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Corte di giustizia UEsentenza

Corte di giustizia UE n. 141/2016

ECLI:EU:C:2016:136
Testo integrale del provvedimento

Testo integrale del provvedimento

62015CJ0138_EN

[OSCURATO:PERSONA] part

[OSCURATO:PERSONA] C‑138/15 P,

APPEAL under [OSCURATO:PERSONA] 56 of the Statute of the [OSCURATO:PERSONA] of Justice of the [OSCURATO:PERSONA], brought on 23 March 2015, [OSCURATO:PERSONA] BV, established in Utrecht (Netherlands), [OSCURATO:PERSONA] BV, established in Utrecht, represented by K. Bacon QC, E. Mackenzie, Barrister, and G. Morgan, Solicitor, appellants, the other parties to the proceedings being: [OSCURATO:PERSONA] (EMA), represented by N. [OSCURATO:PERSONA], M. [OSCURATO:PERSONA], S. Marino and T. Jabłoński, acting as Agents, defendant at first instance, [OSCURATO:PERSONA], represented by A. Sipos and M. Šimerdová, acting as Agents, with an address for service in Luxembourg, intervener at first instance,

[OSCURATO:PERSONA] ([OSCURATO:PERSONA]),

composed of A. Arabadjiev, President of the [OSCURATO:PERSONA], J.-C.

Bonichot and C.G.

Fernlund (Rapporteur), [OSCURATO:PERSONA], [OSCURATO:PERSONA]: P. Mengozzi, Registrar: A. [OSCURATO:PERSONA], having regard to the written procedure, having decided, after hearing the [OSCURATO:PERSONA], to proceed to judgment without an Opinion, gives the following

[OSCURATO:PERSONA]

1. By their appeal, [OSCURATO:PERSONA] BV and [OSCURATO:PERSONA] BV, companies governed by Netherlands law (together, ‘the [OSCURATO:PERSONA] companies’), seek to have set aside the judgment of the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] of 22 January 2015 in [OSCURATO:PERSONA] T‑140/12 [OSCURATO:PERSONA] and [OSCURATO:PERSONA] v EMA (EU:T:2015:41) (‘the judgment under appeal’), by which that court dismissed their action for annulment of the decision of the [OSCURATO:PERSONA] (EMA) of 24 January 2012 rejecting their application to place on the market the generic version of the orphan medicinal product imatinib mesylate, in so far as concerns the therapeutic indications for the treatment of chronic myeloid leukaemia (‘the contested decision’).

Legal context [OSCURATO:PERSONA] (EC) No 141/2000

2. [OSCURATO:PERSONA] (EC) No 141/2000 of the [OSCURATO:PERSONA] and of the [OSCURATO:PERSONA] of 16 December 1999 on orphan medicinal products (OJ 2000 L 18, p. 1), as amended by [OSCURATO:PERSONA] (EC) No 596/2009 of the [OSCURATO:PERSONA] and of the [OSCURATO:PERSONA] of 18 June 2009 (OJ 2009 L 188, p. 14), lays down procedures for the designation of medicinal products as orphan medicinal products and for the marketing authorisation of such products.

3. Recital 8 of [OSCURATO:PERSONA] 141/2000 reads as follows: ‘[E]xperience in the [OSCURATO:PERSONA] of America and Japan shows that the strongest incentive for industry to invest in the development and marketing of orphan medicinal products is where there is a prospect of obtaining market exclusivity for a certain number of years during which part of the investment might be recovered; data protection under [OSCURATO:PERSONA] 4(8)(a)(iii) of [OSCURATO:PERSONA] 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products [OJ, [OSCURATO:PERSONA], 1965, p. 20] is not a sufficient incentive for that purpose; [OSCURATO:PERSONA] acting independently cannot introduce such a measure without a [OSCURATO:PERSONA] dimension as such a provision would be contradictory to [OSCURATO:PERSONA] 65/65/EEC; if such measures were adopted in an uncoordinated manner by the [OSCURATO:PERSONA], this would create obstacles to intra-[OSCURATO:PERSONA] trade, leading to distortions of competition and running counter to the single market; market exclusivity should however be limited to the therapeutic indication for which orphan medicinal product designation has been obtained, without prejudice to existing intellectual property rights; in the interest of patients, the market exclusivity granted to an orphan medicinal product should not prevent the marketing of a similar medicinal product which could be of significant benefit to those affected by the condition.’

4. [OSCURATO:PERSONA] 3(1) of [OSCURATO:PERSONA] 141/2000 is worded as follows: ‘A medicinal product shall be designated as an orphan medicinal product if its sponsor can establish: (a) that it is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting not more than five in 10 thousand persons in the [[OSCURATO:PERSONA]] when the application is made, or that it is intended for the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition in the [[OSCURATO:PERSONA]] and that without incentives it is unlikely that the marketing of the medicinal product in the [[OSCURATO:PERSONA]] would generate sufficient return to justify the necessary investment, and (b) that there exists no satisfactory method of diagnosis, prevention or treatment of the condition in question that has been authorised in the [[OSCURATO:PERSONA]] or, if such method exists, that the medicinal product will be of significant benefit to those affected by that condition.’

5. [OSCURATO:PERSONA] the procedure set out in [OSCURATO:PERSONA] 5 of [OSCURATO:PERSONA] 141/2000, a medicinal product designated as an orphan medicinal product by the [OSCURATO:PERSONA] is entered in the [OSCURATO:PERSONA] of [OSCURATO:PERSONA].

6. [OSCURATO:PERSONA] 8 of [OSCURATO:PERSONA] 141/2000 states as follows: ‘1.

Where a marketing authorisation in respect of an orphan medicinal product is granted pursuant to [[OSCURATO:PERSONA]] [OSCURATO:PERSONA] (EEC) No 2309/93 [of 22 July 1993 laying down [OSCURATO:PERSONA] procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a [OSCURATO:PERSONA] for the Evaluation of [OSCURATO:PERSONA] (OJ 1993 L 241, p. 1)] or where all the [OSCURATO:PERSONA] have granted marketing authorisations in accordance with the procedures for mutual recognition laid down in Articles 7 and 7a of [OSCURATO:PERSONA] 65/65/EEC or [OSCURATO:PERSONA] 9(4) of [OSCURATO:PERSONA] 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products [OJ 1975 L 147, p. 13], and without prejudice to intellectual property law or any other provision of [EU] law, the [[OSCURATO:PERSONA]] and the [OSCURATO:PERSONA] shall not, for a period of 10 years, accept another application for a marketing authorisation, or grant a marketing authorisation or accept an application to extend an existing marketing authorisation, for the same therapeutic indication, in respect of a similar medicinal product. …

3. By way of derogation from paragraph 1, and without prejudice to intellectual property law or any other provision of [EU] law, a marketing authorisation may be granted, for the same therapeutic indication, to a similar medicinal product if: (a) the holder of the marketing authorisation for the original orphan medicinal product has given his consent to the second applicant, or (b) the holder of the marketing authorisation for the original orphan medicinal product is unable to supply sufficient quantities of the medicinal product, or (c) the second applicant can establish in the application that the second medicinal product, although similar to the orphan medicinal product already authorised, is safer, more effective or otherwise clinically superior.

