CELEX: 62010CC0322
Language: en
Date: 2011-07-13
Title: Joined opinion of Advocate General Trstenjak delivered on 13 July 2011.#Medeva BV v Comptroller General of Patents, Designs and Trade Marks.#Reference for a preliminary ruling: Court of Appeal (England & Wales) (Civil Division) - United Kingdom.#Medicinal products for human use - Supplementary protection certificate - Regulation (EC) No 469/2009 - Article 3 - Conditions for obtaining a certificate - Concept of a ‘product protected by a basic patent in force’ - Criteria - Existence of further or different criteria for a medicinal product comprising more than one active ingredient or for a vaccine against multiple diseases (‘Multi-disease vaccine’ or ‘multivalent vaccine’).#Case C-322/10.#Georgetown University and Others v Comptroller General of Patents, Designs and Trade Marks.#Reference for a preliminary ruling: High Court of Justice (England & Wales), Chancery Division (Patents Court) - United Kingdom.#Medicinal products for human use - Supplementary protection certificate - Regulation (EC) No 469/2009 - Article 3 - Conditions for obtaining a certificate - Concept of a ‘product protected by a basic patent in force’ - Criteria - Existence of further or different criteria for a medicinal product comprising more than one active ingredient or for a vaccine against multiple diseases (‘Multi-disease vaccine’ or ‘multivalent vaccine’).#Case C-422/10.

OPINION OF ADVOCATE GENERAL
      TRSTENJAK
      delivered on 13 July 2011 (1)
      
      Case C‑322/10
      Medeva BV
      v
      Comptroller-General of Patents, Designs and Trade Marks
      (Reference for a preliminary ruling from the Court of Appeal (England and Wales) (Civil Division) (United Kingdom))
      Case C‑422/10
      Georgetown University
      University of Rochester
      Loyola University of Chicago
      v
      Comptroller-General of Patents, Designs and Trade Marks
      (Reference for a preliminary ruling from the High Court of Justice of England and Wales, Chancery Division (Patents Court)
         (United Kingdom))
      
      
      (Supplementary protection certificate for medicinal products – Regulation (EC) No 469/2009 – Multi‑disease vaccine – Conditions for the grant of a supplementary protection certificate – Product – Protection by a basic patent in force – Authorisation to place the product on the market as a medicinal product)
      Table of contents
      
      I –  Introduction
      II –  Legal context
      A – Union law 
      B – The European Patent Convention 
      C – National law
      III –  Facts and references for a preliminary ruling
      A – Medeva
      B – Georgetown University and Others
      1. The SPC applications of Georgetown University
      2. The SPC applications of University of Rochester
      3. The SPC applications of Loyola University of Chicago
      4. Question submitted by the referring court
      IV –  Procedure before the Court
      V –  Arguments of the parties
      A – Questions 1 to 5 in Medeva
      B – Sixth question referred in Medeva and sole question referred in Georgetown University and Others
      VI –  Legal assessment
      A – Questions 1 to 5 in Medeva
      1. Interpretation of Regulation No 469/2009 on the basis of its wording and scheme
      a) The subject of the supplementary protection certificate
      b) Issue raised: No supplementary protection certificate for medicinal products with multiple active ingredients, the combination
         of active ingredients of which is only partially patented?
      
      2. Teleological interpretation of Regulation No 469/2009
      a) Necessity of a teleological interpretation of Articles 1 to 3 of Regulation No 469/2009
      b) The product within the meaning of Article 1(b) of Regulation No 469/2009
      c) The product within the meaning of Article 3(a) of Regulation No 469/2009
      d) Interim conclusion
      3. Answers to Questions 1 to 5 in Medeva
      B – Sixth question referred in Medeva and sole question referred in Georgetown University and Others
      VII –  Conclusion
      A – Questions 1 to 5 of the Court of Appeal (England and Wales) (Civil Division) (Case C-322/10)
      B – Sixth question of the Court of Appeal (England and Wales) (Civil Division) (Case C-322/10) and sole question of the High
         Court of Justice of England and Wales Chancery Division (Patents Court) (Case C-422/10)
      
      
      I –  Introduction
      1.        The present references for a preliminary ruling under Article 267 TFEU concern the grant of supplementary protection certificates
         for medicinal products under 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. (2) The referring courts request the Court to clarify the conditions for the grant of supplementary protection certificates in
         respect of multi‑disease vaccines.  
      
      2.        The distinguishing characteristic of multi‑disease vaccines is that they contain a number of active ingredients. In that context,
         by the omission or addition of individual active ingredients a multitude of multi‑disease vaccines with varying composition
         can be developed and placed on the market as medicinal products on the basis of a single patented active ingredient or a single
         patented combination of active ingredients. Against that background, the Court must decide in the present proceedings inter
         alia whether and, if so, under what conditions a supplementary protection certificate (SPC) may be granted for multi‑disease
         vaccines in which only part of the underlying active ingredients is the subject‑matter of a patent. In answering that question,
         the Court is faced with the challenge of including partially patented multi‑disease vaccines within the scope of Regulation
         No 469/2009 in a manner consistent with its objectives, without in so doing jeopardising the balance achieved in that regulation
         between the various interests at stake in the pharmaceutical sector.
      
      II –  Legal context
      A –    Union law (3)
      
      3.        The supplementary protection certificate for medicinal products was introduced into the European Union legal order by Council
         Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal
         products. (4) Because Regulation No 1768/92 was substantially amended several times after its entry into force, it was codified, in the
         interests of clarity and rationality, by Regulation No 469/2009. There are no significant substantive differences between
         the two regulations. 
      
      4.        The preamble to Regulation No 469/2009 states:
      
      ‘…
      (2)      Pharmaceutical research plays a decisive role in the continuing improvement in public health.
      (3)      Medicinal products, especially those that are the result of long, costly research will not continue to be developed in the
         Community and in Europe unless they are covered by favourable rules that provide for sufficient protection to encourage such
         research.
      
      (4)      At the moment, the period that elapses between the filing of an application for a patent for a new medicinal product and authorisation
         to place the medicinal product on the market makes the period of effective protection under the patent insufficient to cover
         the investment put into the research.
      
      (5)      This situation leads to a lack of protection which penalises pharmaceutical research.
      (6)      There exists a risk of research centres situated in the Member States relocating to countries that offer greater protection.
      (7)      A uniform solution at Community level should be provided for, thereby preventing 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 Community and thus directly affect the functioning of the internal market.
      
      (8)      Therefore, the provision of a supplementary protection certificate granted, under the same conditions, by each of the Member
         States at the request of the holder of a national or European patent relating to a medicinal product for which marketing authorisation
         has been granted is necessary. A regulation is therefore the most appropriate legal instrument.
      
      (9)      The duration of the protection granted by the certificate should be such as to provide adequate effective protection. For
         this purpose, the holder of both a patent and a certificate should be able to enjoy an overall maximum of 15 years of exclusivity
         from the time the medicinal product in question first obtains authorisation to be placed on the market in the Community.
      
      (10)      All the interests at stake, including those of public health, in a sector as complex and sensitive as the pharmaceutical sector
         should nevertheless be taken into account. For this purpose, the certificate cannot be granted for a period exceeding five
         years. The protection granted should furthermore be strictly confined to the product which obtained authorisation to be placed
         on the market as a medicinal product.
      
      …’
      5.        Articles 1 to 7 of Regulation No 469/2009 read as follows:
      
      ‘Article 1 – Definitions
      
      For the purposes of this Regulation:
      (a)      “medicinal product” means any substance or combination of substances presented for treating or preventing disease in human
         beings or animals and any substance or combination of substances which may be administered to human beings or animals with
         a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;
      
      (b)      “product” means the active ingredient or combination of active ingredients of a medicinal product;
      (c)      “basic patent” means a patent which protects a product as such, a process to obtain a product or an application of a product,
         and which is designated by its holder for the purpose of the procedure for grant of a certificate;
      
      (d)      “certificate” means the supplementary protection certificate;
      …
      Article 2 – Scope
      
      Any product protected by a patent in the territory of a Member State and subject, prior to being placed on the market as a
         medicinal product, to an administrative authorisation procedure as laid down in Directive 2001/83/EC of the European Parliament
         and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use [OJ 2001 L 311, p.
         67] or Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating
         to veterinary medicinal products [OJ 2001 L 311, p. 1] may, under the terms and conditions provided for in this Regulation,
         be the subject of a certificate.
      
      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 point (b) is the first authorisation to place the product on the market as a medicinal product.
      Article 4 – Subject-matter of protection
      
      Within the limits of the protection conferred by the basic patent, the protection conferred by a certificate shall extend
         only to the product covered by the authorisation to place the corresponding medicinal product on the market and for any use
         of the product as a medicinal product that has been authorised before the expiry of the certificate.
      
      Article 5 – Effects of the certificate
      
      Subject to the provisions of Article 4, the certificate shall confer the same rights as conferred by the basic patent and
         shall be subject to the same limitations and the same obligations.
      
      Article 6 – Entitlement to the certificate
      
      The certificate shall be granted to the holder of the basic patent or his successor in title.
      Article 7 – Application for a certificate
      
      1.       The application for a certificate shall be lodged within six months of the date on which the authorisation referred to in
         Article 3(b) to place the product on the market as a medicinal product was granted.
      
      2.      Notwithstanding paragraph 1, where the authorisation to place the product on the market is granted before the basic patent
         is granted, the application for a certificate shall be lodged within six months of the date on which the patent is granted.
      
      …’
      6.        Article 13 of Regulation No 469/2009 provides, under the heading ‘Duration of the certificate’:
      
      ‘1.      The certificate shall take effect at the end of the lawful term of the basic patent for a period equal to the period which
         elapsed between the date on which the application for a basic patent was lodged and the date of the first authorisation to
         place the product on the market in the Community reduced by a period of five years.
      
