19. Mai 2022
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).
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.
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:
die zentrale erfinderische Tätigkeit |
Kern der erfinderischen Tätigkeit |
l’activité inventive centrale |
le coeur de l’activité inventive |
the core inventive advance |
the core inventive advance |
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).
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.
von Dr. Anja Lunze, LL.M. und Dr. Nora E. Wessendorf, LL.M. (Washington)
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