Indian patent office rejects Gilead's application for hepatitis C drug

The Indian Patent Controller has rejected US firm Gilead's key patent applications for drug sofosbuvir, used to treat hepatitis C (HCV). The oral drug was first received regulatory approval in the US in November 2013.

Patent applications on sofosbuvir were challenged in India by Natco Pharma, Initiative for Medicines, Access & Knowledge (I-MAK) and the Delhi Network of Positive People (DNP+) in November 2013 and March 2014.

According to a statement issued by Medecins Sans Frontieres (MSF), who also oppose various patent applications by MNCs in India, Sofosbuvir has been priced by Gilead at $84,000 for a treatment course, or $1,000 per pill in the US.

The decision by patent office will give Indian generic makers an opportunity to launch cheaper versions of Sofosbuvir in India. Gilead had signed voluntary license agreements with generic drug makers in India for manufacturing this drug.

"India's status as the 'pharmacy of the developing world' is once again in the spotlight and this is a good opportunity for generic producers in India to swiftly ramp up production to levels needed to treat the 185 million people infected with hepatitis C worldwide," said Manica Balasegaram, Executive Director, MSF Access Campaign.

A study from Liverpool University showed that sofosbuvir could be produced for as little as $101 for a three-month treatment course.

"We know from various manufacturers in India that they could produce this drug in the future for as little as $101 for the full three month treatment course. That's roughly $1 per pill, which is a big improvement over the $1,000 per pill Gilead is charging in some countries. At the current prices, sofosbuvir is unaffordable for widespread use in most countries of the world," said Andrew Hill, Senior Research Fellow, Department of Pharmacology and Therapeutics, Liverpool University.