UK: SPCs: A Preliminary Ruling From The CJEU In Actavis v Sanofi

Last Updated: 27 January 2014
Article by Kerry Rees

On 12 December 2013, the Court of Justice of the European Union (CJEU) handed down its preliminary ruling in the case of Actavis Group PTC EHF, Actavis UK Ltd v Sanofi, Sanofi Pharma Bristol-Myers Squibb SNC (C-443/12).

Summary of Facts

Sanofi obtained a first SPC, which covered the active ingredient ibersartan for treating primary hypertension. The SPC was based on the basic patent EP 0454511 and the marketing authorisation (MA) granted on 27 August 1997 in respect of the medicinal product Aprovel (which contained ibersartan as the single active ingredient). Claims 1 to 7 of the basic patent were solely related to ibersartan. The SPC expired on 14 August 2012.

Sanofi subsequently obtained a second SPC, which covered the combination of ibersartan and hydrochlorothiazide. This SPC was based on the same basic patent as the first SPC but on an MA granted on 15 October 1998 in respect of the medicinal product CoAprovel. Claim 20 of the basic patent related to a pharmaceutical composition containing ibersartan in association with a diuretic (in general). The SPC expired on 14 October 2013.

Actavis brought proceedings before the High Court challenging the validity of the second SPC since the generic version of CoAprovel that they intended to market would infringe the second SPC. Actavis argued that the SPC was not protected by the basic patent within the meaning of Article 3(a) of Regulation No. 469/2009, since the combination of ibersartan and hydrochlorothiazide was not expressly identified in any of the claims of the basic patent. Further to this, Actavis argued that the SPC was invalid in light of Article 3(c) of the same Regulation since the 'product', within the meaning of the provision, had already been the subject of an SPC.

Regulation No. 469/2009 can be found using the following link: 

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:152:0001:0010:en:PDF

Questions Referred

 The High Court could not resolve the dispute based on earlier rulings and thus, referred the following questions to the CJEU:

  1. 1.     What are the criteria for deciding whether 'the product is protected by a basic patent in force' in Article 3(a) of Regulation No. 469/2009?
  1. 2.     In a situation in which multiple products are protected by a basic patent in force, does Regulation No. 469/2009, and in particular Article 3(c), preclude the proprietor of the patent being issued a certificate for each of the products protected?

Preliminary Ruling

In answer to the second question, the CJEU ruled that where an SPC had been obtained for an active ingredient based on a basic patent protecting the active ingredient, and an MA for a medicinal product containing that ingredient as the single active ingredient, the patent holder is precluded from obtaining a second SPC relating to the combination of active ingredients, on the basis of the same basic patent but a subsequent MA for a different medical product containing the active ingredient in combination with another active ingredient which is not protected as such by the patent.

In support of this ruling, the CJEU highlighted the objective of Regulation No. 469/2009 to compensate the patent holder for the delay to the marketing of the invention by providing an additional period of exclusivity. It was the CJEUs belief that such compensation was afforded by the granting of an SPC for a single active ingredient, which entitles the patent holder to oppose the use of that active ingredient either alone or in combination with other active ingredients. The CJEU argued that the objective of the Regulation was not to compensate the patent holder for the delay to the marketing of his invention in all of its possible forms.

In view of the answer given to the second question, namely that a second SPC may not be granted to Sanofi for the ibersartan-hydrochlorothiazide combination, the CJEU decided that there was no need to answer the first question.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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