Impact of data exclusivity in Ukraine on access to affordable generic version of sofosbuvir ( direct acting antiviral – DAA used for Hepatitis C treatment)
Chronology of events/facts
- Pharmasset originally developed Sofosbuvir. Gilead Sciences acquired Pharmasset including its Hepatititis C compounds sofosbuvir for $11.2 billion in 2012.
- December 2013 USFDA approves sofosbuvir for inclusion in Hepatitis C treatment regimens, dramatically improving cure rates for the disease.
- In Sept 2014, Gilead signs license with Indian companies covering sofosbuvir and other DAAs, which excludes Ukraine from the list of territories that they can supply/export/register their generic versions.
- No major patent barrier in Ukraine as Gilead has not filed its main sofosbuvir patent applications on Modified fluorinated nucleoside analogues (WO2005003147A2) and on Nucleoside phosphoramidate prodrugs (WO2008121634A2).
- In the absence of patent barriers, Egyptian company Pharco first applied for marketing authorisation (via its distributor Europharma International LLC) on 28 November 2014.
- In April 2015, to protect and encourage generic competition, Ukrainian Network of People Living with HIV/AIDS submitted to the Ukrainian Patent Office a patent opposition against patent application on Nucleoside phosphoramidates (WO2011123645) which is trying to claim the crystalline form of sofosbuvir. The application claims are weak as crystalline forms are considered to be obvious to a person skilled in the art.
- Gilead applied for marketing authorisation on 9 June 2015
- Gilead received marketing authorisation on 9 October 2015
- Pharco received marketing authorisation on 18 November 2015.
- June 2016 Gilead files a court case against Europharma International LLC (Pharco Pharmaceuticals distributor in Ukraine), Ukrainian Drug Regulation Authority and Ministry of Health based on data exclusivity – IP barrier in Ukraine that prohibits registration of generics within 5 years after registration of an originator medicine.
- If Gilead wins the case then the Pharco sofosbuvir product would be de-registered in Ukraine.
To know more, read the Note by All-Ukrainian Network of People living with HIV: