Neutral Citation Number: [2012] EWCA Civ 523
Case No: A3/2010/0295(A)/FC3
IN THE COURT OF APPEAL (CIVIL DIVISION)
ON APPEAL FROM THE HIGH COURT OF JUSTICE, 
CHANCERY DIVISION, PATENTS COURT
MR JUSTICE KITCHIN
(2010)EWHC 68(Pat)
Royal Courts of Justice
Strand, London, WC2A 2LL

Date: 03/05/2012
Before :

THE CHANCELLOR OF THE HIGH COURT
LORD JUSTICE ETHERTON
and
LORD JUSTICE ELIAS
- - - - - - - - - - - - - - - - - - - - -
Between :

	Medeva BV	Appellant	
	- and -		
	Comptroller General of Patents	Respondent	

- - - - - - - - - - - - - - - - - - - - -
- - - - - - - - - - - - - - - - - - - - -

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
- - - - - - - - - - - - - - - - - - - - -
Judgment

The Chancellor : 
1.	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.

2.	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.

3.	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.”

4.	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.”

5.	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”?

6.	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.”

7.	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

8.	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.”

9.	In Re: Takeda Chemical Industries Ltd’s SPC Applications (No.3) [2004] RPC 3 (First Judgment paragraphs 26 and 27) Jacob J rejected the submission that a combination of two substances, X and Y, was protected by a patent in respect of X alone because it would be infringed by, for example, the making of the combination.  Such an infringement test was rejected because, as Jacob J pointed out in paragraph 10 of his judgment:
“The so-called “combination” of lansoprazole and an antibiotic would only infringe because of the presence of the lansoprazole. In truth, the combination is not as such “protected by a basic patent in force”. What is protected is only the lansoprazole element of that combination. It is sleight-of-hand to say that the combination is protected by the patent. The sleight-of-hand is exposed when one realises that any patent in [counsel for the appellant]’s sense protects the product of the patent with anything else in the world. But the patent is not of course for any such “combination”.”

10.	In Re: Gilead Sciences Ltd’s SPC Application [2008] EWHC 1902 (First Judgment paragraphs 28 and 29) it was contended before Kitchin J that Takeda had been wrongly decided.  It was common ground before him that whether or not the product was protected by the basic patent was to be determined in accordance with English law.  The argument was summarised by Kitchin J in paragraph 25 of his judgment in these terms:
“..s.125 of the Patents Act 1977 defines the extent of protection of a patent as being that specified in a claim as interpreted in the light of the specification. For this purpose the Protocol on the Interpretation of Article 69 of the EPC applies and this too refers to the extent of protection conferred by a patent and how it is to be understood. These two provisions make it clear that a product is protected by a patent within the meaning of the Act if it falls within the scope of a claim.”
In the event it was not necessary for him to determine the point.

11.	It was raised again before Arnold J in Astellas Pharma Inc v Comptroller General of Patents [2009] EWHC 1916 (First Judgment paragraph 30).  In paragraph 34 of his judgment he indicated:
“34.	I am not convinced that Takeda is wrong. To my mind, Jacob J's reasoning remains persuasive. Furthermore, I agree that there is a distinction between the scope of protection and the question of infringement. As to Farmitalia, it is not clear to me that the ECJ either endorsed or rejected the infringement test in that case. Nevertheless, I agree with Kitchin J that there are arguments in favour of the infringement test which do not appear to have been considered in Takeda and which merit consideration by a higher court and perhaps the ECJ.”

12.	Thus the nature of the dispute was and is what test to apply to determine whether or not the product is protected by the basic patent.  The shorthand description of the rival candidates is the scope of protection test and the infringement test or, as described by the Advocate General in this case “the subject matter of the patent” or “the protective effect” of the patent.

The arguments advanced before the Court of Justice

13.	The rival submissions made before the Court of Justice were clearly described in paragraph 20 of the judgment of the court.  The Court there stated:
“While the Latvian, Lithuanian and Portuguese Governments submit that only the wording of the claims is relevant for the purpose of determining whether a product is protected by a basic patent in force within the meaning of Article 3(a) of Regulation No 469/2009, Medeva and the United Kingdom Government maintain that the concept of a ‘product … protected by a basic patent in force’ within the meaning of that provision corresponds to any combination of substances of a medicinal product directly infringing the patent.” 

