1. 

In the context of national proceedings concerning issues relating to the patentability of pharmaceutical products and arising as a result of the entry into force of the Agreement on Trade-Related Aspects of Intellectual Property Rights (‘the TRIPs Agreement’), ( 2 ) the Court of Justice has the opportunity to rule on the scope of the exclusive competence of the European Union in matters relating to the common commercial policy (Article 3(1)(e) TFEU), now that that policy includes, pursuant to Article 207(1) TFEU, ‘the commercial aspects of intellectual property’.

2. 

I consider that the central question raised by this case is whether the above expression, in that it is now a matter within the exclusive competence of the European Union, presently applies in a way which is different from that in which it previously applied, in the context of Article 133 TFEU.

3. 

In much more specific terms, the issue which arises is whether or not the rule laid down in Merck Genéricos, ( 3 ) according to which the Member States remain ‘principally competent’ in matters governed by the TRIPs Agreement, is valid.

4. 

The remaining questions referred are raised solely in the event that it is concluded that the Merck Genéricos rule is no longer valid. In so far as I consider that those questions are clearly less problematic, I shall focus my analysis on the first question.

5. 

Since I am aware of the extraordinary interpretative difficulty that this question raises, as will be seen, I shall ultimately propose that the Court’s answer to the Polimeles Protodikio Athinon should be that the matters governed by Article 27 of the TRIPs Agreement (‘patentable subject-matter’), as European Union law now stands, have not fallen within the scope of the ‘commercial aspects of intellectual property’ within the meaning of Article 207(1) TFEU, with resulting consequences concerning jurisdiction to interpret that provision.

6. 

In the alternative, and in the event that the Court reaches the conclusion that, ultimately, it is now for the Court to interpret Article 27 of the TRIPs Agreement, I shall propose that the Court, in accordance with its settled case-law, reinforced in this case by the nature of the obligation contained in that provision, should rule that that provision does not have direct effect.

7. 

Even so, and in the event that the Court should accept the reasons for changing its case-law, I shall still propose that the Court should rule that a patent on a production process for a pharmaceutical product does not in addition acquire the nature of a pharmaceutical product patent by the mere fact that at the time of filing the production patent, when a prohibition on patenting pharmaceutical products was in force, the application also covered the product patent itself.

8. 

Finally, whatever the interpretation provided by the Court and as regards the temporal effect of its ruling, I shall suggest that that interpretation, in view of the particular features of the case, should have no effect in situations which are the outcome of a final court judgment.

9.

Article 27 of the TRIPs Agreement, under the heading ‘Patentable Subject-matter’, provides:

‘1.   Subject to the provisions of paragraphs 2 and 3, patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application. Subject to paragraph 4 of Article 65, paragraph 8 of Article 70 and paragraph 3 of this Article, patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced.

2.   Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law.

3.   Members may also exclude from patentability:

10.

For its part, and under the heading ‘Protection of Existing Subject-matter’, Article 70 of the TRIPs Agreement provides:

‘1.   This Agreement does not give rise to obligations in respect of acts which occurred before the date of application of the Agreement for the Member in question.

2.   Except as otherwise provided for in this Agreement, this Agreement gives rise to obligations in respect of all subject-matter existing at the date of application of this Agreement for the Member in question, and which is protected in that Member on the said date, or which meets or comes subsequently to meet the criteria for protection under the terms of this Agreement. …

…

6.   Members shall not be required to apply Article 31, or the requirement in paragraph 1 of Article 27 that patent rights shall be enjoyable without discrimination as to the field of technology, to use without the authorisation of the right holder where authorisation for such use was granted by the government before the date this Agreement became known.

7.   In the case of intellectual property rights for which protection is conditional upon registration, applications for protection which are pending on the date of application of this Agreement for the Member in question shall be permitted to be amended to claim any enhanced protection provided under the provisions of this Agreement. Such amendments shall not include new matter.

8.   Where a Member does not make available as of the date of entry into force of the WTO Agreement patent protection for pharmaceutical and agricultural chemical products commensurate with its obligations under Article 27, that Member shall:

11.

The Hellenic Republic ratified the Convention on the Grant of European Patents (‘the EPC’) in 1986, making a reservation, for the purposes of Article 167(2)(a) of the EPC, in relation to pharmaceutical products. Pursuant to Article 167(3) of the EPC, that reservation expired on 7 October 1992.

12.

In 1995 the Hellenic Republic also ratified the TRIPs Agreement.

13.

The field of patents is also governed in Greece by Law No 1733/1987 on technology transfer, inventions, technological innovation and the establishment of an atomic energy commission, which entered into force on 22 April 1987.

14.

Article 5 of Law No 1733/1987 provides that products, processes and industrial applications are patentable, and under Article 7 of that law it is for the applicant to state which of those is the subject-matter of the protection sought.

15.

In accordance with Article 11 of Law No 1733/1987, the term of a patent is 20 years and commences on the day after the filing of the patent application.

16.

Article 25(3) of Law No 1733/1987 provided that, while the reservation made by Greece under Article 167(2)(a) of the EPC was in force, European patents would not be granted for pharmaceutical products.

17.

The Greek courts have interpreted Law No 1733/1987 to the effect that it prohibited the granting of national patents for pharmaceutical products and allowed patents to be granted only to protect the invention of a production process for a pharmaceutical product. That restriction already existed under Law No 2527/1920, which preceded Law No 1733/1987, and ended on 7 October 1992.

18.

Daiichi Sankyo Co. Ltd. (‘Daiichi Sankyo’) is a company based in Tokyo (Japan) which has held a national patent granted in Greece on 21 October 1986 relating to the chemical compound ‘levofloxacin hemihydrate’, which is used as an active ingredient in antibiotic treatments. The patent application, filed on 20 June 1986, sought protection for both the compound itself and its production process.

19.

