In an opinion of 6 June 2024, the Advocate General Emiliou suggests a straightforward and literal construction of Article 3 (c) of the SPC Regulation 469/2009, while providing clarifications on Teva I (C-121-17) on the interpretation of paragraph (a) of the same Article.
Background
AG Emiliou opine in the context of the closely followed cases opposing Merck Sharp & Dome Corp. (hereinafter Merck) to:
- Teva BV and Teva Finland Oy (hereinafter Teva), challenging the validity of Merck’s SPC covering a combination of sitagliptin (hereinafter substance A, as the opinion puts it) and metformin (substance B) to treat type 2 diabetes, in front of the Markkinaoikeus (Market Court, Finland) which referred the case to the CJEU (C-119/22);
- Clonmel Healthcare Limited (hereinafter Clonmel), likewise disputing the validity of another Merck’s SPC covering a combination of ezetimibe (substance A), a cholesterol-lowering medicine, and simvastatin (substance B), before the Irish Supreme Court which referred the case to the CJEU (C-149/22).
The facts of these cases are similar and raise identical issues in relation to the validity of the SPCs. In each case, Merck filed a patent for an innovative substance A. Based on a marketing authorisation for this mono-product A (in these cases, sitagliptin and ezetimibe), Merk was granted an SPC. Ultimately, Merck obtained a marketing authorisation for a composition of the innovative substance A with substance B which had already fallen into the public domain (in these cases, metformin and simvastatin) and an SPC covering this second product. In both cases, the combination is disclosed in dependant claim(s) of the patent on which the two generations of SPC are based.
Opinion of the Advocate General
In response to the questions posed by the Finnish Markkinaoikeus and the Irish Supreme Court to the CJEU, AG Emiliou addresses first the issues relating to Article 3 (c), which in his view require a swift response, and then turns to the correct construction of Article 3 (a), which for him is the key to resolving these cases and calls for a more substantial discussion.
Article 3 (c)
According to AG Emiliou, the test to assess Article 3 (c), which requires that “the product has not already been the subject of [an SPC]” consists in (i) defining the product covered by the SPC and (ii) verifying whether the patent holder had already obtained an SPC, at a prior date, for the same product (para. 50). Pursuant to Article 1 (b) which defines the “product” as “the active ingredient or combination of active ingredients of a medicinal product”, AG Emiliou states that, in these cases, the relevant product is necessarily the combination A + B and that the condition is fulfilled because the previous SPC only protected the substance A (para. 51-52).
As AG Emiliou nods, this straightforward interpretation departs from the previous CJEU rulings Actavis I (C-446/12) and Actavis II (C-577-13), in which the CJEU held that the grant of a second SPC for the combination A + B, while B was in public domain and A was only the “core inventive advance” (Actavis I) or the “sole subject matter of the invention” (Actavis II), was de facto equivalent to the grant of a second SPC for A (para. 56). AG Emiliou is of the opinion that such a construction is inappropriate as it imports an analysis which pertains by nature to Article 3 (a) (para. 61), whereas to restore the integrity of the SPC Regulation system any discussion as to what a patent “protects” should be reserved for the assessment of the condition laid down in Article 3 (a), which would constitute the real safeguard preventing so-called “evergreening” strategies (para. 64).
Article 3 (a)
Turning to Article 3 (a), which states that, to be eligible for an SPC, the product must be “protected by a basic patent in force”, AG Emiliou recalls the case law which has attempted to clarify the meaning of the term “protected”, left undefined in the SPC regulation, that is Farmitalia (C‑392/97), Medeva (C‑322/10), Eli Lilly (C‑493/12), Actavis I and II, and Teva I.
According to AG Emiliou, the most recent decision Teva I sets out a “definitive test”, which calls for some clarifications. Among them, the Advocate General considers that Teva I defines a two-prong test, which provides that to be regarded as such, the “product” must not only be expressly mentioned in the claims or, at least, “specifically identifiable” by a person skilled in the art (second prong – identification test), but also “fall under the invention”, that is to say correspond to the innovation for which the patent was granted (first prong – invention test) (para. 85).
The conditions of the test being cumulative and apply to a combination mentioned in the claims, it means that it is not sufficient for a product (e.g. a combination) to be specified in the claims (likewise in the cases at stake), the claim(s) relating to that combination must be read in the light of the description and drawings of that patent to determine whether that combination corresponds to the “invention” for which that patent was granted (para. 98).
The purpose of this construction is to put aside the speculative claims (para. 106). AG Emiliou acknowledges that single active ingredients would easily pass the test, but that combinations of active ingredients would require further analysis (para. 114). In that respect, AG Emiliou makes clear that to consider the combination A + B to be “a feature required” for the solution of a certain technical (medical) problem, the patent should describe the use of A + B given their combined, synergistic effect on the human body, to solve that technical problem (para. 116).
This assessment of Article 3 a) departs from that adopted by the French Court of Appeal on 12 January 2024 in the sitagliptin and metformin case, since the Court decided that it was only necessary that sitagliptin and metformin be specified in the wording of the claims for the combination to comply with Article 3 a) (decision commented on the BLIP! SPC blog).
Next steps?
It remains to be seen whether the court will follow AG Emiliou’s views on Article 3 (a) and (c) of the SPC Regulation (CJUE decision awaited in the next 3‑12 months).
Opinion of Advocate General Nicholas Emiliou delivered on June 6, 2024 (1) Joined Cases C-119/22 and C-149/22
Written by Counsel Agathe Caillé , with the assistance of Gabriel Romano