A group of NGOs working in the health sector like the Initiative for Medicines, Access & Knowledge (I-MAK), Delhi Network of Positive People (DNP+) and Médecins Sans Frontières (MSF) have filed four patent challenge cases in India, two patent challenges on daclatasvir, one on velpatasvir and a further challenge on sofosbuvir. Sofosbuvir, velpatasvir and daclatasvir are all crucial to the first line treatment options that cure people of hepatitis C and stop the progression of liver disease.
These new challenges against patents on crucial new medicines to treat hepatitis C filed in India and Argentina are the latest in a global push to ensure access to affordable treatment. The patent challenges could remove barriers to production and distribution of affordable generic versions of direct-acting antiviral (DAA) medicines, including sofosbuvir, daclatasvir and velpatasvir.
In India, two cases challenge the crystalline forms of sofosbuvir and daclatasvir and should be rejected for not being in compliance with Indian law. India's law recognizes that crystalline forms of known medicines are not inventions and should not be awarded patents. This approach was confirmed by the Indian Supreme Court on 1 April 2013, which refused a patent by holding that a crystalline form of a known pharmaceutically active compound cannot be regarded as involving an inventive step (Novartis vs Union of India).
A critical third opposition shows that the patent on velpatasvir is an obvious structural change to an earlier hepatitis C drug, ledipasvir. This is a classic example of Gilead gaming the patent system in order to strengthen its control on the hepatitis C market. The fourth opposition also seeks to open up the supply of raw materials from India by challenging the patent on the intermediate form of daclatasvir, the NGOs argue.
“Today’s filings are the latest attempts to overturn the abusive strategies of pharmaceutical corporations like Gilead who exploit the flaws in the patent system to obtain unjustified patents that block generic competition”, the NGOs said.
“80 million people worldwide are living with hepatitis C, and we need a wide range of combination treatments available at an affordable price. With patents blocking generic competition, treatment remains prohibitively expensive in many countries,” said Jessica Burry, pharmacist for MSF’s Access Campaign. “Sofosbuvir, velpatasvir and daclatasvir are all crucial to our line-up of first line treatment options that cure people of hepatitis C and stop the progression of liver disease.”
“Together with civil society groups, we have filed legal challenges on multiple invalid patents on three different hepatitis C drugs,” said Tahir Amin, Director of Intellectual Property for I-MAK. "It is time to challenge the unchecked power that pharmaceutical corporations hold through abuse of the patent system.”
“Despite the deadly toll of the hepatitis C epidemic, Gilead and Bristol-Myers Squibb still have far too much control over who can access their lifesaving DAA medicines, and the lack of access is ultimately costing people their lives,” said Loon Gangte, Regional Coordinator, International Treatment Preparedness Coalition-South Asia and Founder of DNP+. “Millions of people in India can’t afford the generic treatments strictly licensed by Gilead and BMS, and millions more people in high- and middle-income countries can’t legally purchase the generic medicines currently being produced in countries like India and Egypt. We need a sustainable supply of low-cost, quality hepatitis C medicines to save lives and contain the disease in all countries.”
Gilead has licenced sofosbuvir and velpatasvir to 11 generic manufacturers in India, but the number of countries able to access these generic versions represents only half the global burden of disease, the NGOs stated.