1.

In its request for a preliminary ruling, the High Court of Justice (England & Wales), Chancery Division (Patents Court), United Kingdom) seeks from the Court an interpretation of Article 3(d) of Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products. ( 2 )

2.

This request was made in the context of a dispute between the company Abraxis Bioscience LLC (‘Abraxis’) and the Comptroller General of Patents, Designs and Trademarks (‘the Comptroller’). Abraxis is seeking from the national court the annulment of the Comptroller’s decision to reject the supplementary protection certificate (‘SPC’) application made by Abraxis for a combination of substances containing the active ingredient paclitaxel in the form of nanoparticles bound to albumin. Abraxis calls that combination of substances ‘nab-paclitaxel’ and markets it under the name of Abraxane.

3.

In accordance with the SPC regime provided for by Regulation No 469/2009, if the commercial exploitation of a patent is delayed because of the regulatory procedures required to obtain marketing authorisation (‘marketing authorisation’, ‘authorisation to place on the market’ or ‘MA’) for a medicinal product incorporating the invention protected by the patent, the holder of that patent is permitted to enjoy an additional period of exclusivity on the expiry of the patent. That period of exclusivity compensates, at least in part, for the erosion of the period of effective exploitation of the exclusivity conferred by the patent. ( 3 )

4.

The grant of an SPC is subject, in the Member State in which it is sought, to compliance with the conditions laid down in Article 3 of Regulation No 469/2009. First of all, the ‘product’ — the concept of which is defined in Article 1(b) of that regulation as ‘the active ingredient or combination of active ingredients of a medicinal product’ — must be protected by a ‘basic patent’. ( 4 ) Next, a valid marketing authorisation for the product must have been granted in accordance with the EU rules. ( 5 ) Article 3(d) of that regulation requires that that marketing authorisation be ‘the first authorisation to place the product on the market as a medicinal product’. Finally, the product must not have already been the subject of an SPC. ( 6 )

5.

In the present case, the active ingredient in Abraxane, paclitaxel, had already been marketed under other brand names for use in eliminating cancer cells pursuant to earlier marketing authorisations. Nab-paclitaxel is a new formulation of that active ingredient and has the same use. That formulation is protected by the basic patent relied upon by Abraxis in support of its SPC application, it being understood that the protection conferred by that patent does not extend to paclitaxel as such.

6.

In that context, the national court asks the Court, in essence, whether the condition set out in Article 3(d) of Regulation No 469/2009 is fulfilled where, although the marketing authorisation relied upon in support of the SPC application is for an active ingredient which has already been granted an earlier marketing authorisation, that earlier marketing authorisation did not concern the new formulation — protected by the basic patent and covered by the marketing authorisation of the applicant for the SPC — of that active ingredient.

7.

The national court invites the Court, by that question, to clarify the scope of its judgment in Neurim Pharmaceuticals (1991) ( 7 ) (‘Neurim’). As I shall recall in more detail in my analysis, ( 8 ) the Court held therein that that condition is fulfilled when the marketing authorisation at issue, even if it is not the first marketing authorisation for the active ingredient concerned, is the first to cover the new therapeutic use — protected by the basic patent — of that active ingredient. The national court seeks to ascertain whether the points of principle set out in that judgment also mean that Article 3(d) of Regulation No 469/2009 does not preclude the grant of an SPC where the marketing authorisation relied upon is the first to fall within the scope of a basic patent protecting the new formulation, for a known therapeutic use, of a previously authorised active ingredient.

8.

At the end of my analysis, I shall propose that the Court answer in the negative the question referred.

9.

As is apparent from recital 1 of Regulation No 469/2009, that regulation was adopted with a view to codifying Regulation (EEC) No 1768/92, ( 9 ) which had been substantially amended several times. The following provisions of Regulation No 469/2009 reproduce the content of the equivalent provisions of Regulation No 1768/92.

10.