14.	Thus the UK Government was making common cause with Medeva notwithstanding that one of its officials, the Comptroller General of Patents, was of the same view as the Governments of Latvia, Lithuania and Portugal.  In the written observations of Medeva it was contended that:
“The problem in this case arises because the UK does not apply an infringement test under Article 3(a). If the UK applied the infringement test Medeva would satisfy Article 3(a) and the first set of SPCs would be granted.  The test applied in the UK has the result that there is a class of case (such as this one) which despite satisfying the infringement test, fails the current test applied under Article 3(a) in the UK.”
The point was repeated in paragraph 72 of Medeva’s written observations in the following terms:
“For all the reasons above Medeva submits that the infringement test ought to be applied under Article 3(a).  On that basis Medeva’s patent is one which satisfies Article 3(a) in relation to the various vaccines the subject of the four applications.  The applications should therefore be granted.”
Medeva went on to submit that if the primary contention was not acceptable and the infringement test was not the appropriate test to apply in all circumstances, it should at least be adopted in the case of multi-disease vaccines.  It concluded its written observations by suggesting that the appropriate answer to question 1 was:
“A ‘product is protected by a basic patent in force’ in Article 3(a) of the Regulation, if, in the absence of consent by the patentee, the production and/or circulation on the market of the product would infringe the patent.  In the absence of Community harmonisation of patent law, the criteria for deciding this should be the national laws of patent infringement.”

15.	The written observations of the UK noted, in paragraph 16 that there are alternative approaches to the question.
“The first approach is that favoured by Medeva in the national proceedings. It involves determining what is protected by a patent by reference to the national law of patent infringement (the infringement test)....The second approach is that adopted by the UK Comptroller of General Patents in the national proceedings....it involves identifying the active ingredients which are protected by the patent in question (the active ingredients test).
The written observations of the UK Government then discussed the various advantages and disadvantages of the rival tests.  Their observations concluded in paragraph 31 relation to the primary point:
“....the UK Government submits that “the product is protected by a basic patent in force” if the product as defined in Article 1(b) falls within the scope of a claim in the basic patent. Assessment of this requires the national patent office to interpret the claims of the patent in the light of the description and drawings in order to determine whether the active ingredient or combination of active ingredients in the medicinal product is protected – in other words, an infringement test.”
The answer to question 1 suggested by the UK Government was that the product is protected by a basic patent if the product directly infringes the patent.

16.	The opposing arguments of the Commission and the Governments of Portugal, Lithuania and Latvia were described by the Advocate General more fully than by the Court of Justice as follows:
“...the referring court must establish which active ingredients are protected by a patent under national law and not which forms of commercial activity the patent proprietor can prohibit third parties from engaging in.” – The Commission.
“...a multi-disease vaccine which contains multiple antigens, only one of which is protected by a basic patent in force, does not satisfy the requirements of Article 3(a).” – The Portuguese Government
“...the grant of a supplementary protection certificate presupposes not only that the product concerned is protected by a basic patent and that a valid authorisation to place that product on the market as a medicinal product exists, but also that the active ingredient of that medicinal product is covered by the patent claims.” – The Lithuanian Government. 
“Only the product described in the patent claims is protected by the basic patent.” – The Latvian Government.”

The Opinion of the Advocate General

17.	After setting out the relevant circumstances and the questions on which a ruling was sought, she noted the various arguments for the parties in paragraphs 43 to 47.   I have already set out the rival arguments at some length because that is the context in which to determine what the Advocate General and the Court of Justice decided. 