      2.      Notwithstanding paragraph 1, the duration of the certificate may not exceed five years from the date on which it takes effect.
      …’
      B –    The European Patent Convention (5)
      
      7.        Article 69 of the European Patent Convention (EPC) reads, under the heading ‘Extent of protection’: 
      
      ‘(1)      The extent of the protection conferred by a European patent or a European patent application shall be determined by the claims.
         Nevertheless, the description and drawings shall be used to interpret the claims. 
      
      (2)      For the period up to grant of the European patent, the extent of the protection conferred by the European patent application
         shall be determined by the claims contained in the application as published. However, the European patent as granted or as
         amended in opposition, limitation or revocation proceedings shall determine retroactively the protection conferred by the
         application, in so far as such protection is not thereby extended.’ 
      
      8.        The Protocol on the Interpretation of Article 69 EPC of 5 October 1973, as revised by the Act revising the European Patent
         Convention of 29 November 2000, reads as follows:
      
      ‘Article 1 – General principles 
      
      ‘Article 69 should not be interpreted as meaning that the extent of the protection conferred by a European patent is to be
         understood as that defined by the strict, literal meaning of the wording used in the claims, the description and drawings
         being employed only for the purpose of resolving an ambiguity found in the claims. Nor should it be taken to mean that the
         claims serve only as a guideline and that the actual protection conferred may extend to what, from a consideration of the
         description and drawings by a person skilled in the art, the patent proprietor has contemplated. On the contrary, it is to
         be interpreted as defining a position between these extremes which combines a fair protection for the patent proprietor with
         a reasonable degree of legal certainty for third parties. 
      
      Article 2 – Equivalents 
      
      For the purpose of determining the extent of protection conferred by a European patent, due account shall be taken of any
         element which is equivalent to an element specified in the claims.’
      
      C –    National law
      9.        Section 60 of the United Kingdom Patents Act 1977 provides:
      
      ‘(1)  Subject to the provisions of this section, a person infringes a patent for an invention if, but only if, while the patent
         is in force, he does any of the following things in the United Kingdom in relation to the invention without the consent of
         the proprietor of the patent, that is to say – 
      
      (a)      where the invention is a product, he makes, disposes of, offers to dispose of, uses or imports the product or keeps it whether
         for disposal or otherwise; 
      
      (b)      where the invention is a process, he uses the process or he offers it for use in the United Kingdom when he knows, or it is
         obvious to a reasonable person in the circumstances, that its use there without the consent of the proprietor would be an
         infringement of the patent;
      
      (c)      where the invention is a process, he disposes of, offers to dispose of, uses or imports any product obtained directly by means
         of that process or keeps any such product whether for disposal or otherwise.
      
      …’ 
      III –  Facts and references for a preliminary ruling
      A –    Medeva
      10.      On 20 April 1990, Medeva BV (‘Medeva’) filed a European patent which protects the antigens ‘pertactin’ and ‘filamentous haemagglutinin
         antigen’ (‘FHA’). Those antigens are usable in vaccines against whooping cough. The patent was granted on 18 February 2009
         and expired on 25 April 2010. 
      
      11.      Patent claim 1 reads as follows: ‘A method for the preparation of an acellular vaccine, which method comprises preparing the
         69kDa antigen of Bordetella pertussis [= pertactin] 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.’
      
      12.      Claim 2 reads: ‘A method according to claim 1 wherein the vaccine is devoid of the B. pertussis toxin.’
      
      13.      In 1996 the first commercial vaccine was made in accordance with that invention and duly launched in the United Kingdom. As
         active ingredients it contained the antigens pertactin, FHA and pertussis toxin, in combination with diphtheria toxoid and
         tetanus toxoid so as to be effective against whooping cough, diphtheria and tetanus. In and after 2000, larger multi‑disease
         vaccines were similarly approved and launched in the United Kingdom, comprising active ingredients against whooping cough,
         diphtheria, tetanus, meningitis (Haemophilus influenzae type B) and polio. Since 2004 the combined vaccine against all five
         diseases, DTPa-IPV/HiB, (6) has been routinely recommended in the United Kingdom as the primary immunisation for babies.
      
      14.      On 17 April 2009, Medeva applied for five supplementary protection certificates under application numbers SPC/GB09/015, SPC/GB09/016,
         SPC/GB09/017, SPC/GB09/018 and SPC/GB09/019 (‘SPC applications 09/015, 09/016, 09/017, 09/018 and 09/019’). Those supplementary
         protection certificates relate to five different multi‑disease vaccines which are effective against whooping cough, diphtheria,
         tetanus, polio and in some cases also against meningitis (haemophilus influenzae type B) and contain the antigens pertactin
         and FHA. Those multi‑disease vaccines also contain a number of further active ingredients. 
      
      15.      SPC applications 09/015 and 09/017 specifically relate to multi‑disease vaccines with nine active ingredients, the application
         relating to all those active ingredients. SPC application 09/019 concerns a multi‑disease vaccine with eight active ingredients,
         and likewise relates to all those active ingredients. SPC applications 09/016 and 09/018 concern multi‑disease vaccines with
         eleven active ingredients, whereas SPC application 09/016 relates to the antigens pertactin and FHA and seven further active
         ingredients and SPC application 09/018 only to the antigens pertactin and FHA. 
      
      16.      It is apparent from that overview that SPC applications 09/016 and 09/018 relate only to part – nine out of eleven and two
         out of eleven respectively – of the active ingredients of the corresponding multi-disease vaccine. SPC application 09/018
         is also the only application which relates only to the active ingredients pertactin and FHA which are used in the process
         described in the basic patent. SPC applications 09/015, 09/016, 09/017 and 09/019, on the other hand, cover more active ingredients
         than are used in the method which is the subject‑matter of the basic patent.
      
      17.      Valid authorisations exist to place the five multi‑disease vaccines to which the SPC applications in question relate on the
         market as medicinal products. Because those authorisations relate to the complete combination of active ingredients of the
         respective multi‑disease vaccine, SPC applications 09/016 and 09/018 relate to fewer active ingredients than the marketing
         authorisations for the corresponding multi‑disease vaccines. By contrast, in the case of SPC applications 09/015, 09/017 and
         09/019, the combinations of active ingredients in the SPC applications are coextensive with the combinations of active ingredients
         of the corresponding multi‑disease vaccines.  
      
      18.      By a decision of 16 November 2009, the Comptroller‑General of Patents rejected SPC applications 09/015, 09/016, 09/017, 09/018
         and 09/019 on the ground that the conditions for obtaining certificates as laid down in Article 3 of Regulation No 469/2009
         were not satisfied. He concluded in particular in that regard that the products to which SPC applications 09/015, 09/016,
         09/017 and 09/019 related were not protected by the basic patent for the purposes of Article 3(a) of that regulation. He further
         concluded that the marketing authorisation for the medicinal product to which SPC application 09/018 related was not, for
         the purposes of Article 3(b) of Regulation No 469/2009, a valid authorisation to place the product described in SPC application
         09/018 on the market as a medicinal product.    
      
      19.      The High Court of England and Wales, Chancery Division, confirmed that view by judgment of 27 January 2010. An appeal against
         the decision of the High Court was lodged before the referring court.
      
      20.      Because the referring court has doubts with regard to the interpretation of Article 3(a) and (b) of Regulation No 469/2009,
         it has referred the following questions to the Court of Justice for a preliminary ruling:
      
      ‘1.      Regulation No 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 proprietors 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.      Does the Regulation and, in particular, Article 3(b), permit the grant of a supplementary protection certificate for a single
         active ingredient or combination of active ingredients where:
      
      (a)      a basic patent in force protects the single active ingredient or combination of active ingredients within the meaning of Article
         3(a) of the Regulation; and
      
      (b)      a medicinal product containing the single active ingredient or combination of active ingredients together with one or more
         other active ingredients is the subject of a valid authorisation granted in accordance with Directive 2001/83/EC or 2001/82/EC
         which is the first marketing authorisation that places the single active ingredient or combination of active ingredients on
         the market?’
      
      B –    Georgetown University and Others 
      21.      The central question in Georgetown University and Others is whether a number of SPC applications by Georgetown University, University of Rochester and Loyola University of Chicago
         satisfy the requirements of Article 3(b) of Regulation No 469/2009.
      
      22.      The SPC applications in question relate to one or more active ingredients of the vaccines ‘Gardasil’ and ‘Cervarix’, which
         provide protection against the human papillomavirus (HPV). The human papillomaviruses are classified according to various
         types which are identified by numbers. In that context, the vaccine ‘Gardasil’ provides protection against human papillomavirus
         types 6, 11, 16 and 18. The vaccine ‘Cervarix’ provides protection against human papillomavirus types 16 and 18.
      
      1.      The SPC applications of Georgetown University 
      23.      Georgetown University is the proprietor of a European patent for the recombinantly produced protein L1 of the human papillomavirus,
         which can produce neutralising antibodies against the virions of that papillomavirus. The patent was applied for on 24 June
         1993 and granted on 12 December 2007. It expires on 23 June 2013. Patent claims 9 and 16 concern a vaccine for the prevention
         of infections with the human papillomavirus.
      
      24.      On the basis of that patent, Georgetown University applied for eight supplementary protection certificates with the numbers
         SPC/GB07/070 to SPC/GB07/074 and SPC/GB07/078 to SPC/GB07/080 (‘SPC applications 07/070 to 07/074 and 07/078 to 07/080’).
      
      25.      Five of those SPC applications are based on the marketing authorisation for the medicinal product ‘Gardasil’:
      
      –        SPC application 07/079, which relates to the product ‘recombinant L1 protein of HPV 6’;
      –        SPC application 07/073, which relates to the product ‘recombinant L1 protein of HPV 11’;
      –        SPC application 07/080, which relates to the product ‘recombinant L1 protein of HPV 16’; 
      –        SPC application 07/078, which relates to the product ‘recombinant L1 protein of HPV 18’ and
      –        SPC application 07/074, which relates to the product ‘combination of the recombinant L1 protein of HPV 6, HPV 11, HPV 16 and
         HPV 18’.
      
