T-844/25

ORDER OF THE PRESIDENT OF THE GENERAL COURT 22 June 2026 (*) ( Interim relief – Medicinal products for human use – Regulation (EC) No 726/2004 – Withdrawal of the application for marketing authorisation for Dazluma – Publication of the assessment report – Application for suspension of operation – Prima facie case – Urgency – Weighing up of interests ) In Case T‑844/25 R, Biohaven Bioscience Ireland Ltd, established in Dublin (Ireland), Biohaven Therapeutics Ltd, established in Tortola (British Virgin Islands), represented by S. Drosos and K. Ewert, lawyers, applicants, v European Medicines Agency (EMA), represented by G. Gavriilidou, H. Kerr and M. van Egmond, acting as Agents, defendant, THE PRESIDENT OF THE GENERAL COURT makes the following Order 1        By their application based on Articles 278 and 279 TFEU, the applicants, Biohaven Bioscience Ireland Ltd and Biohaven Therapeutics Ltd, seek the suspension of operation of the decision of the European Medicines Agency (EMA) of 27 October 2025 to publish the withdrawal European public assessment report (‘withdrawal EPAR’) for the medicinal product Dazluma (‘the contested decision’). Background to the dispute and forms of order sought by the parties 2        The first applicant, Biohaven Bioscience Ireland, is a biopharmaceutical company incorporated under Irish law. 3        The second applicant, Biohaven Therapeutics, is a business company limited by shares formed in the British Virgin Islands. It belongs to the same group of companies as Biohaven Bioscience Ireland. 4        On 9 October 2023, Biohaven Bioscience Ireland submitted to the EMA an application for marketing authorisation for the orphan medicinal product Dazluma. 5        Dazluma is a candidate medicinal product designed for the treatment of a specific subtype of spinocerebellar ataxia, a group of hereditary diseases affecting the parts of the brain responsible for balance, coordination and movements. The active substance in Dazluma is troriluzole, that is, a prodrug of riluzole. Riluzole is authorised in the European Union as a treatment for amyotrophic lateral sclerosis, which is also a neurological disease affecting, inter alia, movements. 6        On 30 January 2025, the EMA Committee for Medicinal Products for Human Use adopted its preliminary assessment report, in which it stated, inter alia, that the justifications provided did not allow troriluzole to be classified as a new active substance and that major objections concerning the efficacy of Dazluma prevented that committee, at that stage, from expressing a positive opinion for the granting of a marketing authorisation. 7        On 24 March 2025, Biohaven Bioscience Ireland informed the EMA of its decision to withdraw the application for marketing authorisation for Dazluma, on the ground that the Committee for Medicinal Products for Human Use had considered that, because of insufficient data, that committee was not in a position to take a decision on the new active substance status for troriluzole. 8        On 2 April 2025, the EMA informed Biohaven Bioscience Ireland of the withdrawal EPAR for Dazluma which it intended to publish, and requested Biohaven Bioscience Ireland to submit, by 17 April 2025, its proposals for the redaction of commercially confidential information and personal data. 9        On 18 April 2025, Biohaven Bioscience Ireland sent to the EMA its proposals for the redaction of commercially confidential information and personal data. 10      On 23 May 2025, the EMA sent to Biohaven Bioscience Ireland its first set of comments on the proposed redactions of commercially confidential information and personal data, rejecting several of those proposals and their justifications. 11      On 7 June 2025, Biohaven Bioscience Ireland submitted its response to the EMA’s comments on the proposed redactions of the withdrawal EPAR. 12      On 1 July 2025, the EMA provided Biohaven Bioscience Ireland with its second set of comments on the proposed redactions of commercially confidential information and personal data, rejecting several of those proposals and their justifications. 13      On 7 July 2025, Biohaven Bioscience Ireland was informed that opposition proceedings had been initiated before the European Patent Office against European Patent No EP 3 706 739; Biohaven Therapeutics was the proprietor of that patent which concerned the use of riluzole-based prodrugs to treat ataxia subtypes (‘the European patent’). The opponent challenged the European patent in its entirety, on the grounds that the subject matter of that patent, in so far as it did not involve an inventive step, was not patentable and that that patent did not disclose the invention in a sufficiently clear and complete manner for it to be carried out by a person skilled in the art. 14      On 7 July 2025, Biohaven Bioscience Ireland sent to the EMA a letter informing the latter of its intention to submit a new application for marketing authorisation for Dazluma in the near future and requesting the EMA not to publish the withdrawal EPAR until that new application had been completed. 15      On 9 July 2025, Biohaven Bioscience Ireland notified the EMA of its intention to submit a new application for marketing authorisation for Dazluma by 9 February 2026. 16      On 30 September 2025, the EMA provided Biohaven Bioscience Ireland with its third set of comments on the proposed redactions of commercially confidential information and personal data, reiterating its decision to reject several of those proposals and their justifications. On 2 October 2025, it informed Biohaven Bioscience Ireland that the withdrawal EPAR had to be regarded as final. 17      On 3 October 2025, Biohaven Bioscience Ireland sent a letter to the EMA in which it asked the EMA, in particular, to reconsider the possibility of suspending the publication at issue pending the outcome of the opposition proceedings brought against the European patent. 18      On 27 October 2025, by the contested decision, to which it attached a final and redacted version of the withdrawal EPAR, the EMA, inter alia, informed Biohaven Bioscience Ireland of its intention to publish the withdrawal EPAR by 10 November 2025. 19      On 4 November 2025, the EMA informed Biohaven Bioscience Ireland that, if, by 10 November 2025, it informed the EMA of its intention to lodge an application for interim relief, the EMA would suspend the contested decision pending the outcome of the interim relief proceedings. 