The patent also covers the raw materials to make the drugs, which means it would allow the manufacturer to disrupt exports of the raw materials from India.

In September, India will witness the first hearing in a crucial court case on the grant of a patent for the anti-hepatitis-C drug sofosbuvir – a drug whose patent was rejected and then approved by the same patent court, albeit by two different officials. A recent report of the international medical charity Medicins Sans Frontiers (MSF) cautions about the likely huge impact of the flip-flop by the Indian patent court in case the Delhi high court, where a writ has been filed against the grant of the patent, upholds the patent office’s decision.

“It is a curious case in which the same patent office first rejects and then grants a patent,” Leena Menghaney, South Asia head at MSF’s Access Campaign, told The Wire. Worldwide, an estimated 150 million people have chronic hepatitis C virus infection, and are without access to treatment and at risk of developing liver failure and liver cancer.

Hepatitis C can be cured with a few months’ treatment with a relatively new class of oral drugs called direct-acting antivirals (DAAs). As their name suggests, they attack the virus directly. One such DAA is sofosbuvir.  Until the advent of DAAs, hepatitis C infection had been difficult to treat, with low success rates, the problem of drug resistance and at risk of discontinuation due to side-effects of previously used drugs. Hence, the development of sofosbuvir was hailed as a critical breakthrough in fighting hepatitis C infections.

Although it can be mass-produced for less than $1 per pill, sofosbuvir was launched by Gilead in 2013 at $1,000 per pill in the US. According to MSF, that’s $84,000 (Rs 55.9 lakh) for a three-month treatment course.

Some countries have already protested Gilead’s patent on sofosbuvir. For example, China and Ukraine have rejected the patent on the pro-drug form of sofosbuvir. In Egypt, the primary patent application was reject even as a company named Pharco developed a generic version of sofosbuvir and applied for WHO pre-qualification for it. More patent oppositions on sofosbuvir have been filed in Argentina, Brazil, France, Russia and Thailand.

India, however, flip-flopped. In May 2016, a patent court granted a patent for sofosbuvir, reversing its prior rejection in January 2015. The timing of that rejection, ahead of US President Barrack Obama’s visit to the country, was seen as particularly awkward. Indeed, an MSF release said the rejection “was seen as vexing the US”.

Eighteen months later, the court decision was reversed and a patent was granted. A media report charged that the official who rejected the patent in 2015 “faced a backlash”. Menghaney concurred: “The US pressure seems to be working in India to the extent that India can reverse its patents decisions.”

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