The patent, which expired on 20 June 2006, was extended by a supplementary protection certificate (‘SPC’) pursuant to Regulation No 1768/92. Under Article 13 of that regulation, the validity of the SPC could not exceed five years, with the result that the protection accorded to Daiichi Sankyo ended in 2011.

20.

‘Levofloxacin hemihydrate’ is used as the active ingredient in an original medicinal product called ‘TAVANIC’; the German company Sanofi-Aventis Deutschland GmbH (‘Sanofi-Aventis’) has marketing authorisation to distribute that medicinal product in Greece. That authorisation, which covers original pharmaceutical products containing the active ingredient ‘levofloxacin hemihydrate’, was granted by the competent Greek authorities on 17 February 1999.

21.

On 22 September 2008 and 22 July 2009, those authorities granted the Greek pharmaceutical company DEMO AVEE Farmakon (‘DEMO’) authorisation to place on the market generic pharmaceutical products containing the active ingredient ‘levofloxacin hemihydrate’. DEMO marketed such products under the name ‘TALERIN’.

22.

On 23 September 2009 Daiichi Sankyo and Sanofi-Aventis brought an action against DEMO before the referring court, seeking the cessation of all marketing by DEMO of the product TALERIN or any other product containing the active ingredient ‘levofloxacin hemihydrate’ until the date of expiry of the SPC.

23.

In the course of the proceedings brought by Daiichi Sankyo and Sanofi-Aventis, the Polimeles Protodikio Athinon referred the following questions:

24.

The referring court explains that the resolution of the dispute brought before it depends on whether Daiichi Sankyo’s patent covers only the production process for the active ingredient ‘levofloxacin hemihydrate’ (the ‘production process for the pharmaceutical product’) or also covers active ingredient itself (the ‘pharmaceutical product’). In the second case, it would be sufficient for the plaintiffs in the main proceedings to establish that TAVANIC and TALERIN have the same active ingredient. If, on the other hand, the protected subject-matter is the procedure, the fact that both pharmaceutical products have the same active ingredient would only raise the presumption that the generic product was manufactured using the process protected by the patent, and DEMO could rebut that presumption if it showed that its product was manufactured using a different process.

25.

The Polimeles Protodikio Athinon notes that pharmaceutical products were not patentable in Greece before 7 October 1992, so that the patent granted to Daiichi Sankyo in 1986 did not initially protect the active ingredient ‘levofloxacin hemihydrate’ as such. In its view, however, this does not preclude the possibility that the patentability of pharmaceutical products imposed by Article 27 of the TRIPs Agreement means that the active ingredient in dispute has been protected by Daiichi Sankyo’s patent since the entry into force of that agreement, an issue on which there is disagreement between the Greek courts.

26.

The request for a preliminary ruling was received by the Court Registry on 8 August 2011.

27.

Written observations were submitted by Daiichi Sankyo and DEMO, and also by the United Kingdom, Greek, Italian and Portuguese Governments and the Commission.

28.

At the hearing, held on 5 June 2012, written observations were presented by the attending representatives of Daiichi Sankyo, the German, United Kingdom, Finnish, Greek, Netherlands, Portuguese, Spanish and Swedish Governments and the Commission. In the notice of the hearing, the parties had been invited to comment on the Commission’s statement in its written observations which is referred to in point 30 of this Opinion.

29.

Although it did not raise a plea of admissibility, DEMO claims that the main proceedings have become devoid of purpose, since both the patent and the SPC have expired.

30.

In relation to the first question raised, all the parties, except the Commission, argued in their written observations that Article 27 of the TRIPs Agreement relates to a field in which the Member States continue to have primary competence, so that whether it has direct application depends on the outcome in each case under the relevant national law. That view, based on the rule established in Merck Genéricos, ( 4 ) is not shared by the Commission, which argues that the basis of that rule has changed with the entry into force of the TFEU, Article 207 of which refers to ‘the commercial aspects of intellectual property’ (the very subject-matter of the TRIPs Agreement) as one of the elements on which the common commercial policy is based. That would mean that the European Union now has a competence which it lacked at the time of the Merck Genéricos ruling and, accordingly, that it is for the European Union to determine whether or not Article 27 of the TRIPs Agreement has direct effect. According to the Commission, that is a question which must be answered in the negative, in the light of the case-law of the Court of Justice concerning the WTO Agreement.

31.

The parties having been requested to comment on that issue at the hearing, Daiichi Sankyo and the German, United Kingdom, Finnish, Greek, Netherlands, Portuguese and Swedish Governments opposed the position adopted by the Commission. Essentially, all the Governments concurred that, beyond its title, the TRIPs Agreement has a subject-matter which is broader than ‘the commercial aspects of intellectual property’ as referred to in Article 207 TFEU. Accordingly, they take the view that it is necessary to examine on a case-by-case basis the subject-matter dealt with in each of its provisions, since the subject-matter of Articles 27 and 70 of the TRIPs Agreement relates to substantive patent law rather than the commercial aspects of intellectual property. In their view, therefore, the situation in terms of legislation and competence has not altered from that which obtained at the time of Merck Genéricos, so the rule which was applied then should also be applied now. The Commission, for its part, argued that since the Lisbon Treaty the European Union has had exclusive competence in relation to the subject-matter of the TRIPs Agreement.

32.

With regard to the second question, Daiichi Sankyo and the United Kingdom, Greek, Italian and Portuguese Governments argue that it unambiguously follows from the wording of Article 27 of the TRIPs Agreement that, subject to the exceptions provided for in that provision, a pharmaceutical product as such may be patentable. The Commission, for its part, argues that, if that provision is held to be applicable, the Court should rule that pharmaceutical and chemical products are patentable if they fulfil the general conditions for the grant of a patent and that those products enjoy the extended protection which is set out in Article 28 of the TRIPs Agreement.

33.

