OPINION OF ADVOCATE GENERAL

SZPUNAR

delivered on 9 January 2019 ( 1 )

Case C‑668/17 P

Viridis Pharmaceutical Ltd

v

European Union Intellectual Property Office (EUIPO)

(Appeal – EU trade mark – Revocation proceedings – EU word mark Boswelan – Declaration of revocation – Use of a mark in the context of a clinical trial)

I. Introduction

1. By its appeal, Viridis Pharmaceutical Ltd (‘the appellant’) asks the Court to set aside the judgment of the General Court of the European Union of 15 September 2017, Viridis Pharmaceutical v EUIPO – Hecht-Pharma (Boswelan), ( 2 ) by which the General Court dismissed its action for annulment of the decision of the Fifth Board of Appeal of the European Union Intellectual Property Office (EUIPO) of 29 February 2016 (Case R 2837/2014-5) relating to revocation proceedings between Hecht-Pharma GmbH and the appellant (‘the decision at issue’). Those proceedings concerned revocation of a trade mark registered, inter alia, for medicinal products for the treatment of multiple sclerosis.

2. In those proceedings, the appellant submitted that genuine use of the trade mark at issue, registered for medicinal products that could not be marketed or advertised until the marketing authorisation was issued, took place in the context of a clinical trial, conducted in order to complete the application for marketing authorisation. In the alternative, the appellant contended that, from the time when the application to conduct a clinical trial of those medicinal products was filed, performance of that clinical trial was at the very least a proper reason for non-use of the mark.

3. The General Court dismissed the action, finding that the appellant was not entitled to claim that it was genuinely using the mark at issue or that it had a proper reason for its non-use.

4. By its appeal, the appellant is disputing, essentially, the General Court’s appraisal relating to genuine use of a trade mark.

5. The points of law arising in this case therefore concern the interpretation of ‘genuine use’ and ‘proper reason for non-use’ within the meaning of Regulations (EC) No 207/2009 ( 3 ) and (EU) No 2017/1001 ( 4 ) in the context of revocation proceedings concerning a mark registered for medicinal products.

II. Legal context

6. Recital 10 of Regulation No 207/2009 reads as follows: ‘There is no justification for protecting [EU] trade marks or, as against them, any trade mark which has been registered before them, except where the trade marks are actually used.’

7. Article 15 of Regulation No 207/2009, headed ‘Use of [EU] trade marks’, states in the first subparagraph of paragraph 1: ‘If, within a period of five years following registration, the proprietor has not put the [EU] trade mark to genuine use in the [European Union] in connection with the goods or services in respect of which it is registered, or if such use has been suspended during an uninterrupted period of five years, the [EU] trade mark shall be subject to the sanctions provided for in this Regulation, unless there are proper reasons for non-use.’

8. The sanctions to which the first subparagraph of Article 15(1) of Regulation No 207/2009 refers are specified in Article 51, headed ‘Grounds for revocation’. Article 51(1)(a) provides: ‘1. The rights of the proprietor of the [EU] trade mark shall be declared to be revoked on application to [EUIPO] or on the basis of a counterclaim in infringement proceedings: (a) if, within a continuous period of five years, the trade mark has not been put to genuine use in the [European Union] in connection with the goods or services in respect of which it is registered, and there are no proper reasons for non-use; however, no person may claim that the proprietor’s rights in [an EU] trade mark should be revoked where, during the interval between expiry of the five-year period and filing of the application or counterclaim, genuine use of the trade mark has been started or resumed; the commencement or resumption of use within a period of three months preceding the filing of the application or counterclaim which began at the earliest on expiry of the continuous period of five years of non-use shall, however, be disregarded where preparations for the commencement or resumption occur only after the proprietor becomes aware that the application or counterclaim may be filed; …’

9. Regulation No 207/2009 was repealed and replaced by Regulation 2017/1001. According to the correlation table in Annex III to Regulation 2017/1001, Articles 15 and 51 of Regulation No 207/2009 correspond to Articles 18 and 58 respectively of Regulation 2017/1001. ( 5 )

III. The proceedings before EUIPO

10. The appellant is successor in title to a company that on 30 September 2003 filed an application with EUIPO to register the word sign ‘Boswelan’ as an EU trade mark for pharmaceutical products and health-care products under Class 5 of the Nice Agreement Concerning the International Classification of Goods and Services for the Purposes of the Registration of Marks of 15 June 1957, as revised and amended (‘the Nice Classification’). The mark was registered on 24 April 2007.

11. On 24 October 2010, the appellant filed a clinical trial application relating to a medicinal product to treat multiple sclerosis, belonging to the wider category of pharmaceutical products and health-care products. The exact date on which that trial was completed is not known.

12. On 18 November 2013, Hecht-Pharma filed an application for revocation of the mark at issue in respect of all the products for which it had been registered, on the ground that there had been no genuine use of that mark for an uninterrupted period of five years before it filed that application.

13. By decision of 26 September 2014, the EUIPO Cancellation Division revoked the appellant’s rights in respect of all the products covered by the registration.

14. On 6 November 2014, the appellant appealed to the Board of Appeal of EUIPO against the decision of the Cancellation Division.

15. By the decision at issue, the Fifth Board of Appeal of EUIPO dismissed that appeal.

16. The Board of Appeal found, first, that the evidence provided by the appellant was not such as to demonstrate genuine use of the mark at issue within the European Union and, secondly, that, in the case before it, conduct of a clinical trial was not, in itself, a reason independent of the will of the appellant such as to justify non-use of the mark at issue.

IV. The action before the General Court and the judgment under appeal

17. By application lodged at the Registry of the General Court on 30 May 2016, the appellant brought an action seeking annulment of the decision at issue in so far as it revoked the mark at issue in respect of medicinal products to treat multiple sclerosis, included in the wider category of ‘pharmaceutical products and health-care products’. In those proceedings the appellant relied on three pleas in law, alleging infringement of Article 51(1)(a) of Regulation No 207/2009 in that the Board of Appeal wrongly found that the facts and evidence adduced were insufficient to demonstrate genuine use of the mark at issue for medicinal products to treat multiple sclerosis (the first plea), infringement of Article 51(1)(a) of Regulation No 207/2009 in that the Board of Appeal wrongly found that the facts and evidence adduced were insufficient to demonstrate a proper reason for non-use of that mark in relation to the same medicinal products (the second plea) and infringement of Article 83 of Regulation No 207/2009, and specifically of the principle of the protection of legitimate expectations, in that the Board of Appeal departed from the guidelines for examination before EUIPO (the third plea).

18. On the grounds set out in the judgment under appeal, the General Court dismissed the action in its entirety.

V. The forms of order sought

19. In its appeal, the appellant asks the Court of Justice to set aside the judgment under appeal, to refer the case back to the General Court and to order that EUIPO pay the costs or, in the alternative, to reserve costs.

