What Happened to the Indian Official that Rejected the US Drug Company Gilead's Patent Application in 2015

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.

That the highest ranks of the Indian government are under pressure from the United States to modify the country’s patent policies is clear. If that pressure transfers down the ranks, and affects those who actually make decisions to grant or reject patents, the consequences could be disastrous. This is particularly true of medical patents, which can decide whether millions of people who need a drug gain access to it. The fact that Karar had rejected Gilead’s application suggested that patent officials were not under any such pressure. But, as we discovered, this wasn’t the complete picture.

We sat in one official’s office. On his desk was a computer, piles of messy files, and a copy of the 1970 Patent Act. The officials were surprised that journalists were enquiring about the Gilead patent more than a year after it was rejected, though one remarked that he had been certain someone would come looking for details some day.

They would speak animatedly for some time, but then fall completely silent each time a peon entered the room to serve us tea or to take away our empty cups. They were clearly concerned about word getting out that they had spoken to journalists. (Karar declined to be interviewed about the matter.)

According to the first official, Karar was approached repeatedly by lawyers representing Gilead to “persuade and convince” him to grant the patent. “Gilead put pressure” on him, this official said. This in itself would constitute an impropriety. But though one of the officials described it as “unethical,” he also conceded that it was a “general trend” in the office.

What followed after the verdict was more surprising—Karar faced an immediate and intense backlash.

“Bas, firing shuru ho gayi” (The firing began), said the first official. The day of the verdict, according to this official, Karar received a call from his boss, Chaitanya Prasad—then India’s controller general of patents, designs and trademarks, a Bihar cadre officer of the Indian Administrative Service. According to the official, Prasad yelled at Karar over the phone, saying, “Dimaag ka istemaal nahin kiya kya?”(Didn’t you use your head?) The official said Prasad also rebuked Karar for not keeping “the timing of Obama’s visit in mind.” The officials were not sure whether this was meant to imply that Karar’s verdict itself should have been different, or whether he should have waited before delivering it. Either way, the first official said, “These aren’t things we normally consider before making decisions about cases.”

Two days after the verdict, the second official said, Prasad called Karar over to his chambers. “He was shouting at Karar,” this official recounted, adding that the dressing-down was loud enough for the entire floor to hear. According to him, the showdown ended with Prasad threatening Karar with a transfer to Nagpur—generally seen as a less prestigious posting, and one that Karar had already been assigned twice. Though eventually Karar wasn’t transferred, according to the third official he did withdraw from the case. Karar, this official said, did so under Prasad’s orders, and was made to cite “bias” as his reason for recusing himself.

When we emailed Chaitanya Prasad to ask him about these allegations, he said, “I never interfered with the content or direction of the order of the controllers in the patent office in individual cases.” He also said that he “did not threaten Mr Karar with any transfer nor did I ask Mr Karar to withdraw himself from the case.” He added: “I don’t even remember that he withdrew himself from the case.”

By the time the file was reopened, Karar had been replaced by another official. “We were horrified at how this official, one of our best, no less, was being treated,” the third official said. “We had never seen such pressure brought to bear on our offices.”