4. [OSCURATO:PERSONA] shall adopt definitions of “similar medicinal product” and “clinical superiority” in the form of an implementing [OSCURATO:PERSONA]. …’ [OSCURATO:PERSONA] (EC) No 847/2000

7. [OSCURATO:PERSONA] 3(2) of [OSCURATO:PERSONA] (EC) No 847/2000 of 27 April 2000 laying down the provisions for implementation of the criteria for designation of a medicinal product as an orphan medicinal product and definitions of the concepts ‘similar medicinal product’ and ‘clinical superiority’ (OJ 2000 L 103, p. 5) provides as follows: ‘For the purposes of the implementation of [OSCURATO:PERSONA] 3 of [OSCURATO:PERSONA] … No 141/2000 on orphan medicinal products, the following definitions shall apply: – “significant benefit” means a clinically relevant advantage or a major contribution to patient care.’ Background to the dispute

8. It is apparent from paragraphs 10 to 20 of the judgment under appeal that by decision of 14 February 2001 the [OSCURATO:PERSONA] designated imatinib mesylate (‘imatinib’) an orphan medicinal product for the treatment of chronic myeloid leukaemia (‘CML’) and entered that product in the [OSCURATO:PERSONA] of [OSCURATO:PERSONA] in accordance with [OSCURATO:PERSONA] 5(9) of [OSCURATO:PERSONA] 141/2000.

9. On 7 November 2001, the [OSCURATO:PERSONA] granted Novartis a marketing authorisation for imatinib under the commercial name Glivec for the treatment of adult patients with CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis.

Subsequently, the [OSCURATO:PERSONA] extended the terms of that marketing authorisation to cover other orphan conditions.

Pursuant to [OSCURATO:PERSONA] 8 of [OSCURATO:PERSONA] 141/2000, the period of exclusivity enjoyed by Glivec expired on 12 November 2011.

10. On 22 May 2006, the [OSCURATO:PERSONA] designated and registered as an orphan medicinal product nilotimib, a medicinal product for the treatment of CML, which was sold under the commercial name Tasigna and developed by the holder of the marketing authorisation for Glivec.

In the course of the marketing authorisation procedure for Tasigna, that holder indicated to the EMA that it consented to authorisation being granted for the marketing of that similar medicinal product for the same therapeutic indications as those covered by the marketing authorisation granted for Glivec, in accordance with [OSCURATO:PERSONA] 8(3)(a) of [OSCURATO:PERSONA] 141/2000.

11. On 19 November 20007, the [OSCURATO:PERSONA] adopted a decision authorising the marketing of Tasigna for the treatment of adult patients with CML in chronic phase and accelerated phase, with resistance or intolerance to prior treatment involving Glivec.

That decision was mentioned in the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] of 28 December 2007 (OJ 2007 C 316, p. 48).

12. On 20 December 2010, the [OSCURATO:PERSONA] extended the terms of that marketing authorisation to cover the treatment of adult patients with newly diagnosed CML in chronic phase.

The relevant decision was mentioned in the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] of 25 February 2011 (OJ 2011 C 61, p. 1).

13. On 5 January 2012, [OSCURATO:PERSONA] BV applied on behalf of [OSCURATO:PERSONA] BV for authorisation to place on the market a generic version of Glivec.

That application referred, inter alia, to certain CML therapeutic indications covered by the marketing authorisation granted for Tasigna.

14. By the contested decision, the EMA refused to grant that application, in so far as it covered the CML therapeutic indications for which Tasigna enjoyed marketing authorisation, on the ground that those therapeutic indications still enjoyed market exclusivity protection under [OSCURATO:PERSONA] 8(1) of [OSCURATO:PERSONA] 141/2000.

The procedure before the [OSCURATO:PERSONA] and the judgment under appeal

15. On 28 March 2012, the [OSCURATO:PERSONA] companies brought an action for the annulment of the contested decision.

16. By order of the President of the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] of 6 September 2012, the [OSCURATO:PERSONA] was granted leave to intervene in support of the EMA.

17. By the judgment under appeal, the [OSCURATO:PERSONA] dismissed the [OSCURATO:PERSONA] companies’ action and ordered them to pay the costs. Forms of order sought by the parties

18. [OSCURATO:PERSONA] companies claim that the [OSCURATO:PERSONA] should set aside the judgment under appeal, annul the contested decision and order the EMA to pay the costs.

19. The EMA and the [OSCURATO:PERSONA] contend that the [OSCURATO:PERSONA] should dismiss the appeal and order the [OSCURATO:PERSONA] companies to pay the costs.

The appeal The first part of the single ground of appeal, alleging that the [OSCURATO:PERSONA] erred in law in its interpretation of the conditions for the application of the ten-year market exclusivity period Arguments of the parties

20. [OSCURATO:PERSONA] takes issue with the [OSCURATO:PERSONA] interpretation of [OSCURATO:PERSONA] 141/2000 in paragraph 78 of the judgment under appeal and does not accept that a marketing authorisation granted pursuant to [OSCURATO:PERSONA] 8(3) of that regulation can enjoy a period of market exclusivity under [OSCURATO:PERSONA] 8(1) of the regulation.

That interpretation fails to take account of the aim of [OSCURATO:PERSONA] 8(3) of the regulation, which is to protect a similar medicinal product notwithstanding the market exclusivity provided for in [OSCURATO:PERSONA] 8(1).

As it constitutes a derogation, [OSCURATO:PERSONA] 8(3) should be construed narrowly; it cannot be interpreted as conferring the right to market exclusivity provided for in [OSCURATO:PERSONA] 8(1).

21. Moreover, the [OSCURATO:PERSONA] interpretation is contrary to the scheme of [OSCURATO:PERSONA] 8 of [OSCURATO:PERSONA] 141/2000. [OSCURATO:PERSONA] 8(1) is intended to provide a reward for the first orphan medicinal product authorised for a particular indication, that reward taking the form of market exclusivity.

The notion of exclusivity implies a status that may be enjoyed by only one product.

If the legislature had intended to confer market exclusivity on several medicinal products at the same time, it would have so stated in an express provision, as is apparent from the [OSCURATO:PERSONA] to the Proposal for a [OSCURATO:PERSONA] and [OSCURATO:PERSONA] (EC) on orphan medicinal products submitted by the [OSCURATO:PERSONA] on 28 July 1998 (OJ 1998 C 276, p. 7).

22. [OSCURATO:PERSONA] companies maintain that the [OSCURATO:PERSONA] interpretation is, in certain respects, conflicting.

In particular, [OSCURATO:PERSONA] 8(3)(a) of [OSCURATO:PERSONA] 141/2000 expressly provides that a medicinal product may be authorised with the consent of the holder of the marketing authorisation for the original orphan medicinal product.

They observe, however, that if the [OSCURATO:PERSONA] has already granted to a third party a marketing authorisation for a second similar orphan medicinal product which independently enjoys a period of market exclusivity, the provisions of [OSCURATO:PERSONA] 8(1) and 8(3) will be in direct conflict.

23. The holder of the marketing authorisation for the original orphan medicinal product would be denied the possibility of consenting to the placing on the market of the product in question, whereas the consent of the holder of the authorisation for the second medicinal product wou ld be required.

