Italy: New developments on the validity of SPCs for a combination of active ingredients

01 October 2014

Giovanni Galimberti, Evelina Marchesoni

In July 2014 the Court of Milan filed two judgments[1] declaring the invalidity of the Italian supplementary protection certificate ("SPC") on the combination of telmisartan and hydrochlorothiazide ("HCTZ") (the "Combination SPC") owned by Boehringer Ingelheim Pharma GmbH & Co. KG ("Boehringer").

Background

Boehringer was the owner of European patent EP0502314 ("EP '314"), relating to compounds used for treating hypertension (high blood pressure).

On the basis of EP '314, which expired on 31 January 2012, Boehringer obtained three SPCs in Italy: one for telmisartan, one for the combination of telmisartan and HCTZ (the Combination SPC) and one for the combination of telmisartan and amlodipine. The SPCs were based on claim 8 of the basic patent which claimed, inter alia, pharmaceutical compositions containing telmisartan.

On December 30 2011, Boehringer filed before the Italian Patent and Trademark Office ("UIBM") an application for the limitation of EP '314. In particular, the patentee asked for the reformulation of the new claim 7[2] providing for "pharmaceutical compositions containing a compound according to at least one of claims 1 to 5 or a physiologically acceptable salt according to claim 6 optionally in combination with bendroflumethiazide, chlorothiazide, hydrochlorothiazide, spironolactone, benzotiazide, ciclotiazide, ethacrynic acid, furosemide, metoprolol, prazosin, atenolol, propranolol, di-hydralazine hydrochloride, diltiazem, felodipine, nicardipine, nifedipine, nisoldipine or nitrendipine, and optionally together with one or more inert carriers and/or diluents" (amendments are underlined).

The patentee specifically mentioned the combination of active ingredients in order to comply with the principles laid down by the judgment of the European Court of Justice ("ECJ") of November 24, 2011 in case Medeva C-322/10 ("Medeva judgment"), providing that, in compliance with Article 3(a) of the EU Regulation 469/2009 (the "SPC Regulation"), an SPC can be granted only if the active ingredient or the combination or active ingredients are mentioned in the claims of the basic patent[3].

According to Boehringer, the requested limitation was supported by the description as originally filed, and therefore the protection of the patent would not be extended but simply limited[4].

Subsequently, on June 21, 2013 Boehringer filed before UIBM a further limitation application in respect of EP '314. By this limitation, the patentee amended claim 7, cancelling the adverb "optionally" written before the list of the anti-hypertensive active ingredients[5].

Both the limitation applications filed by Boehringer were respectively granted by UIBM on June 20, 2013 and on July 31, 2013.

The Italian invalidity proceedings

In 2013 different proceedings for invalidity of the Combination SPC  were filed before the Court of Milan by EG and Zentiva separately. The Italian SPC for the combination of telmisartan and amlodipine was withdrawn by Boehringer during these proceedings.

It was alleged that the Combination SPC of Boehringer was invalid since at the date of the SPC application the product to which it refers to:

-         was not protected by a basic patent in force; and

-         had already been the subject of a SPC.

In its judgment of July 10 2014, the Court declared the invalidity of the Italian Combination SPC for non-compliance with the requirements of Articles 3 (c) and 3 (a) of the SPC Regulation as well as the consequent lawfulness of any activity of manufacturing, importation, commercialization, promotion and sale of generic medicinal products containing the combination of telmisartan and HCTZ.

Grounds of the judgments

Upon examination of the requirement provided by Article 3(c) of the SPC Regulation, the Judges stressed the relevance of the ECJ judgement of December 12 2013 in case Actavis C-443/12 (the "Actavis Judgment"), which – like any ECJ decision – is binding for the national Judges in cases concerning the applicability of the same rule interpreted by the ECJ.

According to the Court, it is clear that the "product" pursuant to article 1(b) of the SPC Regulation was intended to be the active ingredient protected as such by the holder's basic patent and constituting the core inventive step of that patent[6]. The concept of "product" thus excludes combinations of innovative active ingredients and ingredients that are already known.

According to the Italian Court, the product protected by EP '314 wassolely telmisartan, as admitted by Boehringer themselves when they submitted grounds for the limitation[7].

Consequently, in applying the principles set out in the Actavis Judgment - that on the basis of a patent protecting an innovative active ingredient and a marketing authorization ("MA") for a medicinal product containing that ingredient as the single active ingredient, and where the patentee has already obtained an SPC for that active ingredient, Article 3(c) of the SPC Regulation must be interpreted as precluding that patentee from obtaining a second SPC relating to that combination of active ingredients. Consequently the Court of Milan declared the Italian Combination SPC invalid according to Article 3(c) of the SPC Regulation.

Furthermore, upon examination of the requirement of Article 3(a) of the SPC Regulation the Court declared the inadmissibility of the limitation requested by Boehringer. As a matter of fact the Judges deemed that such limitations, by adding to the compositions claimed by claim 7 a set of new active ingredients, extended the subject matter of EP '314 thus allowing them to obtain a different and broader scope of protection. In particular the Court pointed out that the description of the patent referred to a specific dosage of the new active ingredients while in the limited claim such dosages are not included, which had the effect of extending the scope of protection of EP '314[8].

Consequently the Court of Milan declared the Italian Combination SPC invalid also according to Article 3(a) of the SPC Regulation (as interpreted in Medeva) since  the basic patent EP '314 as originally filed did not mention HCTZ in the wording of the claims.

Conclusions

These judgments add to the worldwide litigation involving the Boehringer's Combination SPC.

By applying the principles laid down by the ECJ in the Actavis Judgment, the Court of Milan seems to have modified the opinion previously expressed in the decisions issued in 2013 (see our previous article on http://www.twobirds.com/en/news/articles/2013/global/recent-decisions-on-spcs)and through doing so the Italian Court has reached the same conclusion of many other European countries. As a matter of fact, the Combination SPC has already been declared null and void, inter alia, in Germany, Spain and France (albeit on different grounds).

This in itself is significant, in light of the interpretation of the SPC Regulation carried out by the ECJ, the national Courts uniformly assessed the (in)validity of an SPC pursuant to the objectives of the SPC Regulation set out in Recital 7, "thereby preventing the heterogeneous development of national laws leading to further disparities which would be likely to create obstacles to the free movement of medicinal products within the Community and thus directly affect the functioning of the internal market".

This article is part of the International Life Sciences Update for October 2014

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