OPINION OF ADVOCATE GENERAL
BOBEK
delivered on 21 December 2016 (1)
Joined Cases C‑629/15 P and C‑630/15 P
Novartis Europharm Ltd
v
Commission
(Appeal — Medicinal products for human use — Global marketing authorisation — New therapeutic indication –– Regulatory data protection period)
I.      Introduction
1.        Novartis (‘the Appellant’) holds marketing authorisations for two medicinal products for human use: Zometa and Aclasta. They are both based on zoledronic acid. That active substance was first developed for oncology indications. The resulting medicinal product, Zometa, was granted marketing authorisation in 2001. The Appellant developed that active substance also for non-oncology indications and obtained a separate marketing authorisation for the resulting medicinal product, Aclasta, in 2005. Aclasta differs from Zometa in its strength and its therapeutic indications.
2.        In 2011, Teva Pharma BV and Hospira UK Ltd (‘the interveners’) applied for marketing authorisations for generic copies of Aclasta. Those marketing authorisations were granted in 2012.
3.        The crux of the present case is whether the difference in therapeutic indications between Aclasta and Zometa excludes the marketing authorisation granted to Aclasta from the scope of Zometa’s global marketing authorisation (‘GMA’) as set out in Directive 2001/83/EC. (2) Such an exclusion would give the data related to Aclasta an independent regulatory protection period. That, in turn, would prevent the interveners from relying on that data to obtain marketing authorisations for Aclasta’s generic copies.
II.    Legal framework
4.        The process of granting marketing authorisation of medicinal products for human use within the European Union is regulated by Directive 2001/83, as amended, in particular, by Directive 2004/27/EC. (3)
5.        Article 6(1), first subparagraph of Directive 2001/83 states that: ‘No medicinal product may be placed on the market of a Member State unless a marketing authorisation has been issued by the competent authorities of that Member State in accordance with this Directive or an authorisation has been granted in accordance with Regulation (EC) No 726/2004 …’.
6.        Article 6(1), second subparagraph of Directive 2001/83 provides that: ‘When a medicinal product has been granted an initial marketing authorisation in accordance with the first subparagraph, any additional strengths, pharmaceutical forms, administration routes, presentations, as well as any variations and extensions shall also be granted an authorisation in accordance with the first subparagraph or be included in the initial marketing authorisation. All these marketing authorisations shall be considered as belonging to the same global marketing authorisation, in particular for the purpose of the application of Article 10(1).’
7.        Similarly, pursuant to Article 3(1) of Regulation (EEC) No 2309/93, (4) ‘no medicinal product referred to in Part A of the Annex may be placed on the market within the Community unless a marketing authorisation has been granted by the Community in accordance with the provisions of this Regulation’.
8.        The applicant for marketing authorisation must, as a general rule, demonstrate the quality, safety and efficacy of the medicinal product by submitting the results of pharmaceutical tests and pre-clinical and clinical trials. In this sense Article 8(3) of Directive 2001/83 provides that ‘the application [for marketing authorisation] shall be accompanied by …: (i) Results of: pharmaceutical (physico-chemical, biological or microbiological) tests, pre-clinical (toxicological and pharmacological) tests, clinical trials’.
9.        Article 10(1) of Directive 2001/83 states that ‘by way of derogation from Article 8(3)(i), and without prejudice to the law relating to the protection of industrial and commercial property, the applicant shall not be required to provide the results of pre-clinical tests and of clinical trials if he can demonstrate that the medicinal product is a generic of a reference medicinal product which is or has been authorised under Article 6 for not less than eight years in a Member State or in the Community.
A generic medicinal product authorised pursuant to this provision shall not be placed on the market until 10 years have elapsed from the initial authorisation of the reference product.
…
The 10-year period referred to in the second subparagraph shall be extended to a maximum of 11 years if, during the first 8 years of those 10 years, the marketing authorisation holder obtains an authorisation for 1 or more new therapeutic indications which, during the scientific evaluation prior to their authorisation, are held to bring a significant clinical benefit in comparison with existing therapies.’
