The EU Commission published four proposals for amending the current regime for Supplementary Protection Certificates (SPCs) to enable a centralised examination of national and unitary SPCs. We summarise the proposals and some aspects of concern.
The current framework for obtaining SPCs in the European Union (EU) is set out in Regulation (EC) No 469/2009 for human and veterinary medicinal products and Regulation (EC) No 1610/96 for plant protection products. At present, SPCs can only be examined and granted on a national level, requiring action in each EU country separately. This can be costly for applicants with multiple sets of legal and official fees, and the potential for inconsistencies arising between Member States.
As part of the 2023 ‘EU patent package’, the EU Commission published four proposals for amending the current SPC regime:
- Recasting both of the existing SPC Regulations, mainly for the purpose of introducing the possibility of centralised examination of SPC applications; and
- Introducing two further SPC Regulations relating specifically to unitary SPCs for medicinal products and plant protection products respectively.
The proposals are still in the consultation phase and must still be debated and approved by the European Parliament and Council before they could come into force. In September 2023, our SPC specialists contributed to feedback on the proposals, submitted by the Chartered Institute of Patent Attorneys in the UK.
We summarise the principal aspects of the EU’s proposals below.
All four proposed Regulations include an aspect of centralised examination of SPC applications. This is proposed to be handled by the EU Intellectual Property Office (EUIPO), with input from national SPC examiners from Member States.
Centralised examination will only be allowed where the basic patent is a European patent (including a European patent with unitary effect). SPCs based on national patents will remain available via national patent offices.
For medicinal product SPC applications based on a European patent and a centralised marketing authorisation, centralised examination will be the only mechanism for obtaining SPCs.
In contrast, for plant protection product SPC applications based on a European patent, centralised examination will be an option but would not be mandatory.
In all cases, the result of centralised examination is the issuance of an examination opinion. Where national SPCs are requested via this route, the national offices must subsequently implement a positive examination opinion by granting the national SPCs unless there is an extenuating circumstance. This should allow harmonisation across Member States by avoiding divergent approaches by different offices. The process will be akin to the centralised prosecution of a European patent by the EPO that results in a bundle of national patents (assuming that no unitary effect is requested).
For medicinal products having a European patent with unitary effect and a centralised marketing authorisation, the mandatory centralised examination can lead to the choice of a unitary SPC and/or national SPCs.
For plant protection products having a European patent with unitary effect and, provided that marketing authorisations have been applied for in all Member States of that unitary patent, it will be an option to apply for a unitary SPC by centralised examination. As centralised marketing authorisations are not available for plant protection products, the proposals include various mechanisms for dealing with this disjointed procedure. For example, the marketing authorisations do not need to have been granted by the time the SPC is applied for. Also, a unitary SPC may be granted (or later maintained) with effect in not all of the Member States of the unitary patent in the event that not all of the national marketing authorisations are granted before patent expiry. However, the way that the EU Commission has proposed to handle the mis-match of a unitary patent and non-unitary marketing authorisations has deficiencies: if a reason for invalidity is discovered in at least one of the Member States this could lead to invalidity of the entire unitary SPC with no current proposal for allowing conversion to national SPCs (conversion to national SPCs is only envisaged where the unitary status of the basic patent is revoked).
In both of the proposed Regulations for unitary SPCs, the EU Commission has proposed to clarify the duration of the unitary patent, i.e. to grapple with the differences in interpretation under national law. The clarification itself is not totally clear, but appears to follow the interpretation in France/UK that the SPC would take effect on the 20th anniversary of the filing date. In any event, this does not address the fundamental lack of harmonisation of patent term across Member States, leaving a possible discrepancy in term between unitary and non-unitary SPCs.
If a centralised examination opinion is negative, the applicant may file an appeal at the Boards of Appeal of the EUIPO, subsequently before the General Court and with a possible final appeal to the Court of Justice of the EU (CJEU).
Third parties will be able to file third-party observations at the EUIPO within 3 months after publication of the application.
Moreover, within two months of publication of a positive examination opinion, third parties can file an opposition.
SPCs will only be granted after completion of any appeal and opposition procedures.
Hence, there is concern that pre-grant oppositions could be used tactically by third parties to delay grant of SPCs such that they cannot be enforced against potential infringers until the end of the opposition and appeal process.
CHALLENGING SPCs AFTER GRANT
For national SPCs, stand-alone invalidation proceedings will be able to be started before the body responsible under national law for the revocation of the corresponding basic patent, or before a competent court of a Member State, including the Unified Patent Court (UPC) if applicable. For example, where the basic patent has not been opted out of the UPC, the UPC would have exclusive competence to hear invalidation of the national SPCs (after the end of the UPC transition period).
However, for unitary SPCs, the proposals indicate that stand-alone invalidation proceedings would have to be heard at the EUIPO (with appeals to the Boards of Appeal of the EUIPO, then General Court, then CJEU). Hence, this suggests that validity of unitary SPCs could be heard on a wholly separate route from the UPC.
For all SPCs, an application for a declaration of invalidity can be a counterclaim in litigation before a competent court, which for unitary SPCs would solely be the UPC.
CHANGES TO THE SUBSTANTIVE REQUIREMENTS
As part of recasting the existing SPC Regulations, the EU Commission has proposed to introduce new Recitals (i.e. the passages before the actual Articles of each Regulation) to codify some of the case law given by the CJEU on the requirements in Article 3.
The EU Commission alleges that the substantive requirements for obtaining an SPC will remain unchanged by the recasting, but we have identified some prominent differences introduced by the proposals:
- Removal of the Recital indicating that a new salt/ester form that has its own basic patent can be the subject of its own SPC; instead the proposals indicate that a product (i.e. its active ingredient or combination of active ingredients) may only be the subject of one SPC and that the SPC will cover all equivalent derivatives (therapeutically or from a phytosanitary perspective) that fall within the limits of protection of the basic patent;
- Although it will remain possible for more than one patent holder to obtain an SPC to the same product, the proposed Regulations indicate that those holders must not be economically linked;
- With respect to so-called third-party SPCs (where the patent holder and marketing authorisation holder are different parties), the proposals introduce a restriction that the patent holder must have the consent of the marketing authorisation holder to obtain an SPC.
Notably, the proposals do not currently include any transitional provisions, except to indicate that centralised examination will not apply to SPC applications that were pending at the entry into force of the recast Regulations. Hence, it is unclear how the changes above would be assessed for pending applications.
The proposed new Regulations relating to unitary SPCs mirror the changes proposed for the recast versions of the existing Regulations.
We hope that the EU Commission will appropriately consider the feedback given during the consultation process to address concerns about each of the above changes.
Please contact our SPC and Regulatory team if you have any questions or need any advice or assistance relating to any aspect of SPCs.