European Union: The European Commission Proposes To Revise The Rules On The Supplementary Protection Certificate For Medicinal Products In The European Union

On 26 July 2023, the European Commission presented a proposal to recast Council Regulation (EC) No 469/2009 concerning the supplementary protection certificate ("SPC") for medicinal products. The objective of the Commission's proposal is, among other things, to simplify and improve the efficiency of the application procedure for SPCs in the EU and to improve legal certainty.

Since the 1980s, medicinal products have been subject to increasing documentation requirements that owners must meet before their products can obtain marketing authorisation from the authorities. Without such authorisation, medicinal products cannot be placed on the market. The extensive documentation requirements for, among other things, the safety and effectiveness of the medicinal products mean that the effective patent protection period for medicinal products, i.e. the period during which a patent holder has the opportunity to market a product under patent protection and thereby actually benefit from the exclusive rights provided by the patent protection, is often significantly shorter than is the case for products in other technological areas. Consequently, a number of jurisdictions, including the EU, have introduced rules allowing supplementary protection for medicinal products.

Supplementary protection certificates

Specifically, Regulation 469/2009 (the "SPC Regulation") allows a holder of a patent protecting a marketed medicinal product to apply for an SPC, thereby enabling the holder to extend the period of protection of the medicinal product by up to five years after the expiry of the patent. The duration of the supplementary protection period depends on the period elapsed from the filing of the patent application to the granting of the first marketing authorisation for the product, minus five years. If, for example, seven years have passed from the filing of the patent application to the granting of the first marketing authorisation for the medicinal product, the supplementary protection period will be two years.

The current SPC system is based on application processes at national authorities. A decision made by a national authority to issue an SPC is only effective within the authority's own jurisdiction. This means that patent holders must apply for an SPC in each jurisdiction where additional protection is desired. This leads to an increased risk of diverging national procedures within each jurisdiction, which may result in uncertainty about the state of the law within that area. In addition, it is relatively costly to seek protection in multiple Member States at the same time.

EUIPO as central authority

One of the main objectives of the European Commission's proposal is to simplify and harmonise the SPC system and to improve its predictability and efficiency. In this context, the proposal contemplates, among other things, the introduction of a centralised procedure for applying for the issuance of SPCs within the EU. The centralised procedure is supposed to allow applicants to submit one application for SPCs to the same central authority. The European Commission has proposed that the European Union Intellectual Property Office (EUIPO) should be the central authority. The central authority will have powers, in all Member States, to issue opinions regarding the issuance of SPCs. This means that applicants receiving a positive opinion from the central authority will have a right to issuance of SPCs in any EU Member State.

By introducing a centralised procedure for the application for and review of SPCs, the European Commission wants to improve legal certainty within that area by avoiding diverging interpretation practices by the various national authorities. At the same time, the aim is to reduce the amount of resources that patent holders spend on applying for SPCs in multiple jurisdictions by eliminating the duplication of administrative work associated with the previous system where applications had to be filed in each of the relevant Member States.

In addition to the tasks of reviewing applications, the central authority must also set up and maintain a public database of SPC information.

The proposal for a revised Regulation also seeks to regulate the application procedure for the issuance of Unitary SPCs. Unitary SPCs provide uniform protection across all participating Member States, in the same way as the Unitary Patent. According to the proposal, the EUIPO will be authorised to grant Unitary SPCs based on the same centralised review as that proposed to be introduced for SPCs based on a basic patent that is not a Unitary Patent. The EUIPO's decision to grant or refuse an application for a Unitary SPC will fall under the jurisdiction of the Unified Patent Court (UPC). The Commission's proposal is subject to the ordinary legislative procedure and is currently awaiting first readings in the Council and the Parliament. The proposed rules may therefore be subject to change before adoption.

Part of a major "patent package"

In parallel with the proposal for a new SPC Regulation, the European Commission has presented a new proposal to recast the Regulation on the supplementary protection certificate for plant protection products. Both proposals are part of a major "patent package" published by the EU. The package also includes proposals to change the rules on compulsory licence and standard essential patents (SEPs).

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