10.      Under Article 13(4) of Regulation No 2309/93, ‘medicinal products which have been authorised by the Community in accordance with the provisions of this Regulation shall benefit from the 10-year period of protection referred to in point 8 of the second paragraph of Article 4 of Directive 65/65/EEC’. (5)
11.      Pursuant to Article 14(11) of Regulation (EC) No 726/2004: (6) ‘Without prejudice to the law on the protection of industrial and commercial property, medicinal products for human use which have been authorised in accordance with the provisions of this Regulation shall benefit from an 8-year period of data protection and a 10-year period of marketing protection, in which connection the latter period shall be extended to a maximum of 11 years if, during the first 8 years of those 10 years, the marketing authorisation holder obtains an authorisation for 1 or more new therapeutic indications which, during the scientific evaluation prior to their authorisation, are held to bring a significant clinical benefit in comparison with existing therapies.’
12.      Under Article 89 of Regulation No 726/2004 ‘the periods of protection provided for [in particular, in Article 14(11)] shall not apply to reference medicinal products for which an application for authorisation has been submitted before [20 November 2005]’.
13.      Moreover, Regulation (EC) No 1085/2003 (7) laid down, at the material time, the procedure for the examination of applications for variations to the terms of a marketing authorisation granted in accordance with Regulation No 2309/93. Article 3 of that regulation defined a ‘variation to the terms of a marketing authorisation’ as ‘an amendment to the contents of the documents referred to [inter alia, in Article 6(1) of Regulation No 2309/93] such as they existed at the moment the decision on the marketing authorisation was adopted …’. A ‘minor variation’ of type IA or type IB was defined as ‘a variation listed in Annex I which fulfils the conditions set out therein’. Finally, a ‘major variation’ of type II was defined as ‘a variation that cannot be deemed to be a minor variation or an extension of the marketing authorisation’.
14.      Article 6 of Regulation No 1085/2003 provided for an approval procedure for major variations of type II, and enabled the period for that procedure to be extended for variations concerning changes to or additions to the therapeutic indications.
III. Facts and the decisions adopted by the Commission
15.      Zometa is a medicinal product based on zoledronic acid. It was developed by the Appellant for oncology indications for patients with malignancies of the bone, and for the treatment of tumour-induced hypercalcaemia.
16.      Aclasta is the result of the Appellant’s development of zoledronic acid for non-oncology indications, more specifically, to treat specific cases of osteoporosis and Paget’s disease.
17.      Zometa and Aclasta were both authorised through the centralised procedure pursuant to Regulation No 2309/93. The Commission granted the marketing authorisation for Zometa on 20 March 2001. Under the applicable rules, that marketing authorisation triggered a 10-year data regulatory protection period which commenced on 20 March 2001.
18.      The Commission granted the marketing authorisation for Aclasta on 15 April 2005.
19.      On 25 May 2011 and on 22 June 2011 respectively, the interveners filed applications to obtain marketing authorisations for two medicinal products: Zoledronic acid Teva Pharma — zoledronic acid (‘Zoledronic acid Teva Pharma’) and Zoledronic acid Hospira — zoledronic acid (‘Zoledronic acid Hospira’).
20.      Zoledronic acid Teva Pharma is a generic copy of Aclasta.
21.      The application for marketing authorisation of Zoledronic acid Hospira comprised four different presentations of that medicinal product. One of these is a generic copy of Aclasta and is relevant for the present case.
22.      The Commission granted the authorisations for Zoledronic acid Teva Pharma and Zoledronic acid Hospira by two decisions adopted on 16 August 2012 and 19 November 2012 respectively (‘Commission’s decisions’). (8)
IV.    The judgments of the General Court and the proceedings before the Court
23.      The Appellant lodged two applications for annulment of the Commission’s decisions before the General Court.
24.      In each of them it presented a single plea, alleging infringement of Article 10(1) of Directive 2001/83 and Article 13(4) of Regulation No 2309/93, read in conjunction with Article 14(11) and Article 89 of Regulation No 726/2004. It submitted that the Commission’s decisions infringed its data protection rights as Aclasta benefits from a 10-year regulatory data protection period, independent of the regulatory data protection period for Zometa. Therefore, it submitted, Aclasta should not have been used as a reference medicinal product in the authorisation process of generic products before 15 April 2015.
25.      The Commission (and the interveners) contended that Aclasta is included in the GMA granted for Zometa in March 2001. This meant that Aclasta does not enjoy an independent regulatory data protection period. It submitted that the data protection period applicable both to Zometa and Aclasta expired in March 2011 and that the Commission was thus correct in adopting its decisions.
