Gilead's patent for hepatitis C drug Sofosbuvir rejected in India

US drug company Gilead, which sells hepatitis C drug Sofosbuvir, has been denied its patent by the Indian patent office, boosting indian generics maker Natco Pharma, PTI reported.

Sofosbuvir is sold by Gilead under the brand name Sovaldi in the US and

An order by deputy controller of Patents & Designs, Hardev Karar said that the US company failed to prove that its Sofosbuvir [sold by Gilead under the brand name Sovaldi in the US] provided enhancement of therapeutic efficacy in the new discovery.

Sovaldi comes at a price tag of $84,000 for a 12-week course in the US, which had been the subject of criticism from health advocates in the US.

The patent filed by Gilead had been opposed by Hyderabad-based Natco Pharma, Delhi-based NGO Delhi Network of Positive People (DNP+) and Initiative for Medicines, Access & Knowledge.

Gilead had entered into a licensing agreement for the drug with seven India-based firms , including Cipla, Ranbaxy and Cadila.

The company had also planned to launch its own drug Sovaldi in India at $300 per bottle while Indian companies were allowed to fix their own price for the generic product they produced, paying a royalty on sales.

The decision by the Indian patent office to reject the patent has been hailed by patient groups and organisations campaigning for affordable medicines, Business Today reported.

The reason offered for the rejection was  "minor changes in the molecule" did not improve the drug's efficacy.

India, which does not allow 'incremental innovations', had, on the same ground rejected the patent for Novartis's cancer drug Glivec, after a legal battle that attracted global attention  (See: Novartis loses patent battle in SC over cancer drug Glivec).

The parties opposed to the patent for the drug Sofosbuvir claimed it was not inventive enough compared with a previous formulation.

The rejection would allow Indian generic companies to make and sell cheaper versions of the drug in the country.

The US company had earlier signed voluntary license agreements with multiple generic producers in India for the manufacture of the drug.

According to Tahir Amin, a lawyer and director of I-MAK, the move to reject Gilead's patent application opened up the playing field and would help many other generic companies to start producing more affordable versions of this drug.