20      By application lodged at the Registry of the General Court on 10 December 2025, the applicants brought an action for annulment of the contested decision. 21      By a separate document lodged at the Court Registry on 11 December 2025, the applicants submitted the present application for interim relief, in which they claim that the President of the General Court should: –        order the suspension of operation of the contested decision until final judgment is given in the main proceedings; –        order the EMA to pay the costs. 22      In its observations on the application for interim relief, lodged at the Court Registry on 8 January 2026, the EMA contends that the President of the General Court should: –        dismiss the application for interim relief as unfounded in so far as it seeks full suspension of the operation of the contested decision until final judgment is given in the main proceedings; –        order a partial suspension of operation of the contested decision by authorising the publication planned in that decision, subject to the redaction of the five passages identified in the third plea in law and in Annex A.1.2 to the application for interim relief, until final judgment is given in the main proceedings; –        reserve the costs. 23      By a measure of organisation of procedure of 3 March 2026, the President of the General Court put certain questions to the applicants to be answered in writing. 24      On 18 March 2026, the applicants responded to the questions put by the President of the General Court. 25      On 7 April 2026, the EMA lodged its observations on the applicants’ response to the questions put by the President of the General Court. Law General considerations 26      It is apparent from reading Articles 278 and 279 TFEU together with Article 256(1) TFEU that the judge hearing an application for interim measures may, if he or she considers that the circumstances so require, order that the operation of a measure challenged before the General Court be suspended or prescribe any necessary interim measures, pursuant to Article 156 of the Rules of Procedure of the General Court. Nevertheless, Article 278 TFEU establishes the principle that actions do not have suspensory effect, since acts adopted by the EU institutions are presumed to be lawful. It is therefore only exceptionally that the judge hearing an application for interim measures may order the suspension of operation of an act challenged before the General Court or prescribe any interim measures (order of 19 July 2016, Belgium v Commission, T‑131/16 R, EU:T:2016:427, paragraph 12). 27      The first sentence of Article 156(4) of the Rules of Procedure provides that applications for interim relief 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 measure applied for’. 28      The judge hearing an application for interim relief may order suspension of operation of an act and other interim measures, 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, in order to avoid serious and irreparable harm to the applicant’s interests, it must be made and produce its effects before a decision is reached in the main action. Those conditions are cumulative, and consequently an application for interim measures must be dismissed if any one of them is not satisfied. The judge hearing an application for interim relief is also to undertake, when necessary, a weighing of the competing interests (see order of 2 March 2016, Evonik Degussa v Commission, C‑162/15 P-R, EU:C:2016:142, paragraph 21 and the case-law cited). 29      In the context of that overall examination, the court hearing the application for interim measures enjoys a broad discretion and is free to determine, having regard to the particular circumstances of the case, the manner and order in which those various conditions are to be examined, there being no rule of law imposing a pre‑established scheme of analysis within which the need to order interim measures must be assessed (see order of 19 July 2012, Akhras v Council, C‑110/12 P(R), not published, EU:C:2012:507, paragraph 23 and the case-law cited). 30      In view of the material in the file, the President of the General Court considers that he has all the necessary information in order to rule on the present application for interim relief, without it being necessary first to hear oral argument from the parties. 31      In the circumstances of the present case, it is appropriate first to examine the condition relating to a prima facie case. The condition relating to a prima facie case 32      According to settled case-law, the prima facie case requirement is satisfied where at least one of the pleas in law put forward by the party seeking interim measures in support of the main action appears, at first sight, not unfounded. That is the case where one of the pleas relied on reveals the existence of a major legal or factual disagreement the solution to which is not immediately obvious and therefore calls for a detailed examination that cannot be carried out by the judge hearing the application for interim measures but must be the subject of the main proceedings (see, to that effect, orders of 3 December 2014, Greece v Commission, C‑431/14 P-R, EU:C:2014:2418, paragraph 20 and the case-law cited, and of 1 March 2017, EMA v MSD Animal Health Innovation and Intervet international, C‑512/16 P(R), not published, EU:C:2017:149, paragraph 59 and the case-law cited). 33      With regard more particularly to disputes concerning interim protection for information alleged to be confidential, it should be added that the judge hearing the application for interim measures – if he or she is not to disregard the intrinsically ancillary and provisional nature of proceedings for interim measures and the imminent risk of negation of the fundamental rights relied on by the party seeking interim protection of those rights – may, as a rule, conclude that there is no prima facie case only where the information in question is obviously not confidential (order of 11 March 2013, Pilkington Group v Commission, T‑462/12 R, EU:T:2013:119, paragraph 59). 34      In the present case, in order to demonstrate that the contested decision is, prima facie, vitiated by illegality, the applicants rely on three pleas in law in the present application for interim relief. 