20. EUIPO and Hecht-Pharma request the Court of Justice to dismiss the appeal and order the appellant to pay the costs.

VI. Analysis

A. Preliminary observation on the application ratione temporis of the regulations on the EU trade mark

21. I would draw attention to the fact that, in its appeal, the appellant states that its grounds of appeal allege infringement of Regulation 2017/1001. It is of the view that, in accordance with Article 211 of that regulation, by the date on which the judgment under appeal was delivered, that is to say, 15 September 2017, Regulation No 207/2009 had been repealed and replaced by Regulation 2017/1001. Moreover, Hecht-Pharma also refers in its response to the provisions of Regulation 2017/1001. EUIPO, in contrast, relies on the provisions of Regulation No 207/2009.

22. It should be noted in that regard that the appellant has not advanced any ground of appeal in which it criticises the General Court for delivering the judgment under appeal on an incorrect legal basis or for wrongly applying the transitional provisions of Regulation 2017/1001. In any event, the judgment under appeal was delivered on 15 September 2017, that is to say, after the date on which Regulation 2017/1001 came into force (6 July 2017), but before the date on which it became applicable (1 October 2017). ( 6 ) It was therefore Article 51(1)(a) of Regulation 207/2009 that applied at the time when the judgment under appeal was delivered. ( 7 )

23. Moreover, Article 58(1)(a) of Regulation 2017/1001, referred to in the appeal, corresponds to Article 51(1)(a) of Regulation No 207/2009. Similarly, the first subparagraph of Article 18(1) of Regulation 2017/1001 reproduces the wording of the first subparagraph of Article 15(1) of Regulation No 207/2009. ( 8 ) Both those articles establish an obligation to use the mark and, unless there is a proper reason for non-use, refer to the provisions of those regulations as to the consequences of non-use. Old wine in new bottles. ( 9 )

24. The analysis relating to the provisions of Regulation No 207/2009 can therefore, to my mind, be transposed to the provisions of Regulation 2017/1001. In this Opinion I will therefore refer to the relevant provisions of Regulation No 207/2009 and to their equivalents in Regulation 2017/1001. I will also understand references to the provisions of Regulation 2017/1001, by the appellant and Hecht-Pharma, as references also to the corresponding provisions of Regulation No 207/2009.

B. The appeal

25. The appellant advances two grounds of appeal.

26. The first ground, alleging infringement of Article 51(1)(a) of Regulation No 207/2009 (Article 58(1)(a) of Regulation 2017/1001) is divided into two parts. In the first part, the appellant questions the General Court’s finding that there can only be use such as to maintain rights in respect of a medicinal product where the proprietor of a mark has obtained a marketing authorisation for a medicinal product for which that mark was registered. By the second part, the appellant challenges the judgment under appeal in so far as the General Court found that use of a mark in the context of a clinical trial did not amount to genuine use.

27. It is worth noting that those two parts concern different situations. The second part relates only to use of a mark in the context of a clinical trial, whereas the first part refers, more generally, to use prior to the marketing authorisation. However, according to the findings of the General Court, summarised in paragraph 40 of the judgment under appeal, the appellant was unable to invoke any acts other than those relating to the clinical trial procedure.

28. By the second ground of appeal, the appellant claims that the General Court infringed Article 51(1)(a) of Regulation No 207/2009 (Article 58(1)(a) of Regulation 2017/1001) by ruling out any proper reason for non-use of the mark at issue where the product for which the mark was registered is undergoing a clinical trial.

C. Admissibility of the grounds of appeal

29. In its response, Hecht-Pharma states that the grounds of appeal raised by the appellant are seeking a fresh assessment of the facts and circumstances of the case. Those grounds are therefore, in its view, manifestly inadmissible.

30. It is true that, in the appeal which gave rise to the order in Martín Osete v EUIPO, ( 10 ) an appellant complained that the General Court interpreted the notion of ‘proper reasons for non-use’, within the meaning of Article 51(1) of Regulation No 207/2009, in an overly restrictive manner. Specifically, it stated that certain regulations rendered overly difficult the marketing of the perfumes for which the mark had been registered.

31. In the order in that case, the Court of Justice found that, under the guise of a misinterpretation of the notion of ‘proper reasons for non-use’, the appellant was seeking, in reality, to challenge the factual assessments made by the General Court. The Court of Justice accordingly dismissed the ground in question as manifestly inadmissible. To my mind the appellant did indeed in its appeal focus primarily on the evidence in order to show that proper reasons were, according to the appellant, clearly established. ( 11 )

32. In the present case, however, the appellant is seeking an interpretation – in the true sense – of ‘genuine use’ and ‘proper reasons for non-use’ within the meaning of Regulation No 207/2009 (Regulation 2017/1001) in the context of revocation proceedings concerning a mark registered for a medicinal product for human use, which could not be marketed and advertised until the marketing authorisation was issued. In order to examine the grounds of appeal, it is therefore necessary to interpret the provisions of Regulation No 207/2009 (Regulation 2017/1001) in the light of the rules governing medicinal products for human use within the European Union.

33. Consequently, in my view the grounds of the present appeal are not seeking a fresh assessment of the facts and circumstances of the case, but in reality raise points of law. They are, therefore, admissible.

D. Substance

1. The first ground of appeal

(a) The first part of the first ground of appeal

(1) Positions of the parties

34. By the first part of its first ground of appeal, the appellant criticises the General Court, in the first place, for laying down a principle, in paragraph 36 of the judgment under appeal, that there can only be use such as to maintain the rights conferred by a registered mark for a medicinal product once a marketing authorisation has been obtained. According to the case-law of the Court of Justice, the question as to whether use is sufficient depends on a case-by-case assessment. ( 12 )

35. Challenging the principle purportedly established by the General Court, the appellant submits, in the second place, that the acts performed in the context of the clinical trials, which form part of the marketing authorisation procedure, were lawful. ( 13 )

36. In the third place and lastly, the appellant argues that, given the particular features of the pharmaceutical sector, a five-year period must be regarded as too short.

37. In contrast, EUIPO and, assuming the first ground of appeal to be admissible, Hecht-Pharma, are of the view that the first part of this ground is unfounded.

38. EUIPO argues in particular that, contrary to what the appellant asserts, the General Court did not find that obtaining a marketing authorisation under the pharmaceutical product legislation was an indispensable requirement for there to be genuine use.

39. Hecht-Pharma contends in particular that the mark at issue must be used for the product for which it was registered. In the present case, it is therefore necessary to determine whether that mark was used for a medicinal product to treat multiple sclerosis. According to Hecht-Pharma, genuine use in respect of such a medicinal product can be demonstrated only if the product in question was actually a medicinal product. It is only on completion of the clinical trial conducted by the appellant that it is possible to determine whether the tested product is a medicinal product within the meaning of that definition. Use of that product in the context of the clinical trial therefore cannot amount to genuine use of the mark at issue for a medicinal product.

(2) Assessment

40. First, the appellant’s argument alleging that the General Court erroneously laid down a principle according to which use such as to maintain rights can exist only once marketing authorisation has been obtained is, in my view, and in EUIPO’s, based on a misreading of the judgment under appeal.

41. Admittedly, the General Court did state in paragraph 36 of the judgment under appeal that only obtaining the marketing authorisation could enable use of the mark at issue that was public and directed at the outside world.