Where the marketing authorisation holders are independent entities, it is unlikely in practice that such consent would be forthcoming. [OSCURATO:PERSONA] companies submit that the holder of the marketing authorisation for the second medicinal product would also be denied the possibility of consenting to a subsequent marketing authorisation application for a similar medicinal product, as that application would then be in conflict with the market exclusivity enjoyed by the original product.

24. The fact that [OSCURATO:PERSONA] 8 gives no indication as to how those conflicts could be resolved shows that the legislature did not envisage such situations.

25. The EMA and the [OSCURATO:PERSONA] contend that [OSCURATO:PERSONA] 8(1) of [OSCURATO:PERSONA] 141/2000 is applicable to any medicinal product designated an orphan product in accordance with the criteria laid down in [OSCURATO:PERSONA] 3 of the regulation.

Findings of the [OSCURATO:PERSONA]

26. It should be noted that in paragraph 78 of the judgment under appeal the [OSCURATO:PERSONA] found that ‘the marketing authorisation granted for an orphan medicinal product in respect of the same therapeutic indications as those for which the original orphan product was authorised, including on one of the grounds laid down in [OSCURATO:PERSONA] 8(3) of [OSCURATO:PERSONA] 141/2000, automatically confers on that product the ten-year period of market exclusivity provided for in [OSCURATO:PERSONA] 8(1) of that regulation’.

27. It should be recalled in that connection that, in order to provide the pharmaceutical industry with an incentive to sponsor the research, development and marketing of orphan medicinal products, [OSCURATO:PERSONA] 141/2000 offers the sponsors of such products the prospect of obtaining market exclusivity for a certain number of years.

In line with that objective, referred to in recital 8 of the regulation, [OSCURATO:PERSONA] 8(1) thereof provides that ‘where a marketing authorisation in respect of an orphan medicinal product is granted … the [[OSCURATO:PERSONA]] and the [OSCURATO:PERSONA] shall not, for a period of 10 years, accept another application for a marketing authorisation, or grant a marketing authorisation or accept an application to extend an existing marketing authorisation, for the same therapeutic indication, in respect of a similar medicinal product’.

28. As is apparent from recital 8 of [OSCURATO:PERSONA] 141/2000, that regulation nevertheless seeks to circumscribe that period of exclusivity in order not to prejudice existing intellectual property rights and, in the interests of patients, not to prevent the marketing of a medicinal product similar to the orphan product which could be of significant benefit to those affected by the condition in question.

29. [OSCURATO:PERSONA], [OSCURATO:PERSONA] 8(3) of [OSCURATO:PERSONA] 141/2000 provides that it is possible to derogate from the ten-year exclusivity period and grant marketing authorisation for a similar medicinal product in respect of the same therapeutic indication and to do so in three cases, namely (i) where the holder of the marketing authorisation for the original orphan product consents or (ii) is unable to supply sufficient quantities of the medicinal product and (iii) where the second applicant can establish that his product, ‘although similar to the orphan medicinal product already authorised, is safer, more effective or otherwise clinically superior’.

30. None of the provisions referred to above expressly provides that a marketing authorisation granted on the basis of [OSCURATO:PERSONA] 8(3) of [OSCURATO:PERSONA] 141/2000 is to be denied the benefit of the ten-year period of exclusivity provided for in [OSCURATO:PERSONA] 8(1) of the regulation. [OSCURATO:PERSONA] was therefore entitled to state, in paragraph 73 of the judgment under appeal, that there is nothing in that provision concerning whether the authorisation referred to in [OSCURATO:PERSONA] 8(3) of the regulation confers market exclusivity on a similar medicinal product and, in paragraph 78 of the judgment, that there is nothing in the regulation to suggest that application of [OSCURATO:PERSONA] 8(3) precludes the application of [OSCURATO:PERSONA] 8(1).

31. It is also apparent from the factors referred to above that although the market exclusivity provided in [OSCURATO:PERSONA] 8(1) of [OSCURATO:PERSONA] 141/2000 is reserved for orphan medicinal products alone, the derogations exhaustively set out in [OSCURATO:PERSONA] 8(3) of the regulation relate to any similar medicinal product within the meaning of [OSCURATO:PERSONA] 847/2000, irrespective of whether or not the product is an orphan product.

As the [OSCURATO:PERSONA] was correct to observe in paragraph 80 of the judgment under appeal, [OSCURATO:PERSONA] 141/2000 does not contain any provision under which it is possible not to apply the ten-year period of market exclusivity to orphan medicinal products that have been granted marketing authorisation for certain therapeutic indications, with the exception of the situations set out in [OSCURATO:PERSONA] 8(2) of the regulation.

As a consequence, where a similar medicinal product that has been granted marketing authorisation under [OSCURATO:PERSONA] 8(3) of [OSCURATO:PERSONA] 141/2000 is an orphan product, it enjoys the market exclusivity provided in [OSCURATO:PERSONA] 8(1) of the regulation.

32. Contrary to the contentions of the [OSCURATO:PERSONA] companies, that interpretation is neither illogical nor at odds with the purpose or scheme of [OSCURATO:PERSONA] 8 of [OSCURATO:PERSONA] 141/2000.

Paragraphs 1 and 3 of [OSCURATO:PERSONA] 8 of the regulation, although complementary, are different in scope and purpose.

The fact that an orphan medicinal product enjoys the period of market exclusivity provided in [OSCURATO:PERSONA] 8(1) of [OSCURATO:PERSONA] 141/2000 does not preclude a second, similar product which has been authorised in accordance with [OSCURATO:PERSONA] 8(3) of the regulation being granted, in turn, market exclusivity, as long as it also fulfils the requirements set out in [OSCURATO:PERSONA] 3(1) of the regulation for designation as an orphan medicinal product.

33. [OSCURATO:PERSONA] was therefore correct to state, in paragraph 80 of the judgment under appeal, that it is precisely in order to ensure attainment of the objective pursued by [OSCURATO:PERSONA] 141/2000 — namely to encourage investment in the research, development and marketing of orphan medicinal products — that market exclusivity must be granted in all cases in which an orphan product has been given marketing authorisation.

34. It follows from all the above considerations that the first part of the single ground of appeal is unfounded and must be rejected.

The second part of the single ground of appeal, alleging that the [OSCURATO:PERSONA] erred in law in its interpretation of the term of the market exclusivity period Arguments of the parties

35. [OSCURATO:PERSONA] companies dispute the [OSCURATO:PERSONA] finding in paragraph 74 of the judgment under appeal that ‘if [the similar product] is an orphan medicinal product, the ten-year period of market exclusivity with which it is endowed by virtue of [OSCURATO:PERSONA] 8(1) of the regulation cannot be curtailed as a result of the fact that there exists an orphan medicinal product which has received marketing authorisation for the same therapeutic indications and which benefits from market exclusivity for those indications’ and that ‘similarly, the market exclusivity attaching to that product will not be extended as a result of the fact that marketing authorisation has been granted for the second medicinal product’.

36. [OSCURATO:PERSONA] companies consider that interpretation to be clearly at odds with the objective of [OSCURATO:PERSONA] 8 of [OSCURATO:PERSONA] 141/2000 as it would lead, in practice, to the prolongation of the market exclusivity period beyond its ten-year term. [OSCURATO:PERSONA], they claim that if the marketing authorisation had been granted for Tasigna on 11 November 2011, that interpretation would have the effect of conferring market exclusivity until 11 November 2021, that is, for a period of 20 years, during which no generic version could be placed on the market.