26.      The General Court dismissed both actions (‘judgments under appeal’). (9) It concluded that Aclasta constitutes an additional strength, and a variation consisting of new therapeutic indications in comparison to Zometa, and must therefore be included in the GMA for Zometa. The Commission was thus entitled to permit the interveners’ references to the data in the files relating to the marketing authorisations of Zometa and Aclasta. (10)
27.      The Appellant has lodged appeals against the General Court’s judgments before the Court of Justice, presenting two pleas. The first is that the General Court committed an error of law in its interpretation of Article 6(1) of Directive 2001/83. The second is that the General Court failed to provide an adequate statement of reasons in its judgments.
28.      The appeals are divided into six branches related almost exclusively to the first plea. First, the Appellant alleges that Article 6(1) of Directive 2001/83 is not merely the implementation of the case-law of the Court of Justice and should be interpreted differently from the interpretation embraced by the General Court. Second, it submits that it is irrelevant whether Aclasta could have been authorised as a variation of Zometa instead of through a separate marketing authorisation. Third, the Appellant could not decide whether to apply for a separate marketing authorisation for Aclasta or whether to request the inclusion of the new therapeutic indication in the initial marketing authorisation for Zometa, it did not seek to circumvent or manipulate the applicable regulatory data protection period. Fourth, the Appellant’s interpretation of the applicable provisions does not lead to an indefinite extension of the regulatory data protection period. Fifth, the Appellant commented on the interplay between Directive 2001/83 and Regulation No 2309/03 (now Regulation No 726/2004). Finally, it referred to the objective that the relevant legislation pursues.
V.      Assessment
29.      In accordance with the request made by the Court, this Opinion focuses on the notion of the global marketing authorisation (‘GMA’) and its implications in the present case. It will proceed as follows: first, I explain the relevance of the GMA for the determination of the period of regulatory data protection (A). Second, I distinguish the constitutive elements of a GMA (B) from the variable elements of a GMA (C). The former ones are fixed within one and the same GMA, the latter might be altered. Third, I briefly address the arguments of the Appellant raised in the present case (D).
A.      The relationship between the global marketing authorisation and the regulatory data protection period
30.      All four medicinal products concerned in the present case have been authorised through the centralised procedure, provided for initially in Regulation No 2309/93 and subsequently in Regulation No 726/2004.
31.      It is undisputed that the GMA concept applies to nationally authorised products under Directive 2001/83 in the same way as products authorised in the centralised procedure under Regulation No 726/2004 and, previously, Regulation No 2309/93.
32.      Pursuant to the second subparagraph of Article 6(1) of Directive 2001/83, the initial marketing authorisation as well as those pertaining to the developments of the initial medicinal product shall be considered as belonging to the same GMA, in particular for the purpose of using the abridged procedure upon the expiration of the applicable regulatory data protection period, as specified in Article 10(1) of Directive 2001/83 and, in the present case, in Article 13(4) of Regulation 2309/93.
33.      In the light of the connection established in Article 6(1) of Directive 2001/83 between the regulatory data protection period and the GMA, the latter notion is instrumental in the determination of the conditions under which applicants in the abridged procedure may rely on the data contained in the file of the reference medicinal product. (11)
34.      It follows from the second subparagraph of Article 6(1) of Directive 2001/83 that only one regulatory data protection period is associated with the GMA. That regulatory data protection period applies to the data related to the initial medicinal product as well as to the data submitted in respect of developments based on it.
35.      The second subparagraph of Article 6(1) of Directive 2001/83 lists the developments of the initial medicinal product that constitute variables that would fall, if developed, under the GMA concept. These variables are: additional strengths, pharmaceutical forms, administration routes, presentations, and any variations and extensions.
36.      By contrast, the second subparagraph of Article 6(1) of Directive 2001/83 does not specify the constitutive elements by which a GMA can be identified, and by which a specific GMA can be distinguished from another GMA.
37.      I will now examine those constitutive elements (B) before turning to the GMA’s variable elements (C).
B.      The constitutive elements of a global marketing authorisation
38.      In order to identify the constitutive elements of a GMA, it is necessary to look beyond the wording of Article 6(1) of Directive 2001/83 which, considered in isolation, does not offer much guidance in this respect.
39.      Firstly, the issuance of any marketing authorisation is quite logically linked to a given applicant who, when the marketing authorisation is granted, becomes the ‘marketing authorisation holder’.
40.      The foregoing flows from the wording of Article 10(1), fourth subparagraph (12) of Directive 2001/83 which indicates that the regulatory data protection is granted in respect of the data developed and submitted by a given holder of the initial marketing authorisation.