42. However, in paragraphs 37 to 39 of the judgment under appeal, the General Court analysed the appellant’s situation, even though it had not been granted a marketing authorisation. The General Court therefore did not in any way take the view that a mark registered for a medicinal product could not be put to ‘genuine use’ within the meaning of Article 51(1)(a) of Regulation No 207/2009 (Article 58(1)(a) of Regulation 2017/1001) unless there was a marketing authorisation. Moreover, the second part of the first ground of appeal criticises the General Court’s findings set out primarily in paragraph 39 of the judgment under appeal. Analysis of that part will therefore give an opportunity to assess whether the principle purportedly laid down by the General Court is valid, at least in so far as that principle would relate to use of a mark in the context of clinical trials.

43. Secondly, as regards the legality of the acts performed during clinical trials, it is sufficient to note that the fact that acts in the context of which a mark is used are lawful does not automatically mean that those acts are acts of genuine use of that mark. ( 14 )

44. Thirdly, I am also of the view that the appellant’s argument that the five-year period is insufficient likewise cannot succeed.

45. The five-year period, as prescribed in Article 51(1)(a) of Regulation No 207/2009 (Article 58(1)(a) of Regulation 2017/1001), applies irrespective of the economic sector within which the goods or services for which a mark has been registered fall. Nevertheless, the particular features of an economic sector are taken into account when assessing the circumstances that do or do not constitute genuine use in the light of the market for the goods or services concerned. In any event, I will address that issue when analysing the second part of the first ground of appeal. Furthermore, the circumstances in which the five-year period would become insufficient for commencing genuine use of a mark can be taken into account when examining the reasons justifying non-use, to which I will refer in my analysis of the second ground of appeal.

46. I am therefore of the view that the first part of the first ground of appeal is unfounded.

(b) The second part of the first ground of appeal

(1) Positions of the parties

47. By the second part of the first ground of appeal, the appellant complains that the General Court found, in paragraph 39 of the judgment under appeal, that use of a mark in the context of a clinical trial is purely internal use and that such acts of use cannot, in any event, be regarded as genuine within the meaning of Article 51(1)(a) of Regulation No 207/2009 (Article 58(1)(a) of Regulation 2017/1001).

48. The appellant adds that the obligation to use a registered mark is not an aim in itself and that the requirement to use a mark is intended to prevent the register from being overburdened with unused marks. The notion of ‘use’ should therefore be interpreted with a degree of flexibility, as testified by Article 15(1)(a) of Regulation No 207/2009 (Article 18(1)(a) of Regulation 2017/1001) and recital 25 of Regulation 2017/1001, ( 15 ) which indicate that use of a mark in a form differing from the form in which it was registered should be sufficient to preserve the rights conferred.

49. EUIPO and Hecht-Pharma contend that the second part of the first ground of appeal is unfounded.

50. EUIPO argues that there can be no genuine use where, as the General Court correctly found, the legislation on pharmaceutical products prohibits the advertising of a medicinal product which has not yet been authorised and therefore makes it impossible, in law, to put the product to use such as to enable it to obtain a market share. According to EUIPO, the other factors that the General Court mentions, that is to say, the restricted circle of participants and the fact that the use was internal, were not decisive. The appellant’s arguments in that respect therefore cannot succeed.

51. Hecht-Pharma adds, in particular, that a clinical trial is a trial preparatory to applying for authorisation to market a product as a medicinal product. Such a preparatory trial is intended only to establish that the product is effective, and is neither concerned with nor has the aim of protecting or gaining market shares. Since the trial is a random double-blind placebo-controlled trial, the participants themselves do not know either to what product or to what mark it relates.

52. Hecht-Pharma also asserts that there is no leeway in relation to the notion of ‘genuine use’. In its view, recital 25 of Regulation 2017/1001 relates to a different matter.

(2) Assessment

(i) Preliminary observations

53. Contrary to the appellant’s assertions, paragraph 39 of the judgment under appeal is not based on the premiss that use of a mark in the context of a clinical trial is internal and therefore cannot be regarded as genuine solely because it targets a small number of persons. According to the General Court, the use of the mark at issue in a clinical trial in relation to third parties could not be equated with placement on the market or even with a direct preparatory act for the further reason that it took place outside any competition, and without seeking to obtain or protect market shares.

54. I am therefore of the view that, by the second part of the first ground of appeal, the appellant is seeking to show, essentially, that the question of whether use of a mark registered for a medicinal product in the context of a clinical trial relating to that medicinal product can, contrary to the General Court’s finding in paragraph 39 of the judgment under appeal, constitute ‘genuine use’ within the meaning of Article 51(1)(a) of Regulation No 207/2009 (Article 58(1)(a) of Regulation 2017/1001) should be answered in the affirmative.

55. That question has already been posed and answered in academic writings. Specifically, it has been argued inter alia that clinical trials conducted prior to the marketing authorisation do not constitute genuine use because those trials are not external in nature. ( 16 ) Moreover, it seems to me that this is also how national courts have interpreted the provisions transposing the directives relating to the national trade mark system. ( 17 ) However, to my knowledge the Court of Justice has not yet had an opportunity to rule on such an issue.

(ii) Nature of genuine use in the light of the case-law

56. It is apparent from the case-law that a mark is put to genuine use where it is used, first of all, in order to create or preserve an outlet for the goods or services for which it was registered, which does not include token use for the sole purpose of preserving the rights conferred by the mark, and secondly, in accordance with its essential function. ( 18 )

57. The requirements relating to, first, the commercial raison d’être of the mark, and secondly, its essential function, apply cumulatively.

58. On the one hand, the protection that the mark confers cannot continue to operate if the mark loses its commercial raison d’être, which is to create or preserve an outlet for the goods or services that bear the sign of which it is composed, as distinct from the goods or services of other undertakings. ( 19 ) At the same time, the fact that a mark is used in order to create or preserve an outlet for the goods or services for which it is registered and not for the sole purpose of preserving the rights conferred by the mark is not sufficient to conclude that there is a ‘genuine use’. It is equally necessary that the mark is used consistently with the essential function of a trade mark, which is to guarantee the identity of the origin of goods or services to the consumer or end user by enabling him, without any possibility of confusion, to distinguish the product or service from others which have another origin. ( 20 )

59. Use consisting of creating or preserving an outlet for the goods or services must, inherently, be directed at the outside world. The same applies when the mark is performing its essential function. Performance of that function presupposes that the mark is on the market and, therefore, that it is exposed to the public.

60. It is to be noted that it cannot be inferred from the foregoing that the goods or services for which the mark was registered must be marketed in order for it to be found that there is genuine use.

61. As is apparent from the judgment in Ansul, ( 21 ) genuine use of a registered mark can occur in two situations, that is to say, where the goods are already marketed and where they are about to be marketed. Such use prior to marketing in the strict sense must consist of preparations carried out in order to secure customers.

62. The two situations have a number of things in common. In particular, the Court held in paragraph 37 of the judgment in Ansul ( 22 ) that ‘genuine use’ of the mark entails use of the mark on the market for the goods or services protected by that mark and not just internal use by the undertaking concerned. The Court subsequently clarified those findings in Verein Radetzky-Orden, ( 23 ) distinguishing between two situations: on the one hand, use of the marks to identify and promote its goods or its services to the general public and, on the other, use limited to internal use of those marks.

