SPC Summer Review 2025
01
Oct
2025
Recent developments in Supplementary Protection Certificate law and practice

Our SPC Summer Review, a roundup of the most important developments in Supplementary Protection Certificate (SPC) law over the past 12 months, has been published in two parts in the CIPA Journal.

In part one we discuss the CJEU’s judgment in joint cases C-119/22 and C-149/22. As has so often been the case, the CJEU’s judgment, while providing clarity on some issues, arguably muddies the water on others. We then move on to the latest (and likely final) installment in Merck Serono’s attempts to resurrect Neurim in the UK following its exit from the EU. Staying on this topic, we then provide an overview of the recent updates to the SPC system in the UK. This first installment then moves across the Channel to look at how the Belgian courts applied the manufacturing waiver, before discussing how the French courts handled yet another case relating to antibody SPCs.

The second part of our review looks at a referral from the Czech courts concerning article 1(b) and the question of when a

substance can represent ‘an active ingredient’ for SPC purposes. Turning to national decisions, we report on two interesting decisions from the Swedish courts – one dealing with article 3(d) in the context of combination therapies; and the other dealing with the age old question of exactly how SPC term should be calculated. Finally, we report on a decision from the French courts applying the CJEU’s judgment in Santen.

View part one of the review in the July/August edition and part two in the September edition of the CIPA Journal.