Court of Justice of the European Communities (including Court of First Instance Decisions)

JUDGMENT OF THE GENERAL COURT (Second Chamber)

28 June 2019 (*)

(Access to documents — Regulation (EC) No 1049/2001 — Documents held by EMA containing information submitted by the applicants in the context of the marketing authorisation for the medicinal product Ocaliva — Decision to grant a third party access to a document — Exception relating to the protection of court proceedings)

In Case T‑377/18,

Intercept Pharma Ltd, established in Bristol (United Kingdom),

Intercept Pharmaceuticals, Inc., established in New York, New York (United States),

represented by L. Tsang, J. Mulryne, E. Amos and H. Kerr-Peterson, Solicitors, and F. Campbell, Barrister,

applicants,

v

European Medicines Agency (EMA), represented initially by S. Marino, S. Drosos, A. Rusanov and T. Jabłoński, and subsequently by S. Marino, S. Drosos, T. Jabłoński, R. Pita and G. Gavriilidou, acting as Agents,

defendant,

ACTION under Article 263 TFEU for the annulment of EMA decision ASK-40399 of 15 May 2018, granting to a third party, pursuant to Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ 2001 L 145, p. 43), access to a document containing information submitted in the context of an application for marketing authorisation for the medicinal product Ocaliva,

THE GENERAL COURT (Second Chamber),

composed of M. Prek, President, F. Schalin (Rapporteur) and M.J. Costeira, Judges,

Registrar: E. Artemiou, Administrator,

having regard to the written part of the procedure and further to the hearing on 12 February 2019,

gives the following

Judgment

 Background to the dispute

1        Intercept Pharmaceuticals, Inc. is a biopharmaceutical company and the parent company of Intercept Pharma Ltd (‘the applicants’). The applicants are specialised in the development and marketing of innovative therapies to treat progressive non-viral liver diseases, including primary biliary cholangitis, nonalcoholic steatohepatitis, primary sclerosing cholangitis and biliary atresia.

2        The applicants market the orphan medicinal product Ocaliva, which was approved in the United States on 27 May 2016 and in the European Union on 12 December 2016, in both cases for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid (‘UDCA’) in adults with inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.

3        Marketing authorisation (MA) in the European Union is conditional, 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).

4        On 3 April 2018, the European Medicines Agency (EMA) informed Intercept Pharma that it had received, from a law firm, a request pursuant to Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ 2001 L 145, p. 43), seeking access to several documents relating to Ocaliva. Those documents had been divided into two batches for the purpose of obtaining the comments of Intercept Pharma.

5        On 11 April 2018, Intercept Pharma provided comments on Batch 1, namely the periodic benefit-risk evaluation report in respect of the period from 12 December 2016 to 11 June 2017 (‘the report at issue’) relating to Ocaliva, and on 26 April 2018, on Batch 2, namely the report of the assessment committee for Ocaliva for the period from 12 December 2016 to 11 June 2017 and the risk management plan for Ocaliva.

6        With regard to the report at issue, Intercept Pharma proposed redactions of specific sections relating to the safety of Ocaliva. In that regard, it indicated that it had reason to believe that the request for access had been made on behalf of parties involved in a dispute with its parent company in the United States of America who, at the current stage of those proceedings, did not possess the information requested, which would be the case in the future, in accordance with the procedural rules governing the discovery phase of the proceedings. It claimed that, if the report at issue were released, it would help those parties circumvent US rules of procedure relating to the preliminary investigation and seriously undermine the economic interests of Intercept Pharmaceuticals by increasing its defence costs and the possibility of a settlement in terrorem. Finally, according to Intercept Pharma, disclosure of the report at issue is not justified since there is no overriding public interest or public health interest in providing the information in question to the opposing parties in the proceedings in the United States.

7        Likewise, Intercept Pharma proposed a number of redactions in relation to personal data.

8        On 15 May 2018, EMA informed the applicants of decision ASK-40399 to disclose the report at issue (‘the contested decision’). EMA explained that the justification put forward by Intercept Pharma for some of the proposed redactions relating to the safety of Ocaliva did not constitute a sufficient legal basis to refuse access to that information. In that regard, it indicated that in the case of the exception provided for in the second indent of Article 4(2) of Regulation No 1049/2001, they are documents prepared for the purposes of legal proceedings and not documents held by institutions which, according to the marketing authorisation holder, could be part of future legal proceedings. With regard to the proposed redactions of personal data, EMA accepted some of them and refused others, in so far as it was found that the associated information was not liable to lead to the identification of any natural persons.

