Patent decision

BL number

O/495/12

Concerning rights in

SPC/GB/09/057

Hearing Officer

Patrick Purcell

Decision date

11 December 2012

Person(s) or Company(s) involved

Genzyme Corporation

Provisions discussed

Council Regulation (EC) No. 469/2009; Article 3 and 10. Regulation (EC) No 1610/96; Recitals 13, 17

Keywords

Supplementary Protection Certificates

Related Decisions

None

Summary

The applicant filed an application for an SPC to protect the product “sevelamer carbonate” which was approved in the medicinal product “Renvela”. However, objections were raised under Articles 3(c) and (d) of the Regulation because the applicant had already obtained an SPC for the product “sevelamer”. This granted SPC relies upon the same basic patent but an earlier marketing authorization for the medicinal product “Renagel”, which contains “sevelamer hydrochloride” and is approved to treat the same indication. Although both parties agreed the basic patent protected both approved forms, the applicant argued that “sevelamer carbonate” was a different product from the earlier formulation and so a further SPC could be granted. The hearing officer, having considered the arguments presented and case law, in particular the decision of the CJEU in Farmitalia, found that the earlier granted SPC protected sevelamer in both the approved salts, and so the application should be refused for not meeting the conditions set out in Articles 3(c) and (d).

Full decision O/495/12 83Kb