35      It is appropriate, at the outset, to examine the third plea, alleging infringement of Article 339 TFEU and of Articles 11 and 76 of 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), on account of the failure to redact commercially confidential information. 36      By their third plea, the applicants submit that the EMA failed to fulfil its obligations by refusing to accept, in its comments of 30 September and 2 October 2025, five redaction proposals submitted to it by Biohaven Bioscience Ireland. Those redactions relate to two categories of information, namely Biohaven Bioscience Ireland’s presentation of real-world evidence and the assessment of that evidence by the Committee for Medicinal Products for Human Use (redaction Nos 1 to 4), and the proposed risk management plan (redaction No 5). 37      As regards, on the one hand, the redactions relating to real-world evidence, the applicants claim that the EMA failed to take due account of the arguments which Biohaven Bioscience Ireland put forward as to why disclosure of that information would be liable specifically and actually to undermine its commercial interests. 38      First, according to the applicants, the EMA failed to take into consideration the fact that Dazluma is an orphan medicinal product. 39      Second, the applicants argue that competitors could use the real-world evidence to refine their own data generation strategy and to demonstrate the efficacy of their medicinal products. 40      Third, the applicants claim that the EMA erred in citing its reflection paper on the use of real-world evidence. The reflection paper is not, they argue, legally binding and sets out high-level general considerations. Such a paper does not negate the commercial value inherent in the assessment made by the Committee for Medicinal Products for Human Use in respect of Biohaven Bioscience Ireland’s dossier, that assessment being reflected in the withdrawal EPAR. 41      Fourth, the applicants submit that the EMA failed to taken into account that Biohaven Bioscience Ireland has consistently affirmed its intention to submit a new application for marketing authorisation. 42      Fifth, the applicants claim that the EMA’s position is contrary to the guidance document of the Heads of Medicines Agencies on the identification of personal data and commercially confidential information within the structure of the marketing authorisation application dossier. 43      As regards, on the other hand, the redaction relating to the risk management plan, the applicants submit that the EMA erred in concluding that the elements relating to that plan should not be redacted as commercially confidential information, since disclosure of those elements would be liable specifically and actually to undermine their commercial interests. 44      First, the applicants argue that Dazluma is an orphan medicinal product. 45      Second, the applicants claim that the EMA failed to acknowledge that Biohaven Bioscience Ireland had indicated its intention to resubmit an application for marketing authorisation. 46      Third, the applicants allege that the EMA failed to consider that the comments provided by the Committee for Medicinal Products for Human Use and by the Pharmacovigilance Risk Assessment Committee on the safety specifications and the pharmacovigilance plan, and, in particular, on the recommended approach for post-authorisation studies and monitoring, are akin to scientific opinions, which, in accordance with section 3.5 of the guidance document of the Heads of Medicines Agencies on the identification of personal data and commercially confidential information within the structure of the marketing authorisation application dossier, can be redacted as commercially confidential information. 47      For its part, the EMA considers that the applicants have put forward specific justifications which do not appear to be manifestly unfounded in the context of a prima facie examination. Therefore, without prejudice to the submissions which it made in the action in the main proceedings, the EMA considers that the assertion, namely that the condition relating to a prima facie case as regards the disclosure of the five passages identified in the third plea is satisfied, does not appear to be unfounded. Thus, in the interests of the proper administration of justice, the provisional protection of those five passages could be granted in the context of the present interim relief proceedings, in order to allow for a detailed examination of that plea in the main proceedings. 48      In that regard, it should be noted that the applicants have put forward a series of specific arguments in support of their contention that the five passages identified in the third plea contain commercially confidential information. An examination of the merits of that contention requires a detailed analysis of the information in question. 49      However, it is common ground between the parties that, in the context of that plea, the applicants have put forward arguments which do not appear to be manifestly unfounded in the context of a prima facie examination. 50      As stated in paragraph 47 above, the EMA considers that the assertion that the condition relating to a prima facie case, as regards the disclosure of the five passages identified in the third plea, is satisfied does not appear to be unfounded. 51      According to the case-law cited in paragraph 33 above, the judge hearing the application for interim measures may, as a rule, conclude that there is no prima facie case only where the information in question is obviously not confidential. 52      Consequently, it must be concluded that, without prejudging the Court’s decision on the action in the main proceedings, the applicants’ third plea alleging infringement of Article 339 TFEU and of Articles 11 and 76 of Regulation No 726/2004, on account of a failure to redact commercially confidential information, appears, at first sight, not unfounded within the meaning of the case-law referred to in paragraph 32 above. 