Merck Sharp & Dohme Corporation v The Comptroller-General of Patents, Designs and Trade Marks
| Jurisdiction | England & Wales |
| Judge | Mr Justice Arnold |
| Judgment Date | 29 July 2016 |
| Neutral Citation | [2016] EWHC 1896 (Pat) |
| Court | Chancery Division (Patents Court) |
| Docket Number | Appeal No: CH-2016-000026 |
| Date | 29 July 2016 |
[2016] EWHC 1896 (Pat)
IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
Rolls Building
Fetter Lane, London EC4A 1NL
Mr Justice Arnold
Appeal No: CH-2016-000026
Thomas Hinchliffe QC (instructed by Hogan Lovells International LLP) for the Appellant
Nicholas Saunders and Malcolm Birdling (instructed by the Treasury Solicitor) for the Respondent
Hearing date: 20 July 2016
Introduction
This is an appeal by Merck Sharp & Dohme Corp ("MSD") from a decision of Dr Lawrence Cullen, Deputy Director, acting for the Comptroller-General of Patents, Designs and Trade Marks dated 12 January 2016 (O/117/16) to refuse MSD's application for a supplementary protection certificate SPC/GB14/062 ("the Application") on the ground that it did not comply with Article 3(b) of European Parliament and Council Regulation 469/2009/EC of 6 May 2009 concerning the supplementary protection certificate for medicinal products (codified version) ("the SPC Regulation"). MSD contends that the application did comply with Article 3(b). In the alternative, MSD contends that, to the extent that the application did not comply with Article 3(b) at the application date, this was an irregularity which was capable of being rectified, and was rectified, subsequently pursuant to Article 10(3) of the SPC Regulation.
These issues arise because, as at the date of the Application, MSD did not have a United Kingdom marketing authorisation for its medicinal product Atozet. MSD had applied for marketing authorisations in a number of Member States of the European Union, including the UK, under the decentralised procedure established by European Parliament and Council Directive 2001/83/EC of 6 November 2001 on the Community code relating to medicinal products for human use ("the Medicinal Products Directive"). MSD had been notified of the close of the procedure, but the time for the national competent authorities ("NCAs") to adopt decisions to grant marketing authorisations had not yet expired, and the UK NCA, the Medicines and Healthcare Products Regulatory Agency ("MHRA"), had not done so. The MHRA subsequently granted MSD a marketing authorisation within the time limited for it to do so.
The decentralised procedure
There are currently three different procedures that can be used to submit a medicinal product for marketing authorisations in the EU. These are:
i) the centralised procedure ("the CP") established by European Parliament and Council Regulation 726/2004/EC of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency;
ii) the mutual recognition procedure ("the MRP") established by the Medicinal Products Directive; and
iii) the decentralised procedure ("the DCP").
As its name suggest, the CP is a process whereby the application for a marketing authorisation is made to the European Medicines Agency and, if granted, the marketing authorisation permits the holder to market the medicinal product anywhere in the EU.
The MRP and DCP are both based upon the principle of mutual recognition. This principle requires that, where an application for marketing authorisation has been granted in one Member State for a particular medicinal product, the NCAs in all other Member States ought to recognise that grant and grant corresponding marketing authorisations for that medicinal product in their own countries. The two processes differ in that:
i) The MRP applies when the medicinal product has already been approved in one Member State. Marketing authorisations in the other Member States are granted on the basis of recognition of the existing marketing authorisation.
ii) The DCP applies when the medicinal product has not yet been approved in any Member State. The DCP allows for applications for marketing authorisations to be made simultaneously in several Member States. One of these is designated by the applicant as the "reference member state" ("RMS"). The remaining member states are referred to as "concerned member states" ("CMSs"). The RMS coordinates the process for approval of the marketing authorisation application, as described below.
There are some products that are required to be authorised by the CP (see Regulation 726/2004/EC Article 3 and the Annex). If the product is not one that is required to be authorised centrally, the choice of whether the MRP or DCP should be used depends upon whether or not the medicinal product has already been authorised in any Member State.