Article 1 of Regulation No 469/2009 provides:

‘For the purposes of this Regulation, the following definitions shall apply:

…’

11.

Article 2 of that regulation provides that ‘any product protected by a patent in the territory of a Member State and subject, prior to being placed on the market as a medicinal product, to an administrative authorisation procedure as laid down in Directive 2001/83/EC [ ( 10 )] … or Directive 2001/82/EC [ ( 11 )] … may, under the terms and conditions provided for in this Regulation, be the subject of a certificate’.

12.

Article 3 of that regulation is worded as follows:

‘[An SPC] shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application:

13.

According to Article 4 of Regulation No 469/2009, ‘within the limits of the protection conferred by the basic patent, the protection conferred by [an SPC] shall extend only to the product covered by the authorisation to place the corresponding medicinal product on the market and for any use of the product as a medicinal product that has been authorised before the expiry of the [SPC]’.

14.

Article 5 of that regulation states that ‘subject to the provisions of Article 4, the [SPC] shall confer the same rights as conferred by the basic patent and shall be subject to the same limitations and the same obligations’.

15.

Abraxis markets, under the name Abraxane, a medicinal product indicated for the treatment of certain breast, pancreatic and lung cancers. That medicinal product contains the active ingredient paclitaxel in the form of nanoparticles coated with albumin. Albumin is a protein which acts as a carrier for paclitaxel. Abraxis calls the combination of substances thus formulated ‘nab-paclitaxel’, the term also used in the order for reference for the sake of convenience.

16.

Nab-paclitaxel is protected by European patent (UK) No EP 0 961612, entitled ‘Protein stabilised pharmacologically active agents and their use’ (‘the basic patent’). Claim Nos 1, 32 and 33 of the basic patent are worded as follows:

17.

Abraxane is the subject of Marketing Authorisation EU/1/07/428/001, granted in 2008 by the European Medicines Agency (EMA). Prior to the granting of that marketing authorisation, paclitaxel had already been marketed by other undertakings, under the brand names Paxene and Taxol, pursuant to earlier marketing authorisations. Nab-paclitaxel demonstrates greater efficacy than traditional formulations of paclitaxel for the treatment of certain cancerous tumours. Nab-paclitaxel also has some benefits in terms of patient tolerance. It is common ground that the development of Abraxane has required lengthy and expensive research, with the result that the marketing authorisation for that medicinal product was obtained a particularly long time after the application for the patent was filed.

18.

Abraxis applied for an SPC on the basis of the basic patent and the marketing authorisation for Abraxane. By decision of 26 August 2016, the Comptroller rejected that application on the grounds that, as that marketing authorisation was not the first marketing authorisation for paclitaxel, the condition set out in Article 3(d) of Regulation No 469/2009 was not fulfilled. That authority considered that, although that provision, as interpreted by the Court in Neurim, does not preclude the grant of an SPC on the basis of the first marketing authorisation covering a new and inventive therapeutic use of an active ingredient that had already been the subject of an earlier marketing authorisation, it does preclude the grant of an SPC on the basis of the first marketing authorisation covering a new and inventive formulation of that active ingredient for a known therapeutic use.

19.

Abraxis appealed against that decision to the High Court of Justice (England & Wales), Chancery Division (Patents Court). In its appeal, that company maintains that the condition laid down in Article 3(d) of Regulation No 469/2009 is fulfilled according to the principles set out in Neurim.

20.

Moreover, Abraxis points out that SPCs for nab-paclitaxel have been granted in nine Member States (Denmark, Greece, Spain, France, Italy, Luxembourg, Austria, Portugal and Finland) and rejected in two Member States (Sweden and the United Kingdom). Nab-paclitaxel is also the subject of pending SPC applications in three Member States (Germany, Ireland and the Netherlands), as well as in Switzerland.

21.

