## Facts

- Sanofi owned a European “basic patent” covering the antihypertensive active ingredient irbesartan and certain combinations of irbesartan with other active ingredients, including a diuretic.
- Sanofi obtained a first EU marketing authorization for a medicinal product containing irbesartan as a single active ingredient.
- Based on that authorization and the same basic patent, Sanofi obtained an SPC for irbesartan; the SPC’s protection for irbesartan extended to use of that ingredient alone or in combination with other active ingredients.
- Sanofi later obtained a second marketing authorization for a combination medicinal product containing irbesartan plus hydrochlorothiazide (HCT).
- Using the same basic patent but the later authorization, Sanofi obtained a second SPC for the combination product (irbesartan + HCT).
- Actavis, intending to market generics, challenged the validity of the second SPC in UK proceedings.
- The UK Patents Court referred questions to the CJEU on whether the SPC Regulation permits this second SPC, focusing on Article 3(c).

## Issues

1. Whether Article 3(c) of Regulation (EC) No 469/2009 permits a patentee to obtain, on the basis of the same basic patent, a second SPC for a combination product that includes an active ingredient already covered by an earlier SPC held by that patentee.
2. How the SPC Regulation’s limits on exclusivity affect the interpretation of “has not already been the subject of a certificate” in Article 3(c) in the context of later-authorized combination products.

## Decision

- The CJEU held that, in circumstances like those presented, Article 3(c) precludes the grant of a second SPC for a combination product containing an active ingredient that has already been the subject of an SPC based on the same basic patent.
- Because the first SPC for irbesartan already allowed the patentee to prevent use of irbesartan alone or in combination, a second SPC for irbesartan + HCT would improperly extend exclusivity for the same inventive active ingredient.
- The Court’s answer required the referring national court to treat the combination-product SPC as invalidly granted in the resumed proceedings.
- The Court did not base its ruling on Article 3(a), even though claim-specificity arguments were raised.

## Legal Principles

- Article 3(c) restricts multiple SPCs based on the same basic patent when the later certificate would extend protection for an active ingredient already rewarded by an earlier SPC held by the same patentee.
- Where a first SPC for an innovative active ingredient confers the right to oppose that ingredient’s use alone or in combination, a later SPC for a combination containing that same active ingredient is barred.
- The SPC regime is interpreted in light of its compensatory purpose and built-in limits: it is intended to offset regulatory delay without permitting duplicative or excessive extensions of exclusivity.
- The fact that a basic patent claims multiple products does not, by itself, entitle the patentee to separate SPCs for each later-authorized combination when this would functionally prolong protection for the same active ingredient.

## Conclusion

The CJEU interpreted Article 3(c) to prevent a patentee from obtaining a second SPC, based on the same patent, for a later-authorized combination product when the patentee already holds an SPC for the combination’s key active ingredient and that first SPC already covers the ingredient’s use in combinations.


Actavis Grp. PTC EHF v. Sanofi, Case C-443/12 (C.J.E.U. 2013)