      26.      SPC applications 07/079, 07/073, 07/080 and 07/078, which relate to only one active ingredient of the medicinal product ‘Gardasil’,
         were rejected by decision of the UK Intellectual Property Office (‘the UKIPO’) of 29 December 2009 because evidence of valid
         authorisations to place the products concerned on the market as referred to in Article 3(b) of Regulation No 469/2009 had
         not been produced. SPC application 07/074 was granted in principle by the UKIPO by letter of 22 January 2010. However, at
         the request of Georgetown University, the grant of the supplementary protection certificate was deferred pending the conclusion
         of the current court proceedings.
      
      27.      Georgetown University also applied for three supplementary protection certificates on the basis of the marketing authorisation
         for the medicinal product ‘Cervarix’:
      
      –        SPC application 07/071, which relates to the product ‘recombinant L1 protein of HPV 16’ and was subsequently slightly amended;
      –        SPC application 07/070, which relates to the product ‘recombinant L1 protein of HPV 18’ and was subsequently slightly amended;
      –        SPC application 07/072, which relates to the product ‘combination of the recombinant L1 protein of HPV 16 and HPV 18’.
      28.      SPC applications 07/071 and 07/070, which relates to only one active ingredient of the medicinal product ‘Cervarix’, were
         rejected by UKIPO decision of 29 December 2009 because evidence of valid authorisations to place the products concerned on
         the market as referred to in Article 3(b) of Regulation No 469/2009 had not been produced. SPC application 07/072 was granted
         in principle by the UKIPO by letter of 22 January 2010. However, at the request of Georgetown University, the grant of the
         supplementary protection certificate was deferred until the conclusion of the current court proceedings. 
      
      2.      The SPC applications of University of Rochester
      29.      University of Rochester is the proprietor of a European patent for a purified recombinant human papillomavirus‑like particle
         or capsomere. The patent was applied for on 8 March 1994 and granted on 25 May 2005. It expires on 7 March 2014. Patent claim
         7 concerns a vaccine for the prevention of an infection with the human papillomavirus.
      
      30.      University of Rochester applied for three supplementary protection certificates with the numbers SPC/GB07/018, SPC/GB07/075
         and SPC/GB07/076 (‘SPC applications 07/018, 07/075 and 07/076).
      
      31.      Two of those SPC applications are based on the marketing authorisation for the medicinal product ‘Cervarix’:
      
      –        SPC application 07/075, which relates to the product ‘virus‑like particle of the recombinant L1 protein of HPV 16’ and was
         subsequently slightly amended;
      
      –        SPC application 07/076, which relates to the product ‘combination of the virus‑like particles of the recombinant L1 protein
         of HPV 16 and HPV 18’.
      
      32.      SPC application 07/075, which relates to only one active ingredient of the medicinal product ‘Cervarix’, was rejected by UKIPO
         decision of 29 December 2009 because evidence of a valid authorisation to place the product on the market as referred to in
         Article 3(b) of Regulation No 469/2009 had not been produced. SPC application 07/076 was accepted by the UKIPO and the supplementary
         protection certificate was granted on 5 October 2009.
      
      33.      SPC application 07/018 of University of Rochester, which relates to the product ‘combination of the virus‑like particles of
         the recombinant L1 protein of HPV 6, HPV 11, HPV 16 and HPV 18’ and is based on the marketing authorisation for the medicinal
         product ‘Gardasil’, was accepted by the UKIPO and the supplementary protection certificate was granted on 4 October 2009.
      
      3.      The SPC applications of Loyola University of Chicago
      34.      Loyola University of Chicago is the proprietor of a European patent for recombinantly produced papillomavirus‑like particles.
         The patent was applied for on 9 October 1995 and granted on 10 May 2006. It expires on 8 October 2015.
      
      35.      Loyola University of Chicago applied for two supplementary protection certificates with the numbers SPC/GB07/069 and SPC/GB07/077
         (‘SPC applications 07/069 and 07/077’). Both applications are based on the marketing authorisation for the medicinal product
         ‘Cervarix’.
      
      36.      SPC application 07/069, which relates to the product ‘virus‑like particle of the recombinant L1 protein of HPV 16’ and was
         subsequently slightly amended, was rejected by UKIPO decision of 29 December 2009 because evidence of a valid authorisation
         to place the product concerned on the market as referred to in Article 3(b) of Regulation No 469/2009 had not been produced.
         
      
      37.      SPC application 07/077, which relates to the product ‘combination of the virus‑like particles of the recombinant L1 protein
         of HPV 16 and HPV 18’, was accepted by the UKIPO and the supplementary protection certificate was granted on 5 October 2009.
      
      4.      Question submitted by the referring court
      38.      In the main proceedings, the referring court is required to assess the lawfulness of the UKIPO’s decisions by which the abovementioned
         SPC applications were rejected in all cases in which the product to which those applications related contained fewer active
         ingredients than the combination of active ingredients of the medicinal product which was the subject of the marketing authorisations
         as referred to in Article 3(b) of Regulation No 469/2009. (7)
      
      39.      Because the referring court has doubts regarding the interpretation of Article 3 of Regulation No 469/2009, it has made a
         reference to the Court for a preliminary ruling on the following question:
      
      ‘Does 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 and, in particular, Article 3(b), permit the grant of a supplementary protection
         certificate for a single active ingredient or combination of active ingredients where:
      
      (a)      a basic patent in force protects the single active ingredient or combination of active ingredients within the meaning of Article
         3(a) of the Regulation; and
      
      (b)      a medicinal product containing the single active ingredient or combination of active ingredients together with one or more
         other active ingredients is the subject of a valid authorisation granted in accordance with Directive 2001/83/EC or 2001/82/EC
         which is the first marketing authorisation that places the single active ingredient or combination of active ingredients on
         the market?’
      
      IV –  Procedure before the Court
      40.      The order for reference in Medeva was received by the Court on 5 July 2010 and the order for reference in Georgetown University and Others on 27 August 2010. By order of 12 January 2011, the two cases were joined for the purposes of the oral procedure and the
         judgment.
      
      41.      The European Commission and the Portuguese Government submitted observations in the written procedure in both cases. Medeva
         and the Latvian and Lithuanian Governments and the United Kingdom Government submitted observations in Medeva. Georgetown University, University of Rochester and Loyola University of Chicago submitted observations in Georgetown University and Others. In accordance with Article 54a of the Rules of Procedure, the parties were asked to provide written answers to a number
         of questions. Medeva, Georgetown University, University of Rochester, Loyola University of Chicago, the United Kingdom Government
         and the Portuguese Government replied to those questions in writing. At the hearing on 12 May 2011, the Portuguese Government,
         the United Kingdom Government, Medeva, Georgetown University, University of Rochester, Loyola University of Chicago and the
         Commission made oral submissions and answered questions put by the Court. 
      
      V –  Arguments of the parties
      A –    Questions 1 to 5 in Medeva
      
      42.      By Questions 1 to 5 in Medeva, the referring court asks in essence for clarification concerning the application of Article 3(a) of Regulation No 469/2009
         to an SPC application which relates to a combination of active ingredients which, although not the subject‑matter of a patent
         as such, nevertheless enjoys protection under patent law because a valid patent exists in respect of one or more of the active
         ingredients used in the combination of active ingredients. In that regard, the referring court wishes in particular to know
         whether such a combination of active ingredients is to be regarded as being ‘protected by a basic patent in force’. The referring
         court also enquires whether Article 3(a) of Regulation No 469/2009 applies differently to medicinal products with more than
         one active ingredient or multi‑disease vaccines, on the one hand, and to medicinal products or vaccines with only one active
         ingredient, on the other.   
      
      43.      The question whether a combination of active ingredients which includes both patented and non‑patented active ingredients
         can be classified in its entirety as a ‘product … protected by a basic patent in force’ within the meaning of Article 3(a)
         of Regulation No 469/2009 is answered in the negative by the Commission, the Portuguese Government, the Latvian Government and the Lithuanian Government. Medeva and the United Kingdom Government, on the other hand, answer that question in the affirmative. The question whether Article 3(a) of Regulation No 469/2009
         applies differently to medicinal products with multiple active ingredients or multi‑disease vaccines, on the one hand, and
         to medicinal products or vaccines with only one active ingredient, on the other, is in effect answered in the negative by
         all the parties.
      
      44.      In the view of the Commission, in a case such as this, the referring court is required to determine, in accordance with Article 3(a) of Regulation No 469/2009,
         whether the product within the meaning of Article 1(b) is protected by a basic patent within the meaning of Article 1(c).
         For this purpose, 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. In that regard,
         Article 3(a) should be applied to SPC applications for medicinal products or vaccines with multiple active ingredients in
         the same way as to SPC applications for medicinal products or vaccines with only one active ingredient. That solution applies
         both to multi‑disease vaccines containing multiple antigens, in which only one antigen is protected by a basic patent in force,
         and to multi‑disease vaccines containing multiple antigens, in which all the antigens against one of the diseases are protected
         by a basic patent in force.  
      
      45.      In the view of the Portuguese Government, for the purpose of interpreting Article 3(a) of Regulation No 469/2009, the starting premiss must be that the determination
         of the extent of protection of basic patents must be made in accordance with national law. Under the national laws of the
         Contracting States to the EPC, the extent of protection of a patent is determined by the patent claims. It must therefore
         also be established on the basis of those patent claims whether a product is protected by a basic patent in force within the
         meaning of Article 3(a). It is also true to say of medicinal products with more than one active ingredient and of multi‑disease
         vaccines that a combination of active ingredients is protected by a basic patent only where that combination of active ingredients
         is specified in the patent claims. Against that background, 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). Likewise, a multi‑disease
         vaccine which contains multiple antigens protected by a basic patent satisfies the requirements of Article 3(a) only where
         the combination of active ingredients corresponds completely with the patent claims.       
      
