These days one could be forgiven for questioning the significance of the European Commission’s ongoing public consultation on the potential creation of a single, EU-wide supplementary protection certificate (SPC). First proposed in late 2015, the consultation was initially intended to clear up the last remaining problems with a unitary patent regime whose arrival was regarded as imminent. However, the emergence of serious threats to the proposed Unified Patent Court regime mean that the SPC question may now be purely hypothetical.
The Commission is seeking comments on whether a unitary SPC should be created to accompany Europe’s new patent system – a question left unanswered by the Unitary Patent Court agreement. In its Single Market Strategy communication of October 2015, the Commission identified this question as one of the few issues left to be resolved in establishing the UPC.
At that point, it wrote that Europe was “on the cusp” of establishing the unitary system and “the key challenge” was to “get the endgame right, including addressing uncertainties over how the unitary patent will work together with national patents and national supplementary protection certificates…and the possible creation of a unitary SPC title”.
But since then, circumstances have changed dramatically. The UPC has been thrown into doubt, first by the UK's June 2016 referendum decsion to leave the EU, and more recently by a challenge to the legality of the agreement now before the German Federal Constitutional Court.
While the UK government has committed to ratifying the agreement, the legislation needed to do so has not yet been debated, while it is unclear whether the jurisdiction of the Court of Justice of the European Union will be a stumbling block. In any case, the UPC agreement will need to be altered if a non-EU state is to be part of the system. As for the constitutional challenge in Germany, even if ultimately unsuccessful, it now looks set to delay German ratification of the UPC agreement for an extended period of time. Without EU patents, European SPCs are almost certainly a non-starter.
The role of SPCs will need to be clarified if there is to be a pan-European patent system that will appeal to life sciences rights holders, for whom exended protection is an important compensation for lengthy regulatory proceedings.
Although the option of continuing with national SPCs and the alternative of creating a unitary SPC pose significant legal and administrative challenges, there has never been much doubt where the Commission stands. The consultation may be part of a lengthy formal policy-making process, but it is very likely to favour a unitary SPC system within the context of the UPC. This would be in keeping with the Commission’s commitment to harmonisation and integration expressed in the Single Market Strategy.
In articulating that strategy, it stated: “A Unitary SPC title would bring enhanced certainty to industries whose products are subjects to regulated market authorisations…(and) improve transparency and certainty on the protection of medicines. This would make it easier both for manufacturers of novel and generic/biosimilar medicines to invest, and for Member States to optimise their health budgets, resulting in an improvement of patients’ access to medicines.”
Thus, the consultation should be seen as a process that will inform the Commission’s view on the form a unitary SPC should take, rather than to help determine whether such rights are desirable.
The more pressing question now, though, is not what the EU Commission’s policy on SPCs will be, but whether the whole issue has been made irrelevant by recent developments in the UK and Germany. Put simply, the significance of the consultation has changed. No longer the means to providing the final piece to the UPC puzzle, it has become part of background efforts to keep the show on the road while more decisive issues play out elsewhere.