ORDER OF THE PRESIDENT OF THE COURT OF FIRST INSTANCE
24 April 2009 (*)
(Application for interim measures – Marketing authorisation for a medicinal product – Ultrasound echocardiographic imaging agent for diagnostic purposes (perflubutane) – Refusal by the EMEA to grant a waiver from the obligation to submit a paediatric investigation plan – Application for suspension of operation of a measure and interim measures – No urgency)
In Case T‑52/09 R,
Nycomed Danmark ApS, established in Roskilde (Denmark), represented by C. Schoonderbeek and H. Speyart van Woerden, lawyers,
applicant,
v
European Medicines Agency (EMEA), represented by V. Salvatore and N. Rampal Olmedo, acting as Agents,
defendant,
APPLICATION, first, for suspension of the operation of the EMEA’s decision of 28 November 2008 rejecting the application for a product-specific waiver concerning perflubutane and, secondly, for the grant of interim measures,
THE PRESIDENT OF THE COURT OF FIRST INSTANCE OF THE EUROPEAN COMMUNITIES
makes the following
Order
1 The applicant, Nycomed Danmark ApS, is a Danish manufacturer and supplier of medicines and pharmaceutical products. It is part of the Nycomed group of companies, which operates worldwide out of headquarters in Switzerland. According to its website, the Nycomed group of companies achieved total sales of EUR 3.3 billion in 2008.
2 The applicant developed an ultrasound echocardiographic imaging agent to be marketed under the brand name Imagify (‘Imagify’), which it states is intended to detect coronary artery disease (‘CAD’), that is, chronic disease characterised by obstruction of the coronary arteries, in patients suffering from chest pain and in whom inducible ischemia, that is reduced blood flow to an organ caused by stress or increased physical activity, is suspected.
3 The applicant intends to apply to the Commission for a Community marketing authorisation (‘CMA’) for Imagify.
4 The present dispute concerns the procedure for validation of that CMA application, which takes place before the European Medicines Agency (EMEA) prior to the actual authorisation procedure.
Legal framework
5 Under Articles 1 and 6 of 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), as amended, no medicinal product, including any product intended for diagnostic purposes such as Imagify, 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 the provisions thereof, or the Commission has granted a CMA in accordance with Regulation (EC) No 726/2004 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), in conjunction with Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ 2004 L 378, p. 1).
6 Regulation No 726/2004 provides for a two-stage procedure for granting CMAs: in the first stage of the procedure, which is governed by Articles 5 to 9 of Regulation No 726/2004, the EMEA’s Committee for Medicinal Products for Human Use draws up an opinion on the CMA application; in the second stage of the procedure, which is governed by Article 10 of Regulation No 726/2004, the Commission takes a decision granting or refusing the CMA.
7 Article 6 of Regulation No 726/2004 refers, with respect to the content of a CMA application, to the particulars and documents as referred to in, inter alia, Article 8(3) of Directive 2001/83. It thus follows from a joint application of Article 6 of Regulation No 726/2004 and Article 8(3)(e) of Directive 2001/83 that a CMA application must include the therapeutic indication – an expression which should be taken to include diagnostic indications – for which the CMA is being sought for the medicinal product concerned.
8 A combined reading of Article 1(28a) and Article 26 of Directive 2001/83, and also Article 12 of Regulation No 726/2004, read in the light of recital 14 in the preamble to that regulation, shows that the CMA is refused if, after verification of the relevant particulars and documents, it emerges, inter alia, that the risk-benefit balance of the medicinal product in question is not considered to be favourable. In that regard, the positive therapeutic or diagnostic effects of the medicinal product in question in relation to the risks related to its use, that is, any risk for the health of the patient or for public health relating to the quality, safety or efficacy of the medicinal product and any risk of undesirable effects on the environment, are to be evaluated (Article 1(28) of Directive 2001/83).
9 Regulation No 1901/2006, which is also relevant for the granting of CMAs (see paragraph 5 above), aims to facilitate the development and accessibility of medicinal products for paediatric use, to ensure that those medicinal products are subject to ethical research of high quality and are appropriately authorised for paediatric use, and to improve the information available on the use of medicinal products in the various paediatric populations (recital 4 in the preamble to Regulation No 1901/2006).
10 Under Article 7 of Regulation No 1901/2006, a CMA application can be validated only if it includes, in addition to the particulars and documents referred to in Article 8(3) of Directive 2001/83, the results of the studies performed in compliance with a paediatric investigation plan (‘PIP’) previously agreed by the EMEA, a decision of the EMEA granting a waiver from the obligation to submit a PIP, or a decision of the EMEA granting a deferral for implementation of the PIP.
11 Under Article 11(1) of Regulation No 1901/2006, a waiver is granted if there is evidence, inter alia, that the medicinal product in question is likely to be ineffective or unsafe in the paediatric population (Article 11(1)(a) of Regulation No 1901/2006) or that ‘the disease or condition for which the specific medicinal product … is intended occurs only in adult populations’ (Article 11(1)(b) of Regulation No 1901/2006).
12 Articles 13 and 25 of Regulation No 1901/2006 lay down the applicable procedure for the adoption of a decision on an application for a waiver. Thus, once the Paediatric Committee established within the EMEA adopts an opinion as to whether or not a product-specific waiver should be granted, the EMEA transmits that opinion to the applicant, who may submit to the EMEA a request for a re-examination of the opinion. Following receipt of such a request for re-examination, the Paediatric Committee issues a new opinion confirming or revising its previous opinion. The new opinion, which is definitive, must be duly reasoned and a statement of reasons for the conclusion reached must be annexed thereto. Following receipt of the definitive opinion of the Paediatric Committee, the EMEA adopts a decision, which is communicated to the applicant in writing and must annex the definitive opinion of the Paediatric Committee.