53      It must therefore be held that there is a prima facie case. The condition relating to urgency 54      In order to determine whether the interim measures applied for are urgent, it should be noted that the purpose of the procedure for interim relief is to guarantee the full effectiveness of the future final decision, in order to avoid a lacuna in the legal protection afforded by the EU Courts. In order to attain that objective, urgency must, generally, be assessed in the light of the need for an interlocutory order so as to avoid serious and irreparable damage to the party seeking the adoption of interim measures. That party must demonstrate that it cannot await the outcome of the main proceedings without suffering serious and irreparable damage (see, to that effect, order of 14 January 2016, AGC Glass Europe and Others v Commission, C‑517/15 P-R, EU:C:2016:21, paragraph 27 and the case-law cited). 55      It is in the light of those criteria that it is necessary to examine whether the applicants have succeeded in demonstrating urgency. 56      In the present case, the applicants submit that disclosure of the withdrawal EPAR would cause them serious and irreparable damage as a result of the use of the information, contained in that report, by the opponent in the opposition proceedings brought against the European patent and by an indeterminate number of competitors, who will rely on that information to advance and accelerate their own strategies for the development of medicinal products for the treatment of spinocerebellar ataxia. 57      In the first place, the applicants claim that the potential damage is serious, in so far as the withdrawal EPAR contains detailed information on the clinical development of Dazluma, as well as the initial opinion of the Committee for Medicinal Products for Human Use on the possibility of authorising that medicinal product as it stood at the time of withdrawal of the application for marketing authorisation. Publication of the withdrawal EPAR would allow the European patent opponent to supplement its arguments to challenge that patent and would seriously undermine the applicants’ ability to defend themselves effectively in the opposition proceedings, which would place the validity of the patent at risk. 58      In the second place, the applicants claim that the potential damage is also irreparable. If the President of the General Court does not grant the application for interim relief, annulment of the contested decision could not make good the damage caused to their interests. Publication of the withdrawal EPAR throughout the action in the main proceedings would allow the European patent opponent to rely on the content of the withdrawal EPAR and to adjust its opposition strategy in the light of the information obtained from that publication. In particular, it would allow that opponent to supplement its existing arguments in order to cast doubt on the approvability of Dazluma and, consequently, to challenge the patentability of that medicinal product. Annulment of the contested decision would not undo either any gaining of knowledge of the content of the withdrawal EPAR or any potential future use of the information in the context of the opposition brought against the European patent. If the withdrawal EPAR were to be published, the knowledge which the European patent opponent would gain from reading it could not be erased. Thus, disclosure of that withdrawal EPAR would irreversibly remove the protections afforded to commercially confidential information and would prejudice the effectiveness of any subsequent decision on the merits. 59      In the third place, the applicants submit that the potential damage is reasonably foreseeable and is not purely hypothetical, in so far as the withdrawal EPAR would be disclosed on the EMA’s website and would therefore be disseminated to the general public. 60      In the fourth place, the applicants submit that the potential damage cannot be quantified. Publication on the EMA website would mean that neither the EMA nor the applicants would know or be able to trace those persons who might gain access to the withdrawal EPAR and to the commercially confidential information contained therein, or to know what those persons’ objectives are. Thus, it would be impossible to determine to what extent some of the information might have been used to the applicants’ detriment or even to quantify the damage that may result from that. Consequently, it is impossible to assess the potential damage to the applicants’ economic and financial interests that might result from disclosure of the withdrawal EPAR. 61      In the fifth place, the applicants add that, according to the case-law, they do not need to establish that a refusal to grant them the interim measures applied for would have an impact on their financial viability. 62      In the sixth place, the applicants submit that the urgency of suspending operation of the contested decision is not, in the present case, invalidated by the fact that Biohaven Bioscience Ireland proposed redactions of specific sections of the withdrawal EPAR or by the fact that they dispute, in their third plea, the EMA’s refusal to accept certain redactions. It cannot be inferred from those proposed redactions and from that third plea that the other elements of the withdrawal EPAR are not confidential as regards the opposition brought against the European patent. The applicants consider that they should not be penalised for having chosen a preventive approach in order to protect their interests. 63      The EMA, for its part, disputes the applicants’ line of argument. It considers that the applicants have not demonstrated the urgency of suspending operation of the contested decision in its entirety. It observes that, in so far as the withdrawal EPAR might include certain specific passages which could be of benefit to the European patent opponent or to potential competitors, the applicants had ample opportunity to point out those passages, which were redacted where an appropriate justification had been provided. The EMA adds that its assessment of those passages has not been disputed, with the exception of the five passages identified by the applicants in the context of the third plea; it is prepared to redact those passages temporarily, pending the outcome of the action in the main proceedings. 64      In the first place, the EMA submits that the application for interim relief does not contain any evidence to demonstrate that the contested decision would be the decisive cause of an unfavourable outcome in the opposition proceedings against the European patent. In the absence of such evidence, which it is for the applicants to adduce, the alleged serious and irreparable damage is, in its view, hypothetical. 