      46.      In the view of the Lithuanian Government, it is apparent from the recitals in the preamble to and from the provisions of Regulation No 469/2009 that 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. That is true irrespective of the nature of the medicinal product
         in respect of which a supplementary protection certificate is being applied for. The Latvian Government likewise starts from the premiss that the question whether a product is protected by a basic patent must be answered on the
         basis of the patent claims. Only the product described in the patent claims is protected by the basic patent. This also applies
         to multi‑disease vaccines or medicinal products with multiple active ingredients.
      
      47.      In the view of the United Kingdom Government and Medeva, on the other hand, Article 3(a) of Regulation No 469/2009 must be interpreted as meaning that a combination of active ingredients
         is protected by a basic patent in force where at least one of its active ingredients falls within the extent of protection
         conferred by a patent as specified in the patent claims and the entire combination of ingredients thereby enjoys the protection
         conferred by the patent against the marketing of identical products. That rule applies without restriction to medicinal products
         with more than one active ingredient or multi‑disease vaccines. Where, therefore, a multi‑disease vaccine contains multiple
         antigens, one of which is protected by a basic patent in force, the multi‑disease vaccine must also be regarded as being protected
         by that basic patent. The same must apply where a multi‑disease vaccine contains multiple antigens against one disease and
         all those antigens are protected by a patent in force. In the alternative, Medeva submits that its interpretation of Article
         3(a) of Regulation No 469/2009 must in any event apply to multi‑disease vaccines.
      
      B –    Sixth question referred in Medeva and sole question referred in Georgetown University and Others
      
      48.      By the sixth question referred in Medeva and the sole question referred in Georgetown University and Others, the referring courts request clarification concerning the application of Article 3(b) of Regulation No 469/2009. In that
         regard, they wish in essence to know whether the condition laid down in that provision for obtaining a supplementary protection
         certificate can be satisfied where the medicinal product which is the subject of the marketing authorisation also contains,
         in addition to the active ingredient or combination of active ingredients specified in the SPC application, still further
         active ingredients. 
      
      49.      In the view of the Commission, Georgetown University, University of Rochester, Loyola University of Chicago and Medeva, this question should be answered in the affirmative. However, Medeva formulates this proposed answer only in the event that
         the Court does not agree with its proposed answers to the first five questions referred in Medeva.
      
      50.      In the view of the United Kingdom Government, the Portuguese Government and the Latvian Government, on the other hand, Article 3(b) of Regulation No 469/2009 is to be interpreted as meaning that the medicinal product which
         is the subject of the marketing authorisation must have the same combination of active ingredients as the product in respect
         of which a supplementary protection certificate is applied for. The Lithuanian Government submits that the active ingredient of the medicinal product in respect of which a marketing authorisation has been granted
         must correspond to the active ingredient specified in the patent claims.    
      
      VI –  Legal assessment
      A –    Questions 1 to 5 in Medeva
      
      51.      By Questions 1 to 5 in Medeva, the referring court asks in essence for clarification concerning the application of Article 3(a) of Regulation No 469/2009
         to an SPC application relating to the combination of active ingredients of a medicinal product which is not in its entirety
         the subject‑matter of a patent, but nevertheless enjoys protection under patent law against production and distribution by
         third parties because a valid patent exists in respect of part of the combination of active ingredients. 
      
      52.      Although the referring court has made reference, in its formulation of these questions, only to Article 3(a) of Regulation
         No 469/2009, it raises, by its reference for a preliminary ruling, the question of principle as to whether and, if so, how
         and under what conditions supplementary protection certificates may be applied for and granted in respect of medicinal products
         with multiple active ingredients where their combination of active ingredients is only partially the subject‑matter of a patent.
         To date, the Court has not yet comprehensively ruled on that question of principle. Against that background, it seems to me
         to be necessary to analyse below, first, the issues surrounding the applicability of Regulation No 469/2009 to medicinal products
         with a partially patented combination of active ingredients. That will then enable a meaningful answer to be given to the
         questions referred concerning the application of Article 3(a) of Regulation No 469/2009 to such medicinal products.
      
      53.      In order to answer the question concerning the applicability of Regulation No 469/2009 to medicinal products with a partially
         patented combination of active ingredients, I shall first analyse Regulation No 469/2009 in terms of its wording and scheme.
         I shall then assess the result of that textual interpretation in the light of the objectives of Regulation No 469/2009. Against
         the background of the teleological considerations arising from that assessment, I shall then answer the questions referred.
         
      
      1.      Interpretation of Regulation No 469/2009 on the basis of its wording and scheme 
      a)      The subject of the supplementary protection certificate 
      54.      Under Article 2 of Regulation No 469/2009, a product protected by a patent in the territory of a Member State and subject,
         prior to being placed on the market as a medicinal product, to an administrative authorisation procedure as laid down in Directive 2001/83
         or Directive 2001/82 may, under the terms and conditions provided for in that regulation, be the subject of a supplementary
         protection certificate.
      
      55.      The precise conditions for the grant of such a certificate are laid down in Article 3 of Regulation No 469/2009, in accordance
         with point (a) of which the product must be protected, in the Member State in which the application is submitted and at the
         date of that application, by a basic patent in force. 
      
      56.      The meanings of the terms ‘medicinal product’, ‘product’ and ‘basic patent’ are specified in Article 1 of Regulation No 469/2009.
         According to Article 1(a), a ‘medicinal product’ is any substance or combination of substances intended for treating or preventing
         disease in human beings or animals. A ‘product’, according to Article 1(b), is the active ingredient or combination of active
         ingredients of a medicinal product. The ‘basic patent’, according to Article 1(c), is a patent which protects a product as
         such, a process to obtain a product or an application of a product.  
      
      57.      With regard to the content of the terms ‘product’ and ‘medicinal product’ and their relationship to each other, the Commission
         observed in the Explanatory Memorandum to its proposal for Regulation No 1768/92 (8) that the concept of a medicinal product as used in everyday speech is difficult to define in a legal context. Furthermore,
         the definition of a medicinal product in pharmaceutical law is not necessarily exactly the same as that in patent law. For
         the purposes of the supplementary protection certificate, which lies at the interface of the two systems, the term ‘product’
         was chosen as a common denominator. (9)
      
      58.      When adopting the regulation, the legislature thus sought to distinguish by way of definition between the terms ‘medicinal
         product’, ‘product’ and ‘active ingredient’ and in so doing to bridge the conceptual gap between the spheres of pharmaceutical
         law and intellectual property law. Although the definitions contained in Article 1 of Regulation No 469/2009 also appear to
         contain clear interpretative requirements in that regard, a certain ambiguity is apparent, on detailed analysis of the wording
         of Regulation No 469/2009, in the use of the terms ‘product’ and ‘medicinal product’, and it is not always clear to what extent
         those terms are or are intended to be coextensive in content.   
      
      59.      A first example of this is provided by a comparison of the title of Regulation No 469/2009 with Article 2 of the regulation.
         According to its title, the regulation concerns the supplementary protection certificate for ‘medicinal products’. However,
         Article 2 states that the supplementary protection certificate is to be granted for a ‘product’ protected under patent law.
         
      
      60.      A further example is provided by the wording of Article 2 of Regulation No 469/2009, which provides that a supplementary protection
         certificate is to be granted for a ‘product’ protected by a patent, which was subject, prior to being placed on the market
         ‘as a medicinal product’, to an administrative authorisation procedure as laid down in Directive 2001/83 or Directive 2001/82.
         Article 3(b) of the regulation also talks about an authorisation to place ‘the product’ on the market ‘as a medicinal product’.
      
      61.      An overlap in content between the terms ‘product’ and ‘medicinal product’ also finds expression in the definition of ‘product’
         in Article 1(b) of Regulation No 469/2009. In the various language versions of the regulation which distinguish between the
         definite and indefinite article, the product has been defined as ‘the’ active ingredient or combination of active ingredients
         of a medicinal product. (10) The product thus corresponds to the whole active or effective part of the medicinal product, which turns the latter into
         a preparation for preventing or treating disease and thus into a medicinal product. (11) Viewed in terms of the wording, ‘an’ active ingredient, which together with other active ingredients is only part of the
         combination of active ingredients of a medicinal product, therefore does not constitute a product within the meaning of Article
         1(b) of Regulation No 469/2009. (12)
      
      62.      The latter conclusion regarding the wording of Article 1(b) of Regulation No 469/2009 is of particular relevance to the present
         references for a preliminary ruling. It actually means that, in the case of a multi‑disease vaccine, only the combination
         of all the active ingredients constitutes the product within the meaning of Regulation No 469/2009. According to the wording
         of Article 1(b), on the other hand, a single active ingredient of a multi‑disease vaccine cannot be subsumed under the concept
         of product in Regulation No 469/2009. 
      
      b)      Issue raised: No supplementary protection certificate for medicinal products with multiple active ingredients, the combination
         of active ingredients of which is only partially patented?
      
      63.      According to the wording of Article 1(b) of Regulation No 469/2009, a single active ingredient or combination of active ingredients
         which is part of the larger combination of active ingredients of a medicinal product does not constitute a product within
         the meaning of the regulation. A literal interpretation of Regulation No 469/2009 therefore leads to the conclusion that,
         in the case of medicinal products with multiple active ingredients, a supplementary protection certificate may be granted
         only in relation to the entire combination of active ingredients. That is because, according to the wording of Article 1(b),
         only the combination of active ingredients as such constitutes the product in respect of which a supplementary protection
         certificate may be granted.  
      
      64.      However, that literal interpretation at the same time implies that, in the case of medicinal products with multiple active
         ingredients, only part of which is the subject‑matter of a patent, no supplementary protection certificates may be granted.
         In the case of such medicinal products, it would actually, as a rule, be de facto impossible for the basic patent within the
         meaning of Article 1(c) of the regulation – required under Article 3(a) of Regulation No 469/2009 – to exist.
      
