Medeva BV v Comptroller General of Patents
| Jurisdiction | England & Wales |
| Judge | The Chancellor,Lord Justice Etherton,Lord Justice Elias |
| Judgment Date | 03 May 2012 |
| Neutral Citation | [2012] EWCA Civ 523 |
| Court | Court of Appeal (Civil Division) |
| Docket Number | Case No: A3/2010/0295(A)/FC3 |
| Date | 03 May 2012 |
[2012] EWCA Civ 523
IN THE COURT OF APPEAL (CIVIL DIVISION)
ON APPEAL FROM THE HIGH COURT OF JUSTICE,
CHANCERY DIVISION, PATENTS COURT
MR JUSTICE KITCHIN
Royal Courts of Justice
Strand, London, WC2A 2LL
The Chancellor of the High Court
Lord Justice Etherton
and
Lord Justice Elias
Case No: A3/2010/0295(A)/FC3
Andrew Waugh QC (instructed by Rouse Legal) for the Appellant
Thomas Mitcheson (instructed by the Treasury Solicitor) for the Respondent
Hearing date : 18 April 2012
In the judgment of the Court handed down on 23rd June 2010 ("the First Judgment") we explained why we considered that a decision of the Court of Justice of the European Union on the questions set out in the schedule thereto was necessary to enable us to give judgment on this appeal from the order of Kitchin J made on 27th January 2010. The questions were duly referred by order of this court made on 24th June 2010. The opinion of Advocate General Trstenjak was delivered on 13th July 2011 and the judgment of the Court of Justice on 24th November 2011. On 18th April 2012 we heard further argument as to whether and, if so, how the ruling of the Court of Justice should be applied.
The First Judgment should be treated as incorporated in this judgment. It provides the essential background to the issues we now have to determine. In the briefest summary the appeal concerns the application of Council Regulation (EC) No.469/2009 ("the Regulation"), in particular article 3 thereof, concerning the conditions in which a supplementary protection certificate ("SPC") should be granted. The relevant provisions of the Regulation are set out in paragraph 8 of the First Judgment. For ease of reference I set out again the provisions of article 3:
Conditions for obtaining a certificate
A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application –
(a) the product is protected by a basic patent in force;
(b) a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as appropriate.
(c) the product has not already been the subject of a certificate;
(d) the authorisation referred to in (b) is the first authorisation to place the product on the market as a medicinal product.
The issues which had arisen stemmed from the facts summarised in paragraph 4 of the First Judgment in these terms:
"On 17th April 2009 Medeva filed five applications for SPCs. Three of them relate to vaccines against all five diseases (DTPa-IPV/Hib). The other two omitted the vaccine against meningitis (Hib). These applications came before Dr Cullen, the Hearing Officer acting for the Comptroller General of Patents, following an examination by Dr Patrick Purcell. In his decision dated 16th November 2009 Dr Cullen rejected all five applications. In the case of four of them he concluded that the active ingredients included some, namely the vaccines against diseases other than whooping cough, which are not protected by Medeva's patent. In the case of the fifth, though the active ingredients were limited to those protected by Medeva's patent the market authorisation covered a combination vaccine which included vaccines against the other four diseases. In other words, in the case of all five there was a mismatch between the active ingredients protected by the patent and the active ingredients in the vaccine or medicinal product for which the relevant market authorisations had been given."
Medeva appealed to the High Court. Its appeal was dismissed by Kitchin J. In his judgment Kitchin J considered a number of earlier cases. We reconsidered them in the First Judgment. We determined to make the reference for the reasons set out in paragraph 37 of the First Judgment, namely:
"First, there is substantial doubt whether the judgment of the Court of Justice in Farmitalia, answered any of the questions which we consider now arise. Second, though Jacob J in Takeda considered the issues on Article 3(a) to be acte claire because of the decision of the Swedish Courts to which he referred this may not now be the position in Norway or Germany. Third, both Kitchin J in Gilead and Arnold J in Astellas considered that at least some of the issues which arise on this appeal are not acte claire. Fourth, the repeated emergence of these or similar issues in this jurisdiction, notwithstanding the judgment of the Court of Justice in Farmitalia indicates the need for the definitive answers which only the Court of Justice can give. Fifth, Farmitalia was in any event decided ten years ago and this is a rapidly developing area of jurisprudence."
