Janumet SPC update: Questions referred to the CJEU

As previously reported, the Finnish Market Court recently referred several questions on the interpretation of the SPC Regulation with a view to MSD’s Finnish Janumet SPC to the Court of Justice of the European Union (“CJEU”). The Finnish decision was handed down on 17 February 2022 (file no. 7/2022). In addition to a further referral from the Irish Supreme Court in another SPC matter (Case C-149/22), the CJEU is again tasked with answering a number of relevant questions on the interpretation of the SPC Regulation (Case C-119/22).

The Finnish referral

Regardless of the (German) Federal Patent Court’s refusal to refer the case to the CJEU, the CJEU is tasked with questions on the interpretation of SPC Reg. Art. 3(c) in the context of the Janumet SPC due to a referral by the Finnish Market court. The court had informed the relevant parties in November 2021 that it intended to suspend the pending invalidation proceedings against the Finnish Janumet SPC (file no. 342) pending the outcome of the CJEU’s ruling. In early February 2022, the Finnish Market Court then referred four questions to the CJEU.

Finnish questions to the CJEU

• 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?

Question 4 draws attention to a noteworthy discrepancy in the wording used in Actavis/Sanofi (Case C‑443/12), where the CJEU with a view to Article 3 (c) of the SPC Regulation referred to the assessment of “the core inventive advance” of the basic patent in English, but used diverging terms both in German an in French (Finnish referral, p. 8, marg. no. 23), which could indicate that it might not be the same “core inventive advance” requiring assessment:

Also, the Finnish referral points out that in Actavis/Boehringer (Case C-577/13), the CJEU relied on the “subject matter of the invention” with a regard to Articles 3(a) and (c) of the SPC Regulation. Further, the “core inventive advance” of the basic patent referred to in Actavis/Sanofi was deemed irrelevant with a view to Article 3(a) in Royalty Pharma (Case C-650/17) (Finnish referral, p. 8, marg. no. 23). 

TW comments

The interpretation of the SPC Regulations continues to provide ample need for clarity for pharmaceutical companies throughout Europe in applying the SPC Regulation in practice. It remains to be seen whether the currently pending proceedings can bring about the much sought-after guidance.