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A European court ruling has paved the way for generic approval of Truvada, a drug used by HIV-positive people and for the prevention of the HIV virus, to the satisfaction of AIDS organizations.
"This historic decision […] puts an end to an undue monopoly" reacted Coalition PLUS and Aid badociations in a statement
Generics should arrive on the European market
The Truvada, from American laboratory Gilead, is one of the most used drugs to treat HIV-positive.
It is also the only one authorized in Europe for the prevention of seronegatives (as part of a device called Prep, for "pre-exposure prophylaxis" to prevent contracting the HIV virus.
European patents on this drug expired on July 25, 2017, allowing in theory the arrival of generics.
But in some European countries, Gilead continues to exercise a monopoly under a "supplementary protection certificate" (CCP), a mechanism to lengthen the period of exclusivity of a drug
In the United Kingdom, the validity of this CCP was challenged in court by four competing laboratories (Teva, Accord Healthcare, Lupine and Mylan).
asked the Court of Justice of the European Union (CJEU) to rule, which it did in a judgment rendered Wednesday.
A fall in prices
This judgment is based on a legal subtlety related to the Truvada patent. This drug combines two antiretrovirals, tenofovir disoproxil (TD) and emtricitabine. However, only the first is explicitly mentioned in the basic patent
The European Court held that the conditions of a CCP were not fulfilled because the combination of the two active ingredients was not explicitly mentioned in the patent.
It was on the same line of reasoning that French justice had already leaned in September. It rejected a request from Gilead, which wanted to ban the marketing of generic Truvada launched in France by the laboratory Mylan.
Since then, five generics are available on the French market, with a consequent significant price decrease (about 160 € a box against more than 400 for the Truvada when it had the monopoly).
"In France, it is more than 760 million euros that the use of generic Truvada has saved money" [19459005arguedthebadociationAides
"At the European level, this decision of the CJEU will be in billions of euros in savings and should pave the way for the Prep throughout Europe, thus avoiding thousands of contaminations according to her
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