Request for a preliminary ruling from the Markkinaoikeus (Finland) lodged on 17 February 2022 – Teva B.V. and Teva Finland Oy v Merck Sharp & Dohme Corp.

(Case C-119/22)

Language of the case: Finnish

Referring court

Markkinaoikeus

Parties to the main proceedings

Applicants: Teva B.V. and Teva Finland Oy

Defendant: Merck Sharp & Dohme Corp.

Questions referred

What criteria must be applied to determine when a product has not already been granted a supplementary protection certificate within the meaning of Article 3(c) of Regulation (EC) No 469/2009 ¹ of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (‘SPC Regulation’)?

Must the assessment of the condition set out in Article 3(c) of the SPC Regulation be regarded as being different from the assessment of the condition set out in Article 3(a) of that regulation, and if so, in what way?

Must the statements on the interpretation of Article 3(a) of the SPC Regulation in the judgments of the Court in Case C-121/17 ¹ and Case C-650/17 ² be regarded as relevant to the assessment of the condition in Article 3(c) of the SPC Regulation and, if so, in what way? In that connection, particular attention should be paid to the statements made in those judgments regarding Article 3(a) of the SPC Regulation, specifically:

the essential meaning of patent claims; and

the assessment of the case from the point of view of a person skilled in the art and in the light of the prior art at the filing date or priority date of the basic patent.

Are the concepts ‘core inventive advance’, ‘central inventive step’ and/or ‘subject matter of the invention’ of the basic patent relevant to the interpretation of Article 3(c) of the SPC Regulation and, if any or all of those concepts are relevant, how are they to be understood for purposes of interpreting Article 3(c) of the SPC Regulation? For the purposes of applying those concepts, does it make any difference whether the product in question consists of a single active ingredient (‘mono-product’) or a combination of active ingredients (‘combination product’) and, if so, in what way? How is the latter question to be assessed in a case in which the basic patent contains, on the one hand, a patent claim for a mono-product and, on the other hand, a patent claim for a combination product, the latter patent claim relating to a combination of active ingredients consisting of the active ingredient of the mono-product plus one or more active ingredients from the known prior art?

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¹ OJ 2009 L 152, p. 1.

¹ Judgment of the Court (Grand Chamber) of 25 July 2018 (Case C-121/17 Teva UK Ltd and Others v Gilead Sciences Inc., EU:C:2018:585).

¹ Judgment of the Court (Fourth Chamber) of 30 April 2020 (Case C-650/17 Royalty Pharma Collection Trust v Deutsches Patent- und Markenamt, EU:C:2020:327).