Merck Sharp & Dohme Corp. - 2014/050

Administrative Decision Number2014/050
Date03 August 2017
SectionPatents 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
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
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

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