      65.      That follows from the definition of a basic patent in Article 1(c) of Regulation No 469/2009.
      
      66.      Under Article 1(c) of Regulation No 469/2009, the basic patent is a patent which protects a product as such, a process to
         obtain a product or an application of a product, and which is designated by its holder for the purpose of the procedure for
         grant of a certificate. That definition refers to the three major categories of patent into which the basic patent can fall,
         namely: (1) patents relating to a physical entity; (2) patents relating to a process; and (3) patents relating to the application
         of an object or a process. (13)
      
      67.      In the three categories of patent referred to in Article 1(c) of Regulation No 469/2009, the subject‑matter of the basic patent
         is always the product within the meaning of Article 1(b) of that regulation and therefore ‘the’ active ingredient or (the)
         combination of active ingredients of a medicinal product. It follows from this that a patent for ‘an’ active ingredient or
         ‘a’ combination of active ingredients which forms only part of the combination of active ingredients of a medicinal product
         cannot constitute a basic patent within the meaning of Article 1(c) of Regulation No 469/2009. That is because, on a literal
         interpretation, only the combination of active ingredients of that medicinal product in its entirety, and not the patented
         part of that combination, can be described as a product within the meaning of Article 1(b). 
      
      68.      Nor is that conclusion altered in any way by the discussion conducted in the main proceedings in the context of Article 3(a)
         of Regulation No 469/2009, on the distinction between the subject‑matter – or extent of protection – and the protective effect
         of the basic patent. That debate concerns, in particular, the question whether the fact that an active ingredient which is
         the subject‑matter of a patent is an integral part of a combination of active ingredients and, as a consequence, that entire
         combination of active ingredients may not be produced or placed on the market without the consent of the patent proprietor
         (that is the protective effect of the patent) implies that the combination of active ingredients is deemed to be protected by a patent in force. 
      
      69.      The decisive consideration in that context is the fact that the definition of the basic patent in Article 1(c) of Regulation
         No 469/2009 takes as its basis the subject‑matter of the patent, and not its protective effect. A basic patent within the meaning of Regulation No 469/2009 must therefore be understood as one whose subject‑matter comprises either a product as such, a process to obtain a product or an application of a product within the meaning of Article
         1(b) of Regulation No 469/2009.
      
      70.      In the absence of harmonisation of patent law in the European Union, the question whether a product as such, a process to
         obtain a product or an application of a product within the meaning of Article 1(b) of Regulation No 469/2009 forms the subject‑matter
         of a national or European patent must, as Union law now stands, be answered on the basis of the national rules governing that
         patent. (14) Nevertheless, the definition of the basic patent laid down in Article 1(c) of the Regulation (15) requires that, in the application of that definition, regard is always had to the subject‑matter of the patent in question, and not to its protective effects.
      
      71.      At the same time, that definitional requirement of Article 1(c) of Regulation No 469/2009 also reduces the risk that the absence
         of harmonisation of substantive patent law in the European Union could lead to differences in the protection conferred by
         certificates in the Union. (16)
      
      72.      In the light of those considerations, it would not, in my view, be compatible with the mandatory requirements of Article 1(c)
         of Regulation No 469/2009 for a national court, relying on national patent law, to invoke the protective effect of the patent
         granted for a specific active ingredient in order to declare that patent to be the basic patent for all combinations of active
         ingredients in which the patented active ingredient was to be used. 
      
      73.      On a literal interpretation of Articles 1 to 3 of Regulation No 469/2009, the fact therefore remains that, in the case of
         medicinal products in which the combination of active ingredients is only partially patented, in the absence of a basic patent
         within the meaning of Article 1(c) of the regulation, no supplementary protection certificates may be granted. 
      
      2.      Teleological interpretation of Regulation No 469/2009
      74.      It follows from my above observations that, as a general rule, on a literal interpretation of Regulation No 469/2009, there
         can be no question of a supplementary protection certificate being granted for a multi‑disease vaccine in which the combination
         of active ingredients is only partly patented. I shall now examine below first whether such a conclusion is compatible with
         the aims of Regulation No 469/2009. Since, in my view, the answer to that must be in the negative, I shall then complement
         the literal interpretation of Articles 1 to 3 of Regulation No 469/2009 with a teleological interpretation. 
      
      a)      Necessity of a teleological interpretation of Articles 1 to 3 of Regulation No 469/2009
      75.      The aim of the supplementary protection certificate for medicinal products is essentially to extend the term of patent protection
         for active ingredients used in medicinal products.
      
      76.      The standard term of patent protection is 20 years, calculated from the date of application for registration of the invention.
         If an authorisation to place medicinal products on the market in accordance with Directive 2001/83 or Directive 2001/82 is
         granted following the filing of an application to have the patent registered, manufacturers of medicinal products (17) will be unable commercially to exploit their position of exclusivity in relation to the patented active ingredients of that
         medicinal product during the period which elapses between the application to have the patent registered and the authorisation
         to place the medicinal product concerned on the market. Since, in the view of the European Union legislature, that would make
         the period of effective protection under the patent insufficient to cover the investment in research and to generate the resources
         needed to maintain a high level of research, (18) Regulation No 469/2009 grants those manufacturers the possibility to extend their rights to exclusivity in the patented active
         ingredients of a medicinal product by applying for a supplementary protection certificate to cover a period not exceeding
         15 years from the time at which the medicinal product concerned first obtains authorisation to be placed on the market within
         the European Union. (19)
      
      77.      Those rules are intended to achieve a balance between the various interests at stake in the pharmaceutical sector. Those interests
         include, on the one hand, the interests of the undertakings and institutions, some of which pursue very cost‑intensive research
         in the pharmaceutical sector and therefore favour an extension of the term of protection for their inventions in order to
         be able to recoup the investment costs. On the other hand, there are the interests of the producers of generic medicines who,
         as a consequence of the extension of the term of protection of the active ingredients under patent protection, are precluded
         from producing and marketing generic medicines. It is also relevant in this connection that, in general, the marketing of
         generic medicinal products has the effect of lowering the prices of the relevant medicinal products. Against that background,
         the interests of patients lie between the interests of the undertakings and institutions conducting research and those of
         the producers of generic medicines. That is because patients have an interest, on the one hand, in the development of new
         active ingredients for medicinal products, but, on the other, they also have an interest in those products then being offered
         for sale as cheaply as possible. The same applies to State public health systems in general which, in addition, have a particular
         interest in preventing old active ingredients from being brought onto the market in slightly modified form under the protection
         of certificates but without genuine innovation and thereby artificially driving up expenditure in the health sector.   
      
      78.      Against the background of that complex situation as regards interests, Regulation No 469/2009 sought to achieve a balanced
         solution taking due account of the interests of all parties. In view of the complexity of that balance of interests, (20) it is necessary to proceed with great caution when making a teleological interpretation of the individual provisions of the
         regulation. 
      
      79.      Nevertheless, it is in my view clear that the result of the literal interpretation of Articles 1 to 3 of Regulation No 469/2009,
         according to which, in the case of medicinal products with multiple active ingredients only part of which is the subject‑matter
         of a patent, no supplementary protection certificates can be granted, is not compatible with the objectives of Regulation
         No 469/2009.
      
      80.      If no supplementary protection certificates could be granted in respect of medicinal products with multiple active ingredients
         only part of which is the subject‑matter of a patent, that would actually have the result that, in all spheres in which the
         manufacturers of medicinal products found themselves obliged, for legal or practical reasons, to place patented active ingredients
         on the market in combination with other active ingredients in one medicinal product, an extension of the term of protection
         of the patented active ingredients in accordance with the requirements of Regulation No 469/2009 would not be possible.
      
      81.      The fact that such a result would not be compatible with the objectives of Regulation No 469/2009 can be unequivocally substantiated
         by the example of the development of active ingredients for vaccines with which we are concerned in this case.
      
      82.      The importance of vaccines for public health is difficult to overestimate. It is reflected inter alia in the observations
         of the European Commission’s Directorate‑General for Health and Consumers on the Commission’s vaccination strategy. That directorate‑general
         points out that vaccination offers people immunity to diseases and is unquestionably one of the most cost-effective public
         health measures available. (21) It also stresses that the Commission has supported the introduction of vaccines against cervical cancer, and the vaccines
         Gardasil and Cervarix, which are at issue in Georgetown University and Others, are expressly mentioned. (22)
      
      83.      In their written observations, Georgetown University, University of Rochester and Loyola University of Chicago (23) and Medeva (24) have all pointed out that national health authorities as well as patients have a particular interest in the development of
         multi‑disease vaccines. The use of multi‑disease vaccines makes it possible, in particular, to provide infants and young children
         with fast and complete protection by vaccination against a multitude of diseases by means of only a few vaccinations. That
         in turn means that vaccination schedules are better adhered to, inconvenience for patients is kept to a minimum and delays
         in the achievement of comprehensive protection provided by vaccination are avoided. Accordingly, vaccines are in many cases
         placed on the market only as multi‑disease vaccines. 
      
      84.      To support those arguments, those parties refer, on the one hand, to WHO Fact Sheet No 288 (2005) – Immunisation against diseases of public importance, (25) which, under the heading ‘Types of vaccines’, points out that vaccines are frequently administered as combinations of antigens.
         In that context, Medeva further stresses that it has produced no vaccine containing only FHA and pertactin. (26)
      
      85.      That argument put forward by the undertakings from the pharmaceutical research sector which are represented in the main proceedings
         is supported by several World Health Organisation publications. In its article ‘Six common misconceptions about immunisation’,
         the World Health Organisation points out, for example, that research is under way to find out how to combine more antigens
         in a single vaccine injection. The advantage of complete multi‑disease vaccines lies in the fact that infants receive extensive
         protection by being vaccinated as early as possible. The reduction in the number of vaccinations also saves parents time and
         money and makes the vaccinations less traumatic for the child. (27)
      
      86.      In that context, the referring court has also pointed out in Medeva that vaccine manufacturers are forced by countries’ purchasing policies to produce large combinations of vaccines wherever
         possible. In the view of that court, the market is thus dictated by the State which insists that vaccines be combined where
         possible. In such circumstances, there may not be a market for patented vaccines which are provided on their own. (28)
      
      87.      Those observations prove that manufacturers of medicinal products may have a legitimate interest in marketing multi-disease
         vaccines. In my view, it would therefore run counter to the aims of Regulation No 469/2009 if the balance of interests achieved
         in that regulation, according to which manufacturers of medicinal products should be able to enjoy their position of exclusivity
         for an overall maximum of 15 years from the time the medicinal product in question first obtains authorisation to be placed
         on the market in the European Union, were to be upset by the fact that patented active ingredients are placed on the market
         in combination with other active ingredients in one medicinal product.
      