41.      This interpretation is also confirmed by the Commission’s Notice to Applicants (an explanatory document for marketing authorisation applicants). (13) Although that notice is certainly not legally binding, it may offer helpful guidance, as suggested by Advocate General Wahl in Olainfarm. (14) That notice states that the GMA concept includes the initial authorisation and the abovementioned developments of the initial medicinal product, granted to the marketing authorisation holder of that initial authorisation. (15)
42.      The ‘marketing authorisation holder’ is thus the first constitutive element of a GMA.
43.      Secondly, the most important element of a medicinal product is its active substance. (16) A marketing authorisation granted for a medicinal product that is based on a different active substance to the initial medicinal product can hardly be seen to be a development considering the language of second subparagraph of Article 6(1) of Directive 2001/83. Further, if a difference in active substance does not lead to a different GMA, it would be difficult to perceive what kind of innovation would provide the applicant with a different regulatory data protection period.
44.      The conclusion that the active substance (or a combination of active substances) is a constitutive element of the GMA is also confirmed in the Commission’s Notice to Applicants: ‘If the medicinal product being assessed contains a modification of an existing active substance, it should be clarified … whether the product contains a new active substance or not. This clarification impacts on the existence or not of a global marketing authorisation if the medicinal products belong to the same marketing authorisation holder.’ (17)
45.      The examples provided by the Commission on changes to the initial medicinal product that do not fall within the same GMA all concern scenarios under which there is a change to the active substance (or combination of active substances) in the initial medicinal products. This is the case for, first, fixed combination products pursuant to Article 10b of Directive 2001/83; (18) second, the separation of the substance from a previous combination of active substances or, third, a modification of an existing active substance that amounts to a new active substance. (19)
46.      It thus follows that the notion of GMA is based on identity of the marketing authorisation holder and of the active substance(s). (20) If the marketing authorisation holder or the active substance changes, the same GMA no longer applies.
C.      The variable elements covered by the same global marketing authorisation
47.      It is undisputed that the difference between Aclasta and Zometa lies in their different strengths and therapeutic indications.
48.      It is equally undisputed that the modification in strength has not excluded the marketing authorisation granted for Aclasta from the scope of the concerned GMA. Variations in strength are covered by one and the same GMA.
49.      The central issue of the present dispute is whether the difference in therapeutic indication results in such an exclusion. In other words, the question is whether a therapeutic indication is a constitutive element of the GMA (in which case it would trigger a new regulatory data protection period) or whether it constitutes a variable within one and the same GMA. In the latter case, the therapeutic indication would be equated with the developments listed in the second subparagraph of Article 6(1) of Directive 2001/83 and would not trigger a new regulatory data protection period.
50.      However, neither that nor any other provision of the directive explicitly refers to a relationship between the notion of therapeutic indication and the GMA.
51.      As the text is silent on that matter I will consider that relationship by examining materially related provisions contained in other parts of relevant legislation on the marketing of medicinal products for human use (1). I will then turn to the broader cross-sectoral legislative context, contrasting the provisions on the marketing of medicinal products for human use with other sectoral regimes that provide for data protection periods (2), before examining the overall aim and purpose pursued by Directive 2001/83 (3).
1.      The intra-sectoral argument
52.      Directive 2001/83 does not provide for a definition of therapeutic indication. However, it also does not define any of the abovementioned developments of the initial medicinal product, with the exception of ‘strength’. (21) Other developments listed in the second subparagraph of Article 6(1) of Directive 2001/83 are pharmaceutical forms, administration routes, presentations, variations and extensions.
53.      The notions of ‘variation and extension’, contained in this list, merit particular attention in the present case.
54.      It followed from Articles 3 and 6 of Regulation No 1085/2003 that the addition of a new therapeutic indication was equivalent to a type II variation to the terms of a marketing authorisation.
55.      It emerges from the combined reading of the second subparagraph of Article 6(1) of Directive 2001/83 and of Articles 3 and 6 of Regulation No 1085/2003 that a new therapeutic indication is an example of a variation. It is therefore to be considered as part of the GMA associated with the initial medicinal product.
2.      The cross-sectoral comparison and context
56.      Contrary to other EU legislation, Directive 2001/83 does not link the applicable regulatory data protection period to the respective studies that the producer of the initial medicinal product may add to the file over time. That file may contain not only the documentation related to the initial medicinal product but also subsequent documentation concerning different developments thereof.
57.      REACH, (22) for example, establishes a link between the data protection period and respective studies that are the subject of that protection. Article 25(3) of the REACH, which falls under Title III on ‘Data sharing and avoidance of unnecessary testing’ provides that ‘any study summaries or robust study summaries of studies submitted in the framework of a registration under this Regulation at least 12 years previously can be used for the purposes of registration by another manufacturer or importer’.