9        In response to the applicants’ request, EMA agreed not to release the report at issue until the Court has ruled on the present proceedings and to discontinue the examination of the request for access concerning Batch 2.

 Procedure and forms of order sought

10      By application lodged at the Court Registry on 20 June 2018, the applicants brought the present action.

11      On 12 September 2018, EMA submitted the defence.

12      The parties presented oral argument and their replies to the questions put by the Court at the hearing on 12 February 2019.

13      The applicants claim that the Court should:

–        annul the contested decision;

–        order EMA to pay all costs in these proceedings.

14      EMA contends that the Court should:

–        dismiss the action;

–        order the applicants to pay the costs.

 Law

15      The applicants rely on two pleas in law alleging, respectively, first, infringement of the second indent of Article 4(2) of Regulation No 1049/2001 relating to the protection of court proceedings and, second, that the only permissible outcome of a proper balancing exercise, under the ‘commercial interests’ provisions contained in the first indent of Article 4(2) of that regulation, would have been a decision not to release the report at issue.

 The first plea in law, alleging infringement of the second indent of Article 4(2) of Regulation No 1049/2001 relating to the protection of court proceedings

16      The applicants consider that the report at issue in its entirety falls within the scope of the exception provided for in the second indent of Article 4(2) of Regulation No 1049/2001 and that it should not therefore be released, in so far as its disclosure would undermine the court proceedings pending in the United States.

17      In that regard, the applicants submit that, on 27 September 2017, a shareholder class action was brought against Intercept Pharmaceuticals, its Chief Executive Officer and Chief Financial Officer before a US court (‘the DeSmet action’). That action was brought by a shareholder who claimed to be suing the defendant on behalf of anyone who purchased or otherwise acquired Intercept Pharmaceuticals securities between 31 May 2016 and 20 September 2017 and sought monetary damages.

18      In that context, the applicants explain that the DeSmet action is a typical stock drop lawsuit. That sort of action is often brought in the United States against companies listed on the stock exchange following a decrease in share prices. In the present case, the DeSmet action was triggered by the drop in the share price of Intercept Pharmaceuticals following the publication of a communication by the Food and Drug Administration (FDA, United States) concerning the safety of Ocaliva that stressed the importance of the recommended dosage set out on the label of that medicinal product.

19      In that context, the applicants maintain that the disclosure requested from EMA concerns the type of information that could be useful to the plaintiffs in the context of their action in the United States and submit that US legislation precludes the plaintiffs in that type of action from obtaining the document in question from the other party, unless and until it is established, where appropriate, that the complaint is admissible. Accordingly, it would be contrary to the specific policy pursued by the US legislation for EMA to circumvent that prohibition on document access and thus upset the ‘vital balance’ between the parties in the type of proceedings in question. In addition, the applicants claim that they have been obliged to devote significant financial resources to defend themselves in those proceedings.

20      The applicants maintain that their concerns relating to the disclosure of the report at issue (and the report of the assessment committee for Ocaliva for the period from 12 December 2016 to 11 June 2017, referred to as Batch 2) are based on the fact that the report (i) contains detailed scientific data, (ii) contains nothing which would materially add to the information already placed in the public domain by EMA and the FDA, (iii) would be incomprehensible to the general public and (iv) would create a serious risk that the information contained therein could be misused to provide a misleading picture of the clinical safety and efficacy of Ocaliva if disclosed.

21      The applicants observe that the Court has held that the exception relating to the protection of court proceedings should not be interpreted strictly so as to include only documents such as court pleadings. Moreover, according to the case-law, the protection of court proceedings also implies, in particular, that compliance with the principles of equality of arms and of the sound administration of justice must be ensured.

22      The applicants also recall the case-law resulting from the case which gave rise to the judgment of 3 October 2012, Jurašinović v Council (T‑63/10, EU:T:2012:516), according to which court proceedings referred to in the second indent of Article 4(2) of Regulation No 1049/2001 are not limited to proceedings before the EU courts or the courts of the Member States.

