(The original Italian version is published also on Diritto 24 – Il Sole 24 Ore)

By judgment No. 9855/14 published on 1 August, the Business Chamber “A” of the Court of Milan has decided the lawsuit filed by Sanofi against Teva for the infringement of supplementary protection certificate no. UB99P653 (“SPC ‘653”), which was owned by Sanofi for its CoAproval medicine (irbesartan hydrochlorothiazide) and allegedly infringed by the relevant generic drug from Teva. The decision—departing from earlier judgments of the same Chamber—found for the invalidity of SPC ’653, openly conforming to the judgment of the Court of Justice of the European Union (“CJEU”) in the identical case between Sanofi and Actavis (C-443/12 ).

The key issue of the dispute was essentially the validity of SPC ‘653: according to the defendant, it was invalid both because the relevant basic patent EP 454511 (EP’ 511) did not claim the combination of irbesartan and hydrochlorothiazide and because SPC ’653 had been granted after Sanofi had already obtained an SPC for its medicine Aproval, containing, as its single active ingredient, irbesartan (i.e. the subject matter of EP ’511). According to Teva, such circumstances did not fulfil conditions for a valid SPC to be granted, as laid down in Article 3(a) and (c) of Regulation No. 469/2009: “A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application: (a) the product (alias “the active ingredient or combination of active ingredients of a medicinal product”, according to the definition of “product” in Article 1 of the Regulation) is protected by a basic patent in force; (b) a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as appropriate; (c) the product has not already been the subject of a certificate; (d) the authorisation referred to in point (b) is the first authorisation to place the product on the market as a medicinal product.”

The plaintiff argued that the SPC ’653 should instead be considered valid since EP’ 511 covered not only the “product” consisting of the active ingredient irbesartan but also – in Claim 20 – a “product” containing the combination of irbesartan with a “diuretic”, for which a person skilled in the art would have selected hydrochlorothiazide (which satisfied the condition of art. 3(a)); in addition, its medicine consisting of the combination of irbesartan and hydrochlorothiazide was a “product” that was different from its medicine made of irbesartan only, and it could therefore be protected with an autonomous SPC pursuant to Art. 3(c).

The Milan Business Chamber had initially accepted Sanofi’s view, prohibiting the marketing of Teva’s generic drug as a precautionary measure because of the infringement of SPC ’653, and confirming the decision on appeal. However, in the decision under review, the judges changed the course in part, expressly for the need to comply with the decision of the CJEU in the Actavis case (C-443/12), which concerned the same patent and SPC (allegedly counterfeited in that case by the corresponding generic drug from Actavis).

Specifically, the Milanese judges confirmed what they had stated in the precautionary proceedings on the existence of the condition of Art. 3(a), finding support in another decision of the CJEU (C-493/12, Eli Lilly), “given that Claim 20, which literally indicates the association of irbesartan with a diuretic, could be considered to include the possible combination of irbesartan + hydrochlorothyiazide, since the latter is one of the diuretics commonly used as an antihypertensive and is easily identifiable by a person skilled in the art”.

The Milanese judges, however, reversed the course with regards to the requirement of Art. 3(c), pointing out that, according to the decision of the CJEU in the Actavis case, “it cannot be accepted that the holder of a basic patent in force may obtain a new SPC, potentially for a longer period of protection, each time they place on the market in a Member State a medicinal product containing, on the one hand, the principle active ingredient, protected as such by the holder’s basic patent and constituting, according to the statements of the referring court, the core inventive advance of that patent, and, on the other, another active ingredient which is not protected as such by that patent”(paragraph 30). In this sense, according to the Milanese Specialised Business Chamber (in line with the CJUE findings), hydrochlorothiazide is not “as such protected by the patent”, because “the  concept of “product protected by basic patent” does not include the combinations of the inventive active ingredient with other known ingredients that—even if, as in this case, are claimed in dependent claims enjoying the inventiveness of the principle claim they depend upon—represent forms of mere single administration of medicines already commonly prescribed together for their known synergistic effects (which is the case of antihypertensives and diuretics), which do not preclude any technical problem or general contraindication, and therefore did not require any inventive activity”.

The Court of Milan therefore rejected Sanofi’s claims and declared the invalidity of SPC ’653 as requested by way of counterclaims by Teva, and ordered Sanofi to pay the costs of the proceedings and of the Court Experts.