58.      Similarly, Article 34 of Regulation (EC) No 1107/2009 (23) on the exemption from the obligation to provide studies states that ‘applicants shall be exempted from supplying the test and study reports referred to in Article 33(3) where the Member State to which an application is made has the test and study reports concerned and the applicants demonstrate that they have been granted access in accordance with Article[s] 59, 61 or 62 or that any data protection period has expired’. That regulation also maintains the focus on the protection to be afforded to specific studies as further evidenced in its recital 39.
59.      By contrast, Directive 2001/83 provides for rather broad possibilities as to data that may be referred to in the abridged procedure. Article 10(1) of Directive 2001/83 expressly connects the regulatory data protection period with the GMA notion, irrespective of the fact that that notion covers various developments of the initial product, in relation to which separate data have to be supplied at different points over the course of time. The starting point of the 10-year data protection period is thus determined by the granting of the marketing authorisation for the initial medicinal product. There is no rule on the protection of separate subsequent studies, as acknowledged in the Generics case. (24)
60.      The comparison between these legislative examples and the directive shows that if the legislature intended to define the regulatory data protection in such a manner that it was connected to the studies submitted by the applicants, it could have done so explicitly, as is the case in other regulatory regimes. However, in the context of the marketing of medicinal products for human use, a different solution seems to have been contemplated.
3.      Aim and purpose
61.      The length of the regulatory data protection period and the possibility to resort to the abridged procedure for marketing authorisation reflects a balance that the EU legislature decided to strike between protection of innovative companies and their investment, the general interest in an open market, and the desire to avoid unnecessary testing on animals and humans. (25)
62.      The aim to find that balance emerges from the legislative history of Directive 2004/27 which amended and made the relevant changes (for the present case) to Directive 2001/83. The initial Commission proposal contained a concept of the GMA, albeit with a different name. (26) The European Parliament suggested its deletion because ‘it would also remove the possibility for important innovative advances in medicinal products development to be encouraged, recognised and protected through regulatory data protection’. (27)
63.      That amendment, however, was not accepted. (28) Instead, the search for what was considered to be a fair reward to innovative companies for their investment resulted in an extra year of protection potentially being added to the initial protection period as now evidenced in Article 10(1) of Directive 2001/83 and Article 14(11) of Regulation No 726/2004.
64.      Those provisions state that the 10 year period of protection ‘shall be extended to a maximum of 11 years if, during the first 8 years of those 10 years, the marketing authorisation holder obtains an authorisation for 1 or more new therapeutic indications which, during the scientific evaluation prior to their authorisation, are held to bring a significant clinical benefit in comparison with existing therapies’.
65.      The initial Commission’s proposal indicates that that amendment was put forward ‘in order to promote research on new therapeutic indications with a significant clinical benefit and bringing an improvement to the quality of life and welfare of the patient’. At the same time, the Commission considered it ‘necessary to maintain an appropriate balance between such innovations and the need to favour the production of generic medicines’. (29)
66.      As the Commission pointed out in its written submissions, the additional one year of protection constitutes, in the eyes of the legislature, the appropriate bonus that is given to reward investment in new therapeutic indications. (30) As the wording of that provision shows, that extra year is nonetheless not granted to any new therapeutic indication but only to such therapeutic indications that, as well as having been developed within the first eight years, satisfy the conditions of having ‘significant clinical benefit in comparison with existing therapies’.
67.      A similar logic is also applied in Article 10(5) of Directive 2001/83 (31) which provides for a non-cumulative period of one year of data exclusivity, ‘in addition to the provisions laid down in paragraph 1, where an application is made for a new indication for a well-established substance, … provided that significant pre-clinical or clinical studies were carried out in relation to the new indication’.
68.      If the authorisation of a new therapeutic indication were to trigger a new data protection period, that would, in my view, go against the above-described objective pursued by the very existence of the abridged procedure in combination with the time limits set by the legislature for the data protection. Instead of benefiting from an additional year, a new therapeutic indication would bring about a full 10-year regulatory data protection period, allowing the holder of the initial marketing authorisation to continue to exploit the respective data and to prevent the producers of the generic products from resorting to the abridged procedure.
69.      One may certainly argue whether one year of additional protection represents a fair balance or not but, as the Court had already noted in Generics, (32) that decision is primarily for the legislature to make. In any case, such an assessment is not the subject matter of the present appeal.