The national court has doubts as to the scope of Neurim and, accordingly, as to the interpretation of Article 3(d) of Regulation No 469/2009. In those circumstances, that court decided to stay the proceedings and to refer the following question to the Court for a preliminary ruling:

‘Is Article 3(d) of Regulation No 469/2009 to be interpreted as permitting the grant of an SPC where the marketing authorisation referred to in Article 3(b) [of that regulation] is the first authorisation within the scope of the basic patent to place the product on the market as a medicinal product and where the product is a new formulation of an old active ingredient?’

22.

Abraxis, the United Kingdom Government, the Czech, Hungarian, Netherlands and Polish Governments and the European Commission have submitted written observations to the Court.

23.

Abraxis, the Netherlands Government and the Commission were represented at the hearing held on 21 June 2018.

24.

The conditions to which the grant of an SPC is made subject under Article 3 of Regulation No 469/2009 highlight the links between the SPC and the basic patent, on the one hand, and the marketing authorisation, on the other hand. The present case provides the Court with an opportunity to clarify any possible links between the basic patent and the marketing authorisation relied upon in support of the SPC application. More specifically, this case raises the question of whether Article 3(d) of that regulation refers to the ‘the first authorisation to place the product on the market as a medicinal product’ without further qualification, or to the first marketing authorisation covering the product as a medicinal product and falling within the scope of the protection conferred by the basic patent.

25.

In that regard, while a literal reading of that provision leads to the first of those interpretations (Section 1), the Court departed from that reading in Neurim (Section 2). Although the case giving rise to that judgment had a very specific factual background, the reasoning adopted by the Court does not necessarily appear to be restricted to contexts of that kind. This reference for a preliminary ruling invites the Court to examine the scope of that judgment and the resulting implications in a situation such as that at issue in the main proceedings (Section 3).

26.

For the purposes of a coherent interpretation of the provisions of Regulation No 469/2009, the terms used in Article 3(d) of that regulation must be read by reference to the definitions in Article 1 thereof. In particular, the concept of ‘product’ means, in accordance with Article 1(b) of that regulation, ‘the active ingredient or combination of active ingredients of a medicinal product’.

27.

According to settled case-law beginning with Massachusetts Institute of Technology, ( 12 ) the concept of ‘active ingredient’, within the meaning of that provision, excludes those constituents of a medicinal product which do not have any therapeutic effects of their own on the body, ( 13 ) such as excipients. ( 14 ) The latter, even when necessary for the therapeutic efficacy of a substance which has therapeutic effects of its own, do not constitute ‘active ingredients’. ( 15 ) Nor does the combination of an excipient and such a substance give rise to a ‘combination of active ingredients’. ( 16 )

28.

In the present case, the order for reference states that the national court considered, contrary to what Abraxis maintained before that court, that nab-paclitaxel does not constitute either an active ingredient distinct from paclitaxel or a combination of active ingredients comprising paclitaxel and albumin (since that carrier protein has, according to that court, no therapeutic effects of its own on the body). The question referred to the Court is therefore based on the premiss that, in accordance with the abovementioned case-law, paclitaxel is the only active ingredient in Abraxane. ( 17 )

29.

As is clear from the order in Yissum, ( 18 ) the concept of ‘product’ is also independent of the therapeutic use concerned: an active ingredient (or a combination of active ingredients) remains one and the same ‘product’ regardless of its therapeutic uses. In accordance with Pharmacia Italia, ( 19 ) nor is the definition of ‘product’ influenced by the species (whether an animal species or humans) for which the product is intended.

30.

In the light of that definition of ‘product’, as set out in Article 1(b) of Regulation No 469/2009, a literal interpretation of Article 3(d) of that regulation presupposes, as the Court expressly found in Medeva, ( 20 ) that the ‘first authorisation to place the product on the market as a medicinal product’, within the meaning of that provision, means the first marketing authorisation for a medicinal product incorporating the active ingredient or combination of active ingredients at issue. According to that reading, an SPC can therefore be obtained only on the basis of the first marketing authorisation covering an active ingredient or a combination of specific active ingredients.