23      Furthermore, EMA should have weighed up the particular interest to be protected by non-disclosure against the public interest in the document being made accessible. Moreover, that report would not add, to the benefit of patients, to the information in the public domain.

24      EMA contends that the first plea in law should be rejected as unfounded.

25      As a preliminary observation, it should be noted that, in accordance with recital 1 of Regulation No 1049/2001, that regulation reflects the intention expressed in the second paragraph of Article 1 TEU of marking ‘a new stage in the process of creating an ever closer union among the peoples of Europe, in which decisions are taken as openly as possible and as closely as possible to the citizen’. As is stated in recital 2 of Regulation No 1049/2001, the right of public access to documents of the institutions relates to the democratic nature of those institutions (judgments of 1 July 2008, Sweden and Turco v Council, C‑39/05 P and C‑52/05 P, EU:C:2008:374, paragraph 34, and of 17 October 2013, Council v Access Info Europe, C‑280/11 P, EU:C:2013:671, paragraph 27).

26      To that end, Regulation No 1049/2001 is designed — as is stated in recital 4 and reflected in Article 1 — to confer on the public as wide a right of access as possible to documents of the institutions (judgments of 1 February 2007, Sison v Council, C‑266/05 P, EU:C:2007:75, paragraph 61; of 21 September 2010, Sweden and Others v API and Commission, C‑514/07 P, C‑528/07 P and C‑532/07 P, EU:C:2010:541, paragraph 69; and of 17 October 2013, Council v Access Info Europe, C‑280/11 P, EU:C:2013:671, paragraph 28).

27      That right is nonetheless subject to certain limitations based on grounds of public or private interest (judgment of 1 February 2007, Sison v Council, C‑266/05 P, EU:C:2007:75, paragraph 62). More specifically, and in reflection of recital 11, Article 4 of Regulation No 1049/2001 provides that the institutions are to refuse access to a document where its disclosure would undermine the protection of one of the interests protected by that provision (judgments of 21 September 2010, Sweden and Others v API and Commission, C‑514/07 P, C‑528/07 P and C‑532/07 P, EU:C:2010:541, paragraph 71, and of 17 October 2013, Council v Access Info Europe, C‑280/11 P, EU:C:2013:671, paragraph 29).

28      As such exceptions derogate from the principle of the widest possible public access to documents, they must be interpreted and applied strictly (judgments of 1 February 2007, Sison v Council, C‑266/05 P, EU:C:2007:75, paragraph 63; of 1 July 2008, Sweden and Turco v Council, C‑39/05 P and C‑52/05 P, EU:C:2008:374, paragraph 36; and of 17 October 2013, Council v Access Info Europe, C‑280/11 P, EU:C:2013:671, paragraph 30), with the result that the mere fact that a document concerns an interest protected by an exception is not sufficient to justify application of that exception (judgments of 27 February 2014, Commission v EnBW, C‑365/12 P, EU:C:2014:112, paragraph 64; of 13 April 2005, Verein für Konsumenteninformation v Commission, T‑2/03, EU:T:2005:125, paragraph 69; and of 7 June 2011, Toland v Parliament, T‑471/08, EU:T:2011:252, paragraph 29).

29      If the institution concerned decides to refuse access to a document which it has been asked to disclose, it must, in principle, explain how disclosure of that document could specifically and actually undermine the interest protected by the exception — among those provided for in Article 4 of Regulation No 1049/2001 — upon which it relies. Moreover, the risk of the interest being undermined must be reasonably foreseeable and must not be purely hypothetical (see judgments of 17 October 2013, Council v Access Info Europe, C‑280/11 P, EU:C:2013:671, paragraph 31 and the case-law cited, and of 3 July 2014, Council v in’t Veld, C‑350/12 P, EU:C:2014:2039, paragraph 52).

30      As regards the protection of ‘court proceedings’, referred to in the second indent of Article 4(2) of Regulation No 1049/2001, it is apparent from case-law that the expression ‘court proceedings’ is to be interpreted as meaning that the protection of the public interest precludes disclosure of the content of documents drawn up solely for the purposes of specific court proceedings (see judgments of 6 July 2006, Franchet and Byk v Commission, T‑391/03 and T‑70/04, EU:T:2006:190, paragraphs 88 and 89 and the case-law cited, and 3 October 2012, Jurašinović v Council, T‑63/10, EU:T:2012:516, paragraph 66 and the case-law cited).

