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Gilead to appeal India patent ruling on hepatitis C drug

MUMBAI, Jan 16 (Reuters) - U.S.-based Gilead Sciences Inc will appeal the Indian patent office's rejection of its application for hepatitis C drug Sovaldi, a move that could allow local drugmakers to launch cheaper generic versions of the $1,000-a-pill medicine.

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 compared with 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 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.

The rejection will allow Indian generic companies to make and sell cheaper versions in a country where a majority of the people live on less than $2 a day and health insurance is scarce.

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 drugmakers 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.

(Reporting by Sumeet Chatterjee; Editing by Prateek Chatterjee)

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