Sofosbuvir granted patent in India
Set-back for health groups but they vow to fight on
In a decision that will have far-reaching implications for access to affordable HCV treatment, on 9 May 2016, the Delhi Patent Office granted Gilead, a US-based multinational pharmaceutical company, a patent on Sofosbuvir in India. The pre-grant oppositions filed by Sankalp Rehabilitiation Trust along with those filed by DNP+, I-MAK and three Indian generic companies were rejected by the Deputy Patent Controller of the Delhi Patent Office, Dr. Rajesh Dixit following hearings held from 23-25 February 2016. It may be recalled that a 13 January 2015 order of the Delhi Patent Office rejecting the same patent on Sofosbuvir was remanded back by the Delhi High Court on procedural grounds.
Responding to the order rejecting the pre-grant opposition, Eldred Tellis from Sankalp Rehabilitation Trust said “This comes as a huge disappointment to us. We know there was a lot of pressure to grant the patent considering Gilead had already signed licensing deals with Indian companies but we hoped to knock off the patent.” In September 2014, even before the patent on Sofosbuvir was granted in India Gilead entered into licensing agreements with 7 Indian companies which has now increased to 13. But most high-burden and high-income countries are excluded from the scope of the license. “Knocking off the patent would have meant that non-license companies could have entered the market and forced further price reductions and potentially also supply to countries left out of the licenses” he added.
It is estimated that 180 million people around the world are living with HCV. HCV is primarily transmitted through blood-to-blood contact and may also be transmitted through unprotected sex in high risk groups like MSM. Up to 80% of people living with the virus develop chronic HCV, which, if left untreated, can lead to life-threatening complications, such as liver cirrhosis, liver failure and liver cancer. Sofosbuvir, a highly effective and safe drug to treat HCV. It is now considered the back-bone of the treatment regimen prescribed by the World Health Organisation and is also listed on the WHO’s Essential Medicines List making it a high priority drug for HCV treatment. Sofosbuvir based regimens with other direct acting antivirals (DAAs) like Daclatasvir can cure 98% of people living with HCV 1, 2 and 3 genotypes, the most common genotypes in the world.
Sofosbuvir is priced excessively high in most high-income countries, around 84,000 USD for a 12 week course of treatment in the US and 76,000 USD in France putting considerable strain on national health budgets and forcing rationing of treatment to those who are most sick. In India, the same treatment costs around Rs. 20,000 under the generic versions of Sofosbuvir.
“Prima facie the order lacks legal reasoning but we need to examine it closely to figure out chart out a future course of action. We will explore all options” said Anand Grover, Senior Counsel and Director, Lawyers Collective who appeared for Sankalp Rehabilitation Trust. “There are other patent applications pending on forms of Sofosbuvir so it is important for us to stay on course and fight them out.”
India’s patent laws3 ised attempt to thwart and control competition by generic companies. It is truly worrisome how MNCs are setting the agenda on access to medicines and the role of the government is being side-lined” said Anand Grover. Eldred Tellis added “Patient groups have now become more isolated in the battle for access to medicines but by no means deterred. We will continue to challenge undeserving patents.”
A copy of the order granting the patent can be accessed here.