Finally, in relation to the last question, Daiichi Sankyo argues that it follows from a combined reading of Articles 27(1) and 70(2) of the TRIPs Agreement that patents existing at the time of the entry into force of that agreement protect, from that date, pharmaceutical products for which protection was sought in the applications for such patents. For their part, DEMO and the Greek Government consider that both provisions must be interpreted as meaning that a patent existing prior to the entry into force of the TRIPs Agreement is governed by the rules of that agreement from its entry into force, but that the agreement does not cover a pharmaceutical product which was never protected. The Italian Government argues that patents relating to pharmaceutical products and granted before 7 February 1992 but which, on account of the reservation referred to in Article 167(2) of the EPC, were granted only to protect their production process, enjoy, following the entry into force of that agreement, the protection – for the products and the processes – provided for all patents under the TRIPs Agreement. To that effect, the Italian Government argues that it will be necessary to examine in each case the content of the relevant application. The Portuguese Government submits that the protection conferred by a patent is determined by the content of its application, and that, apart from in the case of Article 70(7) of the TRIPs Agreement, it is not possible to seek an a posteriori extension of the protection initially sought. Accordingly, a patent on a process granted prior to the TRIPs Agreement cannot afterwards become a product patent, and any claim of a product patent while the reservation under Article 167(2)(a) of the EPC was in force is inadmissible. The United Kingdom Government argues that, in view of the lack of substantive legislation of the European Union in that regard, the Court of Justice lacks jurisdiction to interpret, from the point of view of substantive law, Article 27 of the TRIPs Agreement. In the alternative, it argues that, in the circumstances of the case, Article 70 of the TRIPs Agreement does not allow the patent to be extended to the product as such. Finally, the Commission considers that, since the TRIPs Agreement does not have direct effect, its entry into force has not had the effect of automatically extending to products the protection granted to processes.

34.

The Polimeles Protodikio Athinon asks the Court of Justice, first, whether Article 27 of the TRIPs Agreement ‘fall[s] within a field for which the Member States continue to have primary competence’. In the event that it does, the national court then asks whether or not the Member States can accord direct effect to that provision. For their part, the second and third questions relate specifically to the interpretation of the content and the effects of Articles 27 and 70 of the TRIPs Agreement, so that by raising them the referring court proceeds on the assumption that the answer to the first question will be in the negative; that is to say that Article 27 of the TRIPs Agreement falls within a field for which competence now lies not with the Member States but with the European Union.

35.

In my view, the three questions raise three very specific issues. First, there is the issue of the effect of Article 207 TFEU on the interpretative jurisdiction of the Court of Justice with respect to the TRIPs Agreement. The national court refers to that issue when asking whether Article 27 of the TRIPs Agreement falls within a field for which competence now lies not with the Member States but with the European Union. As has been stated in point 31 above, the Commission’s arguments in that respect led the Court to request that the parties express their views at the hearing on the effect of the new Article 207 TFEU with regard to jurisdiction to interpret the TRIPs Agreement.

36.

Secondly, I am of the opinion that the question concerning the possibility that chemical and pharmaceutical products are patentable under Article 27 of the TRIPs Agreement should be reformulated. The reason is that, as the parties pointed out, it is a question which, as worded, raises no difficulties. However, the question implicitly contains a more significant issue, namely the issue of the direct effect of the WTO Agreements. More precisely, as we shall see, the use of the term ‘direct effect’ once again raises, in fact, the issue of whether the WTO Agreements ‘may be relied upon’ in European Union law.

37.

Thirdly and finally, and a question directly relating to the matter at issue in the main proceedings, the Court is asked whether, as a direct result of the TRIPs Agreement, a person should be regarded as having also acquired a product patent where, at the material time, he applied for a manufacturing patent and a pharmaceutical product patent but only obtained the manufacturing patent because the then applicable legislation allowed nothing more. The question is, ultimately, what is meant by ‘subject-matter existing at the time of entry into force of the TRIPs Agreement’ for the purposes of Article 70(2) of that agreement?

38.

Without expressly raising a plea of admissibility against this request for a preliminary ruling, DEMO pointed out that, since both Daiichi Sankyo’s patent and the SPC have expired, the main proceedings have, in its view, become devoid of purpose, so that, whatever the response of the Court, it will not substantially affect the decision finally taken by the referring court.

39.

This may be countered by the fact that, as stated in the order for reference, the national legislation provides for the possibility that, where a patent infringement has been established, the patent holder may claim compensation for the damage suffered. That fact alone would be sufficient to consider that this question is not irrelevant, since the answer to the questions raised by the Greek court must allow it at least to determine whether there has been a patent infringement capable of forming the basis of a claim for damages. Accordingly, the Court must give a ruling not only on an ongoing infringement, but also on an infringement which, though it may have been committed in the past, caused damage for which the injured party may seek reparation using a right which continues to exist beyond the expiry of the legal title which entitled him, as against third parties, to rely on the protection conferred by patent law.

40.

As I have already had occasion to point out, what is, in essence, in dispute in these proceedings is the extent to which the matters governed by the TRIPs agreement – and therefore the interpretation of the relevant law – now fall within the exclusive competence for commercial policy in so far as they constitute ‘commercial aspects of intellectual property’ (Article 207(1) TFEU). Put succinctly, according to the Commission, those matters fall entirely, almost by definition, within the scope of that article. According to the Member States, on the contrary, only a separate examination of the content of the various components of the agreement will make it possible to determine whether they should be classified as ‘commercial aspects’: in any event, according to the Member States, both Article 27 (‘protected subject-matter’) and as a consequence Article 70 (‘existing subject-matter’) of the TRIPs Agreement would be excluded from that classification.

41.

It is undisputed that, at the time of the entry into force of the Lisbon Treaty, jurisdiction to interpret the TRIPs Agreement, whether that of the Court of Justice or that of the national courts, was determined on the basis of whether the specific subject-matter at issue fell within the European Union’s sphere of competence or the Member States’ area of competence. ( 5 ) That rule, established in the Court’s case-law since Hermès, ( 6 ) and continuously upheld until Merck Genéricos, has meant that the complexity of the system of distribution of competences prevailing between the European Union and the Member States has necessarily been carried over into the area of jurisdiction. ( 7 )

42.