Such an extension of the market exclusivity period is particularly unjustified, given that it would not have been possible if Tasigna had represented a development that was sufficiently novel not be regarded as a similar product within the meaning of [OSCURATO:PERSONA] 847/2000.

Paradoxically, the effect of the contested decision would therefore be that a generic version of Glivec could not enjoy market exclusivity after the grant to Novartis of a marketing authorisation for a different product, whereas that company would have the benefit of market exclusivity for a similar medicinal product.

That analysis would create ‘perverse’ incentives for undertakings to develop a series of slightly different, but nevertheless similar, orphan products, thereby benefiting from a prolongation of the period of market exclusivity, which is normally limited to 10 years.

37. The EMA and the [OSCURATO:PERSONA] submit that there is no formal extension of the market exclusivity period of the first orphan medicinal product.

The authorisation of any subsequent similar orphan product would have no impact on the decision to remove the first product from the [OSCURATO:PERSONA] of [OSCURATO:PERSONA] at the end of the ten-year exclusivity period.

Findings of the [OSCURATO:PERSONA]

38. As observed in paragraph 31 above, where a similar medicinal product that has been granted marketing authorisation under [OSCURATO:PERSONA] 8(3) of [OSCURATO:PERSONA] 141/2000 is an orphan medicinal product, it enjoys the market exclusivity provided in [OSCURATO:PERSONA] 8(1) of the regulation.

In line with the objective pursued by [OSCURATO:PERSONA] 141/2000, which is to provide the pharmaceutical industry with an incentive to sponsor the research, development and marketing of orphan medicinal products by granting them a period of market exclusivity, [OSCURATO:PERSONA] 8(1) of the regulation does not provide for any exception to the duration of that period or for any modification of the period. [OSCURATO:PERSONA] was therefore entitled to find, in paragraph 70 of the judgment under appeal, that ‘no provision [is] made for any extension of that period, which may be reduced, under [OSCURATO:PERSONA] 8(2) of [OSCURATO:PERSONA] 141/2000, only in situations in which it is established that the medicinal product in question no longer meets the requirements laid down in [OSCURATO:PERSONA] 3(1) of the regulation’.

39. [OSCURATO:PERSONA] did not therefore err in law in finding, in paragraph 74 of the judgment under appeal, that the ten-year period of market exclusivity with which an orphan medicinal product is endowed by virtue of [OSCURATO:PERSONA] 8(1) of [OSCURATO:PERSONA] 141/2000 ‘cannot be curtailed as a result of the fact that there exists an orphan medicinal product which has received marketing authorisation for the same therapeutic indications and which benefits from market exclusivity for those indications’ and that ‘similarly, the market exclusivity attaching to that product will not be extended as a result of the fact that marketing authorisation has been granted for the [similar] medicinal product’.

40. It follows from all the foregoing considerations that the second part of the single ground of appeal is unfounded and must be rejected.

The third part of the single ground of appeal, alleging that the [OSCURATO:PERSONA] failed to examine the alternative case put forward by the [OSCURATO:PERSONA] companies Arguments of the parties

41. [OSCURATO:PERSONA] companies take issue with the [OSCURATO:PERSONA] on the ground that it distorted the meaning of its alternative case and failed to address that case.

According to paragraph 79 of the judgment under appeal, those companies had argued that ‘if a second, similar orphan medicinal product which has been granted marketing authorisation for the same therapeutic indications as those for which the marketing of the original orphan product was authorised may benefit from a ten-year period of market exclusivity that is independent of that enjoyed by the original orphan product, that period of exclusivity could operate only to prevent marketing authorisation being granted for products that are similar to the second medicinal product’.

42. [OSCURATO:PERSONA] companies contend that that description is not an accurate reflection of paragraphs 42 to 44 of the application which they submitted to the [OSCURATO:PERSONA] or of paragraph 38 of their reply, in which they submitted that the market exclusivity granted to a second medicinal product should prevent only the authorisation of products that are similar to the second product, while not being similar to the first orphan product.

Even if [OSCURATO:PERSONA] 8 of [OSCURATO:PERSONA] 141/2000 may be construed as providing, in principle, an independent period of market exclusivity for the second product, there should be an exception to that market exclusivity so as to permit the authorisation of a generic version of the first product, once the period of exclusivity for that first product has expired.

43. The EMA questions whether the third part of the single ground of appeal is admissible, in that it relates to an appraisal of the facts.

The EMA maintains, like the [OSCURATO:PERSONA], that this part of the ground of appeal is in any event unfounded as the [OSCURATO:PERSONA] did not distort the [OSCURATO:PERSONA] companies’ written pleadings.

Findings of the [OSCURATO:PERSONA]

44. It is apparent from paragraph 42 of the judgment under appeal that the [OSCURATO:PERSONA] companies maintain that the market exclusivity enjoyed by a second orphan medicinal product does not preclude marketing authorisation being granted for a product that is similar to the first orphan product.

In paragraph 58 of the judgment under appeal, the [OSCURATO:PERSONA] stated that the applicants submitted, in the alternative, that even if a similar orphan medicinal product authorised under the derogation in [OSCURATO:PERSONA] 8(3) of [OSCURATO:PERSONA] 141/2000 may benefit from an independent ten-year period of market exclusivity, that second period of exclusivity would preclude only authorisation for the marketing of products that are similar to the second orphan product and that such a period of exclusivity cannot operate to prevent marketing authorisation being granted for medicinal products that are similar to the first authorised orphan product, in particular generic versions of that product, after the expiry of the period of market exclusivity attaching to the first orphan product.

In thus setting out the [OSCURATO:PERSONA] companies’ arguments referred to in paragraph 42 above, the [OSCURATO:PERSONA] did not distort those arguments.

45. As those arguments were rejected on the grounds set out in paragraph 79 of the judgment under appeal, the [OSCURATO:PERSONA] cannot be criticised for failing to rule on the arguments.

46. It follows that the third part of the single ground of appeal is clearly unfounded. The appeal must therefore be dismissed. Costs

47. [OSCURATO:PERSONA] 138(1) of the Rules of Procedure, applicable to the procedure on appeal pursuant to [OSCURATO:PERSONA] 184(1) of those rules, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings.

48. Since the EMA has applied for costs against the [OSCURATO:PERSONA] companies and the [OSCURATO:PERSONA] companies have been unsuccessful, they must be ordered to bear their own costs and pay the costs incurred by the EMA.

49. In accordance with [OSCURATO:PERSONA] 140(1) of the Rules of Procedure, applicable to the procedure on appeal pursuant to [OSCURATO:PERSONA] 184(1) of those rules, the [OSCURATO:PERSONA], which intervened in the proceedings, is to be ordered to bear its own costs. [OSCURATO:PERSONA] part On those grounds, the [OSCURATO:PERSONA] ([OSCURATO:PERSONA]) hereby:

1. Dismisses the appeal.

2. [OSCURATO:PERSONA] BV and [OSCURATO:PERSONA] BV to bear their own costs and to pay the costs incurred by the [OSCURATO:PERSONA] (EMA).

3. [OSCURATO:PERSONA] the [OSCURATO:PERSONA] to bear its own costs.

