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ES – Gilead v. Teva & Mylan / Tenofovir + Emtricitabine / Interim injunction opposition

07 Feb 2018

Gilead Biopharmaceutics Ireland UC., Gilead Sciences, S.L.U., Gilead Sciences Ireland UC., Gilead Sciences, Inc. v. Teva Pharma, S.L.U, Mylan Pharmaceuticals, S.L., Mylan S.A.S., Barcelona Commercial Court No. 4, 20 October 2017, Docket No. 190/2017 – 197/17

In its decision of 20 October 2017, Barcelona Commercial Court No. 4 reversed its previous rulings pursuant to which it had granted interim injunction ex parte against Teva and Mylan, which were ordered, at the request of Gilead, to temporarily refrain from commercializing in Spain generic drugs with the combination of the active compounds emtricitabine + tenofovir for the treatment of HIV sold under the brand name Truvada®.

The Court had to decide whether Gilead’s Spanish SPC C20050034, which relies on the marketing authorization for Truvada® and Spanish Patent ES 2198003 (EP0915894) – which expired on July 25, 2017 – was likely to be ruled invalid according to Article 3(a) of SPC Regulation No. 469/2009.

A summary of the case (in English) can be read here.
A copy of the judgment can be read here.

Headnote and summary: Luis Fernández-Novoa, HOYNG ROKH MONEGIER