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US MNC gets patent for hepatitis C virus, local players see red

According to market experts, the decision would damage India’s role as the provider of affordable generics and raw materials – Active Pharmaceutical Ingredients (API) to the world. The move won’t affect India’s 12 million patients, but countries like Argentina, Egypt, Ukraine, Bangladesh and Iran will be affected as they depend on India for APIs.

Surprisingly, in September 2014, even before the patent on Sofosbuvir was granted in India, Gilead had entered into licensing agreements with seven Indian companies which have now increased to 13. The patent to Gilead was granted on Monday.

Commenting on the issue, the chief executive officer of Bureau of Pharma PSUs of India (BPPI) MD 
Sreekumar told Millennium Post that since patent has been given to a particular drug manufacturing company, there is no question of it being manufactured by any other firm, including government agencies.

“It’s a fact that India plays a major role as API supplier for generic drugs in foreign destinations. As patent has been granted to Gilead for manufacturing HCV, the firm has to abide by the US norms, which restricts pharmaceutical companies from taking APIs from other countries,” Sreekumar said, adding that the move will hit the country’s generic drug API export business, which is great loss to the nation as about 80 per cent of drug raw material requirement is met by India or China.

Commenting on the development, social activists have expressed their dissatisfaction over the decision. “This comes as a huge disappointment to us. We know there was a lot of pressure to grant the patent considering Gilead had already signed licensing deals with Indian companies but we hoped to knock off the patent,” said Eldred Tellis of Sankalp Rehabilitation Trust, which had filed pre-grant opposition of the patent.

Tellis further said, “Knocking off the patent would have meant that non-licensed companies could have entered the market and forced further price reductions. It could potentially also supply to countries left out of the licenses.” Sofosbuvir is priced excessively high in most of the high-income countries, around USD 84,000 for a 12 week course of treatment in US and USD 76,000 in France, while in India, the same treatment costs around Rs 20,000 under the generic versions of life saving drug.

It is estimated that 180 million people around the world are living with HCV. It is primarily transmitted through blood-to-blood contact and may also be transmitted through unprotected sex in high risk groups like men who have sex with men (MSM). Sofosbuvir, a highly effective and safe drug to treat HCV, is also listed on the WHO’s essential medicine list which makes it a high priority drug for treatment of the deadly disease.

Up to 80 per cent of people living with the virus develop chronic HCV, which, if left untreated, can lead to life-threatening complications, such as liver cirrhosis, liver failure and liver cancer.
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