Under the DCP, the process is as follows:
i) the applicant applies simultaneously to the NCAs in multiple Member States. One of those states is nominated by the applicant as the RMS (see Article 28(1) set out below).
ii) The RMS must, within 120 days, prepare a draft assessment report, draft summary of product characteristics ("SmPC") and draft labelling and packaging and send these draft documents to the CMSs (see Article 28(3)).
iii) The CMSs have a further 90 days to approve the draft documents and inform the RMS of their approval (see Article 28(4)).
iv) On agreement of all the CMSs, the RMS records the agreement of all parties, closes the procedure and informs the applicant accordingly (see Article 28(4)).
v) Each Member State has 30 days from the closure of the procedure to adopt a decision (i.e. grant a marketing authorisation) in conformity with the approved assessment report, approved SmPC and approved labelling and packaging (see Article 28(5)).
Member States are required to take all appropriate measures to ensure that the procedure for granting a marketing authorisation (i.e. stages (ii), (iii) and (iv) above) is completed with 210 days after the submission of a valid application (see Article 17(1)). The additional 30 days in which to grant a marketing authorisation takes the total period to 240 days.
The facts
The Application concerns the product "ezetimibe and atorvastatin or pharmaceutically acceptable salts thereof, including atorvastatin as atorvastatin calcium trihydrate". Ezetimibe and atorvastatin is the combination of active ingredients present in Atozet.
The basic patent on which the Application relied is European Patent (UK) No. 0 720 599, entitled "Hydroxy-substituted Azetidinone Compounds Useful as Hypocholesterolemic Agents" ("the Patent"). This was filed on 14 September 1994 with an earliest priority date of 21 September 1993 and granted on 19 May 1999. The Patent protected both ezetimibe and combinations of ezetimibe with certain other active ingredients. It is not disputed for present purposes that a pharmaceutical composition comprising ezetimibe and atorvastatin is protected by claim 17 of the Patent (which refers to atorvastatin by the code CI-981). The Patent expired on 13 September 2014.
On 4 April 2003 MSD obtained a marketing authorisation in respect of a medicinal product whose active ingredient was ezetimibe, and on 23 October 2003 MSD obtained an SPC in respect of that product. On 18 November 2004 MSD obtained a marketing authorisation in respect of a medicinal product whose active ingredients were ezetimibe and simvastatin, and on 30 June 2006 MSD obtained an SPC in respect of that product.
In September 2006 MSD began development of a fixed dose combination of ezetimibe and atorvastatin in tablet form. It encountered problems in establishing a satisfactory formulation, and this work continued until 2013.
In September 2013 MSD filed applications for marketing authorisations in a number of Member States in respect of Atozet under the DCP and designated Germany as the RMS. The NCA in Germany is the Bundesinstitut für Arzneimittel und Medizinprodukte ("BfArM", the German Medicines Agency). It appears that it was not until 13 February 2014 that the BfArM accepted MSD had filed a valid application, however.
The Application was filed on 12 September 2014 i.e. a single day before the Patent expired. At that time MSD did not have a UK marketing authorisation for Atozet. That being so, MSD could not provide any details of any UK marketing authorisation in the Application. Instead, MSD relied upon an email from the BfArM described as the "End of Procedure communication of approval: Number: DE/H/3895–3898/001-004/DC Date: 10 September 2014" ("the EoP Notice"). A copy of the EoP Notice was provided with the Application.
In a covering letter accompanying the Application MSD contended that the effect of the EoP Notice was that all affected Member States, including the UK, had agreed to grant marketing authorisations for Atozet and that "each Member state … will now carry out the formal step of granting the national marketing authorisations". MSD requested that it be permitted to supplement the Application when the UK marketing authorisation was granted.
On 17 September 2014 the Intellectual Property Office's examiner wrote to MSD raising two objections to the Application. The first objection was that the Application did not comply with Article 3(b) of the SPC Regulation since MSD did not hold a valid UK marketing authorisation: the EoP Notice did not satisfy this requirement as the UK marketing authorisation had not yet been granted. The second objection was that the Application did not comply with Article 3(c) of the SPC Regulation. MSD was invited to make any representations in response on or before 18 November 2014.
On 10 October 2014 the MHRA granted a UK marketing authorisation for Atozet to MSD's UK subsidiary Merck Sharp & Dohme Ltd.
On 17 November 2014 MSD submitted a copy of the UK marketing authorisation together with the first EU marketing authorisation for Atozet, which had been granted in France on...
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