18.	The Advocate General then considered at some length (paragraphs 51 to 110) the wider issue of whether and if so how and under what conditions SPCs may be applied for and granted.  In that context she concluded (paragraph 70) that, prima facie and in the absence of harmonisation, the definition of ‘product’ in regulation 1(b) required regard to be had to the subject matter of the patent and not its protective effect.  But that interpretation (paragraph 73) would suggest that an SPC could not be granted in relation to a medicinal product containing a number of active ingredients only some of which were the subject matter of the basic patent.  She considered (paragraph 79) that such a conclusion would be incompatible with the objectives of the regulation because it would fail to provide sufficient protection to those seeking to develop new active ingredients in medicinal products.

19.	In those circumstances she considered (paragraph 88) that the literal interpretation must be complemented by a teleological one so as to ensure that the protection afforded by SPCs is available to medicinal products in which the combination of active ingredients is only partly the subject matter of a patent.  She considered that this would be achieved by construing article 1(b) to include any active ingredient. At the same time, a teleological interpretation must not (paragraph 91) lead to an imbalance of the interests envisaged by the regulation so as to confer too great a benefit on the manufacturer of the medicinal product. In her view the balance was struck by a narrow interpretation of article 3(a) and a broad interpretation of article 3(b). 

20.	As to article 3(a), she considered (paragraph 98) that the product under that article must be the same as the product which is the subject matter of the basic patent in order to prevent ‘evergreening’ and that (paragraph 100) only one SPC could be granted for the active ingredients covered by the basic patent however many combinations it may become part of.  Her answers to questions 1 to 5 concerning the scope of article 3(a) were as follows:
“112. In order to answer the first question, as to how and on the basis of what criteria Article 3(a) of Regulation No 469/2009 is to be interpreted and applied, it is necessary to start from the principle that a product within the meaning of Article 3(a) is to be understood as a product which forms the subject-matter of a basic patent within the meaning of Article 1(c) of the regulation. Whether a product forms the subject-matter of a basic patent within the meaning of Article 1(c) and whether that product is protected by a basic patent in force in accordance with the requirement of Article 3(a) are determined, in principle, according to the rules governing the basic patent. However, the definition of a basic patent laid down in Article 1(c) of the regulation precludes combinations of active ingredients which are not the subject-matter of a basic patent, but nevertheless enjoy patent protection due to the presence of a patented active ingredient, from being characterised as a product within the meaning of Article 3(a). 
113. Against that background, the first question must answered as follows: the condition for the classification of an active ingredient or combination of active ingredients of a medicinal product as a product within the meaning of Article 3(a) of Regulation No 469/2009 is that that active ingredient or combination of active ingredients forms the subject-matter of a basic patent within the meaning of Article 1(c) of that regulation. Whether an active ingredient or combination of active ingredients of a medicinal product forms the subject-matter of a basic patent within the meaning of Article 1(c) and whether that active ingredient or combination of active ingredients is protected by a basic patent in force in accordance with the requirement of Article 3(a) are determined, in principle, according to the rules governing the basic patent. However, the definition of the basic patent laid down in Article 1(c) of the regulation precludes use of the protective effect of the basic patent from being invoked as a criterion for the purpose of answering the question whether an active ingredient or combination of active ingredients of a medicinal product forms the subject-matter of a basic patent.”

21.	It is clear that the Advocate General rejected the infringement test advanced by the UK Government and by Medeva.  The balance of interests to which she referred in paragraph 91 was ensured by her consideration of the application of article 3(b) in paragraphs 118 to 124.  The judgment of the Court of Justice makes no reference to the opinion of the Advocate General but is consistent with the observations set out more fully in her Opinion.

The Judgment of the Court of Justice

22.	The judgment of the Court of Justice sets out the relevant provisions of the Regulation (paragraphs 3 to 8), of the European Patent Convention (paragraphs 9 and 10) and of the national law contained in the Patents Act 1977.  The Court of Justice then summarised the circumstances in which the dispute had arisen and quoted all six questions referred to it by this Court.  Its conclusion and the reasons for it are set out in paragraphs 19 to 28.  First, the Court of Justice reformulated the first five questions referred by this Court into a single question (paragraph 19):
“...whether Article 3(a) of Regulation No 469/2009 must be interpreted as precluding the competent industrial property office of a Member State from granting a SPC where the active ingredients specified in the application include active ingredients not mentioned in the wording of the claims of the basic patent relied on in support of such an application.”
It then summarised the rival arguments (paragraph 20), referred to its previous decision in Farmitalia (paragraphs 21 to 23) and the fact that the Regulation was intended to create a uniform solution at European level to prevent
“the heterogeneous development of national laws leading to further disparities which would be likely to create obstacles to the free movement of medicinal products within the European Union and thus directly affect the establishment and functioning of the internal market.”

