Italy: Recent decisions on SPCs for combinations of active ingredients


In the last few months, the Court of Milan has issued several decisions and orders[1] fitting within the framework of the European-wide litigation concerning Sanofi's combination supplementary protection certificate ("SPC") on irbesartan and hydrochlorothiazide ("HCTZ").


Sanofi was the owner of the European Patent No. EP 0454 511 claiming the anti-hypertensive drug irbesartan. The patent expired on March 20, 2011 and in Italy Sanofi obtained two SPCs based on this patent: one for irbesartan and one for the combination of irbesartan + HCTZ. The latter is based on claim 20 of the basic patent claiming irbesartan in combination with a diuretic.

All the generic companies who were brought into different infringement and preliminary injunction ("PI") proceedings by Sanofi tried to dismiss the claims of the originator, challenging the validity of the combination SPC.

In particular[2], they alleged that the SPC for irbesartan + HCTZ would have been invalid on the grounds that:

i)       the combination was not specified in the wording of the claims in compliance with Article 3(a)            of Regulation 469/2009/EC ("SPC Regulation") as interpreted by the ECJ decision of the                    European Court of Justice ("ECJ") of 24 November 2011 in Medeva (C-322/10 - "Medeva");

ii)      only one SPC is allowed per patent in compliance with Article 3(c) of SPC Regulation.

Furthermore the generic companies asked for the Italian proceedings to be stayed in anticipation of the decision on a referral by Arnold J in September 2012  to the ECJ in parallel UK proceedings. This concerned Actavis' invalidity action relating to the corresponding UK SPC and Articles 3(a) and 3(c) of SPC Regulation (C-443/12).

The Court of Milan, both in the first instance and in the appeal filed against the grant of the PI orders, rejected all the arguments of the generic companies and confirmed the validity of the enforced SPC on the combination product. The Court granted the injunction requested by Sanofi.

Grounds of the first instance decisions

At first, according to the Court of Milan in the first instance decisions, the staying of the proceedings was not necessary since the rules of the SPC Regulation, as well as the case law of the ECJ, are sufficient to decide the issue.

As a matter of fact, the Judge pointed out that "Article 3(a) of SPC Regulation provides that the combination of active ingredients of the "product" has to be protected by a valid basic patent, without setting as requirements ad validatem also the express individuation and description of any single active ingredients".

The Court of Milan highlighted that, by reading the SPC Regulation (in particular Articles 4 and 5), the strict correlation between the basic patent and the extension of the protection granted by the SPC was evident. The latter was not subjected to further requirements not provided by the patent law.

The reference to Medeva was considered irrelevant for the case at issue according to the Judge at first instance.

Firstly Medeva concerned a different case since the SPCs at issue were based on a patent which protected an active ingredient constituted by the combination of two different substances. The relevant marketing authorisations (MAs) also referred to medicinal products containing different active ingredients which did not fall in the scope of protection of the basic patent.

Secondly Medeva stated that the claims have to identify the invention claimed by the basic patent in compliance with the patent law and that, in any case, if the patent protection is conferred to a sole active ingredient, an SPC for the combination of different active ingredients cannot be granted.

The Judge concluded: "there are no indications by the ECJ providing that any element of the product (i.e. the active ingredient or the composition of active ingredients of a medicinal product) has to be expressly and nominally individuated in the claims, in case the patent is valid in compliance to the patent law".

By so doing the Court of Milan seems to have broadly interpreted the ECJ principles.

As to the objection of invalidity to Sanofi's SPC under to Article 3(c), the Court of Milan highlighted that this rule excludes the grant of a further certificate if it has been already granted for the same product but not the grant of a further SPC for the same patent.

As a matter of fact: "if a patent can claim more products or more compounds [in compliance with Article 82 EPC[3]], on the basis of a sole patent more marketing authorizations may be granted and therefore also more SPCs, provided that such different SPCs refers to different products "as medicinal products" (all included in the scope of protection of the basic patent), which are authorized through different MAs".

Furthermore the Court pointed out that the word "product" of Article 3(c) of the SPC Regulation corresponds to "the medicinal product as authorised by the MAs", i.e. the "product as a medicinal product" and not to the term "patent" (which, as seen above, may legitimately claim more products).

Otherwise the alleged invalidity of the SPC could be easily avoided by the owner by simply filing two different patent applications.

Moreover, according to the Court of Milan, even the ECJ decision in Biogen (C-181/95) does not state that a patent can be the basis only and exclusively for one SPC but affirms that a sole SPC can be granted for the same "product".

In the case at issue Sanofi's SPCs covered two different "products", i.e. "irbesartan" and "irbesartan + HCTZ", which had been authorized by two different MAs, both "first authorization[s] to place the product on the market as a medicinal product" in compliance with Article 3(d) of the SPC Regulation.

Grounds of the Appeal Decisions

In the appeal proceedings filed by various generic companies against the PI orders, the Panel of Judges of the Court of Milan confirmed the decisions of first instance.

In their reasoning, with reference to the validity of the SPC on irbesartan + HCTZ according to Article 3(a) of SPC Regulation, the Judges highlighted the peculiarity of the case at issue where the basic patent claims the combination of irbesartan and a diuretic.

In particular, according to the Court of Milan, the person skilled in the art, reading claim 20 of Sanofi's basic patent, would have immediately understood that the diuretic could be HCTZ. As a matter of fact: "one of the active ingredients of the composition is indicated as belonging to the class of substances (diuretics) but in reality it could be directly identified by the person skilled in the art on the basis of his common knowledge and through routine operations".


These decisions provide an important and interesting overview of the interpretation of the SPC Regulation and ECJ case law regarding combination SPCs carried out by the Italian Judges.

Nevertheless, it seems that such an interpretation is not the same across Europe[4].

All we can do is wait for the ECJ decision in the parallel Actavis case, in the hope that this will produce  some clear and unambiguous principles.

[1] Decision of the Court of Milan, 29 December 2012 in Doc Generici vs Sanofi; decision of the Court of Milan, 29 December 2012 in Sanofi vs EG; first instance PI order of the Court of Milan, 22 December 2012 in Sanofi vs Teva; first instance PI order of the Court of Milan, 22 December 2012 in Sanofi vs Mylan; first instance PI order of the Court of Milan, 20 April 2013 in Sanofi vs Sandoz; appeal PI order of the Court of Milan, 6 March 2013 in Teva vs Sanofi; appeal PI order in Mylan vs Sanofi.

[2] The other objections relate to the invalidity of the basic patent for lack of inventive step and insufficiency and the invalidity of the SPC for violation of Article 3(c) of SPC Regulation.

[3] And the possible sanction for having claimed two different inventions in a patent is the obligation to file a divisional application and not the invalidity of the patent.

[4] For example, very recently, by decision dated 27 August 2013, the Court of Appeal of The Hague has decided in the parallel Dutch irbesartan case that Medeva should be read as "one SPC per patent" and not "one SPC per product per patent".