ORDER OF THE PRESIDENT OF THE FIRST CHAMBER OF THE GENERAL COURT
13 September 2013 (*)
(Intervention)
In Case T‑547/12,
Teva Pharma BV, established in Utrecht (Netherlands),
Teva Pharmaceuticals Europe BV, established in Utrecht,
represented by K. Bacon and D. Piccinin, Barristers, and G. Morgan and C. Drew, Solicitors,
applicants,
v
European Medicines Agency (EMA), represented by T. Jabłoński and G. Gavriilidou, acting as Agents,
defendant,
supported by
European Commission, represented by P. Mihaylova, M. Šimerdová and E. White, acting as Agents,
and by
ViiV Healthcare UK Ltd, established in Brentford (United Kingdom), represented by I. Dodds-Smith and J. Mulryne, Solicitors, and J. Stratford, QC,
interveners,
ACTION for annulment of the decision of the European Medicines Agency (EMA) of 26 November 2012 concerning the non-validation of the application for a marketing authorisation for the medicinal product Abacavir/Lamivudine (EMA/H/C/002710/0000),
THE PRESIDENT OF THE FIRST CHAMBER OF THE GENERAL COURT
makes the following
Order
Introduction
1 By document lodged at the Court Registry on 27 March 2013, the European Federation of Pharmaceutical Industries and Associations (EFPIA) requested leave to intervene in this case in support of the form of order sought by the defendant.
2 By document lodged at the Court Registry on 29 March 2013, the European Confederation of Pharmaceutical Entrepreneurs (Eucope) requested leave to intervene in this case in support of the form of order sought by the defendant.
3 The parties were notified of the applications to intervene in accordance with Article 116(1) of the Rules of Procedure of the General Court. By letter received at the Court Registry on 4 June 2013, the applicants, Teva Pharma BV and Teva Pharmaceuticals Europe BV, raised objections to those applications to intervene being granted, which was not the case for the European Medicines Agency (EMA).
4 Under the second paragraph of Article 40 of the Statute of the Court of Justice of the European Union, applicable to the General Court by virtue of the first paragraph of Article 53 thereof, any person which can establish an interest in the result of a case, other than in cases between Member States, between institutions of the European Union or between Member States and institutions of the European Union, may intervene in the case.
5 According to settled case-law, representative associations, whose object is to protect their members, who apply to intervene in cases raising questions of principle liable to affect those members have such an interest (see, to that effect, orders of the President of the Court of Justice in Joined Cases C-151/97 P(I) and C-157/97 P(I) National Power and PowerGen [1997] ECR I-3491, paragraph 66, and in Case C-151/98 P Pharos v Commission [1998] ECR I-5441, paragraph 6; and order of the President of the First Chamber of the General Court of 3 September 2013 in Case T‑486/11 Telekomunikacja Polska v Commission, not published in the ECR, paragraph 13).
6 In support of their applications, EFPIA, a non-profit association representing the pharmaceutical and biotechnology industry operating in the European Union, and Eucope, a European Confederation of the pharmaceutical industry, each claim to have an interest in the result of the case.
Establishment of an interest in the result of the case
Representativeness
7 In this respect, EFPIA claims that it represents an appreciable number of the undertakings active in the pharmaceutical sector. It states that it represents 39 companies and 33 national associations active in that sector, or 1 900 companies in total. EFPIA also states that its members have submitted or intend to submit dossiers for a marketing authorisation in Europe and that they rely on the rules and principles of data exclusivity which preclude the pre-clinical and clinical data generated for the authorisation of their products being referred to and relied on by other manufacturers of medicinal products during the period of data exclusivity.
8 Eucope claims that it represents more than 900 pharmaceutical undertakings which operate in Europe, including individual companies or the German Pharmaceutical Industry Association BPI (Bundesverband des Pharmazeutischen Industrie ev) with 270 member companies; the UK pharmaceutical association EMIG (Ethical Medicines Industry Group), with 170 member companies; BioDeutschland, an association with 275 biotechnology companies; IML, the Swedish Association for medium-sized pharmaceutical companies, and SwedenBio.
9 In their observations on the applications to intervene, the applicants do not dispute that EFPIA and Eucope are representative associations.
10 In the present case, the representativeness of the parties that requested leave to intervene is in fact clear from the data which they produced in that respect. Thus, it is apparent from the list of members of both EFPIA and Eucope that they include undertakings exercising significant activities in the medicinal products sector as well as several associations which themselves represent such undertakings. EFPIA and Eucope can therefore be considered to be representative associations in the medicinal products sector with respect to determining their interest in the result of this case.
Protection of the interests of the members of the applicants to intervene
11 EFPIA and Eucope each claim that they aim to protect their members’ interests, as is apparent from their Statutes and Articles of Association respectively.
12 In their observations on the applications to intervene, the applicants claim that the provisions relied on by the applicants to intervene are too vague to be considered to be satisfactory.
13 In the present case, it is therefore necessary to ensure that the representative associations at issue have demonstrated that their aim is to protect their members.
14 As regards EFPIA, it is apparent from Article 2 of its Statutes that its activities extend ‘to all matters of common interest to its Members’, including those which ‘[aim] to foster an environment that encourages pharmaceutical research and development, manufacture in compliance with high quality standards, intellectual property protection and the introduction of regulatory requirements to allow patients rapid access to medicinal products’. In addition, that provision provides that, in order to achieve that aim, EFPIA guarantees to ‘represent, in courts of law and to administrative authorities, the general interests of its members’.