31      In that context, the existence of a general presumption of non-disclosure has been acknowledged in respect of the pleadings in court proceedings as provided for in the second indent of Article 4(2) of Regulation No 1049/2001, while those proceedings remained pending (judgments of 21 September 2010, Sweden and Others v API and Commission, C‑514/07 P, C‑528/07 P and C‑532/07 P, EU:C:2010:541, paragraph 94; of 15 September 2016, Philip Morris v Commission, T‑796/14, EU:T:2016:483, paragraph 77; and of 15 September 2016, Philip Morris v Commission, T‑18/15, not published, EU:T:2016:487, paragraph 53), although that presumption was applicable only in the case of specific pending proceedings and could not, as a rule, be relied on by the institution concerned where the proceedings in question had been closed by a decision of the Court (judgment of 21 September 2010, Sweden and Others v API and Commission, C‑514/07 P, C‑528/07 P and C‑532/07 P, EU:C:2010:541, paragraph 130).

32      The Court of Justice has also held that the exception relating to the protection of court proceedings meant that such protection was necessary to ensure observance of the principles of equality of arms and of the sound administration of justice. Access to documents by one party could well upset the vital balance between the parties to a dispute — the state of balance which is at the basis of the principle of equality of arms — since only the institution concerned by an application for access to its documents, and not all the parties to the proceedings, would be bound by the obligation of disclosure (judgment of 21 September 2010, Sweden and Others v API and Commission, C‑514/07 P, C‑528/07 P and C‑532/07 P, EU:C:2010:541, paragraphs 85 to 87).

33      It is inter alia for this reason that, in dealing with cases relating to access to preliminary views put together by an institution concerning the drafting of a legislative proposal, the General Court has considered that, notwithstanding what it held in its judgment of 6 July 2006, Franchet and Byk v Commission (T‑391/03 and T‑70/04, EU:T:2006:190, paragraphs 88 to 91), the case-law referred to in paragraph 32 above did not rule out the possibility that documents other than pleadings and documents exchanged with the Legal Service of an institution which are specifically linked to pending proceedings might come within the scope of the exception relating to the protection of court proceedings. In that regard, the General Court stressed that the principle of equality of arms and of the sound administration of justice were at the heart of the protection laid down in the second indent of Article 4(2) of Regulation No 1049/2001 and considered that the need to ensure equality of arms before a court justified the protection not only of documents drawn up solely for the purposes of specific court proceedings, such as pleadings, but also of documents whose disclosure was liable, in the context of specific proceedings, to compromise that equality, which was a corollary of the very concept of a fair trial, since those documents contained internal legal positions (judgments of 15 September 2016, Philip Morris v Commission, T‑796/14, EU:T:2016:483, paragraphs 88 and 97, and of 15 September 2016, Philip Morris v Commission, T‑18/15, not published, EU:T:2016:487, paragraphs 64 and 73).

34      In that case, although those documents have not been drawn up in the context of specific court proceedings, the integrity of the court proceedings concerned and the equality of arms between the parties could have been seriously compromised if parties were to benefit from privileged access to internal information belonging to the other party and closely connected to the legal aspects of pending or potential but imminent proceedings (judgments of 15 September 2016, Philip Morris v Commission, T‑796/14, EU:T:2016:483, paragraph 90, and of 15 September 2016, Philip Morris v Commission, T‑18/15, not published, EU:T:2016:487, paragraph 65).

35      However, in order for the exception to apply, it is necessary that the requested documents, at the time of adoption of the decision refusing access to those documents, have a relevant link either with a dispute pending before the Courts of the European Union, in respect of which the institution concerned is invoking that exception, or with proceedings pending before a national court, on condition that they raise a question of interpretation or validity of an act of EU law so that, having regard to the context of the case, a reference for a preliminary ruling appears particularly likely (judgments of 15 September 2016, Philip Morris v Commission, T‑796/14, EU:T:2016:483, paragraphs 88 and 89, and of 15 September 2016, Philip Morris v Commission, T‑18/15, not published, EU:T:2016:487, paragraph 64).

36      The first plea in law must be examined in the light of those considerations from the Court’s case-law.

37      In the present case, the applicants criticise EMA for having erred in law in concluding that the provisions relating to ‘court proceedings’ of the second indent of Article 4(2) of Regulation No 1049/2001 were not to be taken into account.

