EU door opens for generic version of AIDS medicine Truvada

PARIS: Patient associations lauded an EU decision to allow the sale of generic versions of Truvada, an anti-retroviral medicine used by those diagnosed HIV-positive, the virus causing AIDS.

“This decision is historic ending an inherent monopoly,” said the Coalition PLUS and Aides associations in a statement.

Truvada, made by US lab Gilead, is one of the most widely used medicines to treat patients with the HIV virus and was to date the only one enjoying Europe-wide clearance for patients deemed high infection risk.

But European patents on the medicine expired on Wednesday, providing a window of opportunity for generics.

In some European states, however, Gilead retains a monopoly owing to a complementary certificate of protection ( CCP) which extends the period of exclusivity afforded a product.

Four rival labs – Teva, Accord Healthcare, Lupin and Mylan – had sought to have that overturned in the courts in Britain – which called on the European Court of Justice to make a ruling.

The ruling, which came down on Wednesday, highlighted the fact that Truvada contains two active substances – emtricitabine and tenofovir disoproxil – but only the second of the two is explicitly mentioned in the basic patent.

The judge argued that as a result, the conditions for a CCP were not met. — AFP