Bringing a new medicine or plant protection product to market takes many years of research, testing, and regulatory review. As a result, innovators often have only a limited period to benefit from patent protection once their products reach the market. To help compensate for this time lost during the regulatory process, and support continued investment in research and innovation, the EU provides Supplementary Protection Certificates (SPCs), which can extend protection after a patent expires.
Today, supplementary protection certificates (SPCs) are granted nationally. This means that companies seeking protection across the EU apply separately in each Member State, navigating multiple procedures and often facing diverging national decisions. The result is unnecessary duplication of work, higher administrative costs and a fragmented system that creates legal uncertainty for both innovators and third parties.
To address these challenges, the EU is now discussing the creation of a unitary SPC (uSPC), a single certificate linked to the existing unitary patent system. The objective is to create a more efficient, predictable and less fragmented system. Greater legal certainty would benefit both innovators and third parties by creating a clearer and more harmonised framework across the EU.
A centralised examination procedure building on national expertise
Introducing a unitary SPC in Europe requires a balanced approach: CropLife Europe supports a system in which applications are filed centrally with the European Union Intellectual Property Office (EUIPO) as the EU agency responsible for administering the procedure and issuing the final decision. The technical examination, however, would be carried out by National Patent Offices (NPOs) from Member States across the EU, acting on behalf of the EUIPO. NPO examiners would assess the application against harmonised EU rules and provide expert examination opinions, building on the extensive experience and technical expertise that NPOs have developed through decades of SPC practice. Based on these opinions, the EUIPO would then adopt the formal decision and grant the unitary SPC.
This approach combines the benefits of a single European procedure with the expertise of the Member State’s NPOs. Their examiners would continue to contribute directly to SPC examinations and to the development of a harmonised European examination practice, ensuring that national expertise is not replaced by centralisation, but rather integrated into it.
A balanced approach to uSPC validity
When it comes to invalidity procedures, CropLife Europe proposes to have a clear division of responsibilities.
The EUIPO and the EU courts would have competence over questions relating to EU SPC legislation. The Unified Patent Court (UPC), as the specialised court responsible for patent disputes within the existing unitary patent system, would handle any questions related to patent-law. The objective is to ensure that each institution deals with the issues for which it has the greatest expertise.
The UPC would determine matters such as whether the underlying patent is valid and whether it protects the product concerned. Its decisions on patent-related questions would provide the basis for the EUIPO’s assessment of the SPC application or validity challenge, ensuring consistency between patent and SPC proceedings. Once those patent-related issues have been decided, the EUIPO would act on the UPC’s findings and assess any remaining questions arising under EU SPC legislation.
Combining expertise and legal certainty
This bifurcated model which CropLife Europe proposes allows each institution to focus on the matters for which it has the greatest expertise. National patent offices would contribute their technical knowledge and practical expertise during examination, the EUIPO would ensure a centralised EU procedure, and the UPC would address specialised patent-law issues. Together, these elements would create a unitary SPC system that is efficient, legally robust and predictable, while strengthening legal certainty for innovators and other stakeholders across the EU.
To learn more about CropLife Europe’s position on a Bifurcation model for a Unitary SPC, click here for our position paper.