Thursday, October 1, 2015
ACCESS TO SOFOSBUVIR, LEDIPASVIR AND VELPATASVIR
- The geographic scope of the license excludes millions of people with HCV in middle-income countries
- Aurobindo Pharma Ltd., Biocon Limited, Natco Pharma Ltd., Cadila Healthcare Ltd., Ranbaxy Laboratories Ltd., Sequent Scientific Ltd., Strides Arcolab Ltd., Cipla Ltd., Hetero Labs Ltd., Laurus Labs Pvt. Ltd, Mylan Laboratories Ltd.
- Data exclusivity: Data exclusivity barriers could restrict access to generic versions of DAAs produced by licensees. The license provides for a waiver of Gilead’s regulatory data exclusivity only when a licensee seeks regulatory approval in countries included in the license. No specific clause under the license ensures excluded countries can benefit from a waiver of data exclusivity. If an excluded country uses compulsory licensing for importation or production, domestic legal discretion to avoid enforcement of data exclusivity would be critical to ensure that regulatory approval is not delayed, potentially for many years depending on a term of data exclusivity in the country.