      88.      The literal interpretation of Articles 1 to 3 of Regulation No 469/2009 must therefore be complemented by a teleological interpretation
         which ensures that the rules on supplementary protection certificates contained in those provisions can also be fully effective
         in respect of medicinal products in which the combination of active ingredients is only partly the subject‑matter of a patent. (29)
      
      b)      The product within the meaning of Article 1(b) of Regulation No 469/2009
      89.      In the light of my above observations, it appears to me to be necessary to interpret the definition of ‘product’ in Article
         1(b) of Regulation No 469/2009 teleologically to the effect that the product within the meaning of the regulation includes
         not only ‘the’ active ingredient or ‘the’ combination of active ingredients, but also ‘an’ active ingredient or ‘a’ combination
         of active ingredients of a medicinal product. 
      
      90.      Such an interpretation also brings within the scope of Regulation No 469/2009 medicinal products in which the combination
         of active ingredients is only partly the subject‑matter of a patent. It in fact allows an SPC application to designate the
         part of the combination of active ingredients which forms the subject‑matter of a patent as the product within the meaning
         of Article 1(b). That patent can then automatically be classified as the basic patent within the meaning of Article 1(c) of
         that regulation, so that on that basis the conditions for obtaining the supplementary protection certificate as laid down
         in Article 3 of the regulation can be examined.  
      
      c)      The product within the meaning of Article 3(a) of Regulation No 469/2009
      91.      Although the widening of the concept of product within the meaning of Article 1(b) of Regulation No 469/2009 to include ‘an’
         active ingredient or ‘a’ combination of active ingredients in principle brings within the scope of that regulation medicinal
         products in which the combination of active ingredients is only partially the subject‑matter of a patent, it must be ensured
         that such a teleological interpretation does not go beyond the aim pursued by it of achieving the balance of interests envisaged
         by the European Union legislature.
      
      92.      In that context, there is a danger, in particular, that an interpretation of Article 1(b) of Regulation No 469/2009 to the
         effect that both ‘the’ combination of active ingredients and part of the combination of active ingredients of a medicinal
         product may be classified as the ‘product’ could be exploited in order to undermine the system of limitation of the duration
         of supplementary protection certificates envisaged by the legislature. 
      
      93.      Under Article 13(1) of Regulation No 469/2009, the supplementary protection certificate is to take effect at the end of the
         lawful term of the basic patent for a period equal to the period which elapsed between the date on which the application for
         a basic patent was lodged and the date of the first authorisation to place the product on the market in the European Union
         reduced by a period of five years. Under Article 13(2), the duration of the certificate may not exceed five years from the
         date on which it takes effect.
      
      94.      Those rules reflect the legislature’s decision to grant the proprietor of the patent an extension of his position of exclusivity
         by the period by which the duration of the authorisation procedure for the medicinal product exceeds five years, although
         a maximum limit of five years applies in that regard. Moreover, the uniform starting point for the calculation of the duration
         of the certificate is the first authorisation to place the product on the market ‘in the European Union’, (30) so that, in principle, supplementary protection certificates have the same duration in respect of the same products in all
         the Member States.
      
      95.      Where a manufacturer of medicinal products thus succeeds in placing a medicinal product with a patented active ingredient
         on the market within five years from the date of application for the patent, any protection conferred by a certificate is
         out of the question; however, he enjoys – based on a standard patent term of 20 years – patent protection for at least 15
         years. Where, on the other hand, a manufacturer of medicinal products needs 10 years or more from the date of application
         for the patent in order to obtain the first authorisation to place the product on the market in the European Union, he is
         entitled to the maximum protection of five years under a certificate.    
      
      96.      If both the combination of active ingredients of a medicinal product and a patented active ingredient or combination of active
         ingredients contained in it could in future be classified as a product within the meaning of Article 1(b) of Regulation No 469/2009,
         there would be a risk that a manufacturer of medicinal products could develop a number of medicinal products with different
         combinations of active ingredients on the basis of one patented active ingredient or combination of active ingredients and
         place those products on the market with a time lag in some cases, for the purpose of optimising the protection under the certificate.
         
      
      97.      An optimised duration – from the point of view of the manufacturer of medicinal products – of protection under the patent
         and the certificate could, for example, be achieved by ensuring that a first medicinal product with a patented active ingredient
         is placed on the market as quickly as possible in order to exploit the already existing patent protection commercially. Where
         the procedure for obtaining an authorisation to place the product on the market has taken longer than five years, the manufacturer
         of medicinal products could at the same time apply for a supplementary protection certificate and declare the complete combination
         of active ingredients as the product. He could then attempt to substantiate the protection under patent law for that product,
         required under Article 3(a) of Regulation No 469/2009, by reference to the protective effect of the basic patent for the patented
         active ingredient included in the combination of active ingredients. (31) Subsequently, the manufacturer of medicinal products could place such products with slightly differing combinations of active
         ingredients, also including the patented active ingredient, on the market and, according to the same logic, apply for new
         supplementary protection certificates for them, which could then have a duration of up to five years.
      
      98.      In order to prevent such an undermining of the system of limitation of the duration of the protection conferred by a certificate
         provided for in Regulation No 469/2009, Article 3(a) must be interpreted as meaning that the product within the meaning of
         that provision is the same as the product which forms the subject‑matter of the basic patent within the meaning of Article
         1(c). 
      
      99.      That definition of the product within the meaning of Article 3(a) of Regulation No 469/2009 implies, on the one hand, that,
         in the context of a judicial application of Article 3(a), it must essentially be determined whether a product which forms
         the subject‑matter of the basic patent is before the court. That determination must in principle be made according to the
         rules governing the basic patent. If the answer to that question is in the affirmative, the further condition laid down by
         Article 3(a), namely that that product must be protected by a basic patent in force, is, as a rule, satisfied by that fact
         alone. That is because, although the latter question must also be answered according to the rules governing the basic patent, (32) it must be assumed that a product which, according to the rules governing the basic patent, is the subject‑matter of the
         basic patent, will also be protected by the latter.
      
      100. Having particular regard to Article 3(c) of Regulation No 469/2009, according to which only one supplementary protection certificate
         per product may be granted in the Member State in which the application is submitted, that interpretation of Article 3(a)
         has the effect, on the other hand, that, for each active ingredient or combination of active ingredients which is the subject‑matter
         of a patent, only one supplementary protection certificate for the extension of that patent’s term of protection may be granted,
         regardless of the number of combinations of active ingredients in which the patented active ingredient or combination of active
         ingredients has been used. (33) This makes it impossible for manufacturers of medicinal products to optimise the term of protection under the patent and
         certificate in relation to an active ingredient by placing the patented active ingredient on the market in a number of combinations
         of active ingredients as different medicinal products, with a time lag in some cases.
      
      101. Interpreting Article 3(a) of Regulation No 469/2009 to the effect that the product within the meaning of that provision is
         the same as the product which forms the subject‑matter of the basic patent means that a manufacturer of medicinal products
         who holds a patent for an active ingredient or combination of active ingredients is free to decide how he will place that
         patented active ingredient or combination of active ingredients on the market: in one medicinal product with only that active
         ingredient or that combination of active ingredients, in one medicinal product in combination with other active ingredients,
         or in a number of medicinal products with differing combinations of active ingredients. For each of those medicinal products,
         the patented active ingredient or combination of active ingredients must be classified as the product protected by a basic
         patent in force within the meaning of Article 3(a). Under Article 3(c) of the regulation, however, only one supplementary
         protection certificate may be applied for in respect of that product, regardless of in how many different combinations of
         active ingredients the patented active ingredient or combination of active ingredients is placed on the market as a medicinal
         product. 
      
      102.  Having particular regard to the account of the facts in Georgetown University and Others, the special case in which a patent relates to several active ingredients and also to one or more combinations of those active
         ingredients should not go unmentioned at this point. In such a case, each of those active ingredients and each combination
         of active ingredients which is used in a medicinal product can be classified as a product within the meaning of Article 1(b)
         of Regulation No 469/2009. Moreover, the patent belonging to the manufacturer of medicinal products is to be classified as
         the basic patent within the meaning of Article 1(c) of Regulation No 469/2009 in relation to each of those active ingredients
         and each combination of active ingredients. Nevertheless, there can be no question of applying for supplementary protection
         certificates on the basis of that basic patent in relation to each of those active ingredients and combinations of active
         ingredients used in a medicinal product. That is because, according to the Court’s case‑law, only one supplementary protection
         certificate may be granted for each basic patent. (34)
      
      103. It follows that the proprietor of a patent relating to a number of active ingredients and also to one or more combinations
         of those active ingredients must decide in respect of which active ingredient or combination of active ingredients he is going
         to apply for a supplementary protection certificate on the basis of the basic patent. The grant of a first supplementary protection
         certificate in respect of one active ingredient or combination of active ingredients in reliance on that patent then precludes
         the grant of further supplementary protection certificates in reliance on the same basic patent.
      
      104. On the one hand, that interpretation of Regulation No 469/2009 avoids a situation in which the system of limitation of the
         duration of protection conferred by a certificate, provided for in the regulation, is undermined by the claims in the patent
         application being formulated for the purpose of optimising the duration of protection in the sense that they cover both one
         or more individual active ingredients and a number of combinations of those individual active ingredients. If a supplementary
         protection certificate could be applied for in respect of each of those active ingredients and each combination of active
         ingredients, the term of patent and certificate protection in relation to individual active ingredients could subsequently
         be optimised by placing the individual active ingredients and combinations of those active ingredients on the market in different
         medicinal products with time lags. (35)
      
      105. On the other hand, in my view, that interpretation would normally also afford manufacturers of medicinal products the possibility
         of obtaining appropriate certificate protection by relating their SPC application to the central active ingredient or combination
         of active ingredients contained in the various medicinal products to be developed.  
      
