Sofosbuvir

Sofosbuvir is a hepatitis C (HCV) drug that has been recommended for treatment by the US FDA and EMA. HCV is a significant public health issue for middle-income countries, that are home to 73% of the 150 million people who are infected with HCV. Although HCV is curable, high drug prices make treatment inaccessible, leaving people at risk for liver cancer or liver failure. 

I-MAK and our country partners have filed oppositions against Gilead/Pharmasset's patent applications because we believe that the technologies comprising these patent applications are known and therefore undeserving of a patent grant. We also believe that it is now time that People Living with HIV and HCV obtain affordable access to the drugs they need.

 

Summary of Legal Grounds of Opposition to Sofosbuvir Patents

 

Briefing document summarising the legal grounds of the patent oppositions

 

Legal Documents for Opposition to Sofosbuvir (India)

 

I-MAK and DNP+ Pre-Grant Opposition to the base compound application 6087/DELNP/2005 (without exhibits)


I-MAK and DNP+ Pre-Grant Opposition to the base compound application 6087/DELNP/2005 (with exhibits -  Part I, II, III, IV, V)


I-MAK's Pre-Grant Opposition to the prodrug application 3658/KOLNP/2009 (without exhibits)

 

I-MAK's Pre-Grant Opposition to the prodrug application 3658/KOLNP/2009 (with exhibits)

 

Legal Documents for Opposition to Sofosbuvir (China)

 

I-MAK'S third party observation to the Chinese Patent Office against the prodrug application

[in English] [in Chinese]

 

Background Information

MSF press release

Pricing information and speculation

Treatment Action Group: HIV, HCV and TB Pipeline Report

Implications of Licenses Issued by Gilead for Sofosbuvir

List of Excluded Countries from Gilead's Sofosbuvir License

 

Media Coverage

'Indian health activists move to prevent Gilead’s drug patent' - Financial Times

'Hepatitis C Drug: US Group Opposes Gilead’s Patent Request In India' - Hindu Business Line

'Gilead Attempt To Secure Patent On Hepatitis C Drug Opposed In India' - Times of India

'US group seeks to block Gilead drug patent in India' - Yahoo News

The dirty motivation behind Gilead's hepatitis C agreement - Al Jazeera