Patent decision

BL number

O/117/16

Concerning rights in

SPC/GB14/062, EP0720599 B1

Hearing Officer

Dr L Cullen

Decision date

12 January 2016

Person(s) or Company(s) involved

Merck Sharp & Dohme Corporation

Provisions discussed

Regulation (EC) No. 469/2009, Articles 2, 3, 7 and 8; Directive 2001/83/EC on the Community code relating to medicinal products for human use, Articles 17 and 28

Keywords

Supplementary Protection Certificates

Related Decisions

None

Summary

This SPC application concerns the combination of active ingredients, ezetimibe and atorvastatin, found in the medicinal product, ATOZET (RTM). A marketing authorization for ATOZET was being sought under the decentralised procedure (DCP) but, at the date of application for the SPC on 12 September 2014, which was only 1 day before expiry of the patent, the applicant did not provide details of a granted UK Marketing Authorisation (MA) in support of their SPC application. Instead the applicant referred to a document identified as the ‘End of Procedure Communication of Approval’, dated 10 September 2014, issued by the the German Medicines Agency, as evidence that the product would, within 30 days, be subject to a granted UK authorisation. The examiner considered that the application failed to meet the requirements of Articles 3(b) and 3(c) of the SPC Regulation.

In relation to Article 3(b), the applicant, citing EI du Pont de Nemours & Co v UK IPO [2009] EWCA Civ 966 (DuPont) considered that they should be able to supplement their UK application with the information on the granted MA when it was issued. The hearing officer considered the Directive 2001/83/EC, especially, Article 28, and the timetable and explanation of this timetable provided in the related EU guidance on DCP. He considered the relevance of DuPont which outlined circumstances under which an SPC application may be supplemented with information or documents after the date of application. The Hearing Officer (HO) found that on the date that the application for an SPC was made in the UK, the applicant did not have a granted authorisation for the medicinal product comprising the active ingredients in the UK. The HO also considered that SPC Application could not be rectified or supplemented as proposed by the applicant after the application date, and after the expiry date of the patent, because the circumstances in this case did not result from a failure by the relevant competent body to issue a granted marketing authorisation within the required period (of 30 days) under the Directive.

The basic patent EP0720599 was the subject of two earlier granted SPCs concerning ezetimibe. The HO considered if the present application fulfilled the requirement under Article 3(c). Having considered the relevant CJEU case-law (Sanofi, C-433/12, and Boehringer, C-577/13) and reviewed the description and claims of the basic patent, the HO found that the combination of active ingredients, ezetimibe and atorvastatin, was ‘protected as such’ by the basic patent - it is part of the subject matter or innovation protected by the patent and falls within the core inventive advance disclosed therein. Hence the application, as filed, does meet the requirement under Article 3(c) of the SPC regulation.

As the application was found not to meet the requirement under Article 3(b) of the SPC Regulation, the HO rejected the application under Article 10(2) of this Regulation.

Full decision O/117/16 572Kb