- BL number
- Concerning rights in
- SPC/GB/09/015, SPC/GB/09/016, SPC/GB/09/017, SPC/GB/09/018 and SPC/GB/09/019
- Hearing Officer
- Dr L Cullen
- Decision date
- 16 November 2009
- Person(s) or Company(s) involved
- Medeva B.V.
- Provisions discussed
- Council Regulation (EC) No. 469/2009; Articles 1, 3 and 10
- Supplementary Protection Certificates
- Related Decisions
Applications for SPCs for 5 different combinations of active ingredients in the vaccine field were filed. There were two common components in all the SPC applications, Filamentous Haemagglutinin and Pertactin. The basic patent related to a method for making a vaccine comprising these two active ingredients. Four different marketing authorisations were submitted in support of these SPC applications. The medicinal product Pediacel (RTM) has a combination of 11 active ingredients, the medicinal product Infanrix-IPV Hib has one of 9 active ingredients, Infanrix-IPV has 8 active ingredients and the medicinal product Repevax (RTM) also has one of 9 active components.
For the purposes of Article 3(a), 4 of the combinations of active ingredients for which SPCs were applied for (SPC/GB 09/015, 016, 017 & 019) are not protected by the designated basic patent. The fifth SPC application SPC/GB 09/018 for a combination of Filamentous Haemagglutinin and Pertactin, while meeting the requirements under Article 3(a), does not meet the requirement under Article 3(b), because the marketing authorisation filed in support of it is for the medicinal product Pediacel comprising a further 9 active ingredients in addition to those listed in the product definition of this SPC application. Thus this is not a valid authorisation to place the product applied for on the market.
Since in accordance with Article 10(3), an opportunity to correct the irregularities with these applications has been given, all five applications, as required by Article 10(4), were rejected.
Full decision O/357/09 63Kb