A team at Carpmaels has reviewed the extensive feedback from stakeholders on the new SPC regulations proposed by the European Commission (see here for background) and distilled it down to the following main themes:

Support for centralisation – there is general support for a centralised SPC system and the greater harmonisation and simplification this is expected to bring.

Lack of transparency and absence of transitional provisions – many stakeholders have taken issue with the Commission’s assertion that the proposed reform is not intended to make substantive changes to SPC law, whereas stakeholders in fact see such changes, and without any transitional provisions. There has also been criticism that a number of the proposed amendments do not fully or correctly reflect the CJEU’s existing case law (particularly C-650/17 Royalty Pharma and C‑482/07 AHP Manufacturing) or attempt to pre-empt the outcome of pending CJEU referrals (C-119/22 Teva and C-149/22 MSD on combination product SPCs).

Delays and mischief due to pre-grant opposition – the vast majority of stakeholders requested that the option of filing pre-grant oppositions be dropped. They consider pre-grant opposition unnecessary in light of the ability to file third party observations pre-grant, and the option of challenging SPCs post-grant. There is concern that pre-grant oppositions are open to abusive tactics to evade enforcement, as even a meritless pre-grant opposition might not only stretch out beyond patent expiry but could also consume the practical SPC term. For example, the EPI (the organisation of EPO professional representatives) warned that pre-grant challenges will “result in endless delays” and “the de facto non-useability of the centralised SPC system”. Similarly, EFPIA (the trade body for the European research-based pharmaceutical industry) describe pre-grant opposition as “unreasonable, unnecessary, overly bureaucratic, and inherently open to misuse”.

Ambiguity of the term ‘economically linked’ – one of the Commission’s proposed amendments is that ‘economically linked’ parties may not obtain multiple SPCs for the same product. Many stakeholders noted that this term, and the time point of its assessment, is unclear. They proposed that the exclusion of multiple SPCs per product instead be limited to applicants that are part of the same undertaking at the time of filing the SPC application, hence licence agreements and future mergers, for example, would not preclude the granting of multiple SPCs or affect their future validity.

Unclear how and when an MA holder may ‘consent’ to a third-party SPC – another amendment that does not reflect established practice or case law is the proposal that a marketing authorisation holder must consent to its MA being used by another party as the basis for an SPC (the question was asked but not answered in C-239/19 Eli Lilly). Stakeholders noted that the proposals do not set out how and when an MA holder may grant consent, whether and how this consent should be proven, and whether consent can be withdrawn.

Lack of EUIPO’s expertise in SPC matters – there is concern that the EUIPO (the EU’s administrative body for trade marks and design rights) as the proposed examination and appeal/invalidity body under the new regime does not have the necessary SPC and technical expertise. Many stakeholders proposed that instead the EPO should be responsible for centralised SPC examination, and the UPC should have (exclusive) jurisdiction over appeals and declarations of invalidity.

Unrealistic in the agrochemical space to require an MA in each member state – the proposal that SPC protection would require obtaining an MA in each of the member states led to objections by stakeholders in the plant product field. For example, Business Europe noted that this “does not take into account the specificity of the sector and is detached from reality”, and that plant protection product SPCs should require an MA in relevant member states only. CropLife Europe explains that “for both agronomical and environmental reasons, plant protection products are specific to locations and crops, unlike, for example, pharmaceuticals which would generally be marketed everywhere”.

The feedback was provided by European trade associations, national industry bodies from Europe and the US, patent attorney professional bodies, pharmaceutical companies, and insurance representatives. The full set of feedback can be found here.

We expect that the earliest the new regulations will come into force is mid-2025.

We will keep you updated on the progress of these proposals. If you want to discuss any of the above in more detail, or the potential relevance of the proposals to any specific cases, please get in touch.

Team: Natalia Wegner, Richard Payne, Stephanie Willing, Rhodri Hopes, Alastair Baldry, Kat Langford, Corey Chapman