31.

The Court, moreover, interpreted in the same way Article 1(8) and Article 3(d) of Regulation (EC) No 1610/96 concerning the creation of a supplementary protection certificate for plant protection products, ( 21 ) the content of which reproduces, in the plant protection products sector, the content of Article 1(b) and Article 3(d) of Regulation No 469/2009. Thus, in BASF, ( 22 ) the Court found, first of all, that the concept of ‘product’ used in Article 3 of Regulation No 1610/96 is equivalent to the concept of ‘product’ as defined in Article 1(8) of that regulation. The Court next held that a new plant protection product did not constitute a new ‘product’ within the meaning of those provisions where it differed from a plant protection product granted an earlier marketing authorisation only in the proportion of active ingredient to impurities contained in the respective products, which proportion resulted from the application of a process covered by the basic patent relied upon in support of the SPC application. ( 23 ) Accordingly, Article 3(d) of Regulation No 1610/96 precluded the grant of the SPC applied for on the basis of that basic patent and the marketing authorisation for the new plant protection product, on the ground that that marketing authorisation was not the first granted for the product at issue. ( 24 )

32.

In Neurim, however, the Court replaced the literal interpretation of Article 3(d) of Regulation No 469/2009 with a teleological reading based, in essence, on the consideration that the that regulation is intended to encourage not only research into new active ingredients or new combinations of active ingredients, but also other types of inventive activities in the field of medicinal products. ( 25 )

33.

The case giving rise to that judgment concerned the issue of whether an SPC could be obtained on the basis of the marketing authorisation for a medicinal product, Circadin, which contained an unpatented active ingredient (the natural hormone melatonin) that formed part of a medicinal product already granted a marketing authorisation, Regulin. Although Circadin was intended for the treatment of insomnia in humans, Regulin was used to regulate the reproductive cycle of sheep. Circadin fell within the scope of a patent protecting both the use of melatonin for the new therapeutic indication at issue and the new formulation of melatonin with a view to such use. ( 26 )

34.

The Court held that an SPC could be granted on the basis of that patent and the marketing authorisation for Circadin since, although it was not the first marketing authorisation relating to melatonin, it was the first marketing authorisation covering that active ingredient for a therapeutic use falling within the scope of the protection conferred by the basic patent. Indeed, ‘only the MA of the first medicinal product, comprising the product and authorised for a therapeutic use corresponding to that protected by the patent relied upon for the purposes of the application for the SPC, may be considered to be the first MA of “that product” as a medicinal product exploiting that new use within the meaning of Article 3(d) of [Regulation No 469/2009]’ ( 27 ) (that test is referred to below as the ‘the scope of protection of the basic patent test’). In accordance with Articles 4 and 5 of that regulation, the protection conferred by the SPC is therefore limited to the new use which is the subject of the basic patent and does not extend to melatonin as such. ( 28 )

35.

In the situation brought to the attention of the Court, the new use protected by the basic patent concerned a therapeutic indication in human medicine of a product already covered by an earlier marketing authorisation for a therapeutic indication in a separate therapeutic area as a veterinary medicinal product. The grounds and the operative part of Neurim refer, for their part, in general terms to the possibility of obtaining an SPC on the basis of the first marketing authorisation relating to a new therapeutic ‘application’ or ‘use’ — protected by the basic patent — of a previously authorised product. ( 29 )

36.

As noted by the national court, the Court has not specified, in particular, whether the logic underlying the test set out in that judgment means that an SPC may be granted where the marketing authorisation at issue is the first to fall within the scope of a basic patent protecting the new formulation, for a known therapeutic use (in the present case, eliminating cancer cells), ( 30 ) of a product which is already the subject of a marketing authorisation covering that use.

37.