      106. The extent, scope and content of the protection conferred by a certificate are laid down in Articles 4 and 5 of Regulation
         No 469/2009. Under Article 4 of Regulation No 469/2009, within the limits of the protection conferred by the basic patent,
         the protection conferred by a certificate extends only to the product covered by the authorisation to place the corresponding
         medicinal product on the market and for any use of the product as a medicinal product that has been authorised before the
         expiry of the certificate. Article 5 provides that, subject to Article 4, the certificate is to confer the same rights as
         conferred by the basic patent and to be subject to the same limitations and the same obligations. 
      
      107. It follows from both those provisions that the protection conferred by a certificate is always protection for a specified
         purpose: the extent of protection and protective effect of the supplementary protection certificate are restricted to those
         uses of the product as a medicinal product for which a marketing authorisation exists. (36)
      
      108. Where a supplementary protection certificate is granted for an active ingredient or combination of active ingredients of a
         medicinal product, the protective effect of that certificate therefore extends, within the limits of the protection conferred
         by the basic patent, to all uses of the product in subsequent medicinal products for which marketing is authorised before
         the expiry of the certificate. In so far as the basic patent for the certificate‑protected active ingredient or combination
         of active ingredients offers the patent proprietor protection against unauthorised production and distribution of medicinal
         products containing that active ingredient or combination of active ingredients, the supplementary protection certificate
         for that active ingredient or combination of active ingredients therefore also gives protection against unauthorised production
         and distribution of all subsequent medicinal products which are authorised before the expiry of the certificate and contain
         that active ingredient or combination of active ingredients. 
      
      109. By relating his SPC application to the central active ingredient or combination of active ingredients which is also contained
         in the medicinal products to be placed on the market in the future, the proprietor of a patent covering a number of active
         ingredients and also one or more combinations of those active ingredients can therefore ensure that those subsequent medicinal
         products also enjoy – within the limits of the basic patent and during the term of the supplementary protection certificate
         – protection against unauthorised production and distribution.
      
      d)      Interim conclusion
      110. In the light of the above, a teleological interpretation of Regulation No 469/2009 leads to the conclusion that the definition
         of product in Article 1(b) of the regulation covers not only ‘the’ active ingredient or ‘the’ combination of active ingredients,
         but also ‘an’ active ingredient or ‘a’ combination of active ingredients of a medicinal product. Moreover, Article 3(a) of
         the regulation is to be interpreted to the effect that the product within the meaning of that provision must be the same as
         the product which forms the subject‑matter of the basic patent within the meaning of Article 1(c) of the regulation. 
      
      3.      Answers to Questions 1 to 5 in Medeva
      111. In the light of my above observations, Questions 1 to 5 in Medeva are to be answered 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.
      
      114. That interpretation of Article 3(a) of Regulation No 469/2009 applies both to medicinal products with only one active ingredient
         and to medicinal products with multiple active ingredients.
      
      115. Against that background, the second and third questions are to be answered to the effect that, in the context of the assessment of an SPC application relating to a medicinal
         product with multiple active ingredients or to a multi‑disease vaccine, there are no further or different criteria for determining
         whether a product within the meaning of Article 3(a) of Regulation No 469/2009 exists and whether that product is protected
         by a basic patent in force.
      
      116. On the basis of those premisses, the fourth and fifth questions are to be answered to the effect that the questions whether a multi‑disease vaccine can be classified as a product
         within the meaning of Article 3(a) of Regulation No 469/2009 and whether that product is protected by a basic patent in force
         where only one of its active ingredients or each of its active ingredients against one of the diseases is protected by a basic
         patent in force, in principle, must be answered according to the rules governing the basic patent. However, the protective
         effect of the basic patent must not be used as a criterion for the purpose of answering the question whether a product within
         the meaning of Article 3(a) of the regulation exists.
      
      B –    Sixth question referred in Medeva and sole question referred in Georgetown University and Others
      
      117. By the sixth question in Medeva and the (identically worded) sole question in Georgetown University and Others, the referring courts wish to know whether Article 3(b) of Regulation No 469/2009 precludes the grant of a supplementary
         protection certificate for a patented active ingredient or combination of active ingredients where that active ingredient
         or combination of active ingredients is combined with one or more other active ingredients in a medicinal product, so that
         the marketing authorisation in accordance with Directive 2001/83 or Directive 2001/82 relates to a medicinal product in which
         the patented active ingredient or combination of active ingredients has been combined with other active ingredients.
      
      118. My above observations on the teleological interpretation of Regulation No 469/2009 have led me to the conclusion that the
         regulation is also intended to cover medicinal products in which the combination of active ingredients is not patented in
         its entirety but nevertheless includes a patented active ingredient or combination of active ingredients. 
      
      119. For the purposes of the interpretation of Article 3(b) of Regulation No 469/2009, it follows from the foregoing that a valid
         marketing authorisation within the meaning of that provision may also exist where that authorisation under Directive 2001/83
         or Directive 2001/82 relates to a medicinal product which also contains, together with the patented active ingredient or combination
         of active ingredients, one or more other active ingredients. 
      
      120. However, it should be pointed out in that connection that Article 3(b) of Regulation No 469/2009 must be read in conjunction
         with Article 3(d) and Article 7(1) of the regulation. Under Article 3(d), the authorisation referred to in point (b) of that
         provision is the first authorisation to place the product on the market as a medicinal product. Article 7 of the regulation
         provides, moreover, that the SPC application must be lodged within six months of the date on which the authorisation referred
         to in Article 3(b) to place the product on the market as a medicinal product was granted, or, where the authorisation to place
         the product on the market is granted before the basic patent is granted, within six months of the date on which the patent
         is granted. (37)
      
      121. It thus follows from the combined operation of those provisions that a manufacturer of medicinal products who places an active
         ingredient which is the subject‑matter of a basic patent on the market in combination with other active ingredients in the
         form of a number of medicinal products with differing combinations of active ingredients must lodge the SPC application for
         the patented active ingredient within six months of the date on which the first authorisation to place the first medicinal
         product with the patented active ingredient on the market is granted in the Member State for which the application is made. (38)
      
      122. That analysis is confirmed inter alia by the order of the Court in Yissum, (39) in which the Court dealt with the interpretation of Regulation No 1768/92 in a case in which a patented active ingredient
         was placed on the market in a number of medicinal products and the supplementary protection certificate was not applied for
         with reference to the first medicinal product authorised in the Member State in which the application was made, which contained
         the patented active ingredient. In the main proceedings, the applicant had tried to justify its reliance on the medicinal
         product authorised later by a reference to the differing therapeutic uses of the patented active ingredient in the various
         medicinal products. (40) That line of argument, which could lead to a circumvention of the rule in Article 3(d) of the regulation, was rejected by
         the Court on the ground that the concept of ‘product’ within the meaning of Article 1(b) of the regulation does not include
         the therapeutic use of an active ingredient protected by a basic patent. (41)
      
      123. The rule that, where there are several medicinal products with the same patented active ingredient, the supplementary protection
         certificate must be applied for on the basis of the first authorisation to place on the market the medicinal product which
         was authorised as the first medicinal product with that active ingredient in the Member State in which the application is
         submitted also makes sense within the overall scheme of Regulation No 469/2009. Because the supplementary protection certificate
         relates to the active ingredient or combination of active ingredients which is the subject‑matter of the basic patent, the
         grant of a supplementary protection certificate on the basis of the first medicinal product containing that active ingredient
         or combination of active ingredients leads to the result that all later medicinal products in which the active ingredient
         or combination of active ingredients under certificate protection is used are also protected against production and distribution
         by third parties within the limits of the protection conferred by the basic patent, in accordance with the requirements of
         Articles 4 and 5 of Regulation No 469/2009. (42)
      
      124. In the light of the above, the sixth question referred in Medeva and the sole question referred in Georgetown University and Others must be answered to the effect that a valid authorisation to place the product on the market as a medicinal product within
         the meaning of Article 3(b) of Regulation No 469/2009 exists for a single active ingredient or combination of active ingredients
         where that active ingredient or combination of active ingredients is contained together with one or more other active ingredients
         in a medicinal product which was the subject of a valid marketing authorisation granted in accordance with Directive 2001/83
         or Directive 2001/82. 
      
      VII –  Conclusion
      125. In the light of the foregoing considerations, I propose that the Court answer the questions referred for a preliminary ruling
         as follows:
      
      A –    Questions 1 to 5 of the Court of Appeal (England and Wales) (Civil Division) (Case C-322/10)
      1)         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 (EC) No 469/2009 of the European Parliament and of the Council
         of 6 May 2009 concerning the supplementary protection certificate for medicinal products 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.
      
      2)         In the context of the assessment of a supplementary protection certificate application relating to a medicinal product with
         multiple active ingredients or to a multi‑disease vaccine, there are no further or different criteria for determining whether
         a product within the meaning of Article 3(a) of Regulation No 469/2009 exists and whether that product is protected by a basic
         patent in force.
      
      3)         The questions whether a multi‑disease vaccine can be classified as a product within the meaning of Article 3(a) of Regulation
         No 469/2009 and whether that product is protected by a basic patent in force where only one of its active ingredients or each
         of its active ingredients against one of the diseases is protected by a basic patent in force must, in principle, be answered
         according to the rules governing the basic patent. However, the protective effect of the basic patent must not be used as
         a criterion for the purpose of answering the question whether a product within the meaning of Article 3(a) of the regulation
         exists.
      