Anonimizzato ex art. 52 D.Lgs. 196/2003
62015CJ0138_EN [OSCURATO:PERSONA] part [OSCURATO:PERSONA] C‑138/15 P, APPEAL under [OSCURATO:PERSONA] 56 of the Statute of the [OSCURATO:PERSONA] of Justice of the [OSCURATO:PERSONA], brought on 23 March 2015, [OSCURATO:PERSONA] BV, established in Utrecht (Netherlands), [OSCURATO:PERSONA] BV, established in Utrecht, represented by K. Bacon QC, E. Mackenzie, Barrister, and G. Morgan, Solicitor, appellants, the other parties to the proceedings being: [OSCURATO:PERSONA] (EMA), represented by N. [OSCURATO:PERSONA], M. [OSCURATO:PERSONA], S. Marino and T. Jabłoński, acting as Agents, defendant at first instance, [OSCURATO:PERSONA], represented by A. Sipos and M. Šimerdová, acting as Agents, with an address for service in Luxembourg, intervener at first instance, [OSCURATO:PERSONA] ([OSCURATO:PERSONA]), composed of A. Arabadjiev, President of the [OSCURATO:PERSONA], J.-C. Bonichot and C.G. Fernlund (Rapporteur), [OSCURATO:PERSONA], [OSCURATO:PERSONA]: P. Mengozzi, Registrar: A. [OSCURATO:PERSONA], having regard to the written procedure, having decided, after hearing the [OSCURATO:PERSONA], to proceed to judgment without an Opinion, gives the following [OSCURATO:PERSONA] 1. By their appeal, [OSCURATO:PERSONA] BV and [OSCURATO:PERSONA] BV, companies governed by Netherlands law (together, ‘the [OSCURATO:PERSONA] companies’), seek to have set aside the judgment of the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] of 22 January 2015 in [OSCURATO:PERSONA] T‑140/12 [OSCURATO:PERSONA] and [OSCURATO:PERSONA] v EMA (EU:T:2015:41) (‘the judgment under appeal’), by which that court dismissed their action for annulment of the decision of the [OSCURATO:PERSONA] (EMA) of 24 January 2012 rejecting their application to place on the market the generic version of the orphan medicinal product imatinib mesylate, in so far as concerns the therapeutic indications for the treatment of chronic myeloid leukaemia (‘the contested decision’). Legal context [OSCURATO:PERSONA] (EC) No 141/2000 2. [OSCURATO:PERSONA] (EC) No 141/2000 of the [OSCURATO:PERSONA] and of the [OSCURATO:PERSONA] of 16 December 1999 on orphan medicinal products (OJ 2000 L 18, p. 1), as amended by [OSCURATO:PERSONA] (EC) No 596/2009 of the [OSCURATO:PERSONA] and of the [OSCURATO:PERSONA] of 18 June 2009 (OJ 2009 L 188, p. 14), lays down procedures for the designation of medicinal products as orphan medicinal products and for the marketing authorisation of such products. 3. Recital 8 of [OSCURATO:PERSONA] 141/2000 reads as follows: ‘[E]xperience in the [OSCURATO:PERSONA] of America and Japan shows that the strongest incentive for industry to invest in the development and marketing of orphan medicinal products is where there is a prospect of obtaining market exclusivity for a certain number of years during which part of the investment might be recovered; data protection under [OSCURATO:PERSONA] 4(8)(a)(iii) of [OSCURATO:PERSONA] 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products [OJ, [OSCURATO:PERSONA], 1965, p. 20] is not a sufficient incentive for that purpose; [OSCURATO:PERSONA] acting independently cannot introduce such a measure without a [OSCURATO:PERSONA] dimension as such a provision would be contradictory to [OSCURATO:PERSONA] 65/65/EEC; if such measures were adopted in an uncoordinated manner by the [OSCURATO:PERSONA], this would create obstacles to intra-[OSCURATO:PERSONA] trade, leading to distortions of competition and running counter to the single market; market exclusivity should however be limited to the therapeutic indication for which orphan medicinal product designation has been obtained, without prejudice to existing intellectual property rights; in the interest of patients, the market exclusivity granted to an orphan medicinal product should not prevent the marketing of a similar medicinal product which could be of significant benefit to those affected by the condition.’ 4. [OSCURATO:PERSONA] 3(1) of [OSCURATO:PERSONA] 141/2000 is worded as follows: ‘A medicinal product shall be designated as an orphan medicinal product if its sponsor can establish: (a) that it is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting not more than five in 10 thousand persons in the [[OSCURATO:PERSONA]] when the application is made, or that it is intended for the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition in the [[OSCURATO:PERSONA]] and that without incentives it is unlikely that the marketing of the medicinal product in the [[OSCURATO:PERSONA]] would generate sufficient return to justify the necessary investment, and (b) that there exists no satisfactory method of diagnosis, prevention or treatment of the condition in question that has been authorised in the [[OSCURATO:PERSONA]] or, if such method exists, that the medicinal product will be of significant benefit to those affected by that condition.’ 5. [OSCURATO:PERSONA] the procedure set out in [OSCURATO:PERSONA] 5 of [OSCURATO:PERSONA] 141/2000, a medicinal product designated as an orphan medicinal product by the [OSCURATO:PERSONA] is entered in the [OSCURATO:PERSONA] of [OSCURATO:PERSONA]. 6. [OSCURATO:PERSONA] 8 of [OSCURATO:PERSONA] 141/2000 states as follows: ‘1. Where a marketing authorisation in respect of an orphan medicinal product is granted pursuant to [[OSCURATO:PERSONA]] [OSCURATO:PERSONA] (EEC) No 2309/93 [of 22 July 1993 laying down [OSCURATO:PERSONA] procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a [OSCURATO:PERSONA] for the Evaluation of [OSCURATO:PERSONA] (OJ 1993 L 241, p. 1)] or where all the [OSCURATO:PERSONA] have granted marketing authorisations in accordance with the procedures for mutual recognition laid down in Articles 7 and 7a of [OSCURATO:PERSONA] 65/65/EEC or [OSCURATO:PERSONA] 9(4) of [OSCURATO:PERSONA] 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products [OJ 1975 L 147, p. 13], and without prejudice to intellectual property law or any other provision of [EU] law, the [[OSCURATO:PERSONA]] and the [OSCURATO:PERSONA] shall not, for a period of 10 years, accept another application for a marketing authorisation, or grant a marketing authorisation or accept an application to extend an existing marketing authorisation, for the same therapeutic indication, in respect of a similar medicinal product. … 3. By way of derogation from paragraph 1, and without prejudice to intellectual property law or any other provision of [EU] law, a marketing authorisation may be granted, for the same therapeutic indication, to a similar medicinal product if: (a) the holder of the marketing authorisation for the original orphan medicinal product has given his consent to the second applicant, or (b) the holder of the marketing authorisation for the original orphan medicinal product is unable to supply sufficient quantities of the medicinal product, or (c) the second applicant can establish in the application that the second medicinal product, although similar to the orphan medicinal product already authorised, is safer, more effective or otherwise clinically superior. 4. [OSCURATO:PERSONA] shall adopt definitions of “similar medicinal product” and “clinical superiority” in the form of an implementing [OSCURATO:PERSONA]. …’ [OSCURATO:PERSONA] (EC) No 847/2000 7. [OSCURATO:PERSONA] 3(2) of [OSCURATO:PERSONA] (EC) No 847/2000 of 27 April 2000 laying down the provisions for implementation of the criteria for designation of a medicinal product as an orphan medicinal product and definitions of the concepts ‘similar medicinal product’ and ‘clinical superiority’ (OJ 2000 L 103, p. 5) provides as follows: ‘For the purposes of the implementation of [OSCURATO:PERSONA] 3 of [OSCURATO:PERSONA] … No 141/2000 on orphan medicinal products, the following definitions shall apply: – “significant benefit” means a clinically relevant advantage or a major contribution to patient care.’ Background to the dispute 8. It is apparent from paragraphs 10 to 20 of the judgment under appeal that by decision of 14 February 2001 the [OSCURATO:PERSONA] designated imatinib mesylate (‘imatinib’) an orphan medicinal product for the treatment of chronic myeloid leukaemia (‘CML’) and entered that product in the [OSCURATO:PERSONA] of [OSCURATO:PERSONA] in accordance with [OSCURATO:PERSONA] 5(9) of [OSCURATO:PERSONA] 141/2000. 9. On 7 November 2001, the [OSCURATO:PERSONA] granted Novartis a marketing authorisation for imatinib under the commercial name Glivec for the treatment of adult patients with CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. Subsequently, the [OSCURATO:PERSONA] extended the terms of that marketing authorisation to cover other orphan conditions. Pursuant to [OSCURATO:PERSONA] 8 of [OSCURATO:PERSONA] 141/2000, the period of exclusivity enjoyed by Glivec expired on 12 November 2011. 10. On 22 May 2006, the [OSCURATO:PERSONA] designated and registered as an orphan medicinal product nilotimib, a medicinal product for the treatment of CML, which was sold under the commercial name Tasigna and developed by the holder of the marketing authorisation for Glivec. In the course of the marketing authorisation procedure for Tasigna, that holder indicated to the EMA that it consented to authorisation being granted for the marketing of that similar medicinal product for the same therapeutic indications as those covered by the marketing authorisation granted for Glivec, in accordance with [OSCURATO:PERSONA] 8(3)(a) of [OSCURATO:PERSONA] 141/2000. 11. On 19 November 20007, the [OSCURATO:PERSONA] adopted a decision authorising the marketing of Tasigna for the treatment of adult patients with CML in chronic phase and accelerated phase, with resistance or intolerance to prior treatment involving Glivec. That decision was mentioned in the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] of 28 December 2007 (OJ 2007 C 316, p. 48). 12. On 20 December 2010, the [OSCURATO:PERSONA] extended the terms of that marketing authorisation to cover the treatment of adult patients with newly diagnosed CML in chronic phase. The relevant decision was mentioned in the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] of 25 February 2011 (OJ 2011 C 61, p. 1). 13. On 5 January 2012, [OSCURATO:PERSONA] BV applied on behalf of [OSCURATO:PERSONA] BV for authorisation to place on the market a generic version of Glivec. That application referred, inter alia, to certain CML therapeutic indications covered by the marketing authorisation granted for Tasigna. 14. By the contested decision, the EMA refused to grant that application, in so far as it covered the CML therapeutic indications for which Tasigna enjoyed marketing authorisation, on the ground that those therapeutic indications still enjoyed market exclusivity protection under [OSCURATO:PERSONA] 8(1) of [OSCURATO:PERSONA] 141/2000. The procedure before the [OSCURATO:PERSONA] and the judgment under appeal 15. On 28 March 2012, the [OSCURATO:PERSONA] companies brought an action for the annulment of the contested decision. 16. By order of the President of the [OSCURATO:PERSONA] of the [OSCURATO:PERSONA] of 6 September 2012, the [OSCURATO:PERSONA] was granted leave to intervene in support of the EMA. 17. By the judgment under appeal, the [OSCURATO:PERSONA] dismissed the [OSCURATO:PERSONA] companies’ action and ordered them to pay the costs. Forms of order sought by the parties 18. [OSCURATO:PERSONA] companies claim that the [OSCURATO:PERSONA] should set aside the judgment under appeal, annul the contested decision and order the EMA to pay the costs. 19. The EMA and the [OSCURATO:PERSONA] contend that the [OSCURATO:PERSONA] should dismiss the appeal and order the [OSCURATO:PERSONA] companies to pay the costs. The appeal The first part of the single ground of appeal, alleging that the [OSCURATO:PERSONA] erred in law in its interpretation of the conditions for the application of the ten-year market exclusivity period Arguments of the parties 20. [OSCURATO:PERSONA] takes issue with the [OSCURATO:PERSONA] interpretation of [OSCURATO:PERSONA] 141/2000 in paragraph 78 of the judgment under appeal and does not accept that a marketing authorisation granted pursuant to [OSCURATO:PERSONA] 8(3) of that regulation can enjoy a period of market exclusivity under [OSCURATO:PERSONA] 8(1) of the regulation. That interpretation fails to take account of the aim of [OSCURATO:PERSONA] 8(3) of the regulation, which is to protect a similar medicinal product notwithstanding the market exclusivity provided for in [OSCURATO:PERSONA] 8(1). As it constitutes a derogation, [OSCURATO:PERSONA] 8(3) should be construed narrowly; it cannot be interpreted as conferring the right to market exclusivity provided for in [OSCURATO:PERSONA] 8(1). 21. Moreover, the [OSCURATO:PERSONA] interpretation is contrary to the scheme of [OSCURATO:PERSONA] 8 of [OSCURATO:PERSONA] 141/2000. [OSCURATO:PERSONA] 8(1) is intended to provide a reward for the first orphan medicinal product authorised for a particular indication, that reward taking the form of market exclusivity. The notion of exclusivity implies a status that may be enjoyed by only one product. If the legislature had intended to confer market exclusivity on several medicinal products at the same time, it would have so stated in an express provision, as is apparent from the [OSCURATO:PERSONA] to the Proposal for a [OSCURATO:PERSONA] and [OSCURATO:PERSONA] (EC) on orphan medicinal products submitted by the [OSCURATO:PERSONA] on 28 July 1998 (OJ 1998 C 276, p. 7). 22. [OSCURATO:PERSONA] companies maintain that the [OSCURATO:PERSONA] interpretation is, in certain respects, conflicting. In particular, [OSCURATO:PERSONA] 8(3)(a) of [OSCURATO:PERSONA] 141/2000 expressly provides that a medicinal product may be authorised with the consent of the holder of the marketing authorisation for the original orphan medicinal product. They observe, however, that if the [OSCURATO:PERSONA] has already granted to a third party a marketing authorisation for a second similar orphan medicinal product which independently enjoys a period of market exclusivity, the provisions of [OSCURATO:PERSONA] 8(1) and 8(3) will be in direct conflict. 23. The holder of the marketing authorisation for the original orphan medicinal product would be denied the possibility of consenting to the placing on the market of the product in question, whereas the consent of the holder of the authorisation for the second medicinal product wou ld be required. Where the marketing authorisation holders are independent entities, it is unlikely in practice that such consent would be forthcoming. [OSCURATO:PERSONA] companies submit that the holder of the marketing authorisation for the second medicinal product would also be denied the possibility of consenting to a subsequent marketing authorisation application for a similar medicinal product, as that application would then be in conflict with the market exclusivity enjoyed by the original product. 24. The fact that [OSCURATO:PERSONA] 8 gives no indication as to how those conflicts could be resolved shows that the legislature did not envisage such situations. 