Neurim also raises certain questions concerning the relationship between the concept of new therapeutic ‘application or ‘use’, within the meaning of that judgment, and patent law. In that regard, as I shall indicate below, ( 31 ) the second (and subsequent) therapeutic ‘uses’, or ‘applications’, of known substances which may be patented under the Convention on the Grant of European Patents, signed at Munich on 5 October 1973, as amended in 2000 (‘the European Patent Convention’ or ‘EPC’), are not limited to the uses of a known product for a new therapeutic indication. They also include applications of such a product for a known therapeutic indication whose novelty lies, for example, in the dosage or the route of administration. It is not certain that in Neurim the Court intended to attribute such a broad meaning to the concept at issue. ( 32 )

38.

Moreover, the difficulties relating to the interpretation of that judgment are exacerbated because neither that judgment nor the preceding Opinion of Advocate General Trstenjak ( 33 ) referred to the pre-existing case-law concerning the concept of ‘product’ within the meaning of Article 1(b) of Regulation No 469/2009. However, Neurim is difficult to reconcile with that case-law and, in particular, with the order in Yissum ( 34 ) and, in the event that the test set out therein applies where the basic patent protects the new formulation of a known active ingredient for a known therapeutic use, with Massachusetts Institute of Technology. ( 35 )

39.

Although the questions referred by the national courts concerned the interpretation of Article 1(b) of Regulation No 469/2009, it is clear from those two judgments that the national disputes giving rise to the references for a preliminary ruling concerned the application of Article 3(d) thereof. The SPC applications were rejected on the ground that the marketing authorisations relied upon in support of those applications were not the first marketing authorisations for the products concerned. ( 36 ) If the Court had found that the scope of protection of the basic patent test applied in situations such as those at issue in those disputes, in order to resolve those disputes the Court would have had to rule that, in spite of the strict interpretation given of the concept of ‘product’ within the meaning of Article 1(b) of that regulation, ( 37 ) an SPC could be granted on the basis of a broad interpretation of Article 3(d) thereof. ( 38 )

40.

Subsequent to Neurim, the Court, in the order in Glaxosmithkline Biologicals and Glaxosmithkline Biologicals, Niederlassung der Smithkline Beecham Pharma, ( 39 ) confirmed the interpretation of the concept of ‘product’ within the meaning of Article 1(b) of Regulation No 469/2009 adopted in Massachusetts Institute of Technology, ( 40 ) and stated that Neurim had not called it into question. In Forsgren, ( 41 ) the Court again recalled that interpretation, while emphasising that the SPC regime is intended to cover the cost of research leading to the discovery of new ‘products’. However, the Court did not specifically address the question of whether an SPC may be obtained when the relevant marketing authorisation covers the new formulation — protected by the basic patent — of a known active ingredient (whether or not that formulation permits a new therapeutic use). ( 42 )

41.

In those circumstances, the relationship between, on the one hand, Article 1(b) of Regulation No 469/2009 and the line of case-law relating thereto and, on the other hand, Article 3(d) of that regulation and Neurim requires clarification. In that connection, an independent study by the Max Planck Institute, commissioned by the Commission, ( 43 ) which is referred to in the Commission’s proposal for revision of Regulation No 469/2009 adopted in 2018, ( 44 ) highlights that Neurim has given rise to differing interpretations as between the Member States. Those divergences could explain, at least in part, why, as is clear from the order for reference, some of the Member States have approved and some have rejected the SPC applications for Abraxane. ( 45 )

42.

In determining whether Article 3(d) of Regulation No 469/2009 precludes the grant of an SPC for the new and inventive formulation of a previously authorised active ingredient intended for a known therapeutic use of that active ingredient, the Court will have the opportunity to resolve the contradictions between the above-mentioned lines of case-law. It will have to clarify how they can coexist harmoniously or, where appropriate, indicate whether certain judgments have been, or should be, reversed. In that regard, the interested parties have proposed several distinct approaches.

43.