      B –    Sixth question of the Court of Appeal (England and Wales) (Civil Division) (Case C-322/10) and sole question of the High Court
            of Justice of England and Wales Chancery Division (Patents Court) (Case C-422/10)
      4)         A valid authorisation to place the product on the market as a medicinal product within the meaning of Article 3(b) of Regulation
         No 469/2009 exists for a single active ingredient or combination of active ingredients where that active ingredient or combination
         of active ingredients is contained together with one or more other active ingredients in a medicinal product which was the
         subject of a valid marketing authorisation granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC.
      
      1 –	Original language of the Opinion: German. Language of the case: English.
      
      2 –	OJ 2009 L 152, p. 1.
      
      3 –	In accordance with the terms used in the EU Treaty and in the FEU Treaty, the expression ‘Union law’ will be used as an
         umbrella expression for Community law and European Union law. Where individual provisions of primary law are relevant hereinafter,
         the rules which are applicable ratione temporis will be cited.
      
      4 –	OJ 1992 L 182, p. 1.
      
      5 –	Convention on the Grant of European Patents of 5 October 1973, as amended by the Act revising Article 63 EPC of 17 December
         1991 and by the Act revising the EPC of 29 November 2000.
      
      6 	This abbreviation is made up of the letters ‘D’ for diphtheria, ‘T’ for tetanus, ‘Pa’ for pertussis, that is, whooping cough,
         ‘IPV’ for polio (IPV stands for ‘inactivated polio vaccine’) and ‘HiB’ for haemophilus influenzae type B, a cause of meningitis.
      
      7 –	The main proceedings thus concern SPC applications 07/070, 07/071, 07/073, 07/078, 07/079 and 07/080 of Georgetown University,
         SPC application 07/075 of University of Rochester and SPC application 07/069 of Loyola University of Chicago.
      
      8 –	The Commission’s Explanatory Memorandum to the proposal for a Council Regulation (EEC) concerning the creation of a supplementary
         protection certificate for medicinal products (COM(90) 101 final – SYN 255), reproduced in Schennen, D., Die Verlängerung der Patentlaufzeit für Arzneimittel im Gemeinsamen Markt, Cologne, Bundesanzeiger, 1993, p. 92 et seq.
      
      9 –	Ibid., point 28.
      
      10 –	In the different language versions, that definition reads, inter alia, as follows: French: le principe actif ou la composition de principes actifs d’un médicament; German: der Wirkstoff oder die Wirkstoffzusammensetzung eines Arzneimittels; Dutch: de werkzame stof of de samenstelling van werkzame stoffen van een geneesmiddel; Spanish: el principio activo o la composición de principios activos de un medicamento; Italian: il principio attivo o la composizione di principi attivi di un medicinale.
      
      11 –	In Case C‑431/04 Massachusetts Institute of Technology [2006] ECR I‑4089, paragraph 25, the Court has already held that a substance which does not have any therapeutic effect of
         its own and which is used to obtain a certain pharmaceutical form of the medicinal product is not covered by the concept of
         ‘active ingredient’, which in turn is used to define the term ‘product’.
      
      12 –	The definition of the ‘product’ as the whole active or effective part of a medicinal product in Article 1(b) of Regulation
         No 469/2009 also ultimately explains why the terms ‘product’ and ‘medicinal product’ are sometimes treated alike in Regulation
         No 469/2009.
      
      13 –	See, with regard to these categories of patent, Melullis in Benkard, G. (ed.), Europäisches Patentübereinkommen, Munich, 2002, Art. 52, points 105 and 106, who points out, in the context of the EPC, that patents relating to an object
         cover substances, compositions, machines and apparatus. Patents relating to a process may concern manufacturing processes,
         test methods, applications, etc. A usage patent protects the usage of an object or process, generally known to be in line
         with the state of the art. Such a patent is therefore based on the discovery of a new potential use of a state‑of‑the‑art
         product or process.
      
      14 –	See, in that regard, Case C-392/97 Farmitalia [1999] ECR I‑5553. 
      
      15 –	In this context, it should be recalled that the European Union legal order does not, in principle, aim to define concepts
         on the basis of one or more national legal systems unless there is express provision to that effect; see Case C‑314/06 Société Pipeline Méditerranée et Rhône [2007] ECR I-12273, paragraph 21; Case C-103/01 Commission v Germany [2003] ECR I-5369, paragraph 33; and Case C-296/95 EMU Tabac and Others [1998] ECR I-1605, paragraph 30.
      
      16 –	The Court has already warned against the risks of differences in the protection conferred by certificates in the European
         Union in Case C‑350/95 Spain v Council [1995] ECR I‑1985, paragraph 36, and pointed out in that regard that differences in the protection given in the European
         Union to one and the same medicine would give rise to a fragmentation of the market, whereby the medicine would still be protected
         in some national markets but no longer protected in others. Such differences in protection would mean that the marketing conditions
         for the medicines would vary from one Member State to another. The Court last confirmed that assessment in Case C‑482/07 AHP Manufacturing [2009] ECR I‑7295, paragraph 35, in which it pointed out that a heterogeneous development of the protection conferred by
         certificates in the individual Member States would be likely to create obstacles to the free movement of medicinal products
         within the European Union and thus directly affect the establishment and the functioning of the internal market.
      
      17 –	Although the proprietor of the basic patent for an active ingredient or the holder of the supplementary protection certificate
         does not necessarily have to be the holder of the marketing authorisation for the medicinal product, I am proceeding, for
         the sake of clarity, in my legal assessment of the questions referred, on the assumption that the manufacturer of the medicinal
         product is the proprietor of the basic patent and holds the marketing authorisation and has also applied for the supplementary
         protection certificate.
      
      18 –	See recital 4 in the preamble to Regulation No 469/2009.
      
      19 –	See Article 13 of Regulation No 469/2009 and recital 9 in the preamble thereto.
      
      20 –	See also, in that regard, recital 10 in the preamble to Regulation No 469/2009.
      
      21 –	http://ec.europa.eu/health/vaccination/policy/index_en.htm.
      
      22 –	http://ec.europa.eu/health/vaccination/hpv/index_en.htm.
      
      23 –	Written observations, point 20.
      
      24 –	Written observations, point 74 et seq.
      
      25 –	Attached as Annex 4 to the written observations of Georgetown University, University of Rochester and Loyola University
         of Chicago and as Annex 19 to the written observations of Medeva.
      
      26 –	Written observations, point 74.
      
      27 –	http://www.who.int/immunization_safety/aefi/immunization_misconceptions/en/index6.html# (last update: 11 December 2010).
      
      28 –	Order for reference in Medeva, paragraphs 27 and 28.
      
      29 –	The relevance of teleological interpretation in the context of the interpretation of Regulation No 469/2009 is confirmed
         by the Court in settled case‑law. Thus, the Court, emphasising the objectives of Regulation No 1768/92, has already ruled
         in Farmitalia, cited above in footnote 14, paragraph 17 et seq., in favour of a broad interpretation of Article 3(b) of the regulation.
         
      
      30 –	It is not only authorisations granted in the individual Member States of the European Union that are relevant for consideration
         as the first authorisation to place a product on the market in the European Union; authorisations granted in the EEA States
         Iceland, Norway and Liechtenstein are also relevant in that respect; see, in that regard, Kellner, H., ‘Salz in der Suppe
         oder Sand im Getriebe? Anmerkungen zu Schutzzertifikaten’, GRUR, 1999, p. 805, at p. 808. Furthermore, an authorisation to
         place a medicinal product on the market issued by the Swiss authorities and automatically recognised by the Principality of
         Liechtenstein under that State’s legislation is also to be regarded as a first authorisation to place a product on the market
         in the EEA within the meaning of Article 13 of Regulation No 469/2009, as it is to be read for the purposes of the application
         of the EEA Agreement; see to that effect Joined Cases C‑207/03 and C‑252/03 Novartis and Others [2005] ECR I‑3209.
      
      31 –	See also, in that regard, point 68 of this Opinion.
      
      32 –	See, in this context, Farmitalia, cited above in footnote 14. 
      
      33 –	Where an active ingredient is protected by a number of basic patents in force, which may belong to a number of patent proprietors,
         each of those patents may of course be designated for the purpose of the procedure for the grant of a certificate; however,
         only one certificate may be granted for each basic patent; see Case C‑181/95 Biogen [1997] ECR I‑357, paragraph 28. In AHP Manufacturing, cited above in footnote 16, the Court confirmed, moreover, that the rule in Article 3(c) of Regulation No 1768/92 does not
         preclude the grant of a supplementary protection certificate in favour of the proprietor of a basic patent for a product even
         where, at the date of his SPC application, one or more certificates have already been granted to one or more proprietors of
         one or more other basic patents.
      
      34 –	Biogen, cited above in footnote 33, paragraph 28.
      
      35 –	See, in that regard, points 97 and 98 of this Opinion.
      
      36 –	See, in that regard, Brändel, C., ‘Offene Fragen zum “ergänzenden Schutzzertifikat”’, GRUR, 2001, p. 875, at pp. 876 and
         877.; Hacker, F., PatG – Anhang zu § 16a, in Patentgesetz (founder: Busse, R.), Berlin, 2003, 6th edition, paragraphs 56 to
         67.
      
      37 –	Those time-limits are designed to respect, first, the interests of the patent proprietor and, second, those of third parties
         wishing to know as early as possible whether or not the product in question will be protected by an SPC (AHP Manufacturing, cited above in footnote 16, paragraph 28).
      
      38 –	With regard to that combined operation of Articles 7(1) and 3(b) and (d) of Regulation No 469/2009, see Case C‑66/09 Kirin Amgen [2010] ECR I-0000, paragraph 36, and Case C‑127/00 Hässle [2003] ECR I‑14781, paragraph 26.
      
      39 –	Case C‑202/05 [2007] ECR I‑2839.
      
      40 –	The active ingredient in question had been placed on the market in three different medicinal products: as an aqueous solution
         for intravenous injection, as soft gelatine capsules for oral administration and as an ointment.
      
      41 –	Ibid., paragraph 18.
      
      42 –	See, in that regard, point 105 et seq. of this Opinion.