Addressing that issue directly, the Court recently ruled, in paragraph 34 of Merck Genéricos, that Article 33 of the TRIPs Agreement – and the same could have been said with regard to many other articles thereof – ‘forms part of a sphere in which, at this point in the development of [European Union] law, the Member States remain principally competent’. ( 8 ) Moreover, it need hardly be stated that the present problem arises not because European Union law on intellectual property has, through harmonisation, changed significantly compared to the situation obtaining when that judgment was delivered, which is not the case, but as a result of the change established by the Treaty of Lisbon in relation to the treatment of the ‘commercial aspects of intellectual property’.

43.

The problem having thus been set out, it must be stated that, in particular at the time of the oral hearing and as I have just pointed out, two opposing positions have emerged: the Commission’s position, on the one hand (‘the single dissenting voice’, according to the representative of the Portuguese Republic at the hearing), and the position of the Member States appearing in these proceedings, on the other.

44.

Expressed very succinctly, the Member States’ approach is that the Lisbon Treaty has in no way changed the existing status of intellectual property as a shared competence, now as an element contained in Article 4(2)(a) TFEU (‘internal market’), a harmonised subject-matter to a greater or lesser degree (Article 114 TFEU), which is now covered by additional provisions, including, in particular, one which establishes a unified patent (Article 118 TFEU).

45.

In that context, Article 207(1) TFEU raises to the status of an exclusive competence, forming part of the common commercial policy, the commercial aspects of intellectual property, which are understood as being an entirely determinable part of the rules governing that subject-matter, which in any event does not include the contents of Article 27 of the TRIPs Agreement. The shared competence of the Member States in that regard remains, moreover, expressly guaranteed by Article 207(6) TFEU, which contains an express prohibition on harmonisation where not permitted by the Treaty.

46.

For its part, the Commission’s approach is that the wording of Article 207(1) TFEU constitutes a reference, implicit but no less clear, to the subject-matter governed by the TRIPs Agreement: such a striking parallelism between the wording of Article 207 TFEU and the title of the agreement practically leads to that conclusion. Essentially, its argument is simply that it is impossible to imagine that the European Union legislature had any intention other than that of raising to the status of exclusive competence of the European Union an area of substantive law, the ‘commercial aspects of industrial property’, which was provided for in a very different way by Article 133 EC. ( 9 ) Accordingly, what the TRIPs Agreement covers – and, it should be added, what it may cover – ‘is’ipso facto a ‘commercial aspect of intellectual property’ within the meaning of Article 207(1) TFEU. Moreover, the Commission does not seem to see in that approach any particular problem as regards the nature of the shared competence for intellectual property as such.

47.

It must here be pointed out that, generally speaking, the Commission’s approach has independent support in the legal literature, which, moreover, often uses the same argument, that is to say that it is obvious. ( 10 )

48.

I think that, before undertaking an analysis of each of the those conflicting positions, it is appropriate to recall, if only in a very basic way, first, what constitutes intellectual property law and, secondly, what the TRIPs Agreement governs or contains, or simply ‘is’.

49.

Starting with the first issue, and as the Court ruled in Opinion 1/94, ( 11 )‘[i]ntellectual property rights enable those holding them to prevent third parties from carrying out certain acts. The power to prohibit the use of a trade mark, the manufacture of a product, the copying of a design or the reproduction of a book, a disc or a videocassette inevitably has effects on trade. Intellectual property rights are moreover specifically designed to produce such effects’ (point 57).

50.

However, it is necessary at this point to note that the law governing that intellectual property is not confined to those effects, but, by necessity, also includes its legislative organisation in the form of rights recognised and guaranteed by the legal system. In other words, the economic effect of a legal provision is preceded, as a separate reality, by the establishment of the provision itself and the determination of its status. ( 12 )

51.

With regard to the second issue, that is to say what the TRIPs Agreement ‘is’, it must be agreed that the TRIPs Agreement is an international agreement which lays down minimum requirements concerning intellectual property law. As may be readily acknowledged, the signatories to the agreement established a number of agreed essential elements in the field of law of intellectual property. In that regard, many of its provisions are essential components of any intellectual property legislation, national or otherwise. ( 13 )

52.

Of course, the TRIPs Agreement clearly also contains a number of provisions expressly relating to the trade in goods. The Member States cited some of them at the oral hearing. What must be emphasised is that those provisions constitute neither the core nor the most relevant part of the TRIPs Agreement. In any event, the latter provisions raise no difficulties. It is unlikely that the European Union will be challenged concerning its exclusive competence under the common commercial policy to agree such provisions, and it is not necessary for Article 207(1) TFEU to make any in that regard.

53.

The problem lies in the substantive, or even ‘undeniably’ substantive, provisions of any intellectual property law which such treaties almost inevitably contain: in the case of the TRIPs Agreement, it must be agreed that such provisions constitute its core and, it ought almost be said, its ‘essence’.

54.

In that regard, I think it is now possible to point out that, at least to some degree and to some extent, that type of provision explains precisely why Article 207(1) TFEU contains the wording which is at issue here. As I have just noted, no reform of primary law is needed to justify the European Union’s competence to subscribe to general provisions relating to external trade.

55.

Having set out the relevant positions and the issues they raise, I shall now put forward my own analysis. In that regard, and from the outset, my assessment is that the Member States and the Commission are both correct.

56.

The Member States are correct in that the argument of the Commission is, as a nominalist argument, clearly unsatisfactory. Certainly, the minimal textual differences between the wording of Article 207(1) TFEU and the name of the agreement cannot invalidate the Commission’s approach, ( 14 ) but only invalidate the force of that approach.

57.

Furthermore, that argument is not sufficiently strong to address the consequences of the approach. In the first place, in so far as it means that the scope of an exclusive competence of the European Union would be determined by the present or prospective content of a particular international agreement, or by others having a similar content, that argument would have to be opposed almost on principle.

