## Facts

- Sanofi held European Patent EP 0 454 511 covering compounds for treating high blood pressure, including the active ingredient irbesartan.
- The basic patent was granted in 1998 and later expired in 2011.
- Sanofi obtained two supplementary protection certificates (SPCs) based on the patent: one for irbesartan as a single active ingredient (expiring in 2012) and a second for irbesartan in combination with hydrochlorothiazide (HCT) (expiring in 2013).
- The patent’s relevant claim language referred to administering the claimed compound in association with “a diuretic,” rather than naming HCT expressly; in practice, the diuretic in the fixed-dose product was HCT.
- Before the combination SPC expired, Actavis sought to place generic versions of Sanofi’s antihypertensive products on the German market, including a fixed-dose combination of irbesartan + HCT.
- Sanofi applied to the Düsseldorf Regional Court (Landgericht Düsseldorf) for a preliminary injunction to stop Actavis from marketing the combination generic in Germany during the remaining term of the combination SPC.
- Actavis opposed interim relief and challenged the right asserted, arguing (among other points) that the combination SPC was defective because the basic patent did not specify HCT by name and only used the general term “diuretic,” raising questions under EU SPC law and then-recent CJEU case law (including the “Medeva” line).
- The infringement request proceeded in Düsseldorf after earlier proceedings had upheld the validity of the underlying patent.

## Issues

1. Whether Actavis’s fixed-dose irbesartan + HCT generic fell within the scope of Sanofi’s combination SPC.
2. Whether, for interim enforcement, the combination SPC could be treated as “protected by a basic patent in force” under Article 3(a) of Regulation (EC) No. 469/2009 when the patent referred to a “diuretic” rather than naming HCT.
3. Whether Actavis’s validity objections—based on EU SPC requirements and developing CJEU jurisprudence—created sufficiently serious doubts to defeat a preliminary injunction under German standards.

## Decision

- The court granted Sanofi’s application for a preliminary injunction.
- Actavis was prohibited, until further notice, from marketing its irbesartan + HCT generic product in Germany during the life of the combination SPC.

## Legal Principles

- Under German preliminary-injunction practice in patent/SPC matters, interim relief generally requires (i) a sufficiently strong showing of infringement and (ii) no serious, immediate doubts as to the enforceability of the asserted right at the interim stage.
- In assessing interim enforceability of an SPC, the court may treat the SPC’s grant and continued validity—together with prior confirmation of the basic patent in validity proceedings—as supporting provisional enforcement unless the defendant shows clear grounds that the SPC is invalid or unenforceable.
- Article 3(a) SPC questions about whether a combination product is “protected” by the basic patent can be litigated in interim proceedings; where the patent claim identifies the additional ingredient by a functional class (here, “diuretic”), the court may consider whether that wording is sufficient, in context, to cover the specific ingredient used (HCT) for purposes of provisional relief.
- Unresolved or developing EU-law questions do not automatically bar a preliminary injunction; the key inquiry is whether the defendant’s objections raise a level of doubt that makes interim enforcement inappropriate.

## Conclusion

In Sanofi v. Actavis (Germany), Case No. 4a 0109/12 (2012), the Düsseldorf Regional Court granted a preliminary injunction stopping Actavis from marketing a generic fixed-dose irbesartan/hydrochlorothiazide product in Germany, accepting—at least provisionally—that Sanofi’s combination SPC remained enforceable despite Actavis’s challenge that the basic patent referred only to a “diuretic” rather than naming HCT and despite arguments based on evolving CJEU SPC case law.
