India declines patent for Gilead's Sovaldi

India's patent controller on Wednesday rejected an application seeking a patent for Gilead Sciences' hepatitis C treatment Sovaldi (sofosbuvir) following challenges by Natco Pharma as well as the Initiative for Medicines, Access & Knowledge. In its decision, the country's patent office concluded that "minor changes in the molecule" did not enhance the efficacy of the product.

Activists noted that although Gilead's application for the final form of the drug remains under consideration, the decision by the patent office greatly increases the likelihood that a patent will not be granted for the lead compound. Commenting on the news, Leena Menghaney, a campaigner for Médecins Sans Frontières' Access to Medicines campaign, stated that the decision may permit "open competition" for Sovaldi in India. Menghaney estimated that the price of the therapy could fall to $1 per tablet, compared to its US price of $1000.

In September, Gilead entered into an agreement with seven drugmakers permitting them to manufacture and distribute Sovaldi in 91 developing countries. Gilead indicated that it would introduce the treatment in India at a price of $900 for a full course, which represents about 1 percent of the US price.

"What Gilead was introducing was managed competition, but now there is going to be open competition with companies other than those who have signed licences with Gilead," Menghaney remarked.

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