63. It is to my mind significant that, in its judgment in Ansul, ( 24 ) the Court referred to use of a mark in the context of advertising campaigns as an example of use prior to the marketing of the goods or services for which the mark had been registered. That example is indeed a good illustration of prior use, but it also illustrates genuine use. The launch of advertising campaigns involving a mark therefore does not automatically mean that there is genuine use. Nevertheless, that example shows that, even in a phase before the marketing of goods or services, acts of use must be external and must, at the same time, have effects in terms of the future public for those goods or services. ( 25 )

64. Accordingly, every instance of genuine use is, essentially, directed at the outside world. On the other hand, it is not apparent from the foregoing that every instance of external use of a mark amounts to genuine use. The mere fact that a mark is used in relation to third parties does not mean that there is genuine use. To determine whether there is such use, it is necessary, as I have indicated in points 56 to 59 of this Opinion, to examine whether an act of external use consists in creating or preserving an outlet for the goods or services for which the mark was registered. As part of that examination, the act needs to be analysed in the light of, amongst other matters, the market for the goods or services concerned.

(iii) Having regard for the particular features of an economic sector

65. It is apparent from the Court’s case-law that, when assessing whether there has been genuine use of a trade mark, regard must be had to all the facts and circumstances relevant to establishing whether the commercial exploitation of the mark is real, in particular to the uses viewed as warranted in the economic sector concerned to maintain or create a share in the market for the goods or services protected by the mark. ( 26 ) Assessing the circumstances of the case may thus justify giving consideration, inter alia, to the nature of the goods or service at issue, the characteristics of the market concerned and the scale and frequency of use of the mark. ( 27 )

66. The Court has therefore recognised in its case-law a need to take into account the particular features of the economic sector in which a mark operates. It therefore seems to me appropriate to make a number of comments on the rules governing the sector of medicinal products for human use within the European Union. It is true that the concepts in those rules do not necessarily mean the same as the concepts in trade mark law. However, those rules create the context in which the players in that sector can undertake acts relating to medicinal products for which marks have been registered and it is undisputed that, for a finding that there has been genuine use of a mark, the mark must have been used in the market for the goods or services concerned. ( 28 )

(iv) The rules governing medicinal products for human use

67. The core instruments of the system of EU rules governing the medicines for human use sector are Directive 2001/83/EC ( 29 ) and Regulation (EC) No 726/2004. ( 30 ) That EU legislation establishes a principle that medicinal products cannot be placed on the market unless a marketing authorisation has been issued by the competent authority. ( 31 ) Furthermore, medicinal products may not be the subject of any form of ‘door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products’, vis-à-vis the public or persons qualified to prescribe or supply them. ( 32 )

68. In this system, a clinical trial is essentially an investigation carried out in order to discover or verify the effects of a medicinal product, including adverse reactions, and to ascertain its safety and efficacy. ( 33 ) According to Article 8(3)(i) of Directive 2001/83, the results of such a trial must accompany the application for marketing authorisation. In principle, therefore, clinical trials are conducted before the medicinal products to which Article 6 of Directive 2001/83 refers are marketed or advertised.

69. Moreover, a clinical trial must in principle undergo a scientific and ethical examination and must be authorised before it starts. ( 34 ) Also, any substantial amendments during the clinical trial are subject to monitoring by the Member States. ( 35 ) Furthermore, the sponsor of a clinical trial takes responsibility for its initiation and management and for setting up its financing. ( 36 )

70. To summarise this part of my analysis, I am of the view that the EU legislature took an approach that limits access by consumers and end users to non-authorised medicinal products in order to limit the risks relating to the use of such products.

71. Furthermore, use of a mark registered for a medicinal product during clinical trials can, therefore, be regarded only as use before that product is marketed, for the purposes of the judgment in Ansul. ( 37 ) It is common ground, as is apparent from paragraph 38 of the judgment under appeal, that the appellant’s situation is one of use prior to marketing. The products for which the mark was registered, that is to say, medicinal products to treat multiple sclerosis, were not marketed, since their marketing was prohibited during the relevant period. ( 38 )

(v) Marks registered for medicinal products for human use

72. As academic writers have noted, Class 5 of the Nice Agreement, which includes pharmaceutical products and health-care products, accounts for a particularly high number of registrations. ( 39 ) Moreover, if academic commentaries are to be believed, the actors in the pharmaceutical sector tend to apply for trade marks for medicinal products during the initial phase of their development. ( 40 ) The reason for that haste is said to be a wish to raise awareness in influential circles, because of a perceived risk that, during the development phase of a medicinal product, doctors and specialists will latch onto its generic name rather than the trade mark. ( 41 )

73. It should be said, in that context, that the EU legislature has taken account of that behaviour by actors in the medicinal products for human use sector. Indeed, Directive 2001/83 acknowledges, to an extent at least, the role that trade marks play in the sector. It is apparent from Article 1(20) of that directive that the name given to a medicinal product may be a common or scientific name accompanied by a trade mark. Moreover, under Article 89(1)(b) of Directive 2001/83, advertising, which is permitted only in relation to authorised medicinal products, must contain, amongst other information, the name of the medicinal product.

74. It is apparent from the abovementioned provisions that, in certain cases, a mark registered for a medicinal product may be the same as the name of that medicinal product. Such a mark therefore cannot be used in the proprietor’s communication strategy until marketing authorisation for the medicinal product has been obtained.

(vi) Interim conclusion on the use of a mark during clinical trials

75. In the light of the foregoing, I would emphasise, as is apparent from point 70 of this Opinion, that the EU legislature seeks to limit access by consumers and end users to non-authorised medicinal products. In the system of rules governing medicinal products for human use, clinical trials can be likened to a filtering mechanism that prevents non-authorised medicinal products from gaining access to the market.

76. Similarly, given the role that the trade marks registered for such products play in that system, the aim of the EU legislature is also to limit the presence of such marks on the market in question. The public’s exposure to a mark registered for a medicinal product that is not (yet) authorised is therefore also limited qualitatively and quantitatively, at least to the extent that the mark might be present on the competitive market for medicinal products.

77. It should be noted that, during clinical trials, non-authorised medicinal products are available for the participants, and for other persons involved in those trials. I do not rule out the possibility that persons in those two categories might associate the medicinal product and its name and, therefore, the mark registered for that product with its proprietor. They are also entitled to choose whether or not to be involved in a trial.

78. However, as follows from point 64 of this Opinion, not every instance of external use of a mark is automatically genuine use. Exposure to that mark, which is capable of creating an outlet for the goods for which it has been registered on the market concerned, must necessarily take place on that market.