13 If a waiver is not obtained, the applicant concerned may either terminate the application procedure for obtaining a CMA or submit a draft PIP for agreement by the EMEA and, where applicable, request a deferral. Under Article 15(2) of Regulation No 1901/2006, the PIP must, inter alia, specify the timing and the measures proposed to assess the quality, safety and efficacy of the medicinal product in all subsets of the paediatric population that may be concerned.
14 Articles 20 and 21 of Regulation No 1901/2006 provide as follows with respect to deferrals:
‘Article 20
1. At the same time as the [PIP] is submitted …, a request may be made for deferral of the initiation or completion of some or all of the measures set out in that [PIP]. Such deferral shall be justified on scientific and technical grounds or on grounds related to public health.
In any event, a deferral shall be granted when it is appropriate to conduct studies in adults prior to initiating studies in the paediatric population or when studies in the paediatric population will take longer to conduct than studies in adults.
…
Article 21
1. At the same time as the Paediatric Committee adopts a positive opinion [on the PIP submitted], it shall, … following a request submitted by the applicant under Article 20, adopt an opinion, if the conditions specified in Article 20 are met, in favour of deferring the initiation or completion of some or all of the measures in the [PIP].
An opinion in favour of a deferral shall specify the time-limits for initiating or completing the measures concerned.
2. As soon as the Paediatric Committee adopts an opinion in favour of deferral, as referred to in paragraph 1, the procedure laid down in Article 25 shall apply.’
Background to the dispute
15 Myocardial perfusion defects are a sign of inducible ischemia in the heart muscle, and they may therefore be caused by CAD. It is also possible, however, that those perfusion defects are caused by other diseases, such as congenital heart defects, coronary anomalies or cardiomyopathies.
16 The applicant has focused on the clinical development of Imagify for use in diagnosing adults who suffer from chest pain which might be caused by inducible myocardial ischemia as an early sign of CAD. The CMA application for Imagify which the applicant intends to submit will therefore be for the following therapeutic indication: ‘[d]iagnosing coronary artery disease in patients with chest pain being evaluated for inducible ischemia’.
17 Pre-clinical and clinical studies and tests were performed by the applicant on the specific group of adult patients suffering from chest pains in order to fulfil the requirements for a CMA application for a product with the indication referred to in paragraph 16 above. In the clinical trials, the efficacy and safety of Imagify were compared with those of one of the methods currently used for diagnosing CAD.
18 The latter methods are imaging tests enabling visual examination of the features of the blood flow through the heart muscle and through the various vessels leading to and from it. They include primarily angiography, which is an invasive imaging technique whereby a radio-opaque contrast agent is injected into a blood vessel and imaging is done using X-ray based techniques, which involves radiation exposure; magnetic resonance angiography (MRA) and multi-slice computed tomography (CT), which allow visualisation of the coronaries; and, lastly, nuclear imaging such as myocardial scintigraphy (SPECT), which is currently the only widely-available non-invasive test for direct visualisation of myocardial perfusion.
19 According to the applicant, the advantage of the diagnostic technique applied when using Imagify in comparison with the imaging methods described in paragraph 18 above is that it is based on a relatively harmless ultrasound imaging technique which does not involve any radiation exposure.
20 The applicant acknowledges that, in some cases, the onset of CAD can already start in the paediatric population. It states, however, that the incidence of CAD is so extremely rare in the paediatric population that it is not possible to develop a reliable diagnostic tool of any kind in that population, because there is no testing population big enough to allow for reliable clinical data. In those extremely rare instances where a paediatric patient requires diagnostic evaluation of his or her coronary arteries, the preferred approach would be the use of one of the imaging modalities described in paragraph 18 above. Due to the availability of those diagnostic modalities, there is no unmet diagnostic need for those paediatric patients.
21 On 3 March 2008, the applicant submitted to the EMEA an application for a waiver pursuant to Article 11(1)(b) and Article 13(1) of Regulation No 1901/2006 in relation to the submission of a CMA application for Imagify, stating that Imagify was intended as a diagnostic agent for CAD, which occurs only in the adult population. Whilst acknowledging that the pathophysiological processes which lead to the development of CAD begin in early childhood, it stated that CAD exists only as an incipient clinical condition, primarily in paediatric patients with familial hypercholesterolemia and type 1 diabetes mellitus, adding that, even in those two high-risk paediatric patient populations, clinical signs and symptoms such as chest pain, shortness of breath and more serious cardiovascular events such as unstable angina and myocardial infarction do not occur before early adulthood.
22 The Paediatric Committee gave a negative preliminary view on 8 May 2008, requesting that the applicant propose modifications to its waiver application to address the potential benefit of Imagify in paediatric echocardiography. On 10 July 2008, the applicant indicated that it did not intend to modify its application as requested.
23 Following a meeting with the applicant, on 19 September 2008 the Paediatric Committee adopted its first opinion, recommending to the EMEA that it refuse the waiver sought. In that first opinion, the Paediatric Committee found that the applicant had artificially restricted the scope of its waiver application to the diagnosis of CAD, thereby excluding Imagify’s use as an ultrasound imaging agent in general.
24 By letter of 20 October 2008, the applicant lodged a reasoned request for re-examination of the first opinion. In that request, it observed that it is for the applicant to define the scope of the indication of the medicinal product for which a CMA is requested, and that the Paediatric Committee is not empowered to require amendments thereto so as to include information on the paediatric use of the product concerned for indications other than those applied for in the CMA application.
25 On 3 November 2008, the applicant received a draft final opinion of the Paediatric Committee in which it recommended not granting a waiver. After observing that Imagify is designed to identify myocardial perfusion defects, the Paediatric Committee stated that that condition can be the cause of various underlying diseases which all lead to such perfusion defects. It added that, although CAD is the most likely disease leading to myocardial perfusion defects in adults, those defects can also be caused by diseases occurring in children. In the draft final opinion, the Paediatric Committee proposed, inter alia, that the applicant apply for a deferral pursuant to Articles 20 and 21 of Regulation No 1901/2006.