38      They rely in that regard on the case-law stating that the exception relating to the protection of court proceedings may also apply to documents other than pleadings and that that exception also covers proceedings pending before courts outside the European Union.

39      It is true, as the applicants claim, that the court proceedings referred to in the second indent of Article 4(2) of Regulation No 1049/2001 do not merely cover proceedings before the Courts of the European Union and the courts of its Member States (judgment of 3 October 2012, Jurašinović v Council, T‑63/10, EU:T:2012:516, paragraph 58). However, that exception only covers documents drawn up in the context of specific pending court proceedings or, exceptionally, documents which were not drawn up in the context of specific court proceedings, but which contain legal positions which subsequently became the subject of such proceedings (see paragraphs 30 and 33 to 35 above).

40      In that regard, it should be noted that the report at issue is a scientific document submitted to EMA for the purposes of an administrative procedure in order to establish whether the risk-benefit balance of Ocaliva remained unchanged. That type of report must be periodically updated in the context of monitoring the safety of medicinal products on an ongoing basis and of the general objective of protection of patients and of public health in the European Union.

41      Accordingly, it is not a document drawn up in the context of court proceedings or a document containing internal positions of a legal nature, which by its disclosure, would be likely to compromise the defence of the author of that documents in the context of any such proceedings.

42      Accordingly, having regard to the case-law cited above, the exception laid down in the second indent of Article 4(2) of Regulation No 1049/2001 is not applicable.

43      The other arguments raised by the applicants do not call that finding into question and are, in any event, ineffective.

44      In that regard, the applicants’ argument that the report at issue is a specialist scientific document, which would be incomprehensible to the general public and, if disclosed, would create a serious risk that the information contained therein could be misused to provide a misleading picture of the clinical safety and efficacy of Ocaliva is ineffective. Such an argument does not justify reliance on the exception laid down for court proceedings in Regulation No 1049/2001.

45      The same applies to the applicants’ argument that disclosure of the report at issue would lead to circumvention of the protections conferred by US legislation in the type of proceedings in question. As the applicants themselves maintain, the main purpose of that legislation is characterised by the intention of the United States Congress to limit abusive class actions, given that such actions have a negative impact on the US capital markets. Accordingly, that legislation is not concerned with the protection of court proceedings as interpreted by the EU courts and consequently, the principle of equality of arms.

46      Furthermore, it must be noted that the applicants put particular emphasis on the fact that they would have to devote significant resources both in financial and management terms in order to defend themselves in any future court proceedings in the United States if Intercept Pharmaceuticals did not obtain the summary disposal on which it intends to rely at the appropriate time in the context of the complaint lodged. That circumstance does not constitute an interest protected by Regulation No 1049/2001.

47      Finally, the argument concerning the absence of a specific public interest in disclosure must also be rejected as ineffective in the light of the finding in paragraph 42 above.

48      It follows from the foregoing that the first plea in law must be rejected.

 The second plea in law, alleging that the only acceptable outcome of a proper balancing exercise, under Article 4 of Regulation No 1049/2001, would have been a decision not to release the report at issue

49      The applicants claim that the contested decision should be annulled since disclosure of the report at issue would harm their commercial interests within the meaning of the first indent of Article 4(2) of Regulation No 1049/2001. According to the applicants, the only acceptable outcome of balancing their commercial interests against the public interest in disclosing that report would have been a decision not to release that report.

50      In that regard the applicants submit that:

–        they are likely to suffer severe harm if the report at issue is released in spite of the protections granted to Intercept Pharmaceuticals under US legislation, since that would place an unfair burden on Intercept Pharmaceuticals and would undermine its defence of meritless court proceedings. Intercept Pharmaceuticals would be required to devote to the dispute its scarce financial resources which would otherwise be allocated to the marketing of Ocaliva;

–        there is no specific and compelling public interest in disclosure capable of overriding the prospective harm to the applicants’ commercial interests;

–        disclosure would be contrary to the public interest in a broader sense: EMA and the FDA have entered into specific agreements to ensure that pharmacovigilance is shared between the agencies, and have agreed, as part of this, not to publicly disclose non-public information shared by the other agency;

–        a great deal of information about pharmacovigilance in general, and information in the report at issue specifically, has already been released. Those disclosures were made keeping in mind the careful balance between the need to provide information concerning safety and the level of information that it is appropriate to provide the public with concerning complex scientific matters; the disclosure of Batch 1 (and of Batch 2) would undermine that careful balance;

–        in view of those public announcements, it serves no public or public health interest to make the report at issue itself publicly available: the report at issue, which is a specialised scientific document, would be incomprehensible to the general public and would create a serious risk that the information contained therein could be misused to provide a misleading picture of the clinical safety and efficacy of Ocaliva. Nothing in the report at issue would materially add to the information already placed in the public domain by EMA and the FDA.

