Merck Sharp & Dohme Corp. - 2014/050

• Administrative Decision Number: 2014/050
• Date: 03 August 2017
• Section: Patents and SPC's

Decision in Respect of a Request by Merck Sharp & Dohme Corp. for the

Grant of a Supplementary Protection Certificate (SPC) No. 2014/050

INTRODUCTION

1. This decision concerns a request filed on behalf of Merck Sharp & Dohme Corp.

(‘MSD’ – the applicant) by Tomkins & Co. (the agent) for the grant of an SPC No.

2014/050 filed on 11 September 2014 for a product (Viazet) with the product identity:

“Ezetimibe and rosuvastatin or pharmaceutically acceptable salts thereof, including

rosuvastatin as a zinc salt”. The basic patent cited in support of the request was

European Patent EP0720599 with the title “Hydroxy-substituted azetidinone compounds

useful as hypocholesterolemic agents”. In relation to this patent, the applicant stated

that the product was protected in the following manner: “Viazet is covered by claims 9

and 16, insofar as the latter is dependent on claim 9.”

2. In support of the request, the agent submitted additional documentation in the form of

granted marketing authorisations (MAs) to Egis Pharmaceuticals PLC for three different

formulations of Viazet (10mg/10mg; 20mg/10mg; 40mg/10mg):- (1) Copies of the

Norwegian decisions of 24 July 2014 issued by Statens Legemiddelverk (Norwegian

Medicines Agency); (2) Copies of the Hungarian decisions of 29 July 2014 issued by

OGYÉI (Országos Gyógyszerészeti Intézet - National Institute of Pharmacy and

Nutrition); and (3) Copies of the Irish decisions of 8 August 2014 issued by HPRA

(Health Products Regulatory Authority). In each case, copies of the corresponding

“Summary of Product Characteristics” document were also submitted.

3. The legislation under which such SPCs are granted is Council Regulation (EEC) No.

1768/92 concerning “the supplementary protection certificate for medicinal products” and

as subsequently amended by the Paediatric Regulation to provide for an SPC extension

and codified as Regulation (EC) 469/2009 – hereinafter the ‘SPC Regulation’.

4. The examiner wrote to the agent on 26 November 2014 and stated that the SPC

request did not comply with Article 3(c) of the SPC Regulation on the grounds that “… an

SPC has already been granted (to the same applicant) for “Ezetimibe or a

pharmaceutically acceptable salt thereof”, based on the same basic patent. (See SPC

2003/014)”.

5. The examiner drew the agent’s attention to paragraph 43 of a judgment from the

Court of Justice of the European Union (CJEU) in Sanofi, which she held to be relevant

to the present application: - “… the answer to the second question referred is that, in

circumstances such as those in the main proceedings, where, on the basis of a patent

protecting an innovative active ingredient and a marketing authorisation for a medicinal

product containing that ingredient as the single active ingredient, the holder of that

patent has already obtained a supplementary protection certificate for that active

ingredient entitling him to oppose the use of that active ingredient, either alone or in

combination with other active ingredients, Article 3(c) of Regulation (EC) No 469/2009 of

the European Parliament and of the Council of 6 May 2009 concerning the

supplementary protection certificate for medicinal products must be interpreted as

precluding that patent holder from obtaining – on the basis of that same patent but a

subsequent marketing authorisation for a different medicinal product containing that

active ingredient in conjunction with another active ingredient which is not protected as

such by the patent – a second supplementary protection certificate relating to that

combination of active ingredients.”

6. The examiner also referred to paragraph 30 of the same judgment in which the issue

of multiple marketing authorisations had been raised in relation to the “core inventive

advance of that patent”: - “However, in circumstances such as those in the main

proceedings, even if the condition laid down in Article 3(a) of Regulation No 469/2009

were satisfied, for the purpose of the application of Article 3(c) of that regulation, it

cannot be accepted that the holder of a basic patent in force may obtain a new SPC,

potentially for a longer period of protection, each time he places on the market in a

Member State a medicinal product containing, on the one hand, the principle active

ingredient, protected as such by the holder’s basic patent and constituting, according to

the statements of the referring court, the core inventive advance of that patent, and, on

the other, another active ingredient which is not protected as such by that patent.”

7. She went on to cite paragraph 42 in connection with the possibility of obtaining an

SPC for a combination product, provided that combination was the subject of a patent in