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LATEST NEWS UPDATES | Fillip to cheaper hepatitis C drug -GS Mudur

Fillip to cheaper hepatitis C drug -GS Mudur

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published Published on Jan 16, 2015   modified Modified on Jan 16, 2015
-The Telegraph

New Delhi: India's patent regulating agency today rejected a US company's patent claim on a drug to treat hepatitis C, raising hopes that generic drug makers could now produce cheaper versions of the medicine.

The Indian Patents Controller has denied a patent to sofosbuvir from Gilead, a US biopharmaceutical company that had last year pledged to make the oral drug available in India and 90 other developing countries at $900 (Rs 55,600) for a 12-week course of treatment.

The decision will allow generic drug makers to manufacture their own low-cost versions of the medicine. A research study by scientists at the University of Liverpool, published last year, had calculated that the medicine could be produced for only $101 (Rs 6,240) for the 12-week course of treatment.

"This drug makes hepatitis C treatment more effective. We're hoping this decision opens the floodgates for more open competition that could rapidly lower the price," said Manica Balasegaram, executive director with the Medecins Sans Frontieres' (MSF) Access Campaign, a humanitarian initiative to expand access to drugs.

Sofosbuvir is available in the US for $84,000 (Rs 51.9 lakh) for a course of treatment but Gilead - while awaiting a decision from India's patent office - had last September announced that it would sell the drug in India at $900.

It had also signed pacts with seven Indian drug companies, allowing them to sell generic versions of the drug at even lower prices. But patients' rights groups believe the drug would remain out of reach of most Indian patients even at those lowered prices.

The MSF Access Campaign plans to expand treatment for hepatitis C in India and eight other developing countries. It has been hoping for inexpensive versions of the medicine that it expects will remain the "backbone of (the) hepatitis C treatment regimen in the coming years".

Currently, treatment for the hepatitis C viral infection involves an injectable product called pegylated interferon with an anti-viral drug called ribavarin.

But, an MSF official said, the success rate of the pegylated interferon regimen in eliminating the infection is about 70 per cent, while it is over 90 per cent with sofosbuvir.

"We know from various manufacturers in India that they could produce this drug in future for as little as $101 for a three-month course of treatment," said Andrew Hill, a senior research fellow at Liverpool University in the UK.

Hill and his colleagues had last year published a study in the journal Clinical Infectious Diseases in which they had estimated that the manufacturing costs of several "direct-acting" anti-viral drugs, sofosbuvir among them, could range between $100 and $250 for a 12-week treatment course.

The patent examiners denied the patent claim citing Section 3(d) of India's patent act, which disallows patents on new or tweaked versions of known or old drug molecules. Many health activists regard this clause as a safeguard.

Gilead has the right to move an appeal with the patent authority or approach an Indian court.


The Telegraph, 16 January, 2015, http://www.telegraphindia.com/1150116/jsp/nation/story_8708.jsp#.VLiwoHvxyBE


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