70.      Those elements from the legislative history and subsequent legal development confirm, in my view, the general position that a new therapeutic indication does not lead to a new regulatory data protection period. That position seems to reflect continuous legal developments initiated by the Court in the Generics case, (33) then embraced by the EU legislature in Directive 2004/27 and also adhered to by national authorities. (34)
71.      For all these reasons, I am of the view that the granting of a marketing authorisation for a new therapeutic indication of a previously authorised medicinal product is covered by the same GMA. It does not therefore trigger an independent regulatory data protection period.
D.      Applying the concept of global marketing authorisation to the present case
72.      Neither of the two constitutive elements of the GMA, that is the identity of the marketing authorisation holder and the active substance, are at issue in the present case. It is undisputed that the Appellant is the marketing authorisation holder in respect of Zometa and Aclasta and that both of these products are based on the same active substance.
73.      The only difference between Zometa and Aclasta lies in the differences of strengths and therapeutic indications. The latter, as a type of variation, and in the light of the considerations above, does not trigger an independent regulatory data protection period.
74.      This key conclusion is not altered by the arguments put forward by the Appellant, to which I now turn in a concise manner.
75.      First, as the Appellant submits, it is true that Aclasta was not authorised as a variation under Regulation No 1085/2003 but was granted a separate marketing authorisation. For that reason, according to the Appellant, it should be granted an independent regulatory data protection period.
76.      Although Aclasta was granted a separate marketing authorisation and was not authorised as a mere change to the initial marketing authorisation, that does not affect the conclusion that a therapeutic indication constitutes a variation per se; that is, a type of development within the meaning of second subparagraph of Article 6(1) of Directive 2001/83. Indeed, that provision refers to developments authorised by means of both a variation of the initial marketing authorisation and the granting of a separate marketing authorisation. As the General Court correctly noted, (35) the GMA may encompass a number of separate marketing authorisations. Therefore, the GMA does not prevent a development from being considered as a variation within the meaning of second subparagraph of Article 6(1) of Directive 2001/83, even if that variation has been granted a separate marketing authorisation.
77.      Second, for similar reasons I am not convinced by the arguments of the Appellant concerning the absence of the notion of therapeutic indication in the list of developments in Article 6(1) of Directive 2001/83. The Appellant argues that that list entails a departure by the legislature from the position adopted by the Court in Generics.
78.      In the Generics case, the Court defined the concept of ‘essentially similar’ product under the previous legislation. (36) The Court held that the identity of therapeutic indication is not a criterion which must be satisfied for two medicinal products to be regarded as essentially similar. That definition led the Court to conclude that an applicant in the abridged procedure may resort not only to the data provided for the initial medicinal product but also to more recent data related to subsequently developed therapeutic indications of that initial product. Data submitted in respect of new therapeutic indications do not trigger an independent data protection period.
79.      The definition of ‘essentially similar’ product developed by the Court in the Generics case was later embraced by Directive 2004/27 and translated into the concept of generic medicinal product now defined in Article 10(2)(b) of Directive 2001/83. (37) The fact that a therapeutic indication is not currently an element of the GMA confirms, in my view, the continuity with the previous legal regime as developed also by the Court.
80.      Third, the position taken by the Court in Generics that the regulatory data protection period is not affected by a new therapeutic indication finds support in the current classification of a therapeutic indication as a type of variation under Regulation (EC) No 1234/2008. (38)
81.      Annex II, point 2(a) to that regulation states that ‘variations related to the addition of a new therapeutic indication or to the modification of an existing one’ are to be considered as ‘major variations of type II’.
82.      Thus, if the legislature had intended to exclude therapeutic indications from the GMA, it would have done so expressely.
83.      Fourth, the Appellant’s argument that that conclusion is warranted only for a variation authorised as a variation to an existing marketing authorisation as opposed to a modification authorised by means of a stand-alone marketing authorisation is not convincing. As the General Court rightly noted, (39) the wording of Article 6(1) of Directive 2001/83 makes it clear that the GMA concept applies irrespective of the form in which the given variation was implemented.
84.      Fifth, for the same reasons I am unconvinced by the arguments of the Appellant to the effect that it was irrelevant that Aclasta could have been authorised also as a variation to the initial marketing authorisation instead of obtaining a separate marketing authorisation. This is because according to the Appellant, what matters is the authorisation procedure that was actually chosen.
