Tenofovir disoproxil and Emtricitabine - CJEU

On Jul 25, 2018, Court of Justice of the European Union (CJEU) clarified when a product is ‘protected by a basic patent’ within the meaning of article 3(a) of regulation 469/2009 (the SPC regulation) in TRUVADA case & referred lower court to determine whether basic patent protects the combination.

The request was made in proceedings between Teva, Accord, Lupin and Generics (UK) Ltd, concerning the validity of a supplementary protection certificate (‘the SPC’) granted to the Gilead for TRUVADA® product used for the treatment of human immunodeficiency virus (‘HIV’). High Court of Justice (England & Wales), Chancery Division (Patents Court) referred the following question to the Court of Justice for a preliminary ruling:

‘What are the criteria for deciding whether “the product is protected by a basic patent in force” in Article 3(a) of Regulation No 469/2009?’

CJEU answered the question in case of combination product as:

The answer to the question referred is that Article 3(a) of Regulation No 469/2009 must be interpreted as meaning that a product composed of several active ingredients with a combined effect is ‘protected by a basic patent in force’ within the meaning of that provision where, even if the combination of active ingredients of which that product is composed is not expressly mentioned in the claims of the basic patent, those claims relate necessarily and specifically to that combination. For that purpose, from the point of view of a person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent:

– the combination of those active ingredients must necessarily, in the light of the description and drawings of that patent, fall under the invention covered by that patent, and

– each of those active ingredients must be specifically identifiable, in the light of all the  information disclosed by that patent.

CJEU’s Analysis:

CJEU said that Article 69 should be interpreted as balanced position which combines a fair protection for the patent proprietor with a reasonable degree of legal certainty for third parties. For the purpose to determine whether that product in fact falls under the invention covered by that patent, the description and drawings of the basic patent must be taken into account, as stipulated in Article 69 of the EPC read in the light of the Protocol on the Interpretation of that provision. Thus for the purposes of the application of Article 3(a) of that regulation, the claims of the basic patent must be construed in the light of the limits of that invention, as it appears from the description and the drawings of that patent.

The claims of a patent are to be interpreted from the perspective of a person skilled in the art and, therefore, the issue whether the product which is the subject of the SPC necessarily falls under the invention covered by that patent must be assessed from that perspective. To that end, it is necessary to ascertain whether a person skilled in the art can understand without any doubt, on the basis of their general knowledge and in the light of the description and drawings of the invention in the basic patent, that the product to which the claims of the basic patent relate is a specification required for the solution of the technical problem disclosed by that patent. Also for the purposes of assessing whether a product falls under the invention covered by a basic patent, account must be taken exclusively of the prior art at the filing date or priority date of that patent, such that the product must be specifically identifiable by a person skilled in the art in the light of all the information disclosed by that patent.

Therefore, for the purposes of determining whether a product which is the subject of an SPC is protected by a basic patent, within the meaning of Article 3(a) of that regulation, that product 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.

Thus, as regards the present issue whether a claim such as claim 27 of the basic patent in fact covers a combination such as the Tenofovir disoproxil (TD)/emtricitabine, which is the subject of the SPC at issue, it falls to the referring court to determine whether the general expression ‘other therapeutic ingredients’, associated with the term ‘optionally’, satisfies the requirement that the claims of the basic patent must relate necessarily and specifically to the product. It is for the referring court to ascertain, whether from the point of view of a person skilled in the art, the combination of active ingredients of which the product which is the subject of the SPC at issue consists necessarily falls under the invention covered by that patent, and whether each of those active ingredients is specifically identifiable on the basis of the prior art at the filing date or priority date of that patent.

In the present case it is apparent, first, from the information in the order for reference that the description of the basic patent at issue contains no information as to the possibility that the invention covered by that patent could relate specifically to a combined effect of TD and emtricitabine for the purposes of the treatment of HIV. Consequently, it does not seem possible that a person skilled in the art, on the basis of the prior art at the filing date or priority date of that patent, would be able to understand how emtricitabine, in combination with TD, necessarily falls under the invention covered by that patent.