65      In the second place, the EMA submits that the decision to file a patent application inherently entails acceptance of the risk that the patent, if granted, may be opposed and that the outcome of such an opposition may be unfavourable, in particular if the patent is not actually based on an inventive step or has not been sufficiently disclosed. The fact that the European patent is the subject of opposition proceedings, that the outcome of those proceedings may be unfavourable and that it may result in damage to the applicants stems from their own commercial strategy, and not from the contested decision. 66      Similarly, the EMA considers that Biohaven Bioscience Ireland’s decision to submit to it an application for marketing authorisation for Dazluma carries the inherent risk that that application may be refused or withdrawn, in particular if the dossier submitted is insufficient to substantiate the claims made in the context of that application. According to the EMA, pharmaceutical companies are fully informed of the possible consequences of submitting an application for marketing authorisation, for example the fact that information on unsuccessful applications will be published in accordance with Regulation No 726/2004 and with the applicable guidance from the EMA. In the present case, the only cause of the situation giving rise to the present case is, it argues, the applicants’ commercial strategy. 67      In the third place, the EMA submits that, as regards the applicants’ assertion that the urgency of suspending operation of the contested decision in its entirety cannot be called into question by the fact that they made proposals for the redaction of specific passages of the withdrawal EPAR, it is for the President of the General Court to examine, in the light of those proposals, whether it is possible to authorise partial access to the information concerned, without that authorisation creating a sufficiently probable risk of serious and irreparable damage to the applicant. 68      In the fourth place, the EMA argues that, contrary to what the applicants claim, the examination of urgency in cases seeking interim protection of allegedly confidential information can start from the premiss that that information is confidential and that the damage caused by its disclosure is serious only if an examination of whether there is a prima facie case does not lead to a conclusion that that information is manifestly not confidential. 69      The EMA therefore considers that the applicants have not demonstrated either the likelihood of the alleged damage or the serious and irreparable nature of that damage. 70      In that regard, it is necessary to draw a distinction, as a preliminary point, between two types of serious and irreparable damage that disclosure of the withdrawal EPAR would be liable to cause, namely, on the one hand, the damage which would result from publication of the information to which the five passages identified in the third plea relate and, on the other hand, the damage which would be caused by publication of the withdrawal EPAR, without those five passages. 71      As regards, on the one hand, the first type of damage referred to in paragraph 70 above, it must be recalled that, in order to assess whether there is a risk of serious and irreparable damage, and without prejudice to the examination of the condition that there be a prima facie case, which is linked to but distinct from that assessment, the judge hearing the application for interim measures necessarily has to start from the premiss that the allegedly confidential information is indeed confidential, as claimed by the applicants (see, to that effect, order of 28 November 2013, EMA v AbbVie, C‑389/13 P(R), not published, EU:C:2013:794, paragraph 38). Consequently, it must be held, for the purposes of the present examination of urgency, that the five proposals for redaction of the withdrawal EPAR concern information of a confidential nature. 72      Starting from that premiss, the disclosure of the five passages of the withdrawal EPAR redaction of which has been requested would necessarily cause significant damage to the applicants (see, to that effect, order of 20 July 2016, PTC Therapeutics International v EMA, T‑718/15 R, not published, EU:T:2016:425, paragraph 105 and the case-law cited). 73      It has been held that financial damage that is objectively significant, or even not insignificant, could be considered ‘serious’, without it being necessary in every case to relate that damage to the turnover of the undertaking that fears it will suffer such damage (see, to that effect, order of 7 March 2013, EDF v Commission, C‑551/12 P(R), EU:C:2013:157, paragraphs 32 and 33; see also, by analogy, order of 8 April 2014, Commission v ANKO, C‑78/14 P-R, EU:C:2014:239, paragraph 34). 74      Having regard to the particular features of proceedings for the protection of allegedly confidential information, the applicants are not required to establish, in addition, that they would be in a position that would imperil their financial viability or that their market shares would be seriously and irreparably affected if the interim measures applied for were not granted (see, to that effect, order of 1 September 2015, Pari Pharma v EMA, T‑235/15 R, EU:T:2015:587, paragraph 102 and the case-law cited). 75      It should be noted that, according to the applicants, the five passages of the withdrawal EPAR, redaction of which has been requested, are akin to scientific opinions and that, in view of the particular features of the competitive environment of orphan medicinal products, disclosure of those five passages would enable competitors to improve their own analysis of real-world evidence and to submit an application for marketing authorisation more quickly. In addition, those competitors could use that information to improve their own data generation strategy in order to demonstrate the efficacy of their medicinal products and to enable them to take advantage of the applicants’ experience in order to adapt their own applications for marketing authorisation. 76      The EMA, which contends that operation of the contested decision should be suspended in so far as it concerns those passages, does not specifically dispute those arguments of the applicants. 