Decision from the CJEU in Truvada SPC case

The validity of Gilead's SPC for a combination of tenofovir disoproxil and emtricitabine has been the subject of a larger number of court cases around Europe where the proper construction of the "protected by the basic patent" wording in this Article of the SPC Regulation has been at the center of the dispute.

Additional guidance

Adding to previous rulings of the CJEU on the same topic, the Truvada decision by the CJEU now provides the following additional guidance to national courts struggling with the correct implementation of Article 3(a):

Article 3(a) of Regulation No 469/2009 of the European Parliament and of the Council of 6 May 2009, concerning the supplementary protection certificate for medicinal products, 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.

The real new guidance over previous case law from the CJEU on this topic (i.e. Eli Lilly), which also contains the "relate necessarily and specifically" wording, would appear to be the last dot in the ruling requiring that each of those active ingredients be "specifically identifiable, in light of all the information disclosed by that patent". It seems to suggest that it has to be information in the basic patent itself, and thus, not information content outside the basic patent, that enables the skilled person (based on the prior art at the filing date or the priority date of the basic patent) to specifically identify each of the active ingredients. Accordingly, it would appear that in case the basic patent does not contain such information, the above-mentioned criteria are not met.

CJEU's opinion on Gilead's Truvada SPC

Interestingly, the CJEU appears to venture a step farther in its decision than merely proposing a framework for the construction of Article 3(a), as it seems to suggest in paragraph 56 that Gilead's Truvada SPC does not fulfill the criteria laid out by the CJEU in its decision: 

"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."

As the CJEU further mentions in paragraph 56 "the onus" is now on the referring court to verify the CJEU's findings and to analyse whether the outlined criteria for when a combination of active ingredients are "protected by the basic patent" are met in terms of Gilead's Truvada SPC.

It will be interesting to follow the developments with the national courts.