51      EMA disputes the applicants’ arguments and contends that the second plea in law should be rejected.

52      As recalled above in paragraphs 25 to 29 above, the purpose of Regulation No 1049/2001 is to give the widest possible effect to the right of public access to documents, which means that the exceptions to that law must be interpreted and applied strictly. Likewise, it is for the institution concerned which applies one of the exceptions laid down in Article 4(2) and (3) of Regulation No 1049/2001 to balance the particular interests to be protected by non-disclosure of the document against the public interest in the document being made accessible.

53      As regards the concept of commercial interests, it is apparent from the case-law that it is not possible to regard all information concerning a company and its business relations as requiring the protection which must be guaranteed to commercial interests under the first indent of Article 4(2) of Regulation No 1049/2001 without frustrating the application of the general principle of giving the public the widest possible access to documents held by the institutions (judgments of 15 December 2011, CDC Hydrogene Peroxide v Commission, T‑437/08, EU:T:2011:752, paragraph 44, and of 9 September 2014, MasterCard and Others v Commission, T‑516/11, not published, EU:T:2014:759, paragraph 81).

54      Consequently, in order to apply the exception provided for by the first indent of Article 4(2) of Regulation No 1049/2001, it must be shown that the report at issue contains elements which may, if disclosed, seriously undermine the commercial interests of a legal person. That is the case, in particular, when the requested document contains commercially sensitive information relating, inter alia, to the commercial strategies of the undertakings involved or to their customer relations or where that document contains information particular to that undertaking which reveals its expertise (see, to that effect, judgment of 9 September 2014, MasterCard and Others v Commission, T‑516/11, not published, EU:T:2014:759, paragraphs 82 to 84).

55      In the present case, it must be held that at no stage of the proceedings have the applicants put forward any arguments at all to indicate which part of the report at issue contained sensitive commercial information. The applicants merely indicate that the release of the report at issue would lead to a greater financial investment in connection with the court proceedings pending in the United States.

56      Such a justification does not relate to an interest protected by the exception laid down in the first indent of Article 4(2) of Regulation No 1049/2001.

57      Since the exception relied on by the applicants is not applicable, their line of argument concerning the lack of specific public interest in disclosure is ineffective.

58      Likewise, the argument that the release of the report at issue is contrary to the agreements between EMA and the FDA cannot succeed.

59      In the first place, it must be observed that the confidentiality agreements between EMA and the FDA to facilitate the exchange of non-public information between those two authorities acknowledge that EMA is required to disclose information received from the FDA unless that information falls within the scope of any of the exceptions referred to in Article 4 of Regulation No 1049/2001.

60      In the second place, as EMA maintains, the report at issue was submitted to it by Intercept Pharma and not by the FDA. Accordingly, the abovementioned agreements are irrelevant in the present case.

61      Finally, it must be noted that the applicants themselves state that a great deal of information about pharmacovigilance generally, and information in the report at issue specifically, has already been released. The fact that the report at issue is of a scientific nature and is, to a certain extent, complex, detailed or specialised does not constitute a ground for non-disclosure.

62      It follows from all of the foregoing that the second plea in law must be rejected and, consequently, that the action must be dismissed in its entirety.

 Costs

63      Under Article 134(1) of the Rules of Procedure of the General Court, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. As the applicants have been unsuccessful, they must be ordered to pay the costs, in accordance with the form of order sought by EMA.

On those grounds,

THE GENERAL COURT (Second Chamber)

hereby:

1.      Dismisses the action;

2.      Orders Intercept Pharma Ltd and Intercept Pharmaceuticals, Inc. to pay the costs.

Delivered in open court in Luxembourg on 28 June 2019.

*      Language of the case: English.

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