zurück zur Übersicht Teva UK Ltd and others v Gilead Sciences Inc. (C-121/17)

On July 25, 2018, the CJEU published its ruling in the case C-121/17, Teva UK Ltd and others v Gilead Sciences Inc. on the question whether for a combination product it is mandatory that all active ingredients have to be specified in the wording of the claims of the patent in question in order to obtain an SPC on the basis of a marketing authorization for said combination product. 

In its ruling the court explains that in order to assess whether a combination of active ingredients can form a basis for an SPC, a product which is the subject of the SPC has to be either expressly mentioned in the claims of the patent or those claims relate to that product necessarily and specifically. 

To determine whether the claims relate to that product necessarily and specifically, the description and drawings of the basic patent must be taken into account. It is decisive whether a person skilled in the art could understand at the priority date of the basic patent without any doubt, on the basis of general knowledge and in the light of the description and drawings of the invention in the basic patent, that the product is required for the solution of the technical problem disclosed by that patent. Thus, the product for which an SPC is granted, must be identifiable specifically by a person skilled in the art in the light of all the information disclosed by the basic patent and of the prior art at the filing date or priority date of that patent. 

As a consequence of the above, the court ruled that an SPC should be granted for a product composed of several active ingredients with a combined effect, if the claims of the basic patent relate necessarily and specifically to that combination, even if the combination of active ingredients is not expressly mentioned in those claims. In order to assess whether the claims relate necessarily and specifically to that combination a person skilled in the art must have the point of view on the basis of the prior art at the filing date or the priority date that 

(i) the combination of those active ingredients necessarily falls under the invention covered by that patent (in the light of the description and drawings of that patent), and

(ii) each of those active ingredients is specifically identifiable, in the light of all the information disclosed by that patent.

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