77      In any event, as has just been set out in paragraph 49 above, the existence of a prima facie case has been acknowledged because it is common ground between the parties that the applicants have, in the context of the third plea, put forward arguments which do not appear to be manifestly unfounded in the context of a prima facie examination. That finding, which has supported the conclusion that there is a prima facie case and has supported the presumption, for the purposes of the interim relief proceedings, that the five passages of the withdrawal EPAR identified by the applicants are confidential, cannot be called into question, in the context of urgency, by a denial of the seriousness of the alleged damage. 78      Consequently, the applicants have established, to the requisite legal standard, the seriousness of the financial damage which they would be likely to incur in the event of disclosure of the five identified passages of the withdrawal EPAR. 79      As to whether the alleged damage is irreparable, it must be pointed out that annulment of the contested decision could not reverse the effects of disclosure of the five identified passages of the withdrawal EPAR, since once a person has acquired knowledge of those passages by reading them, that knowledge cannot be erased (see, to that effect, order of 20 July 2016, PTC Therapeutics International v EMA, T‑718/15 R, not published, EU:T:2016:425, paragraph 111 and the case-law cited). 80      As regards the quantification of the financial damage that the applicants would be likely to suffer in the event of disclosure of the five identified passages of the withdrawal EPAR, it should be noted that the applicants would have to expect that an undetermined and potentially unlimited number of current and potential competitors all over the world will obtain that report and exploit those passages in numerous ways, which, depending on the status of the research and development programmes of those competitors, could entail harmful effects in the short, medium or long term, liable to thwart any expansion strategy on the applicants’ part (see, to that effect, order of 1 September 2015, Pari Pharma v EMA, T‑235/15 R, EU:T:2015:587, paragraph 100). 81      It is, therefore, impossible to assess the specific impact that disclosure of the five identified passages of the withdrawal EPAR could have on the applicants’ economic and financial interests. It follows that the damage that the applicants would be likely to suffer in the event of disclosure of those passages cannot be quantified adequately. 82      As regards, on the other hand, the second type of damage referred to in paragraph 70 above, it is necessary to assess whether the EMA’s decision to publish the withdrawal EPAR, after redaction of the five passages identified in the third plea, would be the decisive cause of an unfavourable outcome in the opposition proceedings against the European patent. 83      First, the applicants claim in that regard that publication of the withdrawal EPAR for the duration of the action in the main proceedings would allow the European patent opponent to rely on the withdrawal EPAR’s content and to adapt its opposition strategy to the information obtained through that publication. In particular, it would allow the opponent to supplement its existing arguments in order to cast doubt on the approvability of Dazluma and, consequently, to dispute the patentability of that medicinal product. Moreover, such publication would seriously jeopardise the applicants’ ability to defend themselves effectively in the opposition proceedings, which would place the validity of that patent at risk. 84      In their response to the measure of organisation of procedure of 3 March 2026, the applicants add that, in view of the various different ways in which documents of a regulatory authority such as the EMA have been used in the past and could be used in the future in opposition proceedings regarding patents, it is impossible for the applicants to identify specific aspects of the withdrawal EPAR that the European patent opponent could use to its advantage, or the precise way in which it could use that report. 85      Second, the applicants submit that publication of the withdrawal EPAR would disclose in detail the preliminary assessment of the Committee for Medicinal Products for Human Use on the application for marketing authorisation for Dazluma, thus allowing the European patent opponent to rely on the detailed grounds, set out in that report, on which that committee refused to formulate a positive opinion for the granting of marketing authorisation. 86      Third, the applicants claim that the European patent opponent could benefit from the withdrawal EPAR in its entirety by submitting that report as new evidence or by using it to develop new arguments in support of its grounds of opposition. They observe that it is possible, under the procedural rules of the European Patent Office, that that new evidence or those new arguments, even if filed late, may still be taken into consideration at that stage of the opposition proceedings. 87      The applicants’ arguments cannot be accepted. 88      First, it must be stated that the applicants’ observations have been formulated in an abstract manner, either by referring to the course of patent opposition proceedings in general, or by reiterating their position that, in the particular case of Dazluma, it is impossible to identify specific aspects of the withdrawal EPAR that the European patent opponent could use to its advantage, or the precise way in which it could use that report. 89      In particular, the applicants have not stated the reasons why the full text of the withdrawal EPAR could be of use to the patent opponent in the context of its two grounds of opposition, which allege that the invention does not involve an inventive step and that the disclosure of that invention is insufficiently clear and complete for it to be carried out by a person skilled in the art. 90      As the EMA observes, its assessment of the application for marketing authorisation for Dazluma is based strictly on an examination of the quality, safety and efficacy of that medicinal product. The two grounds of opposition relied on by the European patent opponent are decorrelated from that assessment. A marketing authorisation application procedure is based on public health considerations which differ from the considerations on which the opposition proceedings are based, which relate to the innovative nature of the contested patent. 