The EU Court gave clarifications for obtaining an SPC

Large-3x5-FT-European-Union-EU-Flag-Brand-90-150cm-Wave-Euro-Flag-of-Europe-superThe European Court ruled in the case C‑121/17, Teva UK Lt v Generics (UK) Ltd, which concerns the following:

Gilead is a pharmaceutical company which markets an antiretroviral medicinal product indicated for the treatment of persons infected with HIV, under the name TRUVADA. That medicinal product contains two active ingredients, tenofovir disoproxil (‘TD’) and emtricitabine, which have a combined effect for that treatment. It was granted a marketing authorisation (‘MA’) on 21 November 2005 by the European Medicines Agency (EMA).

Gilead is the holder of the European patent (UK) EP 0 915 894 (‘the basic patent at issue’). The patent application, filed on 25 July 1997, had a priority date, for the purposes of Article 88 of the EPC, of 26 July 1996. That patent was granted by the European Patent Office (EPO) on 14 May 2003 and expired on 24 July 2017. The description of the invention contained in that patent indicates that the patent covers, in general terms, a series of molecules which are helpful in the therapeutic treatment of a number of viral infections in humans and animals, in particular HIV.

That description gives a series of pharmaceutical formulae which may be envisaged for the compounds claimed, without referring specifically to individual compounds or to any particular use for those compounds. Claim 25 of the basic patent at issue expressly mentions TD as one of the claimed compounds.

That description also mentions the fact that those compounds may, if necessary, be associated with ‘other therapeutic ingredients’. The words ‘other therapeutic ingredients’, however, are neither defined nor explained in the basic patent at issue.

In that regard, claim 27 of the basic patent at issue states:

‘A pharmaceutical composition comprising a compound according to any one of claims 1-25 together with a pharmaceutically acceptable carrier and optionally other therapeutic ingredients.’

In 2008, Gilead obtained an SPC on the basis of claim 27 of the basic patent at issue and the MA (‘the SPC at issue’). That SPC relates to a ‘composition containing [TD], optionally in the form of a pharmaceutically acceptable salt, hydrate, tautomer or solvate, together with Emtricitabine’.

The order for reference states that there is no evidence that at the priority date of the basic patent at issue, emtricitabine was an effective agent known to the person skilled in the art for the treatment of HIV in humans. The EMA did not approve emtricitabine until 2003.

The applicants in the main proceedings, who intend to market generic versions of TRUVADA on the UK market, brought an action before the referring court, the High Court of Justice (England & Wales), Chancery Division (Patents Court), seeking to challenge the validity of the SPC at issue.

In support of their action, the applicants in the main proceedings submit that the SPC does not meet the condition laid down in Article 3(a) of Regulation No 469/2009. They point out that to meet the requirement in that provision, the product in question must, in accordance with the judgment of 24 November 2011, Medeva (C‑322/10, EU:C:2011:773), be ‘specified in the wording of the claims’. Where there is a functional definition in the relevant claim relating to the product, that claim must ‘relate, implicitly but necessarily and specifically’ to that product, in accordance with the terms used by the Court in the judgment of 12 December 2013, Eli Lilly and Company (C‑493/12, EU:C:2013:835). The applicants in the main proceedings submit that emtricitabine is not specified in the wording of claim 27 of the basic patent at issue and that the expression ‘other therapeutic ingredients’ used in that claim does not specify any active ingredient, whether structurally or functionally. The TD/emtricitabine combination cannot therefore be considered to be protected by a basic patent in force, within the meaning of Article 3(a) of Regulation No 469/2009.

By contrast, Gilead contends in essence that, in order to check whether Article 3(a) of Regulation No 469/2009 is satisfied, it is necessary and sufficient that the product in question falls within the extent of the protection conferred under at least one claim of the basic patent. It submits that the expression ‘other therapeutic ingredients’ used in claim 27 of the basic patent at issue relates implicitly but necessarily to emtricitabine, in accordance with the judgment of 12 December 2013, Eli Lilly and Company (C‑493/12, EU:C:2013:835). The TD/emtricitabine combination therefore, it argues, satisfies the condition laid down in that article.

The referring court takes the view that, notwithstanding the judgments delivered by the Court on interpretation of Article 3(a) of Regulation No 469/2009, the meaning to be given to that provision remains unclear.

That court states that, admittedly, it is clear from the Court’s case-law that the concept of a ‘product protected by a basic patent’ within the meaning of Article 3(a) of Regulation No 469/2009 refers to the rules governing the extent of protection, not the rules governing infringement. Furthermore, it follows from paragraph 28 of the judgment of 24 November 2011, Medeva (C‑322/10, EU:C:2011:773), that to be considered ‘protected by a basic patent’ within the meaning of that provision, the active ingredients should be specified in the wording of the claims of the patent in question.

Nevertheless, the judgments of 12 December 2013, Actavis Group PTC and Actavis UK (C‑443/12, EU:C:2013:833), of 12 December 2013, Eli Lilly and Company (C‑493/12, EU:C:2013:835), and of 12 March 2015, Actavis Group PTC and Actavis UK (C‑577/13, EU:C:2015:165) imply that the principles described in the preceding paragraph are not sufficient for the purposes of determining whether a ‘product is protected by a basic patent in force’ and that it is also necessary to take into account the ‘subject-matter of the invention covered by the patent’ or the ‘core inventive advance’ of the patent. The referring court takes the view that it is not clear from that case-law whether those requirements are relevant for the purposes of the interpretation of Article 3(a) of Regulation No 469/2009.

According to the referring court, there are also divergent decisions in a number of Member States concerning the issue, before the court in the present case, of the availability of an SPC for the TD/emtricitabine combination and, more generally, concerning the interpretation of Article 3(a) of Regulation No 469/2009.

In those circumstances, the High Court of Justice (England & Wales), Chancery Division (Patents Court) decided to stay the proceedings and to refer the following question to the Court of Justice for a preliminary ruling:

‘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?’

The Court’s decision:

Article 3(a) of Regulation No 469/2009 of the European Parliament and of the Council of 6 May 2009, concerning the supplementary protection certificate for medicinal products, must be interpreted as meaning that a product composed of several active ingredients with a combined effect is ‘protected by a basic patent in force’ within the meaning of that provision where, even if the combination of active ingredients of which that product is composed is not expressly mentioned in the claims of the basic patent, those claims relate necessarily and specifically to that combination. For that purpose, from the point of view of a person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent:

–        the combination of those active ingredients must necessarily, in the light of the description and drawings of that patent, fall under the invention covered by that patent, and

–        each of those active ingredients must be specifically identifiable, in the light of all the information disclosed by that patent.

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