25. The EMA and the [OSCURATO:PERSONA] contend that [OSCURATO:PERSONA] 8(1) of [OSCURATO:PERSONA] 141/2000 is applicable to any medicinal product designated an orphan product in accordance with the criteria laid down in [OSCURATO:PERSONA] 3 of the regulation. Findings of the [OSCURATO:PERSONA] 26. It should be noted that in paragraph 78 of the judgment under appeal the [OSCURATO:PERSONA] found that ‘the marketing authorisation granted for an orphan medicinal product in respect of the same therapeutic indications as those for which the original orphan product was authorised, including on one of the grounds laid down in [OSCURATO:PERSONA] 8(3) of [OSCURATO:PERSONA] 141/2000, automatically confers on that product the ten-year period of market exclusivity provided for in [OSCURATO:PERSONA] 8(1) of that regulation’. 27. It should be recalled in that connection that, in order to provide the pharmaceutical industry with an incentive to sponsor the research, development and marketing of orphan medicinal products, [OSCURATO:PERSONA] 141/2000 offers the sponsors of such products the prospect of obtaining market exclusivity for a certain number of years. In line with that objective, referred to in recital 8 of the regulation, [OSCURATO:PERSONA] 8(1) thereof provides that ‘where a marketing authorisation in respect of an orphan medicinal product is granted … the [[OSCURATO:PERSONA]] and the [OSCURATO:PERSONA] shall not, for a period of 10 years, accept another application for a marketing authorisation, or grant a marketing authorisation or accept an application to extend an existing marketing authorisation, for the same therapeutic indication, in respect of a similar medicinal product’. 28. As is apparent from recital 8 of [OSCURATO:PERSONA] 141/2000, that regulation nevertheless seeks to circumscribe that period of exclusivity in order not to prejudice existing intellectual property rights and, in the interests of patients, not to prevent the marketing of a medicinal product similar to the orphan product which could be of significant benefit to those affected by the condition in question. 29. [OSCURATO:PERSONA], [OSCURATO:PERSONA] 8(3) of [OSCURATO:PERSONA] 141/2000 provides that it is possible to derogate from the ten-year exclusivity period and grant marketing authorisation for a similar medicinal product in respect of the same therapeutic indication and to do so in three cases, namely (i) where the holder of the marketing authorisation for the original orphan product consents or (ii) is unable to supply sufficient quantities of the medicinal product and (iii) where the second applicant can establish that his product, ‘although similar to the orphan medicinal product already authorised, is safer, more effective or otherwise clinically superior’. 30. None of the provisions referred to above expressly provides that a marketing authorisation granted on the basis of [OSCURATO:PERSONA] 8(3) of [OSCURATO:PERSONA] 141/2000 is to be denied the benefit of the ten-year period of exclusivity provided for in [OSCURATO:PERSONA] 8(1) of the regulation. [OSCURATO:PERSONA] was therefore entitled to state, in paragraph 73 of the judgment under appeal, that there is nothing in that provision concerning whether the authorisation referred to in [OSCURATO:PERSONA] 8(3) of the regulation confers market exclusivity on a similar medicinal product and, in paragraph 78 of the judgment, that there is nothing in the regulation to suggest that application of [OSCURATO:PERSONA] 8(3) precludes the application of [OSCURATO:PERSONA] 8(1). 31. It is also apparent from the factors referred to above that although the market exclusivity provided in [OSCURATO:PERSONA] 8(1) of [OSCURATO:PERSONA] 141/2000 is reserved for orphan medicinal products alone, the derogations exhaustively set out in [OSCURATO:PERSONA] 8(3) of the regulation relate to any similar medicinal product within the meaning of [OSCURATO:PERSONA] 847/2000, irrespective of whether or not the product is an orphan product. As the [OSCURATO:PERSONA] was correct to observe in paragraph 80 of the judgment under appeal, [OSCURATO:PERSONA] 141/2000 does not contain any provision under which it is possible not to apply the ten-year period of market exclusivity to orphan medicinal products that have been granted marketing authorisation for certain therapeutic indications, with the exception of the situations set out in [OSCURATO:PERSONA] 8(2) of the regulation. As a consequence, where a similar medicinal product that has been granted marketing authorisation under [OSCURATO:PERSONA] 8(3) of [OSCURATO:PERSONA] 141/2000 is an orphan product, it enjoys the market exclusivity provided in [OSCURATO:PERSONA] 8(1) of the regulation. 32. Contrary to the contentions of the [OSCURATO:PERSONA] companies, that interpretation is neither illogical nor at odds with the purpose or scheme of [OSCURATO:PERSONA] 8 of [OSCURATO:PERSONA] 141/2000. Paragraphs 1 and 3 of [OSCURATO:PERSONA] 8 of the regulation, although complementary, are different in scope and purpose. The fact that an orphan medicinal product enjoys the period of market exclusivity provided in [OSCURATO:PERSONA] 8(1) of [OSCURATO:PERSONA] 141/2000 does not preclude a second, similar product which has been authorised in accordance with [OSCURATO:PERSONA] 8(3) of the regulation being granted, in turn, market exclusivity, as long as it also fulfils the requirements set out in [OSCURATO:PERSONA] 3(1) of the regulation for designation as an orphan medicinal product. 33. [OSCURATO:PERSONA] was therefore correct to state, in paragraph 80 of the judgment under appeal, that it is precisely in order to ensure attainment of the objective pursued by [OSCURATO:PERSONA] 141/2000 — namely to encourage investment in the research, development and marketing of orphan medicinal products — that market exclusivity must be granted in all cases in which an orphan product has been given marketing authorisation. 34. It follows from all the above considerations that the first part of the single ground of appeal is unfounded and must be rejected. The second part of the single ground of appeal, alleging that the [OSCURATO:PERSONA] erred in law in its interpretation of the term of the market exclusivity period Arguments of the parties 35. [OSCURATO:PERSONA] companies dispute the [OSCURATO:PERSONA] finding in paragraph 74 of the judgment under appeal that ‘if [the similar product] is an orphan medicinal product, the ten-year period of market exclusivity with which it is endowed by virtue of [OSCURATO:PERSONA] 8(1) of the regulation cannot be curtailed as a result of the fact that there exists an orphan medicinal product which has received marketing authorisation for the same therapeutic indications and which benefits from market exclusivity for those indications’ and that ‘similarly, the market exclusivity attaching to that product will not be extended as a result of the fact that marketing authorisation has been granted for the second medicinal product’. 36. [OSCURATO:PERSONA] companies consider that interpretation to be clearly at odds with the objective of [OSCURATO:PERSONA] 8 of [OSCURATO:PERSONA] 141/2000 as it would lead, in practice, to the prolongation of the market exclusivity period beyond its ten-year term. [OSCURATO:PERSONA], they claim that if the marketing authorisation had been granted for Tasigna on 11 November 2011, that interpretation would have the effect of conferring market exclusivity until 11 November 2021, that is, for a period of 20 years, during which no generic version could be placed on the market. Such an extension of the market exclusivity period is particularly unjustified, given that it would not have been possible if Tasigna had represented a development that was sufficiently novel not be regarded as a similar product within the meaning of [OSCURATO:PERSONA] 847/2000. Paradoxically, the effect of the contested decision would therefore be that a generic version of Glivec could not enjoy market exclusivity after the grant to Novartis of a marketing authorisation for a different product, whereas that company would have the benefit of market exclusivity for a similar medicinal product. That analysis would create ‘perverse’ incentives for undertakings to develop a series of slightly different, but nevertheless similar, orphan products, thereby benefiting from a prolongation of the period of market exclusivity, which is normally limited to 10 years. 