26 By letter of 6 November 2008, the applicant contested the assessment of the Paediatric Committee. On 14 November 2008, the Paediatric Committee adopted its final opinion, in which it recommended not granting a waiver. By letter of 19 November 2008, the applicant invited the EMEA to reconsider that opinion.
27 By decision of 28 November 2008, the EMEA rejected the product-specific waiver application for perflubutane, brought by the applicant (‘the contested decision’). Regarding the reasoning in the contested decision, the EMEA endorses the reasoning of the Paediatric Committee, referring to the latter’s final opinion of 14 November 2008, which in turn refers to the summary report annexed thereto. That summary report, which is largely identical to the draft final opinion referred to in paragraph 25 above, comprises essentially two parts, the first corresponding to the Paediatric Committee’s first opinion (see paragraph 23 above), whilst the second is devoted to the re-examination of that first opinion.
28 Thus, the EMEA states that echocardiography conducted with perflubutane is proposed by the applicant to be a method to reveal myocardial perfusion abnormalities. The EMEA states, however, that possible causes of these abnormalities can be various heart diseases, which occur both in children and adults. It adds that those anomalies include not only coronary atherosclerosis, but also congenital heart defects, coronary anomalies, cardiomyopathies, coronary problems after surgery for congenital cardiac defects and acquired coronary problems after vasculitis such as Kawasaki disease. As myocardial perfusion abnormalities do indeed occur in the paediatric population, a waiver should not be granted on the ground that one of the underlying diseases, that is CAD, does not occur in children. The condition which Imagify is intended to examine concerns myocardial perfusion abnormalities and not CAD or any other underlying disease.
29 The EMEA takes the view that the waiver application must discuss the condition and not the intended indication, as the latter may be restricted for business or other reasons. As the condition of myocardial perfusion disturbance does exist in children, it is probable that Imagify, if it is beneficial in the adult as claimed by the applicant, will sooner or later be applied in paediatrics. Indeed, a number of paediatric patients with myocardial perfusion disturbances might benefit from this technique and thus avoid more invasive techniques.
30 The EMEA considers that diagnosis of myocardial perfusion is the intended target, even if the applicant has chosen to demonstrate this in patients with coronary artery disease. It states that, although the applicant’s strategic goal is thus to obtain a CMA solely for the specific indication of diagnosing CAD in adults, as it is the most frequent cause of myocardial perfusion abnormalities in adults, it is not for the EMEA to decide on the acceptability of that strategy. In the EMEA’s view, its disagreement with the applicant relates essentially to the fact that Imagify is not intended for treatment of a condition or disease, but rather is designed as a diagnostic tool with an application which is potentially broader than a targeted treatment. The EMEA suggests that the applicant apply for a deferral, in order not to delay authorisation of the product for adults, until more experience is acquired about the efficacy and safety of Imagify.
31 The contested decision was notified to the applicant on 2 December 2008.
Procedure and forms of order sought
32 By application lodged at the Registry of the Court of First Instance on 11 February 2009, the applicant brought an action for annulment of the contested decision on the ground that that decision, first, is based on an incorrect application of the expression ‘disease or condition for which the … medicinal product … is intended’ within the meaning of Article 11(1)(b) of Regulation No 1901/2006 because it does not take account of the therapeutic indication as described in the CMA application and because myocardial perfusion defects are not a disease or condition, but a sign of various diseases; and, secondly, is an attempt by the EMEA to misuse the powers conferred on it by Regulation No 1901/2006 in order to attain an aim which is not contemplated by that regulation, namely the obligation to propose a PIP for indications which are not covered by the CMA application.
33 By separate document, lodged at the Court Registry the same day, the applicant brought the present application for interim measures, in which it claims, essentially, that the President of the Court should:
– suspend the operation of the contested decision;
– order the EMEA to initiate provisionally the procedure provided for by Regulation No 726/2004 for the grant of a CMA for Imagify, and
– if that grant procedure should lead to an opinion of the EMEA within the meaning of Article 5(2) of Regulation No 726/2004 before judgment has been delivered in the main proceedings, stay the procedure before it, pending the main proceedings and, as the case may be, the grant of a waiver; or
– if that grant procedure has not led to such an opinion before judgment has been delivered in the main proceedings, terminate the grant procedure if the main application for annulment is dismissed, or stay the grant procedure before it, pending the grant of a waiver, if the main application is successful;
– order any other interim measures considered appropriate;
– order those measures pending the adoption of a final order in these interim proceedings, pursuant to Article 105(2) of the Rules of Procedure of the Court of First Instance; and
– order the EMEA to pay the costs.
34 By separate document lodged at the Court Registry on 18 February 2009, the applicant applied for the case to be dealt with under the expedited procedure, pursuant to Article 76a of the Rules of Procedure.
35 In its written observations on the application for interim measures, lodged at the Court Registry on 27 February 2009, the EMEA contends that the President of the Court should:
– dismiss the application for interim measures;
– order the applicant to pay the costs.
36 After the EMEA had lodged its observations, the applicant, by document of 6 March 2009, lodged a reply. By document of 17 March 2009, the EMEA responded to that reply and answered written questions from the President of the Court. By document lodged at the Court Registry on 2 April 2009, the United Kingdom of Great Britain and Northern Ireland applied for leave to intervene in support of the form of order sought by the EMEA.
Law
37 Under Articles 242 EC and 243 EC, in conjunction with Article 225(1) EC, the judge hearing the application for interim measures may, if he considers that circumstances so require, order that application of the act contested before the Court be suspended or prescribe any necessary interim measures.
