gilead Sciences, revolutionised the treatment of hepatitis C. DAVID PAUL MORRIS/BLOOMBERG/GETTY IMAGES

THE DELHI OFFICE of the controller general of patents, designs and trademarks is situated in the neighbourhood of Dwarka Sector 14, a 45-minute drive from the capital’s centres of power. There is a placid air about the place, and on winter afternoons you’re likely to spot the odd group of junior employees sunning themselves on the front lawn after lunch. Past the lawn are two wide buildings, inside which sit 30 officials who examine the patent applications submitted to the office.

Most applications that pass through this office are rejected or approved without attracting much attention. Every so often, however, one will draw intense scrutiny from the media, the corporate world and the general public, usually because vast sums of money are at stake in the verdict. Some cases, though rarer, can even determine the fates of tens of millions of people around the world.

One such case came up for hearing in July 2014, before an official named Hardev Karar. The US pharmaceutical company Gilead Sciences had filed a patent application for its drug sofosbuvir, also known as “sofo,” which it sold under the brand name Sovaldi. The drug was approved for use by the United States government in December 2013, and had since revolutionised the treatment of hepatitis C, a viral disease that can lead to liver cirrhosis and cancer. According to estimates by the World Health Organisation, hepatitis C affects between 130 million and 150 million people across the world, and causes approximately 500,000 deaths each year. Sovaldi was far more effective against the disease than anything that had come before. It also did not cause the side effects that earlier drugs did, which were so brutal that patients often chose to forgo treatment altogether.

But Gilead had come under sharp criticism for the price it was charging: Sovaldi was launched in the United States at $1,000 per pill, or $84,000 for the standard 84-day course that cured most patients. This exorbitant price had worked well for the company. In 2014, Sovaldi earned Gilead $10.3 billion, and powered its revenue to nearly $25 billion—more than double the figure for the previous year. The drug was sure to bring in many billions more in the years to come.