The UKIPO has released a decision on SPC applications SPC/GB/04/037 and SPC/GB/04/038 in the name of Imclone Systems, Inc. Ltd. and Aventis Holdings Inc.SPC/GB/04/037 is for the combination of products cetuximab, a monoclonal antibody, and irinotecan, an anti-cancer agent, whereas SPC/GB/04/038 is for cetuximab alone. Both applications rely on the same basic patent EP0667165, which claims a therapeutic composition comprising a monoclonal antibody such as cetuximab, and an anti-neoplastic agent, such as irinotecan. The patent however does not disclose compositions or the use of monoclonal antibodies on their own. The same marketing authorisation (MA) EU/1/04/282/001 for the medicinal product "Erbitux" was cited in support of both SPC applications.
The hearing officer, Dr L. Cullen, held that the MA has to be considered in its entirety in deciding exactly what product can be protected by an SPC. It is not possible to just take account of the clinical particulars. The marketing authorisation was found to authorise "Erbitux", which comprises the product cetuximab, and not the product cetuximab and irinotecan, as claimed by the applicant. The MA was therefore found not to be a valid authorisation in support of SPC/GB/04/037 for the product "cetuximab in combination with irinotecan" according to Article 3(b) of the SPC regulation.
The basic patent was not considered to protect cetuximab which is the subject of SPC application SCP/GB/04/038 according to Article 3(a).
Both applications were rejected in accordance with Article 10(4) after the applicant was provided with an opportunity to correct the irregularities of each of the application.
You can read the decision in full on the IPO website here.
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