38 Article 104(2) of the Rules of Procedure provides that an application for interim measures must state the subject-matter of the proceedings, the circumstances giving rise to urgency, and the pleas of fact and law establishing a prima facie case for the interim measures applied for. Thus, suspension of operation of an act and interim measures may be ordered if it is established that such an order is justified, prima facie, in fact and in law and that it is urgent in so far as it must, in order to avoid serious and irreparable harm to the applicant’s interests, be made and produce its effects before a decision is reached in the main action. Those conditions are cumulative, so that applications for interim measures must be dismissed if any one of them is absent (order of the President of the Court of Justice in Case C‑268/96 P(R) SCK and FNK v Commission [1996] ECR I-4971, paragraph 30).
39 In addition, in the context of that overall examination, the judge hearing the application for interim measures has a wide discretion and is free to determine, having regard to the specific circumstances of the case, the manner and order in which those various conditions are to be examined, there being no rule of Community law imposing a pre-established scheme of analysis within which the need to order interim measures must be assessed (orders of the President of the Court of Justice in Case C‑149/95 P(R) Commission v Atlantic Container Line and Others [1995] ECR I‑2165, paragraph 23, and of 3 April 2007 in Case C‑459/06 P(R) Vischim v Commission, not published in the ECR, paragraph 25).
40 Lastly, it should be borne in mind that Article 242 EC lays down the principle that actions do not have suspensory effect (order of the President of the Court of Justice in Case C‑377/98 R Netherlands v Parliament and Council [2000] ECR I‑6229, paragraph 44, and order of the President of the Court of First Instance in Case T‑191/98 R II Cho Yang Shipping v Commission [2000] ECR II‑2551, paragraph 42). It is thus only exceptionally that the judge hearing the application for interim measures may order the suspension of operation of an act contested before the Court of First Instance or prescribe interim measures.
41 Having regard to the documents in the case, the President of the Court considers that he has all the material needed in order to rule on the present application for interim measures and that it is not necessary first to hear oral argument from the parties.
42 In the circumstances of the present case, it is appropriate to examine, first, whether the condition of urgency is fulfilled.
Arguments of the parties
43 The applicant submits that it will suffer serious and irreparable damage if the interim measures requested are not granted. The introduction of Imagify on the market will be delayed during the entire period in which the waiver sought is not granted. During that time, the applicant will lose turnover and profits from the sales of Imagify.
44 The applicant adds that that delay also means that it will lose part of the effective protection period of the patents granted in respect of Imagify. The 20-year protection period for Imagify commenced on 27 February 1997 with the filing of the first patent application and will therefore lapse on 27 February 2017. The applicant cannot derive the benefits accruing from that protection before obtaining the CMA. The patent protection period may of course be extended beyond the 20-year period through the grant of a supplementary protection certificate, but the effective period resulting from the refusal to grant the waiver sought will still be shorter than that which the applicant would have obtained had the waiver been granted.
45 The applicant argues that any delay in the launching of a patent-protected product will have considerable impact on that product’s life-cycle turnover. Later market entry for the product will delay sales, and the potential turnover should not be calculated from the first year, when sales are modest, but rather in the year before loss of exclusivity, when product sales are peaking. In addition, a change in the order of entry of Imagify into the market in relation to other products will have a significant impact on the applicant’s market position if it reaches the market as manufacturer of the second ultrasound perfusion defect imaging product instead of the first, as is currently envisaged.
46 With respect to the irreparable nature of the alleged damage, the applicant acknowledges that Article 72(2) of Regulation No 726/2004 lays down a system of non-contractual liability for the EMEA, similar to that provided for by Articles 235 EC and 288 EC for the Community institutions. It submits, however, that it is not possible to compensate economically for the loss in turnover and profits and the shortening of the protection period for its patent through the award of damages. Entitlement to damages for loss suffered is subject to a set of conditions relating to the unlawfulness of the conduct alleged against the Community institution, the presence of damage and the existence of a causal link between the conduct and the damage complained of.
47 Moreover, even if the Court were to allow the main action for annulment and hold the contested decision to be unlawful, the applicant would then have to demonstrate, in accordance with settled case-law (Case C‑352/98 P Bergaderm and Goupil v Commission [2000] ECR I‑5291, paragraphs 41 to 43), that the EMEA manifestly and gravely disregarded the limits on its discretion in refusing the waiver sought. Given the scope of that discretion, subsequent reparation of the damage suffered would be subject to uncertainty, to say the least. Furthermore, if the applicant brought an action for damages against the EMEA, it would have considerable difficulty in quantifying the damage suffered, as that would depend on the financial implications of the situation that would have existed had the waiver and subsequent CMA been granted.
48 The applicant concludes from the foregoing that, even if it did manage to recover its financial losses by bringing an action for damages against the EMEA, the damage would still be serious and irreparable because its position on the relevant market would have been affected irremediably. All markets for pharmaceutical products are innovation markets. Competition on innovation markets such as the one at issue is not characterised by static competition for market shares, but rather by dynamic competition for positions afforded by new, innovative products. Time is therefore of the essence in getting a new medicinal product on the market as soon as it has been developed.
49 The applicant states in that regard that if, during the proceedings on the merits of the case, another pharmaceutical company is granted a CMA with respect to an ultrasound echocardiographic imaging agent, that competing product will already have acquired a market share it would not have acquired in the presence of Imagify. The applicant will accordingly be unable to recoup its development costs and will therefore be exposed to serious and immediate loss, the effects of which cannot be offset by the prospect of an unspecified amount of compensation in the future.
50 According to the applicant, the pharmaceutical market is also characterised by the technical complexity of the products and by the high level of investments that are necessary for the development of the products. As a result, competition in that market takes place when new products or innovations are introduced into the market. Afterwards, due to intellectual property rights and the fact that the CMA holder’s product will become the preferred product in that market, competing products will have serious difficulties in entering the market and achieving a substantial presence there. Consequently, it is essential for the applicant to launch Imagify on the market, achieve a market presence and defend its position, as any delay in the processing of its CMA application will harm its commercial presence on the pharmaceutical market.
