Patent decision

BL number

O/066/10

Concerning rights in

SPC/GB/04/037 and SPC/GB/04/038

Hearing Officer

Dr L Cullen

Decision date

23 February 2010

Person(s) or Company(s) involved

Imclone Systems Inc. Ltd & Aventis Holdings Inc.

Provisions discussed

Council Regulation (EC) No. 469/2009; Articles 1, 3, 4, 5 and 10

Keywords

Supplementary Protection Certificates

Related Decisions

None

Summary

A combination of the products, cetuximab, a monoclonal antibody, and irinotecan, an anti-cancer agent, was the subject of application SPC/GB/04/037 and cetuximab alone was the subject of application SPC/GB/04/038 (“the applications"). The same basic patent EP 0667165 B1 and the same European marketing authorisation (MA) EU/1/04/282/001 for the medicinal product “Erbutix-cetuximab” were cited in support of both applications for supplementary protection certificates (SPCs).

The MA was found to authorise the medicinal product “Erbutix” which comprises the product (i.e., active ingredient, as defined in Article 1(b) of the Regulation), cetuximab and not the product cetuximab and irinotecan, as claimed by the applicant. The hearing officer found that the MA has to be considered in its entirely and not just the clinical particulars when deciding what is the authorised medicinal product, and hence what is the product that can be protected by an SPC. As a consequence, this MA was found not to be a valid authorisation in support of SPC/GB/04/037 for the product “cetuximab in combination with irinotecan” as required under Article 3(b) of the Regulation.

The basic patent discloses therapeutic compositions comprising monoclonal antibodies, such as cetuximab, in combination with an anti-neoplastic agent, such as irinotecan, and their use to treat cancer. It did not disclose compositions or use of monoclonal antibodies, such as cetuximab, on their own. The hearing officer rejected the argument that the basic patent protected the product cetuximab because anyone making this product available for the authorised composition or use in combination with irinotecan will infringe the patent. As a consequence, this patent was not considered to be the basic patent to protect the product “cetuximab” which is the subject of SPC application SPC/GB 04/038 as required by Article 3(a) of the Regulation.

As, in accordance with Article 10(3), an opportunity to correct the irregularities with each of these applications has been given, they were rejected in accordance with Article 10(4).