SPCs cannot be based on a medical devices certificate

Angiotech Pharmaceuticals Inc. & University of British Columbia (UBC)(O/466/15) concerns an application for an SPC under article 3(b) of Regulation 469/2009 (SPC Regulation) on a stent using paclitaxel to prevent restonosis. The basis of the application is an EC Design Examination Certificate under Directive 93/42/EEC concerning medical devices (Medical Devices Directive). The applicant argued that the procedure for obtaining such a certificate is sufficiently identical to the procedure under Directive 2001/83/EC concerning medicinal products (Medicinal Products Directive) that it can be used in support of an SPC application.


Rejecting the application, hearing officer Dr L Cullen of the UKIPO concluded that the SPC Regulation does not provide SPC protection for all products which have some form of authorisation before being placed on the market. Instead, it is particular to those authorised under the directives referred to in Article 2 of the SPC Regulation, including the Medicinal Products Directive. Furthermore, the assessment criteria used under the Medical Devices Directive were not the same as those under the Medicinal Products Directive and the objectives of these systems are different.

The decision

If you have any questions on this article or would like to propose a subject to be addressed by Synapse please contact us.


Paul England

Paul is a senior associate and professional support lawyer in the Patents group based in our London office.