Pressure group Médecins Sans Frontières is applauding a decision by India’s Patent Controller to reject a key patent application for Gilead’s hepatitis C blockbuster Sovaldi (sofosbuvir), potentially opening the floodgates to a stream of cheaper copycat drugs in the country.
Sovaldi bagged US approval in November 2013 boasting 97% cure rates across three trials but, with its high efficacy, came a high cost. At $1,000 a pill (in the US), the drug’s pricing and affordability has been under intense global scrutiny, and with it increasing pressures on Gilead to reduce the cost.
The drugmaker has signed voluntary licence agreements with multiple generic producers in India, “but these agreements impose many restrictions, including which countries can access the drugs produced under these licences, as well as invasive restrictions on medical providers and patients with respect to distribution and use of the drug,” MSF noted.
The denial of the key patent in India means that companies that have not signed such agreements can now put their own Sovaldi versions on the market, which could bring prices down dramatically and boost access to the medicine, the group said, urging countries where the drug is unaffordable, if excluded from the licences, to “make every effort to import more affordable generic versions from other producers”.
Andrew Hill, Senior Research Fellow, Department of Pharmacology and Therapeutics, Liverpool University, said at current prices Sovaldi is “unaffordable for widespread use in most countries of the world,” and yet “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,” which works out at about $1 a pill, he argues.