51 Indeed, the market for cardiac diagnostic products is currently moving towards more expensive methods like magnetic resonance and CT scans. The later Imagify enters the market, the more these other methods will have been introduced in centres, which will thus have become dependent on those competing technologies and more reluctant to use perfusion imaging, which would nullify the value of investments made in other techniques.
52 The applicant reiterates that the interim measures sought are necessary in that a request for agreement for a PIP in accordance with Article 15 of Regulation No 1901/2006, accompanied by a request for deferral in accordance with Article 20 of that regulation, is not an option for it.
53 When submitting an application for agreement for a PIP, the applicant would have to specify, pursuant to Article 15(2) of Regulation No 1901/2006, the timing and the measures proposed to assess the quality, safety and efficacy of Imagify in all subsets of the paediatric population that may be concerned. According to the applicant, such measures would be unethical in that they provide for the testing on minors of Imagify as a diagnostic agent for all types of myocardial perfusion defects, whereas Imagify has only been tested on adults for the diagnosis of CAD in patients being examined for induced myocardial ischemia, contrary to Article 4(e) of Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ 2001 L 121, p. 34).
54 Moreover, a deferral, if granted, would always have to specify the time-limits for initiating or completing the measures concerned, as provided for in Article 21(1) of Regulation No 1901/2006. Therefore the applicant would at any rate have to conduct, at some point, the paediatric tests envisaged by the PIP. That would mean that ‘irreparable and inherently risky studies [would be] made on adults and minors’.
55 The EMEA submits that the requirement of urgency is not met in the present case, as the applicant has not established to the requisite legal standard that the damage alleged is sufficiently foreseeable, serious and irreparable.
56 The applicant is not suffering from any damage at present and the damage claimed is caused more by the delay in a future market entry. However, a positive outcome of the CMA procedure is in no way guaranteed for the applicant. Should the contested decision be annulled in the main proceedings, it will still be necessary for a waiver to be granted subsequently and, above all, for the applicant to be granted a CMA.
57 Furthermore, the applicant has failed to demonstrate its position on the relevant market in terms of its current and estimated position if it should receive a CMA for Imagify either after the interim measures sought are granted or after the main proceedings have come to an end, and to put forward an estimate of the loss in turnover and profits caused by the impossibility of selling Imagify, inter alia by references to market penetration studies, information on the target patient population and alternative products available on the market. It has not adduced any specific evidence which would afford an assessment of how its market position would be affected if another pharmaceutical company were to penetrate the market with a competing product and obtain market shares that it would not have obtained had a CMA been granted beforehand for Imagify, including identification of such a competitor and any competing products, and also the estimated market share impact. It follows that the assertions put forward by the applicant remain hypothetical and do not satisfy the condition of foreseeability of the harm alleged with the requisite degree of probability.
58 Even if the applicant had demonstrated that it would lose a significant proportion of its market shares if its application for interim measures were to be rejected, it would still not have proven the impact of such a loss of market shares on its operations in the group of which it forms a part.
Findings of the President of the Court
59 The urgency of an application for interim measures must be assessed on the basis of the need for an interlocutory order in order to prevent serious and irreparable damage being caused to the party requesting the interim measures. That party must prove that it cannot wait for the outcome of the main proceedings without having to suffer damage of this kind (see orders of the President of the Court of First Instance in Case T‑151/01 R Duales System Deutschland v Commission [2001] ECR II‑3295, paragraph 187; Case T‑195/05 R Deloitte Business Advisory v Commission [2005] ECR II‑3485, paragraph 124; and of 25 April 2008 in Case T‑41/08 R Vakakis v Commission, not published in the ECR, paragraph 52 and case-law cited), which presupposes that it provide the judge hearing the application with specific evidence allowing him to determine the precise consequences which the absence of the measures applied for would in all probability entail (order of the President of the Court of Justice in Case 378/87 R Top Hit Holzvertrieb v Commission [1988] ECR 161, paragraph 18; orders of the President of the Court of First Instance in Case T‑196/01 R Aristoteleio Panepistimio Thessalonikis v Commission [2001] ECR II‑3107, paragraph 32, and Case T‑163/00 R Carotti v Court of Auditors [2000] ECR-SC I‑A‑133 and II‑607, paragraph 8; order of the President of the Second Chamber of the Court of First Instance in Case T‑143/99 R Hortiplant v Commission [1999] ECR II‑2451, paragraph 18).
60 Moreover, the damage alleged must be certain or, at the very least, established with a sufficient degree of probability, the applicant being required to prove the facts forming the basis of its claim that such damage is likely. Purely hypothetical damage, based on future and uncertain events, cannot justify the granting of interim measures (see, to that effect, order of the President of the Court of Justice in Case C‑335/99 P(R) HFB and Others v Commission [1999] ECR I‑8705, paragraph 67; orders of the President of the Court of First Instance in Case T‑241/00 R Le Canne v Commission [2001] ECR II‑37, paragraph 37, and Joined Cases T‑195/01 R and T‑207/01 R Government of Gibraltar v Commission [2001] ECR II‑3915, paragraph 101).
61 Furthermore, the application for interim measures must contain the information to demonstrate the imminence of serious and irreparable damage. It is settled case-law that an application for interim measures must be sufficient in itself to enable the defendant to prepare his observations and the judge hearing the application to rule on it, where necessary, without other supporting information, and that the essential elements of fact and law on which it is founded must be set out in the application for interim measures itself (orders of the President of the Court of First Instance in Case T‑236/00 R Stauner and Others v Parliament and Commission [2001] ECR II‑15, paragraph 34; Case T‑306/01 R Aden and Others v Council and Commission [2002] ECR II‑2387, paragraph 52; and Case T‑85/05 R Dimos Ano Liosion and Others v Commission [2005] ECR II‑1721, paragraph 37).