23.	The judgment continued:
“25. Moreover, it should be recalled that Article 5 of Regulation No 469/2009 provides that any SPC confers the same rights as conferred by the basic patent and is subject to the same limitations and the same obligations. It follows that Article 3(a) of the regulation precludes the grant of a SPC relating to active ingredients which are not specified in the wording of the claims of the basic patent. 
26. Similarly, if a patent claims that a product is composed of two active ingredients but does not make any claim in relation to one of those active ingredients individually, a SPC cannot be granted on the basis of such a patent for the one active ingredient considered in isolation. 
27. That approach is also borne out by the second subparagraph of paragraph 20 of the explanatory memorandum to the proposal for Council Regulation (EEC) of 11 April 1990 concerning the creation of a supplementary protection certificate for medicinal products (COM(90) 101 final) (‘the explanatory memorandum’), which, in so far as concerns what is ‘protected by the basic patent’, refers expressly and solely to the wording of the claims of the basic patent. That interpretation also accords with that given in recital 14 in the preamble to Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products (OJ 1996 L 198, p. 30), which refers to the need for ‘products’ to be ‘the subject of patents specifically covering them’. 
28. The answer to the first five questions is, therefore, that Article 3(a) of Regulation No 469/2009 must be interpreted as precluding the competent industrial property office of a Member State from granting a SPC relating to active ingredients which are not specified in the wording of the claims of the basic patent relied on in support of the SPC application.”
 
24.	In paragraphs 29 to 42 the Court of Justice considered the sixth question which no longer arises for determination by us.  In doing so it referred in paragraph 37 to a requirement that the product must be “covered” by a marketing authorisation.  The judgment concludes with the rulings which, so far as necessary I have already set out verbatim in paragraph 6 above.

The submissions of counsel and my conclusions

25.	Counsel for Medeva comments that the Court of Justice failed to set out in an affirmative form the criteria for deciding whether the product was protected by the basic patent as sought by the first question referred to the Court of Justice for its ruling.  The only guidance afforded by paragraph 28 of the Court of Justice’s judgment and ruling is to the effect that an SPC may not be granted in relation to active ingredients “not specified in the wording of the claims” in the patent relied on.  But he observed this takes the matter no further.  He drew our attention to similar criticisms made by Arnold J in Novartis v MedImmune [2012] EWHC 181

26.	The claim in this case relates to:
“A method for the preparation of an acellular vaccine, which method comprises preparing the 69kDa antigen of Bordetella pertussis as an individual component, preparing the filamentous haemagglutinin antigen of Bordetella pertussis as an individual component, and mixing the 69kDa antigen and the filamentous haemagglutinin antigen in amounts that provide the 69kDa antigen and the filamentous haemagglutinin antigen in a weight ratio of between 1:10 and 1:1 so as to provide a synergistic effect in vaccine potency.”
It is well established that under English law the use of the word “comprising” in the claim of a patent specification permits the addition of other elements.   Thus, in Terrell on the Law of Patents 17th Ed. Para 9-127 it is stated:
“A requirement that a claim “comprises” certain elements does not mean that other elements may not be present: “comprising” does not mean “only consisting of”.”
A similar use is recognised in the Guidelines for Examination in the European Patent Office paragraph C-III/4.21 which states:
“While in everyday language the word “comprise” may have both the meaning “include”, “contain” or “comprehend” and “consist of” in drafting patent claims legal certainty normally requires it to be interpreted by the broader meaning “include”.”

