Yesterday, the office of the controller general of patents, designs and trademark contradicted its 2015 decision and granted a patent to the US drug company Gilead for its hepatitis C drug sofosbuvir (also known as "sofo," and sold under the name Sovaldi).
Sovaldi had been approved for sale in the US in December 2013, but Gilead had come under sharp criticism for the price it was charging: it was launched in the United States at $1,000 per pill, or $84,000 for the standard 84-day course that cured most patients. 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.
Wanting to sell Sovaldi in India, in July 2014, Gilead submitted an application for a patent for the sofosbuvir compound to the controller general office, which came before an official named Hardev Karar. In January 2015, just about two weeks before US President Barack Obama was to visit India, Karar rejected Gilead's application. This decision made headlines across the world: it meant that Indian pharmaceutical companies would be free to manufacture generic versions of the drug and sell them at any price they chose. Indian companies would also be free to export the drug to other countries, including places where Gilead was aiming to corner the sofosbuvir market. The application's outcome was also expected to indicate how welcoming India, under the Narendra Modi government, would be to international business. For decades, the country had been accused of having weak protections for intellectual property rights—or IPR—and of thus being unsupportive of innovative foreign firms. Western countries were likely to see the rejection of Gilead’s patent application as yet another sign that India wasn’t serious about strengthening its IPR regime.
In their March 2016 cover story, 'Drug Deals,' Mandakini Gahlot and Vidya Krishnan reported on how Gilead's efforts to secure the patent indicated that India may be giving into the pressure from the US government and big pharma to loosen its IPR policy, and why that would endanger millions of patients globally. In this excerpt from the story, Gahlot and Krishnan recount what they learned happened to Karar after he rejected Gilead's application.
In the second week of February, we drove to Dwarka Sector 14 to meet with three officials—two mid-level and one senior—of the patent office, and to learn about what had happened behind the scenes when Hardev Karar rejected Gilead’s patent application for Sovaldi.