- BL number
- Concerning rights in
- SPC/GB 07/069, SPC/GB 07/070, SPC/GB 07/071, SPC/GB 07/073, SPC/GB 07/075, SPC/GB 07/078, SPC/GB 07/079 and SPC/GB 07/080
- Hearing Officer
- Dr L Cullen
- Decision date
- 29 December 2009
- Person(s) or Company(s) involved
- Georgetown University (for SPC/GB 07/070, SPC/GB 07/071, SPC/GB 07/073, SPC/GB 07/078, SPC/GB 07/079 and SPC/GB 07/080); Loyola University of Chicago (for SPC/GB 07/069 only); University of Rochester (for SPC/GB 07/075 only)
- Provisions discussed
- Council Regulation (EC) No. 469/2009; Articles 1, 3 and 10
- Supplementary Protection Certificates
- Related Decisions
Eight applications for SPCs for single active ingredients in the vaccine field were filed. One application concerned the recombinant L1 protein of Human Papillomavirus (HPV) strain HPV6; one application concerned the recombinant L1 protein of Human Papillomavirus strain HPV11; two applications concerned the recombinant L1 protein of Human Papillomavirus strain HPV16 and four applications concerned the recombinant L1 protein of Human Papillomavirus strain HPV18. Although in the name of three applicants, these applications all currently relate to a single licensee.
Two marketing authorisations were filed in support of these eight applications, Gardasil (RTM), which comprises the recombinant L1 proteins of HPV6, HPV11, HPV16 and HPV18, and Cervarix (RTM), which comprises the recombinant L1 proteins of HPV16 and HPV18.
The Hearing Officer considered the relevant ECJ and UK case law and took account of the alternative interpretation of Article 3(b) put forward by the applicant based on materials such as, the particular nature of vaccines; decisions of the courts and practice of national intellectual property offices in other EU and EFTA jurisdictions; previous practice at the UK Office; other official language versions of the Regulation; the explanatory memorandum of the Regulation; ECJ decision C-392/97 (Farmitalia Carlo Erba Srl’s SPC application). The eight SPC applications were found not to meet the requirement under Article 3(b), because the marketing authorisations filed in support of each of these applications comprises a further one or three active ingredients in addition to the active ingredient listed in the product definition of that SPC application. Thus, in each case, a valid authorisation has not been supplied to place the product (for which an SPC has been applied) on the market as a medicinal product.
Since in accordance with Article 10(3) an opportunity to correct the irregularities with these applications has been given, they were rejected under Article 10(4).
Full decision O/401/09 321Kb