3 April 2023

Supplementary Protection Certificates at the Unified Patent Court (UPC)

SPCs were created by the European Parliament to act as an extension to a patent right in the European Union.

SPCs apply to specific pharmaceutical and plant protection products that have been authorised by regulatory authorities, such as the European Medicines Agency. SPCs aim to offset the loss of patent protection caused by the compulsory lengthy testing and clinical trials associated with these products. The European legislation is mirrored in United Kingdom law, providing legal basis for SPCs in the UK.

When the UPC opens its doors on 1 June 2023, starting a new chapter in the European patent system, the effect on SPC practice will be immediate. The UPC will be able to make infringement and validity decisions in relation to SPCs where the basic patent is subject to the UPC’s jurisdiction – Article 32 of the Agreement on a Unified Patent Court (UPC Agreement) explicitly provides for this. As the goal for the UPC is harmonisation of post-grant issues across UPC participating countries, the UPC may eventually become responsible for all post-grant issues relating to SPCs in UPC participating countries.

SPC applications will still be examined and granted at a national level

At present, there is no centralised body or system for granting “unitary SPCs”. The examination and grant of SPC applications is undertaken by national patent offices, leading to national SPCs. This system will continue until a centralised body or system exists.

A “unitary SPC”?

The current system of pursuing SPCs nationally leads to high costs and considerable administrative burden. Additionally, national patent offices are not always consistent in their application of SPC law, which leads to potentially divergent outcomes across offices and a lack of legal certainty. Thus, there is growing interest in a centralised body or system for granting “unitary SPCs” to harmonise the approach to examining SPC applications.

What form a “unitary SPC” will take and how “unitary SPC” applications might be examined and granted is still under consideration. For example, the system could mimic the European Patent Office (EPO), where patent applications are examined and granted centrally before leading to a bundle of national patents and now, possibly, a Unitary Patent following grant. Alternatively, a “Unitary SPC Office” could be created with the sole purpose of examining and granting “unitary SPCs”. The EPO, or another existing organisation such as the European Union Intellectual Property Office, could therefore become responsible for the examination and grant of SPC applications or a wholly new organisation might need to be created.

A “unitary SPC” is still very much at the concept stage so major considerations such as who will examine and grant SPC applications, which countries would be in scope of a “unitary SPC”, and who will have jurisdiction over post-grant issues, such as enforcement and validity, remain open.

There will be the possibility to litigate SPCs nationally and in the UPC

Until a “unitary SPC” exists, the only route to an SPC is via national patent offices. Thus, the decision to refuse or grant an SPC application remains with the national patent offices. The UPC now provides the option of litigating an SPC either nationally or in the UPC, if the basic patent is subject to the UPC’s jurisdiction. It should be noted that the SPC system contrasts with the patent system where a patent examined and granted by a national patent office in a UPC Agreement member state is not under the jurisdiction of the UPC, but there is the option of a national SPC to be under the jurisdiction of the UPC. A “unitary SPC” could potentially remove this split.

SPCs may be obtained in the UK and will not be subject to the UPC

While SPCs were created by EU legislation, this legislation is now part of UK domestic legislation. SPCs are therefore obtainable in the UK. Since the UK, like a number of other countries illustrated on the map on page 6/7 is not a participant to the UPC Agreement, UK SPCs, and equivalent rights in other non-participating countries, will therefore not be subject to the UPC’s jurisdiction.