[Ip-health] Gilead using Data Exclusivity in Ukraine to monopolise Hep-C drug Sofosbuvir
shailly.17 at gmail.com
Mon Aug 22 03:09:39 PDT 2016
Gilead using Data Exclusivity in Ukraine to monopolise Hep-C drug Sofosbuvir
Posted on August 22, 2016
*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
- 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
Civil society struggle for affordable sofosbuvir in Ukraine
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