The patent office noted that a 'molecule with minor changes, in addition to the novelty, must show significantly enhanced therapeutic efficacy' compared with a prior compound.
New Delhi: India's patent office has rejected an application from US-based Gilead Sciencesfor its hepatitis C drug Sovaldi.
The patent application was opposed by Indian drugmaker Natco Pharma, and the Initiative for Medicines, Access & Knowledge, a non-profit organisation. They opposed the application on the grounds that Sovaldi was not a significant improvement compared with an earlier compound developed by another company.The patent office noted that a 'molecule with minor changes, in addition to the novelty, must show significantly enhanced therapeutic efficacy' compared with a prior compound.
Sovaldi’s $84,000 price tag for a 12-week course in the US has drawn criticism from patient advocates. The rejection will allow the Indian drugmakers to make and sell versions of the drug in country
In September last year, the US pharmaceutical major had announced a licensing deal with seven Indian drugmakers to produce generic versions of Sovaldi that could be sold in 91 countries.
The patent office's decision came amid a growing clamour by healthcare campaigners and doctors to ensure Sovaldi and other new hepatitis C pills are affordable in developing countries.