- BL number
- Concerning rights in
- SPC/GB/07/014; SPC/GB/07/015; SPC/GB/07/016; SPC/GB/07/017, SPC/GB/07/021, SPC/GB/07/081, SPC/GB/07/082 & SPC/GB/07/084
- Hearing Officer
- Dr L Cullen
- Decision date
- 24 September 2010
- Person(s) or Company(s) involved
- University of Queensland & CSL Limited
- Provisions discussed
- Council Regulation (EC) No. 469/2009; Articles 1, 3 and 10.
- Supplementary Protection Certificates
- Related Decisions
- O/401/09, O/357/09
Applications for SPCs for 6 different single Humanpapilloma Virus (HPV) L1 protein virus like particles (VLPs) (2 for HPV16, 2 for HPV18, 1 for HPV11 and 1 for HPV6) were filed in addition to one application for a product comprising HPV16 & HPV18 L1 protein VLPs and one application for a product comprising HPV6, HPV11, HPV16 & HPV18 L1 protein VLPs. Three basic patents were cited in support of these applications, EP 0595535 B1 and two divisionals derived from it, EP 0128911 B1 and EP 1359156 B1. The marketing authorisations (MAs) for Cervarix which is a vaccine against HPV infection by HPV16 and HPV18 and that for Gardasil/Silgard which is a vaccine against infection by HPV6, HPV11, HPV16 and HPV18 were used in support of all these SPC applications.
This is the latest case which concerns the proper interpretation of what ‘protected by the basic patent’ means in Article 3(a) and what is the product in a medicinal product that a valid marketing authorisation allows to be placed on the market under Article 3(b). The hearing officer accepted the applicants request for a decision on these applications rather than to stay the cases pending the outcome of the referal to the Court of Justice of the European Union (CJEU) by the UK courts on appeal from the Medeva (BL O/357/09) and Georgetown et al. (BL O/401/09) decisions as this case raises related relevant questions.
Having reviewed the case law in this area and considered what was the medicinal product that each MA authorised, the hearing officer found that the neither of these MAs was a valid authorisation to place any of the six single HPV L1 protein VLP products on the market as a medicinal product because each related to a combination of active ingredients as distinct from a single active ingredient. As a result, applications SPC/GB/07/015-017, SPC/GB/07/021, SPC/GB/07/081 and SPC/GB/07/082 were found not to meet the requirement of Article 3(b) of the Regulation. The hearing officer found that the examples of SPCs, cited by the applicant, which had been granted on this basis in the past did not justify altering this decision.
The hearing officer also found that the basic patents cited did not protect either of the combination HPV L1 protein VLP products for which an SPC was being sought as they only described methods for preparing single HPV L1 protein VLPs, the HPV L1 protein VLPs made by this method and vaccines prepared from HPV L1 protein VLPs made by this method. Nothing in these patents suggested that these single HPV products would be used in combination with each other. Thus applications SPC/GB/07/014 & SPC/GB/07/084 failed to meet the requirement of Article 3(a) of the Regulation. The relevance of the reference to the CJEU was discussed briefly.
Since in accordance with Article 10(3) an opportunity to correct the irregularities with each application has been given, the application, as required by Article 10(4), was rejected.
Full decision O/335/10 454Kb