79. I do not think that this is what occurs where a mark is used in the context of a clinical trial.

80. In the first place, in the context of clinical trials, non-authorised medicinal products are not, in principle, distributed or advertised with the aim of penetrating the market for goods marketed in the same class. Similarly, a clinical trial, which is an investigation of the risks relating to the use of a medicinal product, under conditions subject to prior authorisation, is not, and should not be, a form of commercial exploitation of a mark registered for that medicinal product consisting in creating or preserving an outlet for that product. A clinical trial therefore cannot be equated even with an act preparatory to marketing for the purposes of the judgment in Ansul. ( 42 )

81. With that in mind, I do not think that large-scale clinical trials for a medicinal product can constitute genuine use of a mark registered for a tested product. As is apparent from recital 10 of Directive 2001/83, the legislature’s intention is to avoid unnecessary tests. ( 43 ) The scale of a clinical trial is in fact determined by scientific need, not by commercial considerations. That scale is furthermore subject to authorisation by a Member State. ( 44 ) I am therefore of the view that the absence of genuine use is due more to the qualitative characteristics of the use of a mark in the context of clinical trials than to its quantitative characteristics.

82. In the second place, exposure to the mark and the choice that the participants and other persons involved in a clinical trial make are due primarily not to the characteristics of the product, its origin or even the proprietor’s commercial strategy, but to their willingness to participate in research relating to the medicinal product in question. It seems significant in that context that, as the General Court stated in paragraph 59 of the judgment under appeal, in the present instance, financial investment plays a decisive role in recruiting the participants and other persons involved in the clinical trial. Moreover, in circumstances such as those in the main proceedings, the mark at issue was registered for products in Class 5 of the Nice Agreement, that is to say, pharmaceutical products and health-care products. That mark was therefore intended to create an outlet not for scientific research but for goods belonging to that class.

83. Lastly, those observations cannot be called into question by the appellant’s argument that the notion of ‘genuine use’ should be interpreted with a degree of flexibility on the ground that, under Article 15(1)(a) of Regulation No 207/2009 (Article 18(1)(a) of Regulation 2017/1001), the EU legislature allows use of a mark in a form differing from the form in which it was registered. The purpose of those articles is to allow the proprietor of a registered trade mark, in the commercial exploitation of the sign, to make variations in that sign which, without altering its distinctive character, enable it to be better adapted to the demands of marketing and promoting the goods or services concerned. ( 45 ) Although a degree of flexibility is permitted as to the form of a mark, such flexibility cannot however relate to characteristics pertaining to whether use is genuine. Genuine use must, in any event, satisfy the requirements set out in points 56 to 59 of this Opinion.

84. In summary, use in the context of clinical trials of a mark registered for a tested medicinal product does not in my view constitute genuine use of that mark. However, it is not my view that, where there is no marketing authorisation, a mark registered for a medicinal product undergoing a clinical trial cannot, under any circumstances, be put to genuine use.

(vii) Exceptions that prove the rule

85. By way of illustration, under Article 83(1) and (2) of Regulation No 726/2004, by way of exemption from Article 6 of Directive 2001/83, Member States may make a non-authorised medicinal product available for compassionate use to a group of patients with a chronically or seriously debilitating disease or whose disease is considered to be life-threatening, which cannot be treated satisfactorily by an authorised medicinal product. They can do so in particular in relation to a medicinal product being tested in a clinical trial. Other aspects of compassionate use are, as a general rule, regulated at national level.

86. Accordingly, because the Member States have a degree of freedom as regards the rules governing compassionate use, I cannot completely rule out that compassionate use of a medicinal product for which a mark has been registered might involve genuine use of that mark.

87. First, it is irrelevant that, in accordance with national provisions which still so provide, it may be that such a medicinal product is made available for compassionate use with no view to making a profit. As is apparent from the Court’s case-law, the fact that a trade mark proprietor does not seek to make a profit does not mean that his objective cannot be to create and, later, to preserve an outlet for his goods or services. ( 46 )

88. Secondly, use of the mark need not be quantitatively significant for it to be considered ‘genuine’. Even minimal use can be sufficient to qualify as genuine, on condition that such use is considered to be justified in the economic sector concerned. ( 47 ) Similarly, a non-authorised medicinal product, which can be put to compassionate use, may be intended to be marketed in the future to patients with a chronically or seriously debilitating disease or whose disease is considered to be life-threatening. That market is therefore restricted and, accordingly, the acts constituting genuine use may likewise be limited in quantity.

89. Thirdly, to my mind, compassionate use of a medicinal product for which a mark has been registered cannot place its proprietor in a less favourable situation than other actors in the market for medicinal products. A mark registered for a medicinal product put to compassionate use might in fact be present on the market in circumstances comparable to those in which an authorised medicinal product is marketed.

90. Fourthly and lastly, it seems to me that a systemic reading of the provisions of Regulation No 726/2004 and Directive 2001/83 corroborates the need for an interpretation that does not automatically rule out genuine use in the context of compassionate use. First, Article 6 of Directive 2001/83, which sets out the principle that non-authorised medicinal products cannot be placed on the market, comes at the beginning of Title III, ‘Placing on the market’, of that directive. Secondly, Article 83(1) of Regulation No 726/2004 explicitly establishes an exemption from Article 6 of Directive 2001/83. If making a medicinal product available in the circumstances described in Article 83(1) and (2) of Regulation No 726/2004 were not a placing on the market, such an exemption would be meaningless.

91. In conclusion, I do not rule out that a mark registered for pharmaceutical products and health-care products, in Class 5 of the Nice Agreement, and, specifically, for a medicinal product covered by Directive 2001/83, may in certain cases be put to genuine use before the marketing authorisation is granted for that medicinal product. Whether or not use is sufficient must be assessed on a case-by-case basis. That said, to my mind, use of such a mark in the context of clinical trials cannot be genuine use within the meaning of Article 51(1)(a) of Regulation No 207/2009 (Article 58(1)(a) of Regulation 2017/1001). In the context of a clinical trial, a mark is not used in order to create or preserve an outlet for the goods or services for which it was registered.

92. In the light of the foregoing observations, in my view the second part of the first ground of appeal is unfounded.

2. The second ground of appeal

(a) Positions of the parties

93. By the second ground of appeal, concerning primarily paragraphs 60 and 61 of the judgment under appeal, the appellant contends that the General Court infringed Article 51(1)(a) of Regulation No 207/2009 (Article 58(1)(a) of Regulation 2017/1001) by ruling out any proper reason for non-use of the mark at issue. Specifically, the appellant asserts that the General Court wrongly ruled out any proper reason for non-use in situations where, first, the application relating to the trial in question is filed a long time after the mark was registered and, secondly, the financial resources committed are not those that would have been necessary to conclude the clinical study as quickly as possible.

94. In support of this ground, the appellant argues, first, that, by criticising it for applying for a clinical trial authorisation a long time after registration of the mark, the General Court rendered the five-year period of grace meaningless. Indeed, according to the appellant, a trade mark for a medicinal product whose period of grace expired would, in practice, become unusable, because only applying for marketing authorisation could justify non-use.

95. Secondly, since the General Court took financial investment into consideration in assessing whether there was a proper reason for non-use, financially sound undertakings would find it easier to protect their investments adequately using trade mark law than financially weaker undertakings. In any event, the General Court cannot rely on the abstract proposition that additional investment would have made it possible to complete the clinical trial in question in the present instance more quickly.

96. EUIPO and, assuming that the second ground of appeal is admissible, Hecht-Pharma, assert that this ground is unfounded.

