The European Commission has recently closed a call for evidence on proposals to introduce a single procedure for granting supplementary protection certificates (SPCs) across the European Union (EU), in order to prepare an impact assessment and any necessary legislation.
SPCs extend patent protection for up to five years for specific innovative medicinal and plant protection products. The requirements for an SPC are set out in the SPC regulations for the grant of medicinal or plant protection products. They are available for European patents granted by the European Patent Office (EPO), national patents granted in each member state and, in the near future, unitary patents granted by the EPO.
Currently, applications for an SPC must be made to each member state in which a basic patent is in force. This leaves open the possibility of territorial variations in the grant procedure and, sometimes, in the duration and scope of SPCs across the EU.
The Commission is proposing legislative changes to set up a centralised SPC system, the details of which are yet to be decided. It could be a 'unitary' SPC to extend the protection of unitary patents; a unified procedure for granting a bundle of SPCs covering multiple territories (equivalent to a European Patent); or a combination of the two. The goal is to streamline and harmonise the grant of SPCs by providing a centralised mechanism for obtaining SPC protection across the EU.
The consultation follows the Commission’s IP Action Plan to unify the EU’s fragmented intellectual property (IP) system. This led to a European Parliament resolution on 11 November 2021 calling on the Commission to take action to unify the SPC system and on member states to support the establishment of a unitary SPC title.
It is common for variations in approach to the grant and scope of SPCs to exist between different countries. The SPC regulations also require granted SPCs to be published. There are, however, differences in published SPC-related information at the national level, such that generic manufacturers may have difficulty in determining whether or not a product is protected by an SPC in a particular territory. Each national patent office also charges its own examination and maintenance costs, creating administration burdens for holders of SPCs in multiple territories.
These territorial differences mean that it can sometimes take longer for generic companies to enter the market in some countries than others.
The details of how the new system would operate are yet to be determined but the Commission has suggested that one option is a 'virtual' examining office, comprising SPC examiners from member states’ national patent offices. There is no agreement on which body should grant unitary SPCs and, in addition to the proposed 'virtual office', the EPO, the European Union Intellectual Property Office (EUIPO), and the European Medicines Agency (EMA) have been suggested.
Since the scope of SPC protection is limited to the product for which a marketing authorisation (MA) has been granted, it is not currently clear how the Commission will deal with the issue of SPC protection in territories not covered by a MA. One possibility would be to limit the scope of a unitary SPC to the territories where MAs exist at the date of the SPC application. The Commission will need to clarify whether or not protection would be automatically extended once equivalent MAs were granted in other member states. As yet, there are no proposals to centralise the marketing authorisation system.
The new Unified Patent Court (UPC) will have jurisdiction over SPCs, unless they have been opted out of the system.
The unitary patent (UP) system and UPC is now in its final preparation phase, with the UPC expected to open for business at the end of 2022 or early 2023. Work has now begun on the final preparations to establish the court, such as setting of budgets, testing of electronic systems and the appointment of judges. This period is expected to last at least eight months.
The UPC will have exclusive jurisdiction over unitary patents and all European patents designated to participating EU member states, unless these have been opted out of its jurisdiction.
During the transition period, there will be a dual jurisdiction arrangement for non-opted out European patents whereby cases can be brought in either the UPC or a national court.
Unitary patents will provide patent protection through a single request to the EPO. Unlike European patents, there will be no need have the patent validated and maintained individually in each country covered, with the associated costs and administration. Renewal fees will be payable directly to the EPO rather than national patent offices.
It will be possible to obtain a UP by request to the EPO for unitary effect within one month of grant of a European patent application. The geographic extent of unitary protection will be determined by the member states participating in the UP system at the date of patent grant.
The territorial scope of a UP will not extend if more countries join the system. It is a prerequisite of being part of the UP system that the relevant country has acceded to the Unified Patent Court Agreement (UPCA). The majority of member states are expected to participate with Spain, Croatia and Poland being the current exceptions. The UK will not participate.
 With a further six months of protection available for medicines that have been tested for paediatric use.