91      Consequently, the applicants have not demonstrated how publication of the withdrawal EPAR, with redaction of the five passages identified by the applicants in their third plea, is liable to have a concrete impact on the patent proceedings. 92      That conclusion is also supported by the fact that the applicants accept, in their response to the measure of organisation of procedure of 3 March 2026, that, in the context of the opposition proceedings in respect of the European patent, the opponent has not yet expressly referred to the application for marketing authorisation for Dazluma. The claim that the withdrawal EPAR might nevertheless be significant in the subsequent stages of those proceedings is hypothetical. 93      Second, it is necessary to reject the applicants’ argument that the potential damage is reasonably foreseeable and is not purely hypothetical, in so far as the withdrawal EPAR would be published on the EMA’s website and disclosed to the general public and, in particular, to an unlimited number of current and potential competitors worldwide. The applicants have not demonstrated that the EMA’s decision to publish the withdrawal EPAR, after redaction of the five passages identified in the third plea, would be liable to have adverse effects in the short, medium or long term that would be capable of adversely affecting the protection of the applicants’ economic and financial interests. 94      The applicants have merely made simple allegations without substantiating the latter with evidence that would enable those allegations to be verified. In the absence of such evidence, which it is for the applicants to provide, the alleged serious and irreparable damage remains hypothetical. 95      Moreover, as the EMA observes, certain information contained in the withdrawal EPAR is public and is not specific to Dazluma, since that information merely summarises the current state of scientific knowledge in relation to which the EMA carried out its assessment. In addition, detailed information on the design, progress and results of clinical trials on that medicinal product is published in registers of clinical trials that are freely accessible for the public. 96      Therefore, publication of the information that is set out in the withdrawal EPAR and that is already in the public domain is not liable to have detrimental effects on the applicants, since that information cannot be regarded as commercially confidential information. 97      Third, as regards the applicants’ argument that there is an urgent need to prevent the publication of other confidential passages that are still set out in the withdrawal EPAR, it must be borne in mind that the EMA and Biohaven Bioscience Ireland had three sets of in-depth exchanges on the proposed redactions of specific elements of the withdrawal EPAR and on the justifications for those proposals. 98      During those in-depth exchanges, Biohaven Bioscience Ireland itself made the five proposals for redaction of the withdrawal EPAR that are identified in the third plea. 99      Consequently, the applicants have not established that they face, with a sufficient degree of probability, the risk of suffering serious and irreparable damage as a result of publication of the withdrawal EPAR with the redaction of the five passages identified in the third plea. 100    In view of the foregoing considerations, it must be concluded that the condition relating to urgency is satisfied in the present case, since the likely occurrence, for the applicants, of serious and irreparable damage resulting from publication of the withdrawal EPAR without redaction of the five passages identified by the applicants in their third plea has been established to the requisite legal standard. The weighingup of the interests 101    According to the case‑law, in weighing up the different interests involved, the judge hearing the application for interim relief has to determine, in particular, whether or not the interest of the party seeking suspension of operation of the contested measure in securing that suspension outweighs the interest in the immediate application of the measure, by examining, more specifically, whether the possible annulment of the measure by the Court when ruling on the main application would allow the situation that would be brought about by its immediate implementation to be reversed and, conversely, whether suspension of operation of the measure would prevent it from being fully effective in the event of the main action being dismissed (see order of 11 March 2013, Iranian Offshore Engineering & Construction v Council, T‑110/12 R, EU:T:2013:118, paragraph 33 and the case-law cited). 102    As regards more particularly the condition that the legal situation created by an interim relief order must be reversible, it must be recalled that the purpose of the procedure for interim relief is to guarantee the full effectiveness of the future decision on the main action. Consequently, that procedure is merely ancillary to the main action to which it is an adjunct, and accordingly the decision made by the judge hearing an application for interim relief must be provisional in the sense that it cannot either prejudge the future decision on the substance of the case or render it illusory by depriving it of practical effect (see order of 1 September 2015, Pari Pharma v EMA, T‑235/15 R, EU:T:2015:587, paragraph 65 and the case-law cited). 103    It is therefore necessary to examine whether the applicants’ interests in obtaining the immediate suspension of operation of the contested decision, in so far as that decision provides for the publication of the withdrawal EPAR, prevail over the interests pursued by the EMA in adopting that decision. 104    As regards, on the one hand, the interests pursued by the applicants, the latter argue, in the first place, that disclosure of the withdrawal EPAR at this stage, pending the outcome of the action in the main proceedings, will deprive the judgment given in that action of any practical effect, given that the information will have been made available to an indefinite number of persons. That disclosure would thereby irreversibly remove the confidentiality of the withdrawal EPAR and the information contained therein. 