58.

I think it should be beyond dispute that the concept of ‘commercial aspects of intellectual property’ within the meaning of Article 207(1) TFEU must be an autonomous concept of European Union law and that the Court must be independently responsible for its interpretation, instead of its meaning being determined, in a more or less stable or consistent way, by the agreements to which the European Union is a party (whether the TRIPs Agreement or other similar ones). The difficulty which developing that concept undeniably raises is a separate matter: that task will from the outset require the abandonment of any abstract or ex ante definition. Instead, the concept must be developed gradually, as I shall attempt to propose in this case.

59.

Secondly, the Commission’s argument is insufficient in that it effectively disregards what a systematic interpretation of the rule makes immediately apparent: intellectual property is a shared competence and must remain so, not only under the provisions of primary law, as is the case, but also, of course, as regards its interpretation.

60.

Furthermore, it is clear that the comprehensive and immediate inclusion of the field governed by the TRIPs Agreement in the concept of ‘commercial aspects’ tends to bring the core of industrial property law within the European Union’s exclusive competence, allowing it to effect a type of ‘indirect’ harmonisation or even ‘to deactivate’ the shared competence. Moreover, subject to what is set out below, understanding the provision as an exclusive ‘external’ competence, capable of existing alongside a shared ‘internal’ competence, leads only to a dead end.

61.

By confining the analysis in so far as possible, that is to say to the content of Article 27 of the TRIPs Agreement, it is clear that that provision, concerning the definition of the protected subject-matter, and also the following one, concerning the ‘rights conferred’, form a core part of any substantive rules on intellectual property, the effect and content of which must above all be defined and specified. Regulating ‘patentable subject-matter’, as does Article 27 of the TRIPs Agreement, is, in my view, to deal with an aspect of intellectual property which is directly concerned with establishing legal rules governing the rights in that special property which a legal system recognises and guarantees. If that is a ‘commercial aspect’ and an exclusive competence, this certainly has an effect on the shared competence of the Member States. ( 15 )

62.

The Member States are correct, then, in arguing that not all of the matters covered by the TRIPs Agreement, and in particular the contents of Article 27 thereof, are the exclusive competence of the European Union. In that regard, it is difficult not to provide the answer that, in essence, the rule in Merck Genéricos continues to be valid.

63.

However, the Commission is also correct or, in any event, is not incorrect. Of course, the argument that something ‘is obvious’ is always somewhat unsatisfactory. However, the very fact that an institution such as the Commission, supported by the legal literature and using terms of rhetoric, argues that its approach seems ‘obvious’ must have some weight.

64.

In my effort to see the ‘obvious’, I must start by recognising that that peculiar expression ‘commercial aspects’ would not have entered primary law had an international agreement entitled the ‘TRIPs’ Agreement not existed for over a decade. In other words, the link between the wording of Article 207(1) TFEU and the wording of the TRIPs Agreement is very powerful as an idea.

65.

It must also be recognised that in departing from the safe ground of ‘reference’, that is to say reference to the TRIPs Agreement, the interpretative difficulties are formidable. Although it has been accepted that the concept of ‘commercial aspects’ must necessarily extend beyond the scope of specifically commercial provisions and fall within the scope of substantive provisions, eliminating from them the most essential ones will be difficult, because they are the ones which are most important. In an international agreement laying down minimum requirements on the identity and nature of intellectual property, the issues which are necessarily addressed will not be collateral issues. In that regard, there can be no better example than the TRIPs Agreement.

66.

In view of the foregoing, the effectiveness of the wording reproduced would strongly support the idea that some substantive rules of intellectual property included in such agreements are based on the wording of the article in question. In short, Article 207(1) TFEU must add something to what was there previously. Furthermore, I think that that ‘something’ relates to the substantive provisions of intellectual property law which may, none the less, occasionally assume a ‘strategic’ position, on account of their impact on trade.

67.

From that perspective also, it would be impossible to exclude matters such as those governed by Article 27 of the TRIPs Agreement (protected subject-matter) from the scope of Article 207(1) TFEU without to some extent undermining the effectiveness of the provision.

68.

The paradoxes of the situation which arises will now be summarised. The significance to international trade of a particular substantive provision is not in itself capable of justifying the European Union’s exclusive competence to determine the rules governing it. Functionality cannot be put forward as the single or even main criterion. It must be weighed against a systematic interpretation. Furthermore, a systematic interpretation immediately indicates that the matter in question cannot be solely determined by Article 207(1) TFEU. The systematic interpretation rule clearly requires a ‘topographic’ or even ‘compartmentalised’ interpretation of the wording of Article 207(1) TFEU: at least a part of intellectual property law must be ‘resistant’ to the sway of its commercial aspects.

69.

However, a ‘topographical’ or ‘compartmentalised’ interpretation would disproportionately undermine the effectiveness of the change in primary law brought about by Article 207(1) TFEU. In the same way as a ‘functional’ interpretation which immediately and without further precautions made reference in each case to the provisions of the TRIPs Agreement and similar agreements would simply destroy, at least potentially, the shared nature which intellectual property undoubtedly retains, thereby also depriving it of its inherent effectiveness.

70.

In short, the functional approach and the systematic approach seem to result in an irreconcilable contradiction. One approach seems to require that competence relating to essential elements of intellectual property law lies with the European Union and the other approach that it lies with the Member States.

71.

Having set out all the foregoing considerations, I consider that, as has been noted, the fact that the Commission is also correct cannot lead me to conclude that, with the entry into force of the Lisbon Treaty, the Court now has jurisdiction to interpret a provision such as Article 27 of the TRIPs Agreement and that there is therefore a need to refine the rule that the national courts have primary jurisdiction to interpret that agreement. However, in order to draw this conclusion, it is necessary to find a way out of the dilemma.

72.