62 It follows that an application for interim measures may not validly be supplemented by a document lodged subsequently by the applicant, possibly in response to observations from the other party to the proceedings, in order to remedy deficiencies. To allow such ‘catch-up’ would be incompatible not only with the expeditiousness required in interim proceedings, but also and above all with the spirit of Article 109 of the Rules of Procedure, under which, where an application for an interim measure is rejected, the applicant may not make a further application unless the latter is ‘on the basis of new facts’.
63 In the present case, the applicant argues that the damage suffered if the interim measures sought are not granted will be caused by the delay in introducing Imagify onto the market and by the loss of a corresponding portion of the protection period of its patents. It emphasises the significant impact of that delay on its position in the market for cardiac diagnostic products and the need for it to introduce Imagify onto that market as the first ultrasound imaging product in order to prevent another pharmaceutical company from gaining an edge and obtaining a CMA for a competing product, thereby acquiring a market share that it would not be able to acquire with Imagify present on the market.
64 However, the damage caused by such a delay in placing the product in question on the market, far from being able to be considered certain or, at the very least, sufficiently probable, is purely hypothetical in nature in that it presupposes the occurrence of future, uncertain events as contemplated in the case-law referred to in paragraph 60 above. There is no certainty whatsoever that that product will be introduced onto the market, as it depends on the Commission’s granting a CMA, for which the applicant has expressly stated it ‘will be applying’ (paragraph 5 of the application for interim measures) after successfully completing the validation procedure pending before the EMEA. In respect of that future authorisation procedure before the Commission, the applicant has not asserted, and even less established, that it would lead to the granting of the CMA, in the sense that the granting of that authorisation would be merely a formality.
65 Moreover, in the application for interim measures, the applicant did not specify the probability of the actual risk that it would be overtaken in the race to get its product onto the market by another pharmaceutical company that would manage to market its competing product before Imagify can be sold. It merely gave a general description of the particularities of the market for cardiac diagnostic products characterised by dynamic competition, without identifying the competing undertakings which have initiated the procedure for obtaining the CMA necessary for one or more products which may be substituted for Imagify.
66 It is true that, in its reply of 6 March 2009, the applicant referred to some companies, products and techniques likely to compete with it and its product Imagify. However, that information should have been set out in the application for interim measures itself (see paragraphs 61 and 62 above) and the applicant has not shown that it was prevented from doing so. In any event, that new information is too vague to show that the applicant would be exposed to an actual competitive risk if the application for interim measures were rejected, as the market entry of the allegedly competing products is purely hypothetical.
67 With respect to the nature of the alleged harm, the applicant states that, during the period in which the placing on the market of Imagify is delayed, it will risk a loss in turnover and profits on sales of Imagify as well as a shortening of the effective protection period of the patents granted for the product, as any delay in launching a patent-protected product has a considerable impact on the turnover achieved for that product.
68 The applicant is thus alleging damage which must be regarded as being purely financial, in that it consists in loss of the income likely to result from future sales of a patent-protected product.
69 Admittedly, the applicant seems not to accept the purely financial nature of the damage alleged, arguing that it would have considerable difficulty in quantifying that loss in an action for damages and that the damage would remain serious and irreparable, even if the financial losses suffered were recovered through an action for damages, because its position on the relevant market would have been affected irremediably. However, far from establishing the objective impossibility of quantifying the damage alleged, the applicant merely alleges difficulties in that regard, which did not prevent it from submitting, in the annexes to its reply of 6 March 2009 and therefore belatedly (see paragraphs 61 and 62 above), relevant estimate figures. Thus the applicant, in alleging such difficulties, is rather attempting to demonstrate the irreparable nature of the damage, due to the alleged uncertainty of reparation through an action for damages (see paragraphs 71 to 73 below). As for the alleged effect on its future position in the relevant market, it cannot be categorised as non-financial loss per se. A market share clearly does translate into financial terms, as its holder can benefit from it only in so far as it generates income for him.
70 It is, moreover, settled case-law that purely financial damage cannot, save in exceptional circumstances, be regarded as irreparable or even as reparable only with difficulty since normally it can be the subject of subsequent financial compensation (order of the President of the Court of Justice in Case C‑471/00 P(R) Commission v Cambridge Healthcare Supplies [2001] ECR I‑2865, paragraph 113; order of the President of the Court of First Instance of 27 August 2008 in Case T‑246/08 R Melli Bank v Council, not published in the ECR, paragraph 33).
71 In the present case, the applicant has expressly accepted the principle of pecuniary compensation under the system of non-contractual liability established by Article 72(2) of Regulation No 726/2004, similar to Articles 235 EC and 288 EC, whilst taking the view that subsequent reparation of the damage suffered is, at the least, uncertain in the present case, as it is very difficult for it to quantify the loss suffered and to prove that the EMEA, which has broad discretion in the area, manifestly and gravely disregarded the limits on its discretion in refusing the waiver sought (see paragraphs 46 and 47 above). In support of that line of argument, the applicant referred to the order of the President of the Court of First Instance in Case T‑132/01 R Euroalliages and Others v Commission [2001] ECR II‑2307, paragraph 74.