85.      As explained above, the GMA concept does not distinguish between the respective developments that have been authorised via a change to the existing marketing authorisation or by means of a separate marketing authorisation. The procedure followed is irrelevant because under both scenarios, a change consisting in the development of a new therapeutic indication falls under the GMA of the initial product. For the same reasons, it is equally irrelevant whether or not the Appellant could have chosen freely between those two scenarios.
86.      In the light of the above considerations, I am of the view that the General Court did not err in law in its interpretation of the concept of GMA.
VI.    Conclusion
87.      For those reasons, and without prejudice to the examination of the second ground of appeal, I propose to the Court to conclude that the General Court did not err in its interpretation of the concept of the global marketing authorisation under the second subparagraph of Article 6(1) of Directive 2001/83 of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use.
1      Original language: English.
2      Directive 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).
3      Directive of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83 on the Community code relating to medicinal products for human use (OJ 2004 L 136, p. 34).
4      Council Regulation of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (OJ 1993 L 214, p. 1).
5      Council Directive of 26 January 1965 on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products (OJ, English Special Edition, Series I Volume 1965-1966, p. 20). That directive is the legal predecessor of Directive 2001/83 and was repealed on 17 December 2001.
6      Regulation of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ 2004 L 136, p. 1).
7      Commission Regulation of 3 June 2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products falling within the scope of Council Regulation (EEC) No 2309/93 (OJ 2003 L 159, p. 24).
8      Commission Implementing Decisions C(2012) 5894 final and C(2012) 8605 final.
9      Judgments of 15 September 2015, Novartis Europharm v Commission (T‑472/12, EU:T:2015:637), and Novartis Europharm v Commission (T‑67/13, EU:T:2015:636).
10      Judgments of 15 September 2015, Novartis Europharm v Commission (T‑472/12, EU:T:2015:637, paragraph 87), and Novartis Europharm v Commission (T‑67/13, EU:T:2015:636, paragraph 87).
11      Pursuant to Article 10(2)(a) of Directive 2001/83, a reference medicinal product is defined as ‘a medicinal product authorised under Article 6, in accordance with the provisions of Article 8’.
12      ‘The 10-year period referred to in the second subparagraph shall be extended to a maximum of 11 years if, during the first 8 years of those 10 years, the marketing authorisation holder obtains an authorisation for 1 or more new therapeutic indications ….’ Emphasis added.
13      European Commission, Notice to Applicants, Volume 2A: Procedures for marketing authorisation, Chapter 1: Marketing authorisation, July 2015, Section 2.3, p. 9.
14      C‑104/13, EU:C:2014:342, point 39 and the case-law cited.
15      Emphasis added.
16      See the definition of the notions of the medicinal product and active substance in Article 1, points 2 and 3a of Directive 2001/83. A medicinal product is defined as ‘any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or (b) any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis’. An active substance is defined in Article 1(3a) of the same directive as ‘any substance or mixture of substances intended to be used in the manufacture of a medicinal product and that, when used in its production, becomes an active ingredient of that product intended to exert a pharmacological, immunological or metabolic action with a view to restoring, correcting or modifying physiological functions or to make a medical diagnosis’.
17      Notice to Applicants, Volume 2A: Procedures for marketing authorisation, Chapter 1: Marketing authorisation, July 2015, point 2.3, p. 9. Emphasis added.
18      ‘In the case of medicinal products containing active substances used in the composition of authorised medicinal products but not hitherto used in combination for therapeutic purposes, the results of new pre-clinical tests or new clinical trials relating to that combination shall be provided in accordance with Article 8(3)(i), but it shall not be necessary to provide scientific references relating to each individual active substance.’
19      Notice to Applicants, Volume 2A: Procedures for marketing authorisation, Chapter 1: Marketing authorisation, July 2015, Section 2.3, pp. 9 to 10.
20      See also Manley, M.I., and Vickers, M., Navigating European Pharmaceutical Law, Oxford, Oxford University Press, 2015, p. 264, point 8.33.
21      Article 1(22) of Directive 2001/83: ‘The content of the active substances expressed quantitatively per dosage unit, per unit of volume or weight according to the dosage form.’
22      Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ 2006 L 396, p. 1).
