HvJ EU: Is einde van erkenningsprocedure onder 28 lid 4 Geneesmiddelenverordening hetzelfde als handelscertificaat

Prejudiciële vraag gesteld aan HvJ EU 29 juli 2016, IEF 16169; IEFbe 1893; RB 2746; LS&R 1354 (MSD tegen Comptroller-General)
ABC. Octrooi. Erkenning handelsvergunning .

(1) Is an end of procedure notice issued by the reference member state under Article 28(4) of the Medicinal Products Directive equivalent to a granted marketing authorisation for the purposes of Article 3(b) of the SPC Regulation?
(2) If the answer to question (1) is no, is the absence of a granted marketing authorisation at the date of the application for a certificate an irregularity which can be cured under Article 10(3) of the SPC Regulation once the marketing authorisation has been granted?

Via bailii en IPO.gov.uk:

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.