I am of the view that that dilemma can be resolved only through an analysis based on the respective consequences, in terms of effectiveness in each case, which arise when opting for either of the opposing approaches. In other words, it is necessary to provide the best possible interpretation of the legislative provisions on which each of those approaches is based.

73.

Having been thus set out, that interpretive task must be limited in two dimensions: the spatial and the temporal. The first is easy to explain: it means that the correspondence rule must not be applied to the scope of the wording of Article 207(1) TFEU or to the TRIPs Agreement as a whole. To that effect, I would refer to my preceding statements. The question refers to Article 27 of the TRIPs Agreement.

74.

More explanation is required for the temporal limitation, which obviously can mean only that the relevant time is the present. It is true that Article 207(1) TFEU contains a competence which is ‘external’ in nature, in particular if it is examined in the light of the form of its previous version, that in Article 133 EC, and the caveat concerning competences in Article 207(6) TFEU is taken into account. However, this cannot lead us to think that the answer may be found through an approach in which the European Union’s external competence could entirely coexist with the Member States’ internal competence. Rather, I consider that, in the absence of instruments defining the scope of each competence, that coexistence is conceptually unviable, in any event in the long term.

75.

It is a separate matter whether this is possible at the present time, that is to say, in the initial stages of that new exclusive competence. I consider that it is possible to argue that the European Union’s exclusive external competence calls for the prominent role of the Member States’ shared external competence to be somewhat ‘eclipsed’ or lost. However, that cannot take place by abruptly favouring the former over the latter.

76.

Still with a view to effectiveness, the effectiveness of Article 207 TFEU is likely to be undermined less at present by a decision ruling that a provision such as Article 27 of the TRIPs Agreement remains in the sphere of competence of the Member States than it would be by the contrary decision. The European Union currently has a broad remit in the field of harmonisation and the creation of a unified title. The Member States, on the other hand, have only a shared competence. At present, there are therefore good reasons to avoid the general and immediate development of an interpretation of Article 207(1) TFEU linked to the content of international agreements such as the TRIPs Agreement. In that regard, to cite just one situation, the general and immediate ‘expulsion’ of the Member State from the negotiations for such agreements does not seem viable.

77.

However, I also consider that it is necessary to ensure from the outset that the wording of Article 207(1) TFEU has some degree of effectiveness. In other words, it is very obvious that it is necessary to reject any interpretation which renders practically nugatory the change to primary law brought about by that provision.

78.

That means, in the first place, that, having stated that intellectual property continues to be a share competence, this must be interpreted so as to facilitate in so far as possible the exercise by the European Union of its exclusive competence for commercial aspects. That would preclude an interpretation of ‘commercial aspects’ which is excessively influenced by the maxim that the exception proves the rule. In other words, it is necessary to avoid an overly strict interpretation of ‘commercial aspects’.

79.

In the second place, I consider that a means for achieving the effectiveness of Article 207(1) TFEU could lie in its interpretation as an implicit rule directed towards the progressive harmonisation of intellectual property matters. The justification for the wording of Article 207(1) TFEU would also be strengthened by effective progress in the field of harmonisation.

80.

As a final consideration in my approach, I do not consider that ‘shortcuts’ are appropriate in this context, even if they paradoxically take the form of ‘detours’. It is necessary to recognise that, in the past, difficulties have been encountered in harmonising patent law within the European Union. Furthermore, it can readily be understood that, in response to such difficulties, it has been possible to view the European Union’s new exclusive competence as an indirect instrument for attaining the desired harmonisation of patent law. However, if there is anything that is unambiguous in the wording of Article 207(1) TFEU it is the statement that the European Union’s exclusive competence relates to the ‘commercial aspects of intellectual property’ and not simply to ‘intellectual property’. It is not in dispute that there remains an area of ‘intellectual property’ which goes beyond its ‘commercial aspects’, and the European Union has available several instruments for harmonisation in that area. Article 207(1) TFEU is not one of them, however.

81.

In conclusion, I consider that, in particular as European Union law now stands, Article 27 of the TRIPs Agreement does not regulate subject-matter which falls within the commercial aspects of intellectual property within the meaning of Article 207(1) TFEU, and accordingly, with regard to its interpretation, the case-law of the Court which links the scope of the Court’s jurisdiction to interpret provisions set out in international treaties to the substantive competence for the subject-matter in question continues to be valid.

82.

Notwithstanding the above, and in the event that the Court should draw a different conclusion, I shall, in the alternative, now consider the question relating to the effectiveness of that provision.

83.

By raising the question of whether the Member States may accord ‘direct effect’ to Article 27 of the TRIPs Agreement, the referring court is effectively asking whether the national court may apply that provision of the agreement. In fact, in the final part of its first question, it uses the expression ‘apply it directly’.

84.

I am of the view that it is questionable whether the order for reference is correct in using the expression ‘direct effect’, despite its widespread use. I concur in that regard with Advocate General Maduro in his Opinion in FIAMM and Others v Council and Commission ( 16 ) that the distance between the ‘direct effect’ of treaties and the ‘direct effect’ of European Union law is so great, ‘in both concept and scope’, that it would be advisable ‘to use different terms to describe them in future in order to avoid any unfortunate confusion, and hence to speak only of the possibility of relying on international agreements’. ( 17 )

85.

In my opinion, the question at issue here relates primarily to the possibility of relying on the TRIPs Agreement before the courts, which entails taking into account the settled case-law of the Court concerning the possibility of relying on the WTO Agreements. ( 18 )

86.

That case-law, the source of which dates back to International Fruit Company, ( 19 ) has been reiterated on numerous occasions and in relation to a wide range of WTO instruments. ( 20 )

87.

It is true that this approach continues to have weaknesses, as has been pointed out in some of the legal literature (which criticises what it regards as a weak conception of the principle of legality, or the political nature of the reciprocity argument, or, finally, the lack of legal protection which it entails for individuals). ( 21 ) Nevertheless, the arguments of those who criticise the Court’s approach also warrant several objections, as shown by the voices less hostile to the case-law (which object that its critics fail both to explain the democratic basis for the WTO rules and to specify the level of legal regulation which has been achieved in international trade law, and justify the reciprocity argument in terms of a true constitutional principle or point out that the direct effect rule is meaningful only in the context of the creation of a common market). ( 22 )

88.

