Two gaps instead of one: the CJEU's effect on Supplementary Protection Certificate jurisprudence

This is the Guest Editorial for the June 2014 issue of JIPLP, written by editorial board member Darren Smyth (EIP, London).
Two gaps instead of one: the CJEU's effect on Supplementary Protection Certificate jurisprudence

Richard Dawkins reports an observation of interactions with proponents of creationism, who point to gaps in the fossil record as showing that evolution by natural selection is not correct. If, Dawkins says, an intermediate species fossil is subsequently discovered, the creationists consider their position to be strengthened, not weakened, because “Now there are two gaps instead of one!”.

A similar pattern can be discerned in the realm of referrals to the Court of Justice of the European Union (CJEU) concerning the SPC Regulation (1) When a national judge makes a referral because there is a particular area of uncertainty, a judgment from the CJEU follows that fails to clarify the original uncertainty, and creates a new one. Now there are two gaps instead of one.

Thus, to take one example, when there was uncertainty about the meaning of whether a product is “protected by a basic patent” according to Article 3(a) of the Regulation, the Medeva Quintet (2) of cases gave not one but two answers, neither of which was illuminating. Depending on which judgment is read, the court enlightened the world that the product must be “specified”, or “identified”, in the wording of the claims. As to with what degree of particularity, or whether the two verbs meant the same thing or something different, answer came there none.

So further referrals ensued, resulting in the “Lilly Trio”(3), in which the CJEU spectacularly failed to clarify the point, adding further terms requiring judicial interpretation. For example, in the Lilly case itself, it was ruled that it is not necessary for the claims to specify a structural formula identifying the active ingredient, but that it is sufficient “that the claims relate, implicitly but necessarily and specifically, to the active ingredient in question”. What, in this context, is “necessarily” supposed to mean? Or, for that matter, “specifically”? In fact, the degree of particularity – the whole point of the referral – is not significantly illuminated by this answer.

There seem to be two possible solutions to this sorry state of affairs. Either national judges can stop referring, and just decide cases as best they can on the basis of the existing state of the jurisprudence: if this results in divergent decisions, then so be it. Or the EU legislature can rewrite the Regulation.

A report has reached JIPLP that, after the speeches in the combined hearing for the Lilly Trio of cases, the first question from the court, addressed to the representatives of the Commission, was whether there was any plan to amend or rewrite the Regulation. It seems that even the CJEU realises that the status quo is untenable (the answer from the Commission side was, naturally, non-committal). It seems that all political capital and goodwill relating to intellectual property in Europe has been squandered on the Unitary Patent and Unified Patent Court. It therefore appears scarcely likely that legislative time will be found for a new SPC law.

So, we invite the judges of Europe to consider (and maybe discuss at the next European Patent Judges' Symposium). You have all the guidance from the CJEU you are going to get. Every referral you make will result in more “gaps”, not fewer, in the legislative framework. Decide some cases; aim for consistency; but if there happen to be some anomalies, well, it is better than spending the time, effort, and money on a referral that will simply make the issues more complex than they were to begin with.

1 Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products.

2 Medeva BV ( C-322/10), Georgetown University (C-422/10), Yeda (C-518/10), University of Queensland (C-630/10), and Daiichi Sankyo (C-6/11).

3 Lilly (Case C-493/12), Actavis (C-443/12), and Georgetown (Case C-484/12).

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