Profender SPC (UK)

Astellas Pharma Inc's application, another decision on an SPC application on a combination product was handed down by the UK's IPO recently, where the Takeda decision was followed.

In the case in question, a combination of active ingredients emodepside and praziquantel, marketed under the trade mark Profender, was the subject of supplementary protection certificate (SPC) application number SPC/GB/06/002. The marketing authorisation on which this application was based was for the combination product emodepside and praziquantel. However, the patent on which the application was based clearly disclosed the active ingredient emodepside but provided no indication, specific or generic, of the other active ingredient praziquantel.

The Examiner refused the application on the grounds that the product, Profender, was not covered by the basic patent. Moreover, the Examiner had issues with the applicant's request to change the product definition to read "a product comprising Emodepside." Particularly, a product defined with reference to Emodepside alone would require a corresponding authorisation for Emodepside alone to satisfy Article 3(b).

In his decision, Lawrence Cullen, acting for the Comptroller, considered the case law on the interpretation of Art. 3(a) to determine what is "protected" and felt obliged to follow the decision in Takeda Chemical Industries Ltd's SPC Applications (No 3) [2004] RPC 3, and distinguished Gilead's SPC application [2008] EWHC 1902 (Pat) because in that case the patent included a claim for the patented compound in a carrier and "optionally other therapeutic ingredients". In this case there was no equivalent broad composition claim. The product, Profender was not protected by the designated basic patent for the purposes of satisfying Art. 3(a) of EC Regulation 1768/92.

In addition, the 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. Therefore, the proposed product was not authorised and Article 3(b) was not complied with.

An appeal may be lodged by the applicant within 28 days of the decision, and we understand that it is likely that this will happen.