CJEU provides guidance on SPCs for combination products

Dr Sarah-Jane Poingdestre | August 2018

On the 25 July 2018, the Court of Justice of the European Union (the CJEU) handed down its judgement in Teva v Gilead (C-121/17) on the topic of the interpretation of Article 3(a) of the regulation for supplementary protection certificates for medicinal products (the SPC Regulation).  The interpretation of this article has been the subject of a number of referrals to the CJEU, with referrals pending form the German Federal Patent Court in the Sitagliptin case (C-651/17) and from the UK Court of Appeal in Sandoz v Searle (C‑114/18).

The case concerned Gilead’s SPC for their antiviral medicinal product marketed under the name TRUVADA®.  The medicinal product contains a mixture of two active ingredients: tenofovir disoproxil (TD) and emtricitabine. 

Gilead is the proprietor of EP (UK) 0 915 894 (the basic patent) which discloses and claims TD and combinations of TD with “other therapeutic ingredients”.  Gilead obtained a SPC based on the basic patent to extend patent protection for TRUVADA®.  The SPC relates to “a composition containing TD, optionally in the form of a pharmaceutically acceptable salt, hydrate, tautomer, or solvate, together with Emtricitabine”.

Article 3(a) of the SPC Regulation specifies that a SPC can only be granted if the product is “protected by a basic patent in force”.  The UK High Court concluded that the test to be applied in order to determine whether this requirement is satisfied remained unclear and referred the following question to the CJEU:

What are the criteria for deciding whether ‘the product is protected by a basic patent in force’ in Article 3(a) of the SPC Regulation?”

Referring to the CJEU’s decision in Medeva (C-322/10), Teva argued that Gilead’s SPC did not meet the condition laid down in the SPC Regulation as emtricitabine is not specified in the relevant claim of the basic patent and that the expression “other therapeutic ingredients” does not specify any active ingredient.  On that basis, they argued that the TD/emtricitabine combination could not be considered to be protected by a basic patent in force”.

Gilead argued that in order to check whether Article 3(a) of the SPC Regulation was satisfied, it was necessary and sufficient that the product in question fell within the extent of the protection conferred under at least one claim of the basic patent and that the expression “other therapeutic ingredients” in the claims of the basic patent related “implicitly but necessarily” to emtricitabine, in accordance with Eli Lilly & Company (C-493/12). 

The CJEU’s decision is broadly in line with its previous case law on this issue.  It confirmed that Article 3(a) of the SPC Regulation 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” where, even if the active ingredients are not expressly mentioned in the claims of the basic patent, those claims relate necessarily and specifically to that combination.  The CJEU has formulated a two-stage test for determining whether claims satisfy this criteria:

“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 wording of the CJEU’s decision suggests that Gilead’s SPC does not satisfy Article 3(a) of the SPC Regulation as it does not seem possible that the person skilled in the art would understand that the TD/emtricitabine combination product necessarily falls under the invention covered by the patent.  However, it will now be up to the UK High Court to apply the two-stage test set out above.

Although this decision provides some further clarification on the interpretation of Article 3(a) of the SPC Regulation, it does not provide the clarity and certainty that the industry requires.  Hopefully, the pending referrals in Sitagliptin and Sandoz v Searle will shed further light on the matter.