Of the six questions referred the sixth related to the interpretation of article 3(b) which was relevant only to the determination of the fifth of the applications referred to by the Hearing Officer. That application has been withdrawn. Accordingly only the first five questions remain. They were:
On Article 3(a)
1. Regulation 469/2009 (the Regulation) recognises amongst the other purposes identified in the recitals, the need for the grant of an SPC by each of the Member States of the Community to holders of national or European patents to be under the same conditions, as indicated in recitals 7 and 8. In the absence of Community harmonisation of patent law, what is meant in Article 3(a) of the Regulation by "the product is protected by a basic patent in force" and what are the criteria for deciding this?
2. In a case like the present one involving a medicinal product comprising more than one active ingredient, are there further or different criteria for determining whether or not "the product is protected by a basic patent" according to Article 3(a) of the Regulation and, if so, what are those further or different criteria?
3. In a case like the present one involving a multi-disease vaccine, are there further or different criteria for determining whether or not "the product is protected by a basic patent" according to Article 3(a) of the Regulation and, if so, what are those further or different criteria?
4. For the purposes of Article 3(a), is a multi-disease vaccine comprising multiple antigens "protected by a basic patent" if one antigen of the vaccine is "protected by the basic patent in force"?
5. For the purposes of Article 3(a), is a multi-disease vaccine comprising multiple antigens "protected by a basic patent" if all antigens directed against one disease are "protected by the basic patent in force"?
The ruling of the Court of Justice is in the following terms:
"Article 3(a) 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 the competent industrial property office of a Member State from granting a supplementary protection certificate relating to active ingredients which are not specified in the wording of the claims of the basic patent relied on in support of the application for such a certificate."
Counsel for Medeva submits, for reasons that I will describe in more detail later, that that ruling entitles Medeva to the grant of SPCs on the first four of its applications. In the alternative he contends that the Court of Justice did not sufficiently answer the questions referred to it so that we should make another reference. By contrast counsel for the Comptroller points out that the active ingredients of the vaccines against diseases other than whooping cough covered by the marketing authorisations but not the basic patent are neither named nor described in the wording of the claims of the basic patent. Accordingly it is clear that the condition imposed by article 3(a) is not satisfied so that the appeal should be dismissed. In order to deal with those submissions it is necessary first to consider the nature of the dispute before Kitchin J, the arguments presented to the Court of Justice, the Opinion of the Advocate General and the reasons for the ruling of the Court of Justice.
The nature of the dispute
The previous cases to which Kitchin J referred and which we summarised in paragraphs 17 to 30 of the First Judgment show clearly the scope of the underlying dispute. Thus in Farmitalia Carlo Erba SRL's SPC Application [1999] ECR I-5553 (" Farmitalia") (paragraphs 17 to 25 of the First Judgment) the Court of Justice considered the requirement of article 3(a) that "the product is protected by a basic patent in force". The Court of Justice concluded that:
"[26] As Community law now stands, the provisions concerning patents have not yet been made the subject of harmonisation at Community level or of an approximation of laws.
[27] Accordingly, in the absence of Community harmonisation of patent law, the extent of patent protection can be determined only in the light of the non-Community rules which govern patents.
[28] As is clear in particular from paragraph [21] of this judgment, the protection conferred by the certificate cannot exceed the scope of the protection conferred by the basic patent.
[29] The answer to be given to the second question must therefore be that, in order to determine, in connection with the application of Regulation 1768/92 and, in particular, Article 3(a) thereof, whether a product is protected by a basic patent, reference must be made to the rules which govern that patent."
In Re: Takeda Chemical Industries Ltd's SPC Applications (No.3) [2004] RPC 3 (First Judgment...
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