Gilead appeals India’s rejection of patent on Rs60,000 a pill hepatitis drug

US-based Gilead Sciences Inc will appeal against the Indian patent office's rejection of its application to patent its hepatitis C drug Sovaldi in India, which would prevent domestic drug-makers from launching cheaper generic versions of the medicine that costs a whopping $1,000 or around Rs60,000 for a single pill.

The rejection relates to the patent application covering the metabolites, or small molecules, of sofosbuvir, the chemical name of Sovaldi.

Indian drugmaker Natco Pharma and the Initiative for Medicines, Access & Knowledge (I-MAK) had opposed Gilead's application on the grounds that the drug is not inventive enough over a previous formulation.

"Gilead strongly defends its intellectual property. The company will be appealing the decision as well as exploring additional procedural options," the company said in a statement on Friday. It did not elaborate.

The patent office order said Gilead's request was rejected as "minor changes in the molecule" did not improve the efficacy of the drug, which is normally given for either three or six months and costs $84,000 for a 12-week course in the United States.

In a bid to make Sovaldi available in 91 developing nations, including in India, Gilead licensed the drug, hailed by doctors as a breakthrough in treating the liver-destroying disease, to seven India-based drug makers in April 2014.

"These proceedings do not impact our commitment to enabling access to our hepatitis C medicines in India and other developing countries, and our generic licensing program with our Indian partners continues as normal," the Gilead statement said.

Médecins Sans Frontières (MSF) said the entry for additional generic drugmakers after the patent office order should increase competition needed to bring prices down, especially in countries that have been excluded from the licence agreement. (See: Gilead's patent for hepatitis C drug Sofosbuvir rejected in India)