23      Regulation of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ 2009 L 309, p. 1).
24      ‘… where it has been shown that a medicinal product is essentially similar to a product which has been authorised for not less than 6 or 10 years in the Community and is marketed in the Member State for which the application is made, the applicant is not required, … to provide results of pharmacological and toxicological tests or of clinical trials. In such a situation, the competent authority for the grant of marketing authorisation uses the pharmacological, toxicological and clinical documentation relating to the original medicinal product. That documentation may, inter alia, cover both the therapeutic indications of the original product which has been authorised for not less than 6 or 10 years in the Community and more recent therapeutic indications.’ Emphasis added. Judgment of 3 December 1998, Generics (UK) and Others (C‑368/96, EU:C:1998:583, paragraphs 39 to 40).
25      Recital 9 of Directive 2001/83 provides that: ‘it is advisable to stipulate more precisely the cases in which the results of toxicological and pharmacological tests or clinical trials do not have to be provided with a view to obtaining authorisation for a medicinal product which is essentially similar to an authorised product, while ensuring that innovative firms are not placed at a disadvantage’. Recital 10 provides that ‘there are reasons of public policy for not conducting repetitive tests on humans or animals without over-riding cause’. See also judgment of 16 October 2003, AstraZeneca (C‑223/01, EU:C:2003:546, paragraphs 42 and 43).
26      ‘The various strengths, pharmaceutical forms, administration routes, presentations and any variation under Article 35 shall be authorised under the first subparagraph and shall be considered as part of the same authorisation’ (Proposal for a Directive of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human (COM(2001) 404 final, p. 91).
27      Instead the European Parliament suggested that the relevant part be: ‘The various strengths, pharmaceutical forms, administration routes, presentations, and any variation under Article 35 shall be authorised under the first subparagraph.’ Position of the European Parliament adopted at first reading on 23 October 2002 with a view to the adoption of European Parliament and Council Directive 2002/…/EC amending Directive 2001/83/EC on the Community code relating to medicinal products for human use. P5_TC1-COD(2001) 0253.
28      See amended proposal for a Directive of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use (COM(2003) 163 final) and Common position (EC) No 61/2003 adopted by the Council on 29 September 2003 with a view to the adoption of a Directive 2003/. . ./EC of the European Parliament and of the Council of … amending Council Directive 2001/83/EC on the Community code relating to medicinal products for human use (2003/C 297 E/02).
29      Proposal for a Directive of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human (COM(2001) 404 final, p. 81.
30      See also judgment of 29 April 2004, Novartis Pharmaceuticals (C‑106/01, EU:C:2004:245, paragraph 62) where the Court held that the regulatory data protection is not necessarily correlated to the costs engaged by the producer to develop a given medicinal product.
31      As amended by Directive 2004/27 of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use (OJ 2004 L 136, p. 34).
32      Judgment of 3 December 1998, Generics (UK) and Others (C‑368/96, EU:C:1998:583, paragraph 52).
33      See also judgments of 9 December 2004, APS (C‑36/03, EU:C:2004:781, paragraph 26), and of 29 April 2004, Novartis Pharmaceuticals (C‑106/01, EU:C:2004:245, paragraphs 58 and 59).
34      See, for example, for illustration, in the German context: Oberverwaltungsgericht Münster (Higher Administrative Court of Münster) order dated 27.11.2014, Case No 13 B 950/14, pursuant to which further authorisations with different therapeutic indications, strengths and dosages are to be regarded as extensions and, hence, should be treated under the principle of GMA for the purposes of document protection as part of the first authorisation granted for the original product, or also Verwaltungsgericht Köln (Administrative Court of Cologne) order dated 11.03.2016, Case No 7 L 3011/15. For similar views of the legal scholarship, see, for example, Ambrosius, in: Fuhrmann/Klein/Fleischfresser, Arzneimittelrecht, 2nd edition, Nomos, 2014, Teil 2, § 6 at No 214 or Kortland, in: Kügel/Müller/Hofmann, Arzneimittelgesetz, 2nd edition, Beck, 2016, § 24b at No 19.
35      Judgments of 15 September 2015, Novartis Europharm v Commission (T‑472/12, EU:T:2015:637, paragraph 52), and of 15 September 2015, Novartis Europharm v Commission (T‑67/13, EU:T:2015:636, paragraph 52).
36      Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products (OJ 1965 L 66, p. 369).
37      As acknowledged in the proposal for a Directive of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human (COM(2001) 404 final, p. 81).
38      Commission Regulation of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (OJ 2008 L 334, p. 7). That regulation replaced Regulation No 1085/2003.
39      Judgments of 15 September 2015, Novartis Europharm v Commission (T‑472/12, EU:T:2015:637, paragraph 52), and of 15 September 2015, Novartis Europharm v Commission (T‑67/13, EU:T:2015:636, paragraph 52).