105    In the second place, the applicants state that the application for marketing authorisation for Dazluma has been withdrawn and, as a result, it does not currently have a marketing authorisation in the EU market or, moreover, anywhere in the world. That medicinal product is therefore not commercially available in the European Union at the moment. Consequently, in the applicants’ view, there is no valid public health argument to be weighed against the need to suspend publication of the withdrawal EPAR, since there are no healthcare professionals or patients in the European Union who would need access to the information set out in that report for the safe and effective use of that medicinal product. As a result, the only persons who could have an interest in obtaining that information are the European patent opponent and the applicants’ competitors, who would likely use that information to the detriment of the applicants. Their interest in disclosure of the withdrawal EPAR cannot prevail over the applicants’ interest in having their confidential information protected pending the outcome of the dispute in the main proceedings. 106    As regards, on the other hand, the EMA’s interest, the EMA submits that the weighing up of interests militates in favour of partial suspension of the operation of the contested decision by allowing access to the withdrawal EPAR, in the format envisaged in the contested decision, subject to the redaction of the five passages identified by the applicants in their third plea and in Annex A.1.2 to the application for interim relief. 107    In the first place, the EMA claims that the suspension of the contested decision would prevent it from complying with Article 11 of Regulation No 726/2004, under which it is expressly required to publish a withdrawal EPAR, subject to the protection of commercially confidential information. By granting the suspension of operation of the contested decision in its entirety, the public interest objective pursued by Article 11 of Regulation No 726/2004 would be compromised in a manner that is not justified. Publication of a partially redacted version of the withdrawal EPAR would ensure that the clear wording of Article 11 of Regulation No 726/2004 is not rendered meaningless. It would also ensure the preservation of the applicants’ alleged interests in protecting the information which they and the EMA had previously agreed to redact, as well as the five additional passages identified in their third plea and in Annex A.1.2 to the application for interim relief. 108    In the second place, according to the EMA, publication of a partially redacted version of the withdrawal EPAR complies with the principle of proportionality, enshrined in Article 5 TEU. It follows that, when there is a choice between several appropriate measures, recourse must be had to the least onerous, and the disadvantages caused must not be disproportionate to the aims pursued. 109    In the third place, as regards the applicants’ assertion that there is allegedly a lesser interest in the publication of the withdrawal EPAR in view of the fact that Dazluma is not available on the market, the EMA considers that that argument must be rejected in the light of the clear legislative intention of Article 11 of Regulation No 726/2004, which was introduced precisely on the ground that transparency had to be ensured as regards the assessment of withdrawn applications for marketing authorisation for medicinal products which have not been placed on the market. 110    In the present case, it is a question of weighing up, on the one hand, the interest in preventing serious and irreparable damage from being caused by the publication of confidential information and, on the other hand, the public interest pursued by Article 11 of Regulation No 726/2004, under which the EMA is expressly required to publish the assessment report when an applicant withdraws an application for marketing authorisation. 111    First, it follows from Article 11 of Regulation No 726/2004 that, where an applicant withdraws an application for marketing authorisation, the EMA is expressly required to publish the assessment report, subject to the protection of commercially confidential information. 112    Second, it is true that, as stated in paragraphs 88 to 92 above, the applicants have not demonstrated to the requisite legal standard that the EMA’s decision to publish the withdrawal EPAR, after redaction of the five passages identified in their third plea, would be the decisive cause of an unfavourable outcome in the patent opposition proceedings. 113    However, as demonstrated in paragraphs 71 to 81 above, disclosure of those five passages of the withdrawal EPAR would cause serious and irreparable damage to the applicants. 114    In those circumstances, it must be held that the weighing up of competing interests leans in favour of granting in part the suspension of operation of the contested decision, in so far as that decision concerns the five passages identified by the applicants in their third plea; the interests of transparency defended by the EMA are sufficiently satisfied. Conclusion 115    It follows from all of the foregoing that the application for interim relief must be granted in part and that the operation of the contested decision must be suspended in so far as that decision concerns the publication of the five passages identified by the applicants in the third plea of the present application for interim relief. Costs 116    In accordance with Article 158(5) of the Rules of Procedure, the costs must be reserved. On those grounds, THE PRESIDENT OF THE GENERAL COURT hereby orders: 1.      The operation of the decision of the European Medicines Agency of 27 October 2025 to publish the withdrawal European public assessment report on the medicinal product Dazluma is suspended in so far as that decision concerns the publication of the five passages identified by Biohaven Bioscience Ireland Ltd and Biohaven Therapeutics Ltd in the third plea of the present application for interim relief. 2.      The application for interim relief is dismissed as to the remainder. 3.      The costs are reserved. Luxembourg, 22 June 2026. V. Di Bucci M. van der Woude Registrar President *      Language of the case: English.