The Indian Intellectual Property Office (IIPO) granted Gilead’s application for the patent on 7 May, after rejecting its initial application in January last year.
The IIPO initially rejected the application on the ground of evergreening, ruling that the mere discovery of a new form of a known substance, which does not result in the enhancement of the known efficacy of the substance, is not eligible for patent protection.
Gilead appealed against the decision and on 7 May the IIPO approved the formulation, describing the drug compound as novel and inventive.
Gilead faced opposition from the Initiative for Medicines, Access and Knowledge (I-MAK) over access to the drug in certain countries.
I-MAK claimed the treatment was too expensive. The recommended 12-week course of treatments costs $84,000 in the US, or $1,000 per pill.
But in India, Gilead is engaged in voluntary licensing programmes with 11 generic manufacturers.
As of 26 April, the cost of Sovaldi was $384 per bottle, or around $14 per pill, in India, according to the Asia Pacific Network of People Living with HIV.
A spokesperson for Gilead commented: “We welcome news that the [IIPO] of New Delhi has granted our patent application.”
The spokesperson added: “[Our current] licensing programme enables the manufacture and distribution of high-quality, low-cost versions of the company’s medicines for HIV, hepatitis B and hepatitis C.”