97. According to EUIPO, the finding that the acts carried out by the appellant were within its field of influence and the clinical trial could not amount to a proper reason for non-use in the present instance is based on an overall assessment that takes into account inter alia, besides the passage of time and the investment made, the fact that no evidence was produced indicating that the trial in question was concluded, that the clinical trial in question is subject to national rules and is merely one stage in a process seeking to market a medicinal product to treat multiple sclerosis and, lastly, that there is no obligation in law to designate a medicinal product during a clinical trial.

98. Hecht-Pharma acknowledges that an abnormally long procedure for authorisation of a medicinal product could constitute a proper reason for non-use. However, as regards the present case, Hecht-Pharma asserts, in particular, that the appellant allowed three years to pass between registration of the mark at issue and the application for authorisation to carry out a clinical trial and that, to date, it has not filed an application for marketing authorisation.

(b) Assessment

99. In Häupl, ( 48 ) the Court established that three requirements must all be satisfied to justify non-use of a mark. The obstacle must, first, arise independently of the will of the owner of the trade mark concerned, secondly, it must have a sufficiently direct relationship with the trade mark, and, thirdly, it must make use of that mark impossible or unreasonable.

100. However, in denying the existence of a proper reason for non-use the General Court relied on factors related only to the first requirement, that the obstacle must be independent of the will of the proprietor. To be precise, in paragraph 61 of the judgment under appeal, the General Court found that, although conducting a clinical trial could in fact be a reason for non-use of a mark, the acts and events that the appellant adduced in the present instance were within its field of influence and area of responsibility, and therefore did not relate to obstacles independent of its will.

101. In reaching that finding, the General Court took account of several criteria, that is to say, first, the time that elapsed between registration of the mark – which was the result not of any legal obligation but of the appellant’s own choice – and the start of the clinical trial (the exact date of whose completion could not be determined) ( 49 ) and, second, whether or not the investment that the appellant made was adequate. ( 50 )

102. Accordingly, whilst I do not wish to express an opinion on issues relating to the presence of a sufficiently direct relationship between the obstacle and the mark at issue, or to the impact of that obstacle on whether use of that mark was possible or reasonable, on which the General Court did not rule in the judgment under appeal, it should be examined whether, where there is an obstacle for reasons relating to the initiation and financing of the clinical trial for a medicinal product in respect of which that mark is registered, that obstacle is (or is not) independent of the will of a proprietor. ( 51 )

103. In Häupl, ( 52 ) the Court stated that Article 19(1) of the Agreement on Trade-Related Aspects of Intellectual Property Rights ( 53 ) may constitute a factor in the interpretation of the concept of proper reasons as used in EU law. As examples, Article 19(1) cites import restrictions on or other government requirements for goods or services protected by a trade mark. A legal obstacle can therefore also be a proper reason for non-use.

104. It is true that, according to my analysis of the first ground of appeal, in the system set up inter alia by Directive 2001/83 and Regulation No 726/2004 there can be genuine use of a mark registered for a non-authorised medicinal product in exceptional situations only and genuine use of such a mark in the context of clinical trials is impossible. ( 54 )

105. However, first, it cannot be argued that every legal constraint directly linked to the mark that makes its use impossible constitutes an obstacle which should automatically be classified as a proper reason for non-use. Every commercial activity must be carried on in accordance with certain legislative provisions. I note that in this context the Court has already held that the concept of ‘proper reasons’ must not be given too broad a scope. ( 55 ) Accordingly, to my mind, the mere fact that there is an obstacle to the use of a trade mark, such as the requirement to comply with EU legislation in order to market the goods covered by that mark, is not sufficient to justify non-use of that mark. ( 56 )

106. Secondly, as regards EU marks and irrespective of considerations relating to the role of clinical trials in the regulation of medicinal products for human use, conducting a clinical trial for a medicinal product for which a mark has been registered is, for its proprietor, an act by means of which the proprietor seeks to eliminate an obstacle to genuine use of that mark.

107. Indeed, where a proprietor can perform acts liable to eliminate an obstacle to use of the mark or, at least, to reduce the duration of such an obstacle, that obstacle cannot be said to be fully independent of his will. Nevertheless, I do not exclude the possibility that, where those acts require the proprietor to undergo a specific procedure, that proprietor may encounter other obstacles caused by the authorities responsible for conducting that procedure. I am inclined to think that such obstacles can be proper reasons for non-use. In relation, for example, to the situation of the proprietor of a registered mark for a medicinal product, it could be that the authorities responsible for giving prior authorisation for a clinical trial failed to examine within the time limit laid down the application for authorisation made by the proprietor.

108. The Court’s case-law according to which the notion of ‘proper reasons’ refers, essentially, to circumstances unconnected with the trade mark proprietor corroborates that view. ( 57 )

109. Admittedly, a clinical trial and any substantial modifications made to it must be authorised in advance by a Member State. ( 58 ) Nevertheless, such authorisations are granted in accordance with criteria set out in the relevant legislation, which are, therefore, predictable for a proprietor acting as sponsor of a clinical trial. Indeed, the sponsor takes responsibility for the initiation, for the management and for setting up the financing of a clinical trial. ( 59 )

110. In respect of the present appeal, it should be noted that the criteria used by the General Court in the judgment under appeal and criticised in the second ground of appeal are covered by the appellant’s responsibility so defined. ( 60 ) Nor is there anything to indicate that the appellant adduced other facts capable of showing that obstacles for which it was not responsible affected the commencement or performance of the clinical trial. In any event, assessing those facts does not fall within the jurisdiction of the Court of Justice hearing an appeal against the judgment of the General Court.

111. Moreover, I am of the view that, if the applicant were to rely on such facts, it would be necessary to assess on a case-by-case basis whether, during the period laid down in Article 51(1)(a) of Regulation No 207/2009 (Article 58(1)(a) of Regulation 2017/1001), there was an appreciable likelihood that a change in company strategy aimed at overcoming the obstacle could have made it possible to use the mark at issue before expiry of that period. If there was not, a proper reason for non-use should in my view be found to have existed. If there was such a likelihood, a proprietor cannot contend that there was a proper reason for non-use.

112. In the light of the foregoing, my view is that the second ground of appeal is unfounded.

VII. Conclusion

113. Having regard to the foregoing, I propose that the Court should dismiss the appeal and order the appellant to pay the costs.

( 1 ) Original language: French.

( 2 ) T‑276/16, EU:T:2017:611, ‘the judgment under appeal’.

( 3 ) Council Regulation of 26 February 2009 on the European Union trade mark (OJ 2009 L 78, p. 1).

( 4 ) Regulation of the European Parliament and of the Council of 14 June 2017 on the European Union trade mark (OJ 2017 L 154, p. 1).

( 5 ) On the equivalence of those articles, see point 23 of this Opinion.

