- BL number
- Concerning rights in
- Hearing Officer
- Dr L Cullen
- Decision date
- 20 February 2009
- Person(s) or Company(s) involved
- Astellas Pharma Inc
- Provisions discussed
- Council Regulation (EC) No. 1768/92; Articles 1, 3 and 10
- Supplementary Protection Certificates
- Related Decisions
A combination of active ingredients emodepside and praziquantel, referred to as Profender (RTM), was the subject of supplementary protection certificate (SPC) application number SPC/GB/06/002 (“the application"). The marketing authorisation on which the application is based is for the combination product emodepside and praziquantel. However, the patent on which the application is based clearly discloses the active ingredient emodepside but gives no indication, specific or generic, of the other active ingredient praziquantel. For the purposes of Article 3(a) of Council Regulation (EEC) No. 1768/92 (“the Regulation”), the product, emodepside and praziquantel (Profender) is not protected by the designated basic patent.
In addition, a request by the applicant to change the product definition to read “A product comprising Emodepside” was found to be contrary to Article 3(b) of the Regulation. Article 1(b) of the Regulation dictates that the authorised combination of emodepside and praziquantel is a different product from emodepside alone. Thus the proposed product is not athorised and Article 3(b) is not complied with.
Since in accordance with Article 10(3) an opportunity to correct the irregularities with this application have been given, the application, as required by Article 10(4), was rejected.
Full decision O/052/09 237Kb