72 In that regard, it must be noted that the order in Euroalliages and Others v Commission, paragraph 71 above, was set aside on appeal by the order of the President of the Court of Justice in Case C‑404/01 P(R) Commission v Euroalliages and Others [2001] ECR I‑10367, paragraphs 70 to 75. In that order, the President of the Court of Justice, after referring to the case-law on interim measures relating to the possibility of obtaining pecuniary compensation in an action for damages, noted that, in that case-law, the Court of Justice had never examined the actual likelihood of success of an action for damages which might be brought in the event of the contested measure being annulled. The President of the Court of Justice ruled out the possibility that the uncertainty of obtaining compensation for pecuniary damage through an action for damages might in itself be regarded as a factor capable of establishing that such damage is irreparable, since, at the interlocutory stage, the possibility of subsequently obtaining compensation for pecuniary damage through an action for damages is necessarily uncertain. Interlocutory proceedings are not intended to replace an action for damages in order to remove that uncertainty. Lastly, the President of the Court of Justice stated that that conclusion was not affected by the link between the wide discretion that the defendant institution may have enjoyed and the uncertainty of success in any action for damages since, if that criterion were applied systematically, the irreparable nature of the damage would depend on the characteristics of the contested measure and not on the applicant’s individual circumstances.
73 It follows from that order of the President of the Court of Justice that the possibility of bringing an action for damages is in itself sufficient to demonstrate that financial damage is, as a rule, reparable. Accordingly, in the present interim proceedings, it is not necessary to take account of the uncertainty of success of any action for damages which the applicant might bring if the contested decision were annulled in order to establish whether the financial damage alleged is reparable or not.
74 It follows that that damage is irreparable in the present case only if, were the interim measures sought not granted, the applicant would be in a position that could imperil its existence before final judgment in the main action (order in Melli Bank v Council, paragraph 70 above, paragraph 34).
75 The applicant has not stated, and even less established, that that would be the case if its application for interim measures were to be rejected.
76 It is also noteworthy in this context that in the case-law account has also been taken of the fact that, if the interim measure sought were not granted, the applicant’s market share would be irremediably affected (orders of the President of the Court of First Instance in Case T‑13/99 R Pfizer Animal Health v Council [1999] ECR II‑1961, paragraph 138, and Case T-392/02 R Solvay Pharmaceuticals v Council [2003] ECR II‑1825, paragraph 107). However, that situation can be placed on an equal footing with that of the risk of disappearance from the market and justify adoption of the interim measure sought only if the irremediable effect on market share is also of a serious nature, which implies that the market share which may be irremediably lost must be sufficiently large (order in Melli Bank v Council, paragraph 70 above, paragraph 35; see, to that effect, order of the President of the Court of First Instance in Case T-369/03 R Arizona Chemical and Others v Commission [2004] ECR II-205, paragraphs 83 and 84).
77 In that regard, it must be assessed whether the damage alleged may be held to be serious in the light of, inter alia, the size and turnover of the applicant undertaking and the characteristics of the group to which it belongs (see order of the President of the Court of Justice in Case C‑43/98 P(R) Camar v Commission and Council [1998] ECR I‑1815, paragraph 36, and case-law cited, and order of the President of the Court of First Instance in Case T‑326/07 R Cheminova and Others v Commission [2007] ECR II‑4877, paragraph 102).
78 That approach is based on the idea that the objective interests of the undertaking concerned are not distinct from those of the persons who control it. The serious and irreparable nature of the damage alleged must therefore be assessed also by reference to the financial position of the persons who control the undertaking. That coincidence of interests is justification in particular for not assessing the undertaking’s interest in its own survival separately from the interest of the persons controlling it in seeing it survive (order in Melli Bank v Council, paragraph 70 above, paragraph 38).
79 In the present case, it must be borne in mind that the market share which the applicant fears losing if the interim measures sought are not granted does not yet exist, but rather is dependent on the occurrence of future and uncertain events, namely the granting of a CMA, as it has not yet filed the relevant application (see paragraph 64 above). Consequently, it is not certain, or sufficiently probable, that Imagify might one day be placed on the market and that the market share in question will ever be acquired by the applicant. As that is purely hypothetical damage, it cannot be taken into account in the present context.
80 Nor, at any stage of the proceedings, has the applicant provided particulars enabling an assessment of the financial characteristics of the Nycomed group of companies, to which it belongs, or any reliable details to demonstrate that other companies in that group do not have an interest in supporting it financially; this type of information should have been set out in the application for interim measures (see paragraph 61 above). Consequently, the President of the Court is unable to examine specifically the seriousness of the damage alleged by the applicant by comparing that damage with the overall turnover of the Nycomed group of companies, which totalled EUR 3.3 billion in 2008, as stated on publicly-accessible internet sources (see, to that effect, orders of the President of the Court of First Instance of 26 February 2007 in Case T‑416/06 R Sumitomo Chemical Agro Europe v Commission, not published in the ECR, paragraphs 71 and 72, and in Melli Bank v Council, paragraph 70 above, paragraph 44).
81 It follows from the foregoing that the applicant has not succeeded in establishing that the damage alleged may be considered to be serious and irreparable.
82 Lastly, it is settled case-law (see order of the President of the Court of First Instance of 15 July 2008 in Case T‑202/08 R CLL Centres de langues v Commission, not published in the ECR, paragraph 73 and case-law cited) that urgency in ordering an interim measure must result from the effects produced by the contested measure and not from a lack of diligence on the part of the applicant. The latter must, if it is not itself to bear the loss as part of the ‘risks of the undertaking’, show reasonable diligence in limiting the extent of the loss.
83 In the present case, it must be borne in mind that, during the procedure before the EMEA, the applicant was informed, on 8 May 2008, of the Paediatric Committee’s reluctance to recommend granting a waiver (see paragraph 22 above). That reluctance was confirmed by the successive official statements of that committee, of 19 September and also 3 and 14 November 2008, which recommended refusing the waiver sought (see paragraphs 23 to 26 above). It was in the draft final opinion of 3 November 2008 (see paragraph 25 above) that the Paediatric Committee ruled against granting a waiver, stating that Imagify was designed to detect myocardial perfusion defects, that that condition could be the cause of various underlying diseases which all lead to such perfusion defects and that those defects could also be caused by diseases occurring in children. It states that the disagreement with the applicant relates essentially to the fact that Imagify is not intended for treatment of a condition or disease, but rather is designed as a diagnostic tool with an application which is potentially broader than a targeted treatment, and suggests that the applicant apply for a deferral pursuant to Articles 20 and 21 of Regulation No 1901/2006.
