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Supplementary Protection Certificates for combination products: another Court of Justice of the EU referral

Posted: July 21, 2023

The ability to obtain a Supplementary Protection Certificate (SPC) where the active ingredient is a combination of products and one of these products has already been granted SPC protection is a hot topic in the SPC world.

As previously reported, national courts have taken divergent approaches in the tests used to assess whether combination products are deemed “protected by a basic patent” and whether an SPC has already been granted for the combination product. This resulted in referrals from both the Finnish and Irish Courts to the Court of Justice of the European Union (CJEU) in the hope that a decision would be issued to harmonise national practice.

The plot has subsequently thickened with the Swedish Courts also referring questions up to the CJEU following a recent decision from the Swedish Supreme Court.

Reason for referral

The referral relates to AstraZeneca’s combination product containing dapagliflozin and metformin. AstraZeneca obtained an SPC for dapagliflozin individually based on EP1506211.

Since dapagliflozin was already granted SPC protection, the SPC application for the combination product was rejected by the Swedish Patent Office and the subsequent appeal to the Patent and Market Court was dismissed. The main reasoning was that, while it was clear that the combination product was protected by the basic patent, AstraZeneca were precluded from obtaining an SPC for the combination because dapagliflozin was already the subject of an SPC help by AstraZeneca. This is in line with the teachings laid down in Actavis (C-443/12).

Upon appeal, the Swedish Supreme Court decided that the Swedish Patent and Market Court should have referred questions up to the CJEU so that a definitive answer on when obtaining an SPC for a combination product when one of the active ingredients is already the subject of an SPC is allowable. The reasoning of the Supreme Court was:

• It is unclear whether recent case law (Teva and Royalty Pharma) on the assessment of whether a combination product is protected by a basic patent might affect obtaining an SPC for a combination product when one of the active ingredients is already the subject of an SPC.
• The existing case law (e.g. Actavis) seems to adopt a stricter approach than that stated in the SPC regulation.
• There is a lack of harmonisation between approaches taken by national courts.
• AstraZeneca’s referral was similar to the Finnish and Irish cases, which have also been referred up to the CJEU.

The Swedish Patent and Market Court will in due course refer questions up to the CJEU. However, the wording of these questions is not yet known. Since the UK’s departure from the European Union, the decision of the CJEU will not be binding on UK proceedings. However, examiners and judges may well consider the decision(s) when assessing whether SPCs should be granted for combination products when one of the active ingredients has already been afforded SPC protection.

If you have any questions, please contact one of Forresters’ SPC experts.