In either case, that rule, as Advocate General Maduro explained in his Opinion in FIAMM, ( 23 ) only accords direct effect where the international rule in question fulfils a dual condition: ‘the terms, nature and general scheme of the agreement do not prevent it being relied upon and … the provisions relied upon appear, in the light of both the object and purpose of the agreement and of its context, to be unconditional and sufficiently precise, in other words contain a clear and precise obligation which is not subject, in its implementation or effects, to the adoption of any subsequent measure’. ( 24 )

89.

In my view, Article 27 and, since it is connected, Article 70 of the TRIPs Agreement are not ‘unconditional and sufficiently precise’, that is they do not contain ‘a clear and precise obligation’ not subject ‘in its implementation or effects, to the adoption of any subsequent measure’.

90.

That is demonstrated, in my view, by the experience of the national courts which have addressed the issue of the direct applicability of the TRIPs Agreement.

91.

Until now, the national courts have had jurisdiction to rule on the possible direct effect of the TRIPs Agreement in so far as it relates to the patentability of medicinal products and the possible extension to medicinal products of patents covering their manufacturing processes. Naturally, the practice followed by those courts may now be most useful to the Court in determining a rule on the solution which should be adopted in that regard at European Union level.

92.

There are no court rulings on this matter in those Member States which recognised the patentability of medicinal products prior to the 1980s. ( 25 ) That is also true in those Member States whose patent legislation is very recent. ( 26 ) Accordingly, the relevant judicial practice is to be found only in those countries which, having had patent legislation prior to the European Patent Convention (1973) and the TRIPs Agreement (1994), did not allow the patenting of medicinal products at the time of the entry into force of those international provisions. That is perfectly logical, since Article 70 of the TRIPs Agreement specifically affects the situation in the latter Member States.

93.

The courts of three Member States (Slovenia, Finland and Portugal) have ruled that Article 70 of the TRIPs Agreement is not applicable, on the ground that the content of the provision is not sufficiently precise.

94.

The courts of Austria, Spain and Greece (Member States which at the material time adopted the reservation set out in Article 167 of the Munich Convention) have given rulings on the applicability of Article 70 of the TRIPs Agreement to existing patents on processes for the manufacture of medicinal products which when they were granted could not, under national law, have covered the medicinal product itself.

95.

In the case of Spain, the Audiencia Provincial de Madrid (2006) and the Juzgado Mercantil No 3 de Barcelona (2007) have ruled that the TRIPs Agreement applies both to patent applications pending at the time of its entry into force and to existing patents. The Tribunal Supremo confirmed that interpretation (2011), adding that the TRIPs Agreement has abrogated the effects of the reservation made under the Munich Agreement.

96.

The Audiencia Provincial de Madrid also ruled that Article 70(7) of the TRIPs Agreement (amendment of pending applications) has direct effect . ( 27 )

97.

As regards the Austrian experience, the Supreme Court (2008) accorded direct effect to the TRIPs Agreement, ruling that the protection conferred by Article 70 of the agreement is the protection provided for by Austrian law. Applying its national rules, it concluded that the patents granted for processes could not be extended to medicinal products before those products were patentable in Austria.

98.

In the case of Greece, it should be noted that two positions have been upheld by the Regional Court of Athens, which in 2009 ruled that the TRIPs Agreement is retroactive, with the result that all medicinal product patent applications are valid retroactively from 9 February 1995 for a period of 20 years from the date of filing. However, in 2011 it reviewed that position and stated that retroactivity required the existence valid title in force from the outset.

99.

The solutions adopted in the Member States are therefore far from uniform, which places the Court in a position to adopt a solution in accordance with its own criteria.

100.

In my view, the competence accorded to the European Union to rule on the effect of Articles 27 and 70 of the TRIPs Agreement can only mean, by definition, that it must be concluded that under no circumstances may that effect be direct. There are two reasons for this.

101.

The first reason is inherent in European Union law as it now stands. The second reason stems from the actual content of Article 27 of the TRIPs Agreement itself.

102.

As regards the first reason, it is sufficient to point out that Article 27 of the TRIPs Agreement establishes principles and rules concerning ‘patentability’ which are clearly directed at the public authority responsible for substantive patent law. It is not necessary here to consider which public authority that ought to be: suffice to say that it must have legislative powers.

103.

In my view, Article 27 of the TRIPs Agreement actually constitutes a requirement placed upon the legislature competent in patent matters, imposing upon it the obligation to establish a patent system which, in principle, and in so far as is relevant here, provides for the ‘patentability’ of medicinal products. If the legislature having primary substantive competence continues to be the national one, the European Union could, where appropriate, derive from that requirement, by contrary inference, only a right for individuals to whom the Member States grant patents for medicinal products, provided that those Member States have not opted to exclude the ‘patentability’ of some inventions for reasons of ordre public, morality, the protection of life, health or the environment (Article 27(2)). If, however, the European Union now has the competence in question, that requirement is addressed to its institutions. ( 28 )

104.

In conclusion, I am of the opinion that Article 27 of the TRIPs Agreement, in conjunction with Article 70 of that agreement, does not have direct effect, in that it is not a provision that can be relied on directly by individuals either against the public authorities or, as in this case, against other individuals.

105.

Nevertheless, and in the event that the Court should draw a different conclusion, I shall now turn to the third of the issues raised by the referring court.

106.