37. The EMA and the [OSCURATO:PERSONA] submit that there is no formal extension of the market exclusivity period of the first orphan medicinal product. The authorisation of any subsequent similar orphan product would have no impact on the decision to remove the first product from the [OSCURATO:PERSONA] of [OSCURATO:PERSONA] at the end of the ten-year exclusivity period. Findings of the [OSCURATO:PERSONA] 38. As observed in paragraph 31 above, where a similar medicinal product that has been granted marketing authorisation under [OSCURATO:PERSONA] 8(3) of [OSCURATO:PERSONA] 141/2000 is an orphan medicinal product, it enjoys the market exclusivity provided in [OSCURATO:PERSONA] 8(1) of the regulation. In line with the objective pursued by [OSCURATO:PERSONA] 141/2000, which is to provide the pharmaceutical industry with an incentive to sponsor the research, development and marketing of orphan medicinal products by granting them a period of market exclusivity, [OSCURATO:PERSONA] 8(1) of the regulation does not provide for any exception to the duration of that period or for any modification of the period. [OSCURATO:PERSONA] was therefore entitled to find, in paragraph 70 of the judgment under appeal, that ‘no provision [is] made for any extension of that period, which may be reduced, under [OSCURATO:PERSONA] 8(2) of [OSCURATO:PERSONA] 141/2000, only in situations in which it is established that the medicinal product in question no longer meets the requirements laid down in [OSCURATO:PERSONA] 3(1) of the regulation’. 39. [OSCURATO:PERSONA] did not therefore err in law in finding, in paragraph 74 of the judgment under appeal, that the ten-year period of market exclusivity with which an orphan medicinal product is endowed by virtue of [OSCURATO:PERSONA] 8(1) of [OSCURATO:PERSONA] 141/2000 ‘cannot be curtailed as a result of the fact that there exists an orphan medicinal product which has received marketing authorisation for the same therapeutic indications and which benefits from market exclusivity for those indications’ and that ‘similarly, the market exclusivity attaching to that product will not be extended as a result of the fact that marketing authorisation has been granted for the [similar] medicinal product’. 40. It follows from all the foregoing considerations that the second part of the single ground of appeal is unfounded and must be rejected. The third part of the single ground of appeal, alleging that the [OSCURATO:PERSONA] failed to examine the alternative case put forward by the [OSCURATO:PERSONA] companies Arguments of the parties 41. [OSCURATO:PERSONA] companies take issue with the [OSCURATO:PERSONA] on the ground that it distorted the meaning of its alternative case and failed to address that case. According to paragraph 79 of the judgment under appeal, those companies had argued that ‘if a second, similar orphan medicinal product which has been granted marketing authorisation for the same therapeutic indications as those for which the marketing of the original orphan product was authorised may benefit from a ten-year period of market exclusivity that is independent of that enjoyed by the original orphan product, that period of exclusivity could operate only to prevent marketing authorisation being granted for products that are similar to the second medicinal product’. 42. [OSCURATO:PERSONA] companies contend that that description is not an accurate reflection of paragraphs 42 to 44 of the application which they submitted to the [OSCURATO:PERSONA] or of paragraph 38 of their reply, in which they submitted that the market exclusivity granted to a second medicinal product should prevent only the authorisation of products that are similar to the second product, while not being similar to the first orphan product. Even if [OSCURATO:PERSONA] 8 of [OSCURATO:PERSONA] 141/2000 may be construed as providing, in principle, an independent period of market exclusivity for the second product, there should be an exception to that market exclusivity so as to permit the authorisation of a generic version of the first product, once the period of exclusivity for that first product has expired. 43. The EMA questions whether the third part of the single ground of appeal is admissible, in that it relates to an appraisal of the facts. The EMA maintains, like the [OSCURATO:PERSONA], that this part of the ground of appeal is in any event unfounded as the [OSCURATO:PERSONA] did not distort the [OSCURATO:PERSONA] companies’ written pleadings. Findings of the [OSCURATO:PERSONA] 44. It is apparent from paragraph 42 of the judgment under appeal that the [OSCURATO:PERSONA] companies maintain that the market exclusivity enjoyed by a second orphan medicinal product does not preclude marketing authorisation being granted for a product that is similar to the first orphan product. In paragraph 58 of the judgment under appeal, the [OSCURATO:PERSONA] stated that the applicants submitted, in the alternative, that even if a similar orphan medicinal product authorised under the derogation in [OSCURATO:PERSONA] 8(3) of [OSCURATO:PERSONA] 141/2000 may benefit from an independent ten-year period of market exclusivity, that second period of exclusivity would preclude only authorisation for the marketing of products that are similar to the second orphan product and that such a period of exclusivity cannot operate to prevent marketing authorisation being granted for medicinal products that are similar to the first authorised orphan product, in particular generic versions of that product, after the expiry of the period of market exclusivity attaching to the first orphan product. In thus setting out the [OSCURATO:PERSONA] companies’ arguments referred to in paragraph 42 above, the [OSCURATO:PERSONA] did not distort those arguments. 45. As those arguments were rejected on the grounds set out in paragraph 79 of the judgment under appeal, the [OSCURATO:PERSONA] cannot be criticised for failing to rule on the arguments. 46. It follows that the third part of the single ground of appeal is clearly unfounded. The appeal must therefore be dismissed. Costs 47. [OSCURATO:PERSONA] 138(1) of the Rules of Procedure, applicable to the procedure on appeal pursuant to [OSCURATO:PERSONA] 184(1) of those rules, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. 48. Since the EMA has applied for costs against the [OSCURATO:PERSONA] companies and the [OSCURATO:PERSONA] companies have been unsuccessful, they must be ordered to bear their own costs and pay the costs incurred by the EMA. 49. In accordance with [OSCURATO:PERSONA] 140(1) of the Rules of Procedure, applicable to the procedure on appeal pursuant to [OSCURATO:PERSONA] 184(1) of those rules, the [OSCURATO:PERSONA], which intervened in the proceedings, is to be ordered to bear its own costs. [OSCURATO:PERSONA] part On those grounds, the [OSCURATO:PERSONA] ([OSCURATO:PERSONA]) hereby: 1. Dismisses the appeal. 2. [OSCURATO:PERSONA] BV and [OSCURATO:PERSONA] BV to bear their own costs and to pay the costs incurred by the [OSCURATO:PERSONA] (EMA). 3. [OSCURATO:PERSONA] the [OSCURATO:PERSONA] to bear its own costs.
Sentenza Corte di giustizia UE n. 141/2016 — Fons Iuris — Fons Iuris