27.	In those circumstances, counsel for Medeva submitted, the wording of the claim in this patent admits of the addition of active ingredients other than the two expressly referred to.  Accordingly such additional ingredients are “specified” in the wording of the claims of the basic patent, not least because that is the effect of s.125 Patents Act 1977 quoted by the Court of Justice in paragraph 12 when applied in conjunction with the use of the word “comprises” in claim 1.

28.	Counsel for Medeva pointed out that article 5 of the Regulation contemplated that an SPC will confer the same rights in relation to infringement as the patent itself and to that extent did recognise the infringement test.  In addition he submitted that if the phrase “specified in the wording of the claims” is interpreted more narrowly so as to require the active ingredients to be expressly named then it will not be possible to grant SPCs in relation to ‘Markush’ claims and other classes of product such as salts and antibodies as well as combination products generally.   

29.	The secondary submission of counsel for Medeva was to the effect that there was good reason to ask all five questions in the first place, the Court of Justice had not answered them so that this court should now make a further reference.

30.	Counsel for the Comptroller pointed out that the imbalance which had concerned the Advocate General had been catered for by the determination of both the Advocate General and the Court of Justice of the question relating to article 3(b). He submitted that if the broad interpretation of that part of the article were complemented by the broad interpretation of article 3(a) for which Medeva contended then the imbalance would be perpetuated by an excessive availability of an SPC.  His submission was, quite simply, that whatever the limits to the test formulated by the Court of Justice for determining which active ingredients are protected by the patent those in the vaccines against diphtheria, tetanus, meningitis and polio and comprised in the various marketing authorisations are not protected by the patent relied on.

31.	I can express my conclusions quite shortly.  It is clear that the test originally formulated by the Court of Justice in Farmitalia, namely that the extent of patent protection for the purposes of article 3(a) must, in the absence of harmonisation, be determined in the light of non-Community rules governing patents, was insufficiently clear in those jurisdictions where the national law admitted of more than one answer.  In England the contrast is well described by Arnold J in Novartis paras 38 to 40.   I infer that the national law of both Portugal, Lithuania and Latvia is similar.   There may well be others.  It is clear from the rival arguments before the Court of Justice in this case that the choice was between what is easily recognised as the infringement test and what the Advocate General described as “the subject matter of the patent” but may also be labelled “the scope of protection” test.

32.	In my view it is quite clear, as concluded by Arnold J in Novartis paragraph 53, that the Advocate General and the Court of Justice rejected the infringement test.  In the case of the former she said in terms that “the protective effect” of the basic patent was not the test, see paragraphs 70, 113 and 116 of her Opinion.  The judgment of the Court of Justice is not so clear, but the language used in, for example, paragraphs 26 and 28 is inconsistent with any implication that the protective effect of the patent had any relevance to the issue before the Court.

33.	Thus the issue for the national court is to determine which active ingredients are specified in the wording of the claims.  The ambit of “specified” may range from express naming, through description, necessary implication to reasonable interpretation.   Where on that scale the dividing line is to be drawn will necessitate further references in due course in the light of the facts of the cases in which the issue arises.  The problem for Medeva in this case is that wherever the dividing line is to be drawn the active ingredients relating to vaccines against diphtheria, tetanus, meningitis and polio are excluded.

34.	The only ground for suggesting that they may be included is a rule or convention used in drafting patent specifications to the effect that the word “comprising” does not exclude other elements.  But that is insufficient.  The ruling of the Court of Justice requires that the other elements or active ingredients are specified in the wording of the claims.  There must be some wording indicating that they are included in the claims.  Were it otherwise the Court of Justice would be imposing the infringement test which the Advocate General expressly and the Court of Justice by necessary implication had excluded.  There is no wording in the claims of the patent relevant to this case to indicate that the active ingredients of the vaccines against diphtheria, tetanus, meningitis and polio are included.   That is sufficient to determine this appeal. It follows that there is no occasion to make any further reference.
 
35.	In these circumstances, it is clear that the hearing officer and Kitchin J correctly applied the provisions of article 3(a) to the facts of this case.   Accordingly I would dismiss this appeal.
Lord Justice Etherton:
36.	I agree.
Lord Justice Elias:
37.	I also agree.