Author
Paul England

Paul England, DPhil

Senior professional support lawyer

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Author
Paul England

Paul England, DPhil

Senior professional support lawyer

Read More

3 December 2015

Upgrading the single market: a unitary SPC?

  • Quick read

We have previously reported how the approaching unitary patent system raises complex questions about the nature of the SPC protection that will be available on the new patent. Will a unitary SPC be created, or will the existing system of national SPCs be adapted for Unitary Patents? Both alternatives would require amendment to the current European legislation, although the second option would require the less far-reaching changes. In particular, the prospect of a unitary SPC raises issues including the type of marketing authorisations on which the unitary SPC would be based: would it require a central marketing authorisation or be based on the first national authorisation? On the other hand, if SPCs were to remain nationally granted rights, it is unclear how uniformity of protection would be ensured across the participating Member States, given that national approaches to UPC legislation differ. Furthermore, requiring patentees to apply nationally for SPC protection would detract from the efficiencies and cost savings that Unitary Patents are intended to introduce.

Whatever the answers to these questions may turn out to be, the European Commission Communication titled "Upgrading the Single Market: more opportunities for people and business", published on 28 October 2015, suggests for now that the Commission may be moving in the direction of the unitary SPC option. The Communication states:

The Unitary Patent system will play an essential role in enabling innovation in the participating Member States. Europe is now on the cusp of making this patent a reality and establishing the European patent specialised court for which the industry has been calling for decades. However, the key challenge now is to get the endgame right, including addressing uncertainties over how the Unitary Patent will work together with national patents and national supplementary protection certificates (SPC) granted under the SPC regime and the possible creation of a unitary SPC title.

The Commission's idea is that a unitary SPC title would bring enhanced certainty to industries whose products are subject to regulated market authorisations, compared to the current system in which SPCs are granted by national patent offices, which can take varying approaches to grant, and have only national territorial effect. The Commission also considers that increased certainty will make it easier both for manufacturers of novel and generic/biosimilar medicines to make investment decisions on the launch of their products.

As a result, the Commission states in a Commission staff working document accompanying the Communication, that it is considering a "recalibration" of the SPC regulatory framework in the EU to include a unitary SPC, in order to provide a "one stop shop" for the granting of SPCs in Europe.

There is no precise timescale given to any of the ideas outlined in the Communication. The Commission states only that it will come forward with initiatives to consolidate and modernise the intellectual property framework and that it envisages that its overall strategy for upgrading the single market will be launched in 2016 and 2017.

Other initiatives being considered by the Commission include an SPC manufacturing waiver and modifications to the Bolar exemption regime in the EU.

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

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