The effect of opt-out on SPCs

Momentum is clearly building towards the day when the UPC will open for business. Therefore, it is imperative that patentees and their competitors now begin to assess the approach they wish to take to unitary patents in their businesses and how to deal with European patents ("classicals", to distinguish them from unitary patents) in the UPC. In particular, this means addressing the issue of opt-out. To assist, we have prepared four articles this month addressing different aspects of opt-out.

This article deals with the effect of opt-out on supplementary protection certificates.

The right to opt-out (see the UPC opt-out and withdrawal: meaning and effect) is also expressed to apply to SPCs and it is evident from Rule 5.2 of the Rules of Procedure1 that opt-out automatically extends to an SPC that is issued for a product protected by the opted-out patent. Also, Rule 5.1 states that a classical European patent that has expired can be opted-out, with the intention that any SPC granted based on that patent is automatically opted-out as a result. However, if there has been an assignment so that the owner of the SPC is different from the proprietor of the patent on which it is based, it is important to note that the SPC owner must lodge the opt-out Application together with the patent proprietor for the opt-out to be effective (see also responsibility for opting-out).

EU flagsIt is clear from the Rules that an SPC granted on the basis of a Unitary Patent cannot be opted-out2. However, big questions remain in respect of whether SPCs will be granted as unitary rights on the basis of a Unitary Patent, or whether the existing system of national SPCs will be adapted for Unitary Patents. Both alternatives would require the European legislation to be amended but the second option is more conservative and would require fewer changes to the legislation and the way that system operates.  Having said that, requiring patentees to apply nationally for SPC protection would take away some of the efficiencies and cost savings associated with Unitary Patents.  The issue of how SPCs on Unitary Patents will work raises further complex issues, including the nature of the marketing authorisations upon which these SPCs will be based (i.e. whether they are centralised, decentralised or national) and how uniformity of protection will be ensured across the participating states whose patent offices may take different approaches to SPCs and so might result in patchwork SPC coverage. These issues are currently under consideration by the European Commission.

If you have any questions on this article or would like to propose a subject to be addressed by Synapse please contact us.

1 16th draft Rules of Procedure.

2 Rule 5.2(e), 16th draft Rules of Procedure.

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Matthew Royle

Matthew is a senior associate in the Intellectual Property department based in our London office.