## Facts

- Sanofi owned European Patent (UK) No. 0 454 511 claiming the antihypertensive active ingredient irbesartan; the patent expired in March 2011.
- To address regulatory delay, Sanofi obtained two supplementary protection certificates (SPCs) under Regulation (EC) No 469/2009: one for irbesartan alone (expiring August 2012) and a later SPC for the combination irbesartan + hydrochlorothiazide (HCT) (expiring October 2013).
- HCT was a well-known diuretic and was not claimed as such in the basic patent; evidence indicated that combining an angiotensin II receptor blocker with a diuretic for hypertension was routine at the relevant time.
- Actavis planned to launch generic irbesartan and generic irbesartan/HCT products and sought a declaration that the combination SPC was invalid; infringement of the combination SPC was accepted if that SPC were valid.
- The dispute turned on whether the combination was “protected by a basic patent in force” and whether more than one SPC could be obtained from the same patent for related products.
- The case was tried on an expedited basis in a one-day hearing before the Patents Court.

## Issues

1. Under Regulation 469/2009 art. 3(a), when is a combination product (irbesartan + HCT) “protected by a basic patent in force” where the patent claims the core active ingredient but does not expressly claim the second active ingredient?
2. Under Regulation 469/2009 art. 3(c), does “the product has not already been the subject of a certificate” bar a second SPC based on the same patent where an SPC has already issued for the core active ingredient and a later marketing authorization covers a combination with an additional, non-claimed active ingredient?

## Decision

- The Patents Court did not issue a final merits ruling on the validity of the combination SPC.
- The court held that the meaning and interaction of arts. 3(a) and 3(c) in this setting were not clear from existing authority.
- The court referred the two EU-law questions to the Court of Justice of the European Union for a preliminary ruling and effectively stayed further determination pending that ruling.

## Legal Principles

- Where the outcome depends on unresolved questions of EU law, a national court may refer questions to the CJEU under the preliminary ruling procedure rather than decide the point definitively.
- For SPC eligibility, art. 3(a) raises a claim-scope question: whether a “product” is “protected” requires analysis of whether the active ingredient(s) are covered by the basic patent’s claims, and existing EU case law may not fully resolve how that applies to combination products when a second active is not expressly claimed.
- Art. 3(c) addresses serial SPCs and requires close attention to whether permitting an SPC for a patented active ingredient and a further SPC for a later combination would extend exclusivity beyond the limited compensation objective of the SPC regime.
- Policy considerations relevant to interpretation include avoiding repeated extensions tied to the same core patented inventive contribution when later products add non-patented active ingredients.

## Conclusion

The Patents Court treated the dispute over Sanofi’s irbesartan/HCT combination SPC as turning on unsettled interpretation of Regulation 469/2009, and it referred to the CJEU the questions whether the combination was “protected” by the basic patent under art. 3(a) and whether a prior SPC for irbesartan barred a later SPC for irbesartan plus a non-claimed active ingredient under art. 3(c).


Actavis Grp. PTC EHF v. Sanofi, [2012] EWHC 2545 (Pat) (Eng.)