In recent ex-parte appeal proceedings (decision 14 W (pat) 10/16 of January 23 2018), the German Federal Patent Court (GFPC) contributed to the interpretation of Article 3(a) of Regulation (EC) No 469/2009 (the Regulation).
The appellant based the request to obtain a Supplementary Protection Certificate (SPC) for the product – a hexavalent combination vaccine containing previously known antigens in a formulation with special adjuvants – on the corresponding market authorisations and the German part of granted European patent EP 0 835 663 B1 (the basic patent in the sense of Article 3(a) of the Regulation).
The German Patent and Trademark Office (GPTO) rejected the request and pointed out that the combination vaccine composition is not protected by the basic patent. The requirement of Article 3(a) of the Regulation is not fulfilled, and, therefore, an SPC cannot be granted. According to the CJEU decisions Actavis/Sanofi (C-443/12), Georgetown II (C-484/12) and Actavis/Boehringer (C-577/13), a product can only be regarded as being protected by a basic patent if the active ingredient or combination of active ingredients is protected as such.
The product in question must represent the central inventive concept of the subject matter claimed in the basic patent. In the present case, however, the central inventive concept was seen in the use of the special adjuvants in the preparation of the combination vaccine, but not in the combination vaccine composition itself. Therefore, the combination vaccine composition is not protected as such by the basic patent.
The GFPC did not agree and granted the SPC. It was emphasised that in the present case the principles defined in the CJEU’s decisions Medeva (C-322/10) and Eli Lilly (C-493/12) for the assessment of whether a product can be regarded as being protected by the basic patent are fulfilled.
Furthermore, decisions Actavis/Sanofi, Georgetown II and Actavis/Boehringer do not contain criteria extending beyond the principles defined in Medeva and Eli Lilly. Instead, these decisions primarily relate to the requirement of Article 3(c) of the Regulation, i.e. the assessment of whether the product has not already been the subject of an SPC.
It remains to be seen whether the CJEU will comment on the GFPC’s view when ruling on aspects of the interpretation of Article 3(a) of the Regulation in the future. The GFPC and the English Patents Court recently directed referrals to the CJEU concerning the interpretation of Article 3(a) of the Regulation.