US-based drug-maker Gilead Sciences has said that its Indian patent application for hepatitis C drug sofosbuvir complies with domestic patent laws.
“We will respond to the opposition in due course,” Gilead said in a response to Business Line , following the pre-grant opposition filed against its drug at the Kolkata patent office by US-based lawyer group I-MAK (Initiative for Medicines, Access & Knowledge).
“Gilead is currently conducting the necessary clinical trials that are required to register sofosbuvir in India, which we hope will be completed by the end of 2014,” the company said.
“Providing treatment in resource-limited settings presents complex challenges, and Gilead will work with partners in multiple sectors around the world to ensure our HCV medicines reach as many patients as possible.”
In a pre-grant opposition, the patent application on a product is opposed before the Patent Office takes a decision.
On the rationale behind the opposition, Tahir Amin, lawyer and director of I-MAK.org, had said: “India’s patent law doesn’t give monopolies for old science or for compounds that are already in the public domain. We believe this patent on sofosbuvir does not deserve to be granted in India and have the legal grounds to prove it.”
Health advocacy groups are also concerned that the drug will be priced beyond the reach of people, especially in developing countries like India.
On its part, Gilead said it is committed to helping ensure access to its HCV medicines in “resource-limited settings, including India”. It further added that “IP should not be a barrier to access and used responsibly can drive medical innovation while also enabling access to treatment for patients in need.”