( 6 ) Moreover, the application for revocation that gave rise to the proceedings in which the EUIPO decisions were adopted and the judgment under appeal was delivered was indeed lodged on 18 November 2013, that is to say, under Regulation No 207/2009. Nevertheless, in a similar situation, relating to the relationship between Council Regulation (EC) No 40/94 of 20 December 1993 on the Community trade mark (OJ 1994 L 11, p. 1) and Regulation No 207/2009, the Court of Justice referred to the provisions of Regulation No 207/2009, which was applicable at the time when the EUIPO decisions were adopted and, therefore, at the time when the judgment under appeal was delivered, even though the revocation proceedings in question had been commenced under Regulation 40/94. See judgment of 26 September 2013, Centrotherm Systemtechnik v centrotherm Clean Solutions, C‑609/11 P, EU:C:2013:592. The Court of Justice held, in paragraph 31 of that judgment: ‘However, since [Regulation No 207/2009] merely codified Regulation No 40/94 and the relevant provisions thereof did not undergo any amendment in the course of that codification, references will be made only to Regulation No 207/2009 in the discussion below’. See, also, Opinion of Advocate General Sharpston in Centrotherm Systemtechnik v centrotherm Clean Solutions (C‑609/11 P and C‑610/11 P, EU:C:2013:308, point 4).

( 7 ) See, by analogy, judgment of 21 February 2018, Repower v EUIPO – repowermap.org (REPOWER) (T‑727/16, EU:T:2018:88, paragraph 27).

( 8 ) Furthermore, the same applies as regards the second subparagraph of Article 18(1) of Regulation 2017/1001, which is almost identical to the second subparagraph of Article 15(1) of Regulation No 207/2009. The only difference is that the following words have been added at the end of that article in Regulation 2017/1001: ‘regardless of whether or not the trade mark in the form as used is also registered in the name of the proprietor’. In addition, recital 25 of Regulation 2017/1001 has no equivalent in Regulation No 207/2009. It reads as follows: ‘For reasons of equity and legal certainty, the use of an EU trade mark in a form that differs in elements which do not alter the distinctive character of that mark in the form in which it is registered should be sufficient to preserve the rights conferred regardless of whether the trade mark in the form as used is also registered’. However, the appellant’s situation is not the same as that described in recital 25. There is nothing to indicate that the appellant used the mark at issue in a form that differed from that in which it was registered.

( 9 ) This case will therefore not afford the Court of Justice an opportunity to rule on whether provisions of Regulation 2017/1001 that have no equivalent in its predecessor regulation apply in the context of proceedings commenced under Regulation No 207/2009. See Textilis (C‑21/18, pending before the Court of Justice) for a similar issue.

( 10 ) Order of 22 February 2018, Martín Osete v EUIPO (C‑529/17 P, not published, EU:C:2018:105).

( 11 ) See, in particular, paragraph 27 of the appeal which gave rise to the order of 22 February 2018, Martín Osete v EUIPO (C‑529/17 P, not published, EU:C:2018:105), in which the appellant criticised the General Court’s finding that ‘that the evidence provided by the [EU trade mark proprietor] relating to regulatory hurdles faced by the latter failed to (sufficiently) demonstrate that in the specified period proper reasons for non-use were at hand’. Similarly, in paragraph 29 of that appeal, the appellant stated that ‘it should be reiterated and stressed that the existence of proper reasons is nonetheless clearly demonstrated by the extensive evidence regrouped …’.

( 12 ) Judgment of 13 September 2007, Il Ponte Finanziaria v OHIM (C‑234/06 P, EU:C:2007:514, paragraph 73). To illustrate that line of case-law, the appellant also refers to the order of 27 January 2004, La Mer Technology (C‑259/02, EU:C:2004:50, paragraphs 21 and 24), and the judgment of 21 November 2013, Recaro v OHIM – Certino Mode (RECARO) (T‑524/12, not published, EU:T:2013:604, paragraphs 25 and 26).

( 13 ) The appellant is referring here to a clinical trial in the strict sense, and the acts performed as part of that trial, that is to say, delivery of over 400000 capsules bearing the mark Boswelan to a university hospital, the invoicing in respect of the products by a third party undertaking acting as intermediary, and use of the mark when recruiting participants for the trials and in relation to publicly accessible data relating to those trials.

( 14 ) See, to that effect, Opinion of Advocate General Ruiz-Jarabo Colomer in Ansul (C‑40/01, EU:C:2002:412, point 49).

( 15 ) See footnote 8 of this Opinion.

( 16 ) See, amongst others, Sitko, J.J., ‘Special Criteria of Trade Mark Protection with Regard to Pharmaceutical Products in the European Union Legal System’, International Review of Intellectual Property and Competition Law, 2014, No 6, pp. 667 and 668; Trzebiatowski, M., Obowiązek używania znaku towarowego. Studium z prawa polskiego na tle prawnoporównawczym, C.H. Beck, Warsaw 2007, pp. 147 and 148.

( 17 ) In its judgment of 24 November 1999, I ZB 17/97 (Neue Juristische Wochenschrift 2000, 1487), the Bundesgerichtshof (Federal Court of Justice, Germany) decided a similar question in the context of interpreting a German provision transposing Article 10 of First Council Directive 89/104/EEC of 21 December 1988 to approximate the laws of the Member States relating to trade marks (OJ 1989 L 40, p. 1) into domestic law. In paragraphs 18 and 19 of that judgment, that court stated that use of a mark in the context of a procedure for the licensing of medicinal products cannot be regarded as genuine use. However, it also stated that performing a prescribed authorisation procedure can, in principle, be regarded as a legitimate reason for non-use. A number of French courts, likewise, have accepted that a marketing authorisation application, which is the logical consequence of clinical trials, is a proper reason for non-use of a mark registered for a medicinal product subject to the authorisation procedure (see judgment of 1 June 1999, tribunal de grande instance de Paris (Regional Court, Paris, France), Third Chamber, Almonda Sociedade Gestora de participacoes sociais v Opfermann Arzneimittel GmbH, PIBD 1999 682 III-354). It can therefore be inferred from those judgments that use in the context of clinical trials of a mark registered for a tested product is not genuine use.

( 18 ) See, to that effect, judgment of 8 June 2017, W. F. Gözze Frottierweberei and Gözze (C‑689/15, EU:C:2017:434, paragraph 37).

( 19 ) Judgment of 15 January 2009, Silberquelle (C‑495/07, EU:C:2009:10, paragraph 18). See also judgment of 17 July 2014, Reber Holding v OHIM (C‑141/13 P, not published, EU:C:2014:2089, paragraph 32), in which the Court of Justice held that not all proven commercial exploitation can automatically qualify as ‘genuine use’ of the mark at issue.

( 20 ) Judgment of 8 June 2017, W. F. Gözze Frottierweberei and Gözze (C‑689/15, EU:C:2017:434, paragraphs 39 to 41). See, also, Opinion of Advocate General Kokott in Pandalis v EUIPO (C‑194/17 P, EU:C:2018:725, point 65).

( 21 ) Judgment of 11 March 2003 (C‑40/01, EU:C:2003:145).

( 22 ) Judgment of 11 March 2003 (C‑40/01, EU:C:2003:145).

( 23 ) Judgment of 9 December 2008 (C‑442/07, EU:C:2008:696, paragraph 23).

( 24 ) Judgment of 11 March 2003 (C‑40/01, EU:C:2003:145).

( 25 ) See, to that effect, Trzebiatowski, M., ‘Pojęcie rzeczywistego używania znaku towarowego (orzecznictwo krajowe na tle orzecznictwa wspólnotowego)’, Europejski Przegląd Sądowy, 2010, p. 22.

