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15 September 2014
On July 21 and 28 2014 the IP Specialised Division of the Court of Milan issued two important decisions concerning the validity of supplementary protection certificates (SPCs) granted for the same patented invention.
Contrary to a previous decision of the Court of Milan – which held valid an SPC for a combination of irbesartan (a drug used for the treatment of hypertension, by itself covered under a previous SPC) and hydrochlorothiazide (a well-known diuretic) – in these two cases the court cancelled the Italian SPC for a drug whose active ingredient was a combination of telmisartan (another drug used to treat hypertension, by itself covered under a previous SPC that had expired) and hydrochlorothiazide.
The new Court of Milan decisions were based on the same grounds as decisions rendered by the European Court of Justice (ECJ) – in particular, Actavis (Case C-443/2012), which was issued with regard to the same case previously dealt with by the Court of Milan (involving irbesartan). Like the ECJ, the Court of Milan held that where a patentee has already obtained, on the basis of a first marketing authorisation, an SPC for an active ingredient:
"Article 3(c) of Regulation No. 469/2009 must be interpreted as precluding the holder of that patent from obtaining, on the basis of that same patent but a [marketing authorisation] for a different medicinal product containing that active ingredient in combination with another active ingredient which is not protected as such by the patent, a second SPC relating to that combination of active ingredients."
The Court of Milan relied on the ECJ's reasoning in Actavis (as expressed in Point 40 of the decision), which held that "the grant of the first SPC in respect of the single active ingredient irbesartan has already afforded the holder such compensation" – that is, compensation for the delay in first marketing a form of the patented drug – since:
"the objective of that regulation is not to compensate the holder fully for the delay to the marketing of his invention or to compensate for such delay in connection with the marketing of that invention in all its possible forms, including in the form of combinations based on that active ingredient."
The Court of Milan also rejected the SPC owner's argument based on the ECJ decision in Georgetown (Case C-484/2013), which held that two different SPCs had been validly granted for a single active ingredient and a combination of this active ingredient with another active ingredient, provided that both SPCs expired on the same date.
In this respect, the Court of Milan ruling gives decisive importance to the reasoning that what really matters is not the number of SPCs that may be granted for the same patent, but the duration of the supplementary protection, precisely because EU Regulation 469/2009 does not allow further extensions of the supplementary protection based on first marketing authorisation – as would be the case if an SPC for the combination were to cover a period after expiry of the first SPC for the active ingredient.
The Court of Milan also rejected the SPC owner's argument that this case differed from the irbesartan case, since the patent at issue had been specifically limited in such a way that it explicitly (if not exclusively) claimed the coupling of telmisartan and hydrochlorothiazide, while in Actavis the patent claimed the coupling of irbesartan with a diuretic, indicated in a generic way. The Court of Milan noted on the one hand that this difference was irrelevant, since the previously mentioned rationale for the exclusion of the second SPC applied to both cases; on the other, it noted that the limitation of the patent was illicit, since it was not grounded in the original application.
The decision in Actavis is clear in stating that the prerequisite for granting a second SPC for a combination of active ingredients is that the combination include – together with the first active ingredient protected by itself under the first SPC – a second active ingredient that is protected "as such" in the patent. This is expressed in Point 43 of Actavis:
"[I]n circumstances such as those in the main proceedings, where, on the basis of a patent protecting an innovative active ingredient and [a marketing authorisation] for a medicinal product containing that ingredient as the single active ingredient, the holder of that patent has already obtained an SPC for that active ingredient entitling him to oppose the use of that active ingredient, either alone or in combination with other active ingredients, Article 3(c) of Regulation No 469/2009 must be interpreted as precluding that patent holder from obtaining – on the basis of that same patent but a subsequent [marketing authorisation] for a different medicinal product containing that active ingredient in conjunction with another active ingredient which is not protected as such by the patent – a second SPC relating to that combination of active ingredients."
Point 41 of the decision expressly states that the term 'protected as such' refers to the second active ingredient of the combination, not the combination.
Therefore, the decision's reference to the fact that the patent for irbesartan claimed the combination of irbesartan with an unlimited number of other active ingredients – generically mentioned in the claims as 'diuretics' or 'beta-blocking ingredients' – was merely a further ground, in addition to the rationale set out at Point 36 of Actavis, which states:
"Article 13 of Regulation No 469/2009 dictates that, upon expiry of the initial SPC, the holder thereof may no longer, in connection with the basic patent used as the basis for the grant of the SPC, oppose the marketing by third parties of the active ingredient which was the subject of the protection conferred by that SPC. This means that, after that date, it must be possible for third parties to place on the market not only medicinal products consisting of the formerly protected active ingredient but also any medicinal product containing that active ingredient in combination with another active ingredient that is not protected as such by the basic patent or any other patent."
For these reasons, the Court of Milan rejected the SPC owner's request for further remittal of the case to the ECJ.
These decisions are not only in line with ECJ case law, but even go beyond it, since they derive further implications from the general principles set out by the ECJ judges.
For further information on this topic please contact Cesare Galli at IP Law Galli by telephone (+39 02 5412 3094), fax (+39 02 5412 4344) or email (firstname.lastname@example.org). The IP Law Galli website can be accessed at www.iplawgalli.it.
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