25 July 2018 - Interpretation of article 3a) of Regulation (EC) No. 469/2009

Gérard Dossmann, French and European Patent Attorney comments the judgment of 25 July 2018 of the Grand Chamber of the COURT OFJUSTICE OF THE EUROPEAN UNION (CJEU). The Chamber rules on the interpretation of article 3a) of Regulation (EC) No. 469/2009 applying a two stages criterion.

Background:

The company GILEAD markets under the name TRUVADA®, an antiretroviral drug indicated for the treatment of HIV patients. This medicine contains two active substances, tenofovir disoproxil and emtricitabine, which have a combined effect for this treatment.

Gilead is the holder of European Patent EP 0 915 894 (the basic patent) which relates to "Nucleotide analogues", useful for the therapeutic treatment of several viral infections in humans or animals, in particular HIV, and claims specifically tenofovir disoproxil.

The patent also claims that these compounds may be combined together with a pharmaceutically acceptable carrier and optionally other therapeutic ingredients.
The terms "other therapeutic ingredients" are however not defined or explained in the basic patent.

Gilead has obtained a SPC on the basis of this basic patent and the MA of TRUVADA® in various European countries, including the United Kingdom. This SPC is directed to a composition:

«containing tenofovir disoproxil, optionally in the form of a pharmaceutically acceptable salt, hydrate, tautomer or solvate, together with emtricitabine».

The question relating to the validity of this SPC under the provisions of Article 3 (a) of Regulation No. 469/2009 has been referred to the CJEU by the High Court of Justice (England & Wales), Chancery Division.

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