Mismatch of patent + marketing authoristion + product = SPCs rejected

The Patents Court has considered Yeda Research Development Ltd's appeal from the Comptroller who refused to grant it Supplementary Protection Certificates (SPCs) in respect of its patented combination treatment for tumours.

The request to the Comptroller by Yeda was for two SPCs regarding its patent now expired. Claim 1 related to a tumour treatment composition comprising a combination of an anti-neoplastic agent (a cytotoxic) and a monoclonal antibody with particular features (a cytostatic). Claim 2 covered the therapeutic composition of claim 1, but separate administration of the components. The marketing authorisation which Yeda was relying on was arguably for cetuximab alone.

The Comptroller refused Yeda's request for an SPC for its combination treatment because it was wider than the marketing authorisation relied on. It also refused the request for an SPC for cetuximab alone because the basic patent only covered cetuximab in combination with an anti-neoplastic. The court upheld these refusals and our expert in-depth analysis explains the decision.