15 As regards Eucope, it is apparent from Article 3.2 of its Articles of Association that it aims to represent ‘member companies and associations operating in [the European Union] ... in particular towards the European institutions’.
16 Such provisions indeed include the possibility for each applicant to intervene before the Court in this case in order to protect the interests of its members in so far as those interests could be affected by the result of the case.
The existence of questions of principle liable to affect the interests of the members of the applicants to intervene
17 EFPIA claims that this case raises questions of principle affecting the functioning of the pharmaceutical sector. In their action, the applicants dispute the application by EMA of rules relating to data exclusivity, and in particular the principle that medicinal combinations (namely medicinal products containing a combination of active substances) do not come under the global marketing authorisation of the individual components and are entitled to a period of independent data exclusivity.
18 Data exclusivity serves to offer a guarantee to innovative companies that the data generated for the marketing authorisation of the innovative medicinal product will be used only by the competent authorities to assess applications from manufacturers of generic or second medicinal products after expiry of the data exclusivity which the innovative medicinal product enjoyed. Innovative companies have to be able to rely on that protection in order to plan and execute their commercial activities not only with regard to earning back investments in already authorised medicinal products, but also to invest in the development of future medicinal products. The protection of innovative companies is therefore also in the interest of public health.
19 Eucope states in that regard that the product which is the subject of the EMA’s decision of 26 November 2012 concerning the non-validation of the application for a marketing authorisation for the medicinal product Abacavir/Lamivudine (EMA/H/C/002710/0000) is referred to as a combination product. It states that the applicants’ action raises questions of principle, which are very important in practice, as to the protection of the data relating to that type of medicinal product.
20 In this respect, as this case raises a question of principle affecting the functioning of the pharmaceutical sector, EFPIA claims that the interests of its members will be significantly affected by the forthcoming judgment, due in particular to the sums which they have invested in the research and development of fixed combination medicinal products.
21 Similarly, Eucope claims that its members include innovative undertakings that rely on regulatory data protection to justify their investments in new pharmaceutical products, new indications for existing products and new combination medicinal products. In particular, Eucope states that, if the Court were to allow the applicants’ plea in law, first, regulatory data protection would be removed for the new preclinical and clinical trials which must be provided for all combination medicinal products; second, the extension of the concept of a ‘global marketing authorisation’ sought by the applicants would remove other types of regulatory data protection for new tests and trials; third, more broadly, Eucope and its members would have an interest in maintaining the balance struck between the interests of innovative undertakings (in the form of regulatory data protection) and the interests of other concerned parties, as introduced by the Community legislature.
22 In their observations on the applications to intervene, the applicants take the view, in essence, that the applicants to intervene are mistaken as to the nature of the proceedings, which, in the applicant’s view, do not concern questions of principle as suggested by the applicants to intervene, but rather a very specific factual configuration, given that the applicants’ position is that only one specific product, Kivexa, cannot benefit from the protection which was granted to it by EMA as the basis for the decision of 26 November 2012. The interests of their members would not therefore be affected, particularly since the Commission and ViiV Healthcare UK, which hold the rights at issue in this case, have already been recognised as interveners.
23 However, the Court considers that, contrary to what the applicants state in their observations, it cannot be inferred in the present case that the questions of principle referred to by EFPIA and Eucope do not arise. Those questions of principle are indeed likely to affect the interests of the various members of those representative associations, the situation of many of which is comparable to that of ViiV Healthcare UK. In this respect, account must be taken of the fact that these proceedings concern questions of title and exclusivity, the financial stakes of which are high for all stakeholders likely to be involved in such proceedings due to the rights which they hold in relation to data such as those at issue in this case.
24 EFPIA and Eucope state that their interventions will facilitate the assessment of the context of this case, while avoiding multiple individual interventions by their members, which would adversely affect the effectiveness and the proper conduct of the proceedings.
25 That interest is not called into question by the fact that ViiV Healthcare UK has already been granted leave to intervene in this case.
Conclusion
26 It is apparent from the foregoing that EFPIA and Eucope have duly established their interest in the result of the case and must be granted leave to intervene in support of the form of order sought by EMA.
27 The notice in the Official Journal of the European Union, referred to in Article 24(6) of the Rules of Procedure, having been published on 1 February 2013, the applications for leave to intervene were made within the time allowed under Article 115(1) of the Rules of Procedure and the rights of the interveners are to be those laid down in Article 116(2) to (4) of those Rules.
On those grounds,
THE PRESIDENT OF THE FIRST CHAMBER OF THE GENERAL COURT
hereby orders:
1. The European Federation of Pharmaceutical Industries and Associations (EFPIA) and the European Confederation of Pharmaceutical Entrepreneurs (Eucope) are granted leave to intervene in Case T‑547/12 in support of the form of order sought by the European Medicines Agency (EMA).
2. The Registrar shall send to EFPIA and Eucope a copy of the procedural documents served on the parties.
3. A period shall be prescribed within which EFPIA may submit a statement in intervention.
4. A period shall be prescribed within which Eucope may submit a statement in intervention.
5. The costs are reserved.
Luxembourg, 13 September 2013.