By decision no. 4136/2015 of 31 March (in Mylan v. Boehringer), the Court of Milan declared the invalidity of a supplementary protection certificate (“SPC”) for a combination of two active ingredients, one the object of a basic patent (and already covered by an SPC) and the other one in the public domain but claimed in the patent in combination with the ingredient object of the invention. Specifically, the subject matter was exactly the same as that of the recent ruling of the European Court of Justice (“ECJ”) in Case C-577/13 (Actavis v. Boehringer), which we discussed here on this blog:the issue in dispute was in fact the supplementary protection certificate (“SPC”) held by Boehringer on the combination of the active principle “telmisartan” with the diuretic “hydrochlorothiazide”, and the parties’ defences were similar, as well as the conclusions of Judges.

It should be noted that the ECJ judgment in C-577/13 was actually not mentioned in the Milan decision being discussed, probably because it was issued after the date of adoption of the latter (which was adopted on 18 December 2014, despite the publication on 31 March 2015). However, the same ECJ decision in C-577/13 largely followed the earlier ECJ judgment in C-443/12 (Actavis v. Sanofi), whose teachings were already applied by the Court of Milan amongst others in judgment no. 9855/14 (Sanofi v. Teva) commented on here on this blog, and which have been confirmed in this new decision.

The Milan Court found that, in relation to the requirements for the grant of a valid SPC posed by Art. 3 of EU Regulation no. 469/09, “preliminary rulings of the Court of Justice have been issued on the interpretation of that Community law provision, which are directly applicable in national proceedings and bind the national courts”. Hence, the Judges stated, according to what was affirmed by the ECJ in C-443/12, “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”. As a consequence, the Milan Court stated, “the notion of a ‘product protected by basic patent’”, for which an SPC may be granted under Art. 3 of EU Regulation no. 469/09 “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 main 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 anti-hypertensives and diuretics), which are not precluded by any technical problem or general contraindication, and therefore did not require any inventive activity”.

In applying them, the Milan Court stated that the conclusions reached by the Court of Justice “are not such as to frustrate the research related to combinations of principles (even if already known) that have in itself surprising new effects and new uses, which may, where appropriate, give rise to dependent patents”.

The Judges then concluded that, in the case at issue, “the compound that is the subject of the invention is not the active ingredient selected from the list of diuretics (hydrochlorothiazide), but its main partner, i.e. telmisartan”, being instead hydrochlorothiazide not protected by any patent. Therefore, as an SPC for telmisartan had already been granted, “Boehringer had exhausted its exclusive right upon the expiry of that first SPC”. The Court therefore declared the nullity of the second SPC on the combination of telmisartan and hydrochlorothiazide, and the lawfulness of the marketing by Mylan of medicines containing this combination.