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India’s Section 3(d) strikes again

The India patent controller has rejected Gilead’s sofosbuvir patent application, citing the controversial Section 3(d) of the Patents Act

In an order that came down earlier this week, the patent controller found that the molecule was not patentable, as it was a merely new form of a known substance that did not have enhanced therapeutic efficacy and thus in violation of Section 3(d).

Sofosbuvir, which is marketed under the name Sovaldi, is used to treat Hepatitis C. Generic manufacturer Natco as well as the Initiative for Medicines, Access & Knowledge and the Delhi Network for Positive People, brought oppositions against the application.

Section 3(d) was at the centre of the controversial 2013 decision by the India Supreme Court to reject Novartis’s patent application for its Glivec anti-cancer drug.

In August, seven Indian generic manufacturers, not including Natco, entered into an agreement to manufacture and export sofosbuvir. The drug reportedly costs $1,000 a tablet in the US, or $84,000 for the minimum 12 week treatment. Furthermore, even before the agreement, Gilead had entered in agreements with several countries, such as Egypt, to sell 12-week supplies for $900.

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