Court of Justice holds firm on restrictive approach to SPCs for combination products

Court of Justice holds firm on restrictive approach to SPCs for combination products

Case: Teva UK Ltd and others v Gilead Sciences Inc. (case C-121/17)

In a decision handed down on 25 July 2018 the Court of Justice of the European Union (CJEU) has confirmed that a Supplementary Protection Certificate (SPC) will only be available for a combination product if the claims of the basic patent relied on relate ‘necessarily and specifically’ to that combination. This does not mean that the combination of active ingredients in the product must necessarily be expressly mentioned in the claims.  However, based on the description and drawings in the patent, it must have been clear to the person skilled in the art at the priority date that the combination fell within the patented invention. In addition, each of the active ingredients must be specifically identifiable from the information disclosed in the patent.

Gilead’s Truvada at risk

The ruling will be unwelcome news for Gilead Sciences whose SPC for its antiretroviral combination product Truvada is likely to be invalidated when the case returns to the English High Court for judgment.  Truvada is a combination of two active ingredients, tenofovir disoproxil (TD) and emtricitabine.  Whereas TD is expressly mentioned in the basic patent relied on, emtricitabine is not.  Gilead’s argument is that reference in Claim 27 of the patent to the inclusion of “other therapeutic ingredients” relates “implicitly but necessarily to emtricitabine”.  Taking a strong line against this argument, however, the CJEU, comments that: “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 the patent”. The Court acknowledges, however, that it is for the English Court to decide this factual question based on the principles referred to above.

Implications of the case

There have been a string of cases addressing the question of combination products and SPCs, and the interpretation of Article 3(a) of the SPC Regulation.  One of the key issues – as arose here – is the extent to which an SPC can be granted where the basic patent relied on relates to one active ingredient but a later product adds a second or further active ingredient. Such products have a very important therapeutic role to play and can constitute significant medical advances.  The underlying concern addressed by the courts in relation to the grant of SPCs is, however, the fear of “double dipping”. This is the situation where an SPC is granted on the basis of ingredient A and then later a second one is granted on ingredients A and B in combination – this will only be justifiable if the patent relied on genuinely does cover both products.  This latest decision is helpful in setting out clear principles to be applied in such situations where, as here, generics are often waiting in the wings to enter the market.  It remains to be seen, however, whether in practice this will be enough to ensure a consistent approach by the courts in future.

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