FINLAND Trends and Developments Contributed by: Rainer Hilli, Mikael Segercrantz, Johanna Lilja and Johanna Flythström, Roschier
In that connection, particular attention should be paid to the statements made in those judg- ments regarding Article 3(a) of the SPC Regula- tion, 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 of “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 ingredi- ent (“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 pat- ent 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 ingre- dients from the known prior art? The judgment of the CJEU was announced on 19 December 2024. The CJEU ruled as follows. Article 3(c) of the SPC Regulation must be inter- preted as not precluding the granting of an SPC for a product consisting of two active ingredients even if one of those two active ingredients has
already been – alone – the subject of an earlier SPC and is the only one to have been disclosed by the basic patent, whereas the other active ingredient was known at the filing date or priority date of that patent. Article 3(a) of the SPC Regulation must be inter- preted as meaning that it does not suffice that a product is expressly mentioned in the claims of the basic patent in order for that product to be regarded as being protected by that patent, within the meaning of that provision. It is also necessary, in order to satisfy the condition laid down in that provision, that that product neces- sarily falls – from the point of view of a person skilled in the art, and in the light of the descrip- tion and drawings of that patent – under the invention covered by that patent at the filing date or priority date. Article 3(a) of the SPC Regulation must also be interpreted as meaning that a product consisting of two active ingredients (A+B) is protected by a basic patent, within the meaning of that provi- sion, where A and B are expressly mentioned in the claims of that patent and the specification of that patent teaches that A may be used as a medicinal product for human use alone or in combination with B, which is an active ingredient in the public domain at the filing date or priority date of that patent, provided that the combina- tion of those two active ingredients necessarily falls under the invention covered by the same patent. The case is still pending with the Market Court. Liability to Compensate in Damages for Unnecessary PI In pending damages proceedings, Mylan has claimed damages from Gilead due to a PI having been granted by the Market Court and thereafter
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