84 In that situation, the applicant, if it actually wished to reduce to a strict minimum any delay in placing Imagify on the market, could have acted as a prudent and well-informed trader and applied for a deferral, as suggested by the Paediatric Committee, and also submitted an application for agreement for a PIP. The file for those applications could have been duly prepared in May 2008 and the applications should have been filed with the EMEA at the latest after receipt of the contested decision by the applicant, that is, the beginning of December 2008. The applicant could have indicated at that time that those applications had been filed as a precautionary measure only and that it reserved the right to bring an action for annulment before the Court of First Instance if the waiver sought were refused and, in the event of annulment of the contested decision, an action for damages in order to recover from the EMEA costs unduly incurred.
85 As a first point, without its being necessary to consider whether there is a prima facie case, it must be noted that the applicant ought to have been aware that the reasons given by the Paediatric Committee (see paragraph 25 above) and reiterated by the EMEA in the contested decision (see paragraphs 27 to 30) could not from the outset be regarded as totally nonsensical. The applicant itself, moreover, described Imagify as an ‘ultrasound perfusion defect imaging product’ and stated that the relevant market was that for ‘agents and technologies used for myocardial perfusion imaging’. The applicant made the choice to focus on the application for a waiver alone as part of its commercial policy and it must bear the economic risk of that choice.
86 Secondly, the applicant has not provided any information showing that it would have been financially incapable of bearing the costs relating to an application for deferral, accompanied by an application for agreement for a PIP, and to carrying out the paediatric tests envisaged by the PIP.
87 Thirdly, the applicant has not succeeded in establishing that the relevant legislation prevented it from applying for a deferral and agreement for a PIP in the present case. It merely stated that it could not submit a PIP likely to be approved by the EMEA and that, even if it did obtain a deferral, it would have to carry out the paediatric tests envisaged by the PIP subsequently, which would mean that ‘irreparable and inherently risky studies will have been made on adults and minors’.
88 Those are mere unsubstantiated statements which seem, moreover, to be contradicted by the fact that the EMEA, explicitly and in knowledge of the particularities of the case filed by the applicant, suggested to the latter to make an application for a deferral, accompanied by an application for agreement for a PIP. As to the alleged risks for minors, it is sufficient to recall that the applicant based its application for a waiver solely on Article 11(1)(b) of Regulation No 1901/2006, without referring to Article 11(1)(a) of that regulation, which provides for the situation where a medicinal product is unsafe for the paediatric population (see paragraphs 11 and 21 above). Accordingly, it may not profitably rely on dangers for minors in the present context, without providing any further explanation whatsoever on the point.
89 The applicant argues further that the paediatric trials envisaged by a PIP would be unethical because Imagify has only been tested on adults and Article 4(e) of Directive 2001/20 prohibits testing on minors unless the same tests have already been conducted on adults. In that context, the applicant also refers to the ethical principles in the Declaration of Helsinki, referred to in the second paragraph of Article 3 of Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products (OJ 2005 L 91, p. 13).
90 In so doing, the applicant, first, merely refers to the wording of Article 4(e) of Directive 2001/20. That provision, however, allows for clinical trials to be conducted on minors, inter alia, in order to validate data obtained in clinical trials on persons able to give informed consent ‘or by other research methods’. The applicant has not alleged, and even less established, that it was not possible to consider clinical trials carried out on adults, such as those conducted to test Imagify, to be such ‘other research methods’. Secondly, its mere reference to the wording of the second paragraph of Article 3 of Directive 2005/28, which states that ‘[c]linical trials shall be conducted in accordance with the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects, adopted by the General Assembly of the World Medical Association (1996)’, is not, at first blush and in the absence of other factual or legal clarifications, of any support for its line of argument to the effect that filing a draft PIP along with an application for deferral is not an option for it.
91 As to the argument that the paediatric trials envisaged by a PIP would not be ethical, it is appropriate, at this stage, to note again that that statement is vague and unsubstantiated. Moreover, the EMEA, as the competent public body in the field, suggested to the applicant that it apply for a deferral and at the same time file a draft PIP. It necessarily follows that that body does not consider that it would be unethical for the applicant to conduct paediatric clinical trials.
92 It follows that if the applicant had applied for a deferral and filed a draft PIP, that might have reduced significantly the delay in starting the procedure for the granting or refusal of a CMA for Imagify. As the EMEA has, moreover, stated, as the present case involves a medicinal product which can be of use in both adult and paediatric populations, if the Paediatric Committee had allowed a deferral of the studies – and the applicant has not demonstrated why such a deferral could not have been granted –, it would not theoretically have been necessary for the applicant to conduct the paediatric studies before the CMA assessment for the adult indication and even less before filing the CMA application.
93 It follows from the foregoing that the situation which gave rise to the present application for interim measures has resulted from a free choice on the part of the applicant in the implementation of its commercial strategy. Accordingly the loss alleged cannot establish the urgency for ordering the interim measures sought.
94 Consequently, the present application for interim measures must be dismissed for lack of urgency, without any need to examine, first, whether it is admissible – which the EMEA maintains it is not, arguing that the interim measures sought go beyond what the applicant may obtain in the main proceedings and beyond the purpose of those proceedings – and, secondly, whether the other conditions for granting the interim measures sought, including the establishment of a prima facie case, are fulfilled. In those circumstances, it is not necessary to rule on the United Kingdom’s application to intervene.
On those grounds,
THE PRESIDENT OF THE COURT OF FIRST INSTANCE
hereby orders:
1. The application for interim measures is dismissed.
2. Costs are reserved.
Luxembourg, 24 April 2009.