Actavis Group PTC EHF & Anor v Sanofi Pharma Bristol-Myers Squibb SNC

For the purposes of Article 3(a) of Regulation 469/2009/EC, a product must embody the inventive advance or technical contribution of the basic patent. It is insufficient that marketing the product would infringe a broadly drafted claim. Accordingly, where the patent’s inventive advance lies in a new active ingredient, a medicinal product combining that ingredient with a conventional, non-inventive additional ingredient is not protected by the patent as a combination product.

The proper interpretation of Articles 3(a) and 3(c) remained insufficiently clear. The court therefore referred questions to the CJEU.

Actavis sought to market generic versions of Aprovel and CoAprovel after expiry of the patent covering irbesartan. Sanofi relied on a supplementary protection certificate for the combination of irbesartan and hydrochlorothiazide.

Actavis challenged the combination SPC under Articles 3(a), 3(c) and 3(d) of Regulation 469/2009/EC. The central issues were whether the combination was protected by the basic patent, whether the earlier irbesartan SPC prevented a further certificate, and whether the earlier Aprovel authorisations were the first authorisations for the relevant product.

1. The court held that claim 20 was not limited to irbesartan combined with hydrochlorothiazide, to treatment of hypertension, or to fixed-dose combinations. It also covered compositions prepared ex tempore by a pharmacist.

2. The inventive advance or technical contribution of the patent lay in the disclosure of the new compounds of formula I, including irbesartan. Combining such a compound with a diuretic for hypertension was an obvious step and claim 20 disclosed no independent inventive advance.

3. Article 3(a) involved a question of European law. It was necessary, but insufficient, that marketing the product by a non-proprietor would infringe the basic patent. The product must also infringe because it contains an active ingredient, or combination of active ingredients, embodying the patent’s inventive advance.

4. On that approach, irbesartan alone was protected by the patent, but a combination of irbesartan and hydrochlorothiazide was not. The result would be different where a later patent disclosed an inventive combination, such as irbesartan and another substance producing a surprising synergistic effect.

5. The interpretation of Article 3(c) depended on Article 3(a). If a patent protected two inventively distinct products, one SPC might be granted for each product. The court nevertheless considered the existing CJEU guidance unclear, particularly after Medeva BV v Comptroller-General of Patents, Designs and Trade Marks and the related cases.

6. The court referred two questions to the CJEU concerning the interpretation of Articles 3(a) and 3(c). The parties were invited to address the precise wording of the questions, especially the second question.

First-instance decision. The court referred two questions concerning Regulation 469/2009/EC to the CJEU for a preliminary ruling.