Above all, it must not be forgotten that a product patent and a patent on a process are separate entities, subject to different conditions. I note that there has been some attempt to argue that the existing ‘subject-matter’ in the case of a patent for a process also covers, in some way, the product itself. It suffices to point out that they have different protection. Under Article 28(1) of the TRIPs Agreement, the ‘product’ patent is more advantageous to its holder, since it allows him to prevent competitors from the acts of ‘making, using, offering for sale, selling, or importing’. On the other hand, a patent on a ‘process’ does not prevent competitors from manufacturing the same product through a different process. ( 29 )

107.

In any event, that question may primarily be answered in conjunction with the considerations set out above concerning the need for legislative development.

108.

What is ultimately at issue in the main proceedings is whether, pursuant to Article 27, in conjunction with Article 70, of the TRIPs Agreement, the entry into force of that agreement allows a patent granted for a process when it was not possible to patent a pharmaceutical product to be extended to that product once the prohibition which prevented this no longer exists, where, in spite of that prohibition, the product patent was also applied for at the material time.

109.

In that regard, it is necessary to take into account that in the case of Greece, the impossibility of patenting medicinal products derived solely from the reservation under Article 167 of the Munich Agreement, the expiry of which led to the possibility of again applying the national legislation which made it possible to patent medicinal products before the reservation was entered into. Once the reservation expired on 7 October 1992, nothing prevented the filing of an application for a medicinal product patent, and there was no need to rely on the mechanism provided for in Article 70(8) of the TRIPs Agreement.

110.

That provision actually provides that ‘[w]here a Member does not make available as of the date of entry into force of the WTO Agreement patent protection for pharmaceutical and agricultural chemical products commensurate with its obligations under Article 27, that Member shall … provide as from the date of entry into force of the WTO Agreement a means by which applications for patents for such inventions can be filed …’.

111.

Upon the entry into force of the TRIPs Agreement in Greece it was not necessary to provide ‘a means by which applications for patents for [medicinal products could] be filed’, since, as I have noted, once the effects of the reservation under Article 167 of the Munich Convention had expired, the ordinary patent rules in force in Greece prior to that reservation applied in their entirety, and those rules did not exclude the ‘patentability’ of medicinal products.

112.

However, I am of the view that it follows from Article 70(8) of the TRIPs Agreement that that agreement is based on the principle that in every case it is necessary to file an express application for a patent. That application must be processed through the channel laid down by paragraph 8 or through the normal channel for patents where the national legislation does not require the extension of the ordinary rules to medicinal products, which is precisely the case with Greece.

113.

Therefore, I consider that the TRIPs Agreement does not, under any circumstances, provide for the type of ‘automatic extension’ of a patent on a process to a patent on a pharmaceutical product claimed by Daiichi Sankyo. Nor does it allow for the ‘deferred granting’ of a patent for a medicinal product which was applied for at a time when it could not be granted. In short, for reasons which I consider fundamental to safety in a field as sensitive as that of the patenting and resulting marketing of medicinal products, the TRIPs agreement must be interpreted as meaning that a patent for a pharmaceutical product can be granted only following a specific examination and control procedure which must be initiated by an express application.

114.

In conclusion, in the event that the Court considers that it has jurisdiction to interpret Article 27 of the TRIPs Agreement – and, since it is connected, Article 70 of that agreement – and that the above provision is directly applicable, I propose that the Court rule that the mere entry into force of that agreement does not have the effect that persons acquire a patent on the product itself where they held patents on the production of that pharmaceutical product at the material time under a law which did not allow patents on pharmaceutical products themselves, even in cases where at the time of applying for the patent on the process those persons applied for a patent on the product itself.

115.

My analysis in the alternative of the interpretation which the Court should give to the TRIPs Agreement must take into account the temporal effects of the Court’s judgment, whatever its answer to the third question.

116.

The first point to be noted is that there is, in any event, a lower limit: the date of entry into force of the Lisbon Treaty.

117.

In my view, it is clear that the Court’s decision could relate to the effect of the provision only from 1 December 2009, that is to say after the entry into force of the Lisbon Treaty, Articles 3 and 207 of which confer on the European Union the competence under which the Court has jurisdiction to give such a ruling.

118.

Until that time, after all, in accordance with the rule established by the Court itself, the Member States had exclusive jurisdiction to determine whether or not provisions such as Article 27 of the TRIPs Agreement could be directly effective in their national law.

119.

The change brought about by the new distribution of powers established in the Lisbon Treaty means that the Member States no longer have the power to resolve this question. Nevertheless, it is clear that, if only on account of the possible consequences, the Court’s ruling should in no way undermine the effects produced prior to that date in the national legal systems as a result of the solution adopted in this matter by their courts.

120.

The decision taken by the Court therefore cannot have any effect on legal situations established within the substantive scope of Article 27 of the TRIPs Agreement prior to 1 December 2009.

121.

However, this may not be sufficient: the diversity and enormous quantity of litigation, largely resolved, justifies taking into account very basic considerations of legal certainty. In my view, given the uncertainty that has, with good reason, existed until now concerning the magnitude of the change brought about by the Lisbon Treaty in that field – as evidenced by this very reference for a preliminary ruling and the dispute between the parties on this issue – the Court’s decision on the effect, whether direct or indirect, of Article 27 of the TRIPs Agreement should apply only from the date of publication of the judgment setting out that decision and bringing these proceedings to a close. In any case, it is necessary to ensure the inviolability of judgments which have the force of res judicata on the date of publication of the Court’s judgment bringing these proceedings to a close. In my opinion, there are in this case ‘overriding considerations of legal certainty’, which, according to the case-law of the Court, justify the exercise of ‘discretion’ on its part in order to preserve the finality of judgments delivered prior to a ruling which, as would be the case in the present dispute, changes the present legislative framework in a radical and, to some extent, surprising way. ( 30 )

122.

In the light of the foregoing observations, I suggest that the Court should answer the question referred as follows:

‘(1)

Article 27 of the TRIPs Agreement, which defines the scope of patent protection, falls within a field for which the Member States remain principally competent.

(2)

Accordingly, it is not necessary to give any ruling on the remaining questions raised by the Polimeles Protodikio Athinon.’