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15 August 2018

CJEU answers question on SPCs related to combination products

Further to Siân Gill’s SPC update in the most recent edition of Inside IP, a decision handed down by the Court of Justice of the European Union (CJEU) on 25 July 2018 provides clarification for how Article 3(a) of Regulation No 469/2009 is to be interpreted when assessing combination products.

The question referred to the CJEU by the UK High Court, concerns an SPC for an antiretroviral drug marketed under the name “Truvada”.  The SPC relates to a composition comprising a first active ingredient, tenofovir disoproxil (TD), in the form of a pharmaceutically acceptable salt, hydrate, tautomer or solvate, together with a second active ingredient, emtricitabine.  Gilead owned the basic patent for this drug which expired in 2017, but although the patent contained a claim to TD as well as “other therapeutic ingredients” there was no claim explicitly mentioning emtricitabine.  As a result of the absence of emtricitabine in the patent but presence of it in the SPC, Teva contested the validity of the SPC and due to a lack of clarity surrounding the interpretation of Article 3(a) of Regulation No 469/2009 the UK High Court sought input from the CJEU.

In this decision, the CJEU reiterated that “a product cannot be considered to be protected by a basic patent in force within the meaning of Article 3(a) of Regulation No 469/2009 unless the product which is the subject of the SPC is either expressly mentioned in the claims of that patent or those claims relate to that product necessarily and specifically”.  In other words, “the product must, from the point of view of a person skilled in the art and in the light of the description and drawings of the basic patent, necessarily fall under the invention covered by that patent and the person skilled in the art must be able to identify that product specifically in the light of all the information disclosed by that patent, on the basis of the prior art at the filing date or priority date of the patent concerned”. 

The Court concludes:

“Article 3(a) of Regulation No 469/2009 of the European Parliament and of the Council of 6 May 2009, concerning the SPC 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”.

After identifying the above criteria, the CJEU refers the case back to the UK High Court in order for a decision to be made, but the CJEU does briefly discuss their preliminary opinion. In particular they note that from the information contained in the referral and the description of the basic patent, no information can be found discussing the combined effect of TD and emtricitabine for the treatment of HIV.  In view of this, the Court suggests that it would seem impossible for a person skilled in the art, at the priority date of the patent, to understand how emtricitabine in combination with TD falls within the scope of protection conferred by the claims of the basic patent.

We will provide an update when the decision from the High Court is available.

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