Patent attorneys Kate Hickinson, Partner, and David Jasiewicz discuss when European unitary supplementary protection certificates (unitary SPCs) could be introduced.
With the Unified Patent Court (UPC) now live, owners of European patents which are in force in member states of the UPC have started to experience the benefits and pitfalls of centralised revocation and infringement proceedings.
The Unitary Patent (UP) provides a single patent which is enforceable in all UPC member states. Meanwhile, the European Patent Office has long offered a centralised application and examination procedure for European patent applications.
In contrast, supplementary protection certificates (SPCs) currently have no such centralised procedures.
What are supplementary protection certificates (SPCs)?
Supplementary protection certificates (SPCs) are national rights that apply to certain pharmaceutical and plant protection products that have been authorized for use by the regulatory authorities. Regulatory approval is necessary in order to bring these products to market but can be a lengthy process which results in a loss of useful patent term for the patentee. SPCs are intended to compensate a patent owner for this loss of useful patent term and can extend the term of the patent for a maximum of five years. A six-month additional extension is available if the SPC relates to a medicinal product for children for which data has been submitted according to a Paediatric Investigation Plan (PIP). The extension compensates for the additional clinical trials and testing that a PIP requires.
How do I obtain an SPC?
Currently, to obtain an SPC in multiple countries across the European Union (EU), it is necessary to file an application with the national patent office of each EU country, even if each application relates to the same European patent (or UP) and the same EU marketing authorisation.
What is the current relationship between the Unified Patent Court (UPC) and SPCs?
When the Unified Patent Court (UPC) opened its doors on 1 June 2023, the court received jurisdiction over actions relating to SPCs based on nationally validated European patents and SPCs, based on European patents with unitary effect (i.e. Unitary Patents/UPs). The UPC does not have jurisdiction over SPCs based on national patents, just as it does not have jurisdiction over national patents granted by national Patent Offices. The UPC also will not hear actions relating to a Patent Office decision to refuse an SPC, these actions will still be dealt with by national courts.
SPCs and opting out of the UPC
If an SPC owner wishes to avoid the jurisdiction of the UPC, it will be possible to opt an SPC out of the UPC system, provided that the SPC is based on a nationally validated European patent. It will not be possible to opt out SPCs that are based on a European patent with unitary effect.
Opt outs of SPCs will follow the opt out of the European patent upon which it is based, such that any opt out of the patent shall extend to any SPC based on it. In other words, if the European patent is opted out, then the SPC must also be opted out. If the European patent has expired, the expired patent can still be opted out so as to enable the opt out the SPC. When an SPC is granted subsequent to applying for an opt out, the opt out shall take effect automatically upon grant of the SPC. Thus, neither the patent nor the SPC may be removed from the jurisdiction of the UPC independently of each other.
The holder of an SPC may be different to the proprietor of the European patent on which the SPC is based. In this case, the holder of the SPC and the patent proprietor must apply for the opt out together.
It is possible to withdraw an opt-out request in order to opt back into the jurisdiction of the UPC. As for opt outs, withdrawal of an opt out for a SPC must follow withdrawal of the opt out for the patent upon which the SPC is based.
What new changes has the European Commission proposed on SPCs?
The European Commission has recently published several proposals for new regulations on supplementary protection certificates (SPCs). The major changes that have been proposed are:
■ the introduction of a centralised application procedure for SPCs (for both medicines and plant protection products); and
■ the introduction of unitary SPCs (for both medicines and plant protection products) for UPs.
The European Commission has proposed that the European Union Intellectual Property Office (EUIPO) should be responsible both for the centralised application procedure and for granting unitary SPCs.
The potential benefits of the proposals are similar to the benefits provided by the EPO and the UPC. The centralised application procedure would remove the lack of legal certainty and predictability caused by divergent decisions of national offices at the examination stage and also reduce the cost of obtaining SPC protection over the whole of the EU. The unitary SPC would further reduce the cost of obtaining EU-wide protection. The European Commission has estimated that a 5-year unitary SPC protected across the EU would cost 55% less overall than with the current procedures. In terms of costs alone, the proposals appear to be very attractive to SPC applicants.
The European Commission has also proposed providing a single publicly available access point (such as a website) which provides information on the status of all SPCs in the EU, in order to improve transparency and reduce the burden of monitoring SPCs. This would be very convenient for third parties (such as generics companies) checking that they are able to launch a product potentially covered by an SPC in the EU.
Will the European Commission’s proposed changes on SPCs definitely come into force?
Not necessarily. The proposals must still be accepted by the European Parliament and the Council of the European Union. However, in view of the existing centralisation of the rest of the patent procedure in the EU, it seems like only a matter of time before EU SPCs follow suit.
Note: since the UK is not part of the EU, the proposals discussed above would not affect SPCs in the UK.
Originally published: May 2022
Updated: May 2023, September 2023