( 26 ) Judgment of 11 March 2003, Ansul (C‑40/01, EU:C:2003:145, paragraph 38).

( 27 ) Judgment of 11 March 2003, Ansul (C‑40/01, EU:C:2003:145, paragraph 39). See, also, order of 27 January 2004, La Mer Technology (C‑259/02, EU:C:2004:50, paragraph 23).

( 28 ) See, to that effect, judgment of 15 January 2009, Silberquelle (C‑495/07, EU:C:2009:10, paragraph 19).

( 29 ) Directive of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67).

( 30 ) Regulation of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 2004 136, p. 1).

( 31 ) Under Article 6 of Directive 2001/83, no medicinal product may be placed on the market of a Member State unless a marketing authorisation has been issued by the competent authorities of that Member State in accordance with that directive or an authorisation has been granted in accordance with Regulation No 726/2004. Similarly, it can be seen from Article 76 of Directive 2001/83 that the Member States must take all appropriate action to ensure that only medicinal products in respect of which a marketing authorisation has been granted in accordance with EU law are distributed on their territory. Regulation No 726/2004 provides in Article 3(1) that no medicinal product appearing in the annex to that regulation may be placed on the market within the European Union unless a marketing authorisation has been granted by the European Union in accordance with the provisions of that regulation. Furthermore, under Article 3(2) of that regulation, any medicinal product not appearing in the annex may be granted a marketing authorisation by the European Union in accordance with the provisions of that regulation, if: (a) the medicinal product contains a new active substance which, on the date of entry into force of that regulation, was not authorised in the European Union; or (b) the applicant shows that the medicinal product constitutes a significant therapeutic, scientific or technical innovation or that the granting of authorisation in accordance with Regulation No 726/2004 is in the interests of patients or animal health at EU level.

( 32 ) See Article 86(1) and Article 87 of Directive 2001/83.

( 33 ) See Article 2(a) 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) and Annex I to that directive in so far as it clarifies the concept of a ‘clinical trial’. See also Article 2(2)(a) of Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ 2014 L 158, p. 1).

( 34 ) See Article 9 of Directive 2001/20 and Article 4 of Regulation No 536/2014.

( 35 ) See, inter alia, Article 10 of Directive 2001/20 and Article 15 of Regulation No 536/2014.

( 36 ) See, inter alia, Article 2(e) of Directive 2001/20 and Article 2(2)(14) of Regulation No 536/2014 which, in order to determine responsibilities clearly, define a sponsor as an individual, company, institution or organisation which takes responsibility for the initiation, for the management and for setting up the financing of the clinical trial.

( 37 ) Judgment of 11 March 2003, Ansul (C‑40/01, EU:C:2003:145, paragraph 37). See also point 61 of this Opinion.

( 38 ) That is moreover also the approach that the appellant adopted in its appeal. In particular, in paragraph 17 of the appeal the appellant states that that ‘it is clear that denying any genuine use essentially on the basis of the sole argument that the product in question cannot be marketed or promoted to the public at large is incorrect’. The appellant also argues, in relation to the second part of the first ground of appeal, that, according to that judgment, there can be genuine use provided that the marketing is being prepared or is imminent. Thereafter, it asserts in relation to the second part of the first ground of appeal that, ‘irrespective of whether those conditions are satisfied in the present case, that judgment of the Court of Justice shows that there can also be genuine use even where there is no act directed at an unlimited or, at the very least, very great number of persons’. It is thus true that concepts used in relation to Directive 2001/83 do not necessarily correspond to concepts used in the context of trade mark law. Nevertheless, the appellant itself seems to believe that the concept of ‘marketing’ within the meaning of Article 6 of Directive 2001/83 corresponds to the concept of ‘marketed’ used by the Court Justice in its judgment of 11 March 2003, Ansul (C‑40/01, EU:C:2003:145).

( 39 ) Sitko, J.J., op. cit., p. 658.

( 40 ) Mosback H., ‘Protection of pharmaceutical trade marks in Europe’, Journal of Intellectual Property Law Practice, 2013, vol. 8, no 1, p. 71, and Sitko, J.J., op. cit., p. 658.

( 41 ) Mosback H., op. cit., p. 71.

( 42 ) Judgment of 11 March 2003 (C‑40/01, EU:C:2003:145, paragraph 37).

( 43 ) See also, to that effect, Opinion of Advocate General Wahl in Olainfarm (C‑104/13, EU:C:2014:342, point 25).

( 44 ) See point 69 of this Opinion.

( 45 ) See my Opinion in OHIM v Grau Ferrer (C‑597/14 P, EU:C:2016:2, point 102 and the case-law cited).

( 46 ) Judgment of 9 December 2008, Verein Radetzky-Orden (C‑442/07, EU:C:2008:696, paragraphs 16 and 17).

( 47 ) See order of 27 January 2004, La Mer Technology (C‑259/02, EU:C:2004:50, paragraph 24). See also, as regards the use of marks in the pharmaceutical sector, judgment no 13-11513 of 5 July 2017 of the commercial chamber of the Cour de cassation (Court of Cassation, France).

( 48 ) Judgment of 14 June 2007 (C‑246/05, EU:C:2007:340, paragraphs 54 and 55).

( 49 ) See paragraphs 55 to 58 and 60 of the judgment under appeal.

( 50 ) See paragraph 59 of the judgment under appeal.

( 51 ) Furthermore, as I set out above in the part of this Opinion on the admissibility of the grounds of appeal, the second ground is in my view admissible, as it relates to the nature of the circumstances that can be taken into account in order to find that an obstacle is independent of the will of the proprietor. It seems to me that the Court of Justice found a similar ground to be admissible in its judgment of 13 September 2007, Il Ponte Finanziaria v OHIM (C‑234/06 P, EU:C:2007:514, paragraph 99).

( 52 ) Judgment of 14 June 2007 (C‑246/05, EU:C:2007:340, paragraph 48).

( 53 ) Agreement on Trade-Related Aspects of Intellectual Property Rights, which is contained in Annex 1C to the Marrakesh Agreement establishing the World Trade Organisation, approved on behalf of the European Community by Council Decision 94/800/EC of 22 December 1994 concerning the conclusion on behalf of the European Community, as regards matters within its competence, of the agreements reached in the Uruguay Round multilateral negotiations (1986-1994) (OJ 1994 L 336, p. 1).

( 54 ) See point 91 of this Opinion.

( 55 ) Judgment of 14 June 2007, Häupl (C‑246/05, EU:C:2007:340, paragraph 51).

( 56 ) See, to that effect, judgment of 8 June 2017, Kaane American International Tobacco v EUIPO – Global Tobacco (GOLD MOUNT) (T‑294/16, not published, EU:T:2017:382, paragraph 42).

( 57 ) Judgment of 13 September 2007, Il Ponte Finanziaria v OHIM (C‑234/06 P, EU:C:2007:514, paragraph 102).

( 58 ) See point 69 of this Opinion.

( 59 ) See point 69 of this Opinion.

( 60 ) See point 109 of this Opinion.