First, Abraxis considers that the reasoning adopted in Neurim justifies the conclusion that the condition set out in Article 3(d) of that regulation is fulfilled whenever the marketing authorisation for a medicinal product incorporating a product which is already the subject of an earlier marketing authorisation is the first to fall within the scope of the protection conferred by the basic patent. That interpretation would open the way for the grant of an SPC for, inter alia, any new and inventive formulation of a known active ingredient covered by a new marketing authorisation.

44.

If it adopted that approach, the Court would, in my view, be rejecting the approach adopted in Massachusetts Institute of Technology ( 46 ) and the order in Yissum. ( 47 ) Moreover, the scope of protection of the basic patent test, if it were extended by analogy to the plant protection products sector, would call into question the reasoning followed in BASF. ( 48 )

45.

Secondly, the United Kingdom Government and the Commission in its written observations propose limiting the applicability of that test to situations where the marketing authorisation at issue is the first to cover a new therapeutic use protected by the basic patent. ( 49 ) That option would entail the abandonment of the approach previously adopted by the Court in situations of the kind at issue in the order in Yissum. ( 50 )

46.

Thirdly, the Czech and Netherlands Governments take the view that the approach adopted in Neurim should be confined even more narrowly. According to them, that approach is justified only in situations where the marketing authorisation concerned is the first to cover a therapeutic indication of the product in human medicine, when the earlier marketing authorisations relating to the product concern another therapeutic indication in veterinary medicine. The Polish Government essentially shares the view that the principles set out in that judgment covered a very specific situation and cannot be applied automatically in all cases where an SPC is applied for on the basis of a patent protecting a new therapeutic use of an old active ingredient.

47.

A fourth approach could be to abandon the scope of protection of the basic patent test in order to return to a literal interpretation of Article 3(d) of Regulation No 469/2009 in all situations. The Hungarian Government, although it has not expressly taken a position on the scope of Neurim, suggests that the question referred should be answered in the negative on the basis of such a literal interpretation.

48.

For the reasons set out below, I shall indicate my preference for the last of those approaches and, in the alternative, for the third approach.

49.

As I have already stated, a textual interpretation of Article 3(d) of Regulation No 469/2009, read in conjunction with Article 1(b) thereof, implies that an SPC application must be rejected where the marketing authorisation at issue is not the first marketing authorisation for the product as a medicinal product, irrespective of whether or not that marketing authorisation is the first to fall within the scope of the protection conferred by the basic patent. ( 51 ) Although the provisions of the regulation must be interpreted in consideration not only of their wording but also the general scheme and objectives of the system established by that regulation, ( 52 ) according to settled case-law, the Court has no power to depart from the clear and precise wording of a provision of EU legislation. ( 53 ) That applies in particular where, as in the present case, the analysis of the objectives and context of the provision at issue and of the regulation of which the provision forms part support the literal interpretation.

50.

According to recitals 3, 4, 5 and 9 of Regulation No 469/2009, the SPC regime has the purpose of compensating for the lack of protection conferred by a patent with respect to covering the investment put into research concerning new medicinal products and, therefore, of encouraging that research. Recitals 7 and 8 of that regulation add that a uniform solution to that problem should be provided for at European Union level in order to prevent a heterogeneous development of national laws which would create obstacles to the proper functioning of the internal market. ( 54 )

51.

Recital 10 of Regulation No 469/2009 emphasises that the legislature intended to achieve that objective so as to take into account in a balanced way all the interests involved in the ‘complex and sensitive’ sector of medicinal products. Those interests include those of pharmaceutical companies, those of manufacturers of generic medicinal products and, at the place where those competing interests converge, the interests of patients and sickness insurance funds. ( 55 )

52.

The condition set out in Article 3(d) of that regulation actually forms part of the effort to strike such a balance between the interests involved by limiting the benefit of the SPC to products placed on the market for the first time as medicinal products. In that regard, the Explanatory Memorandum ( 56 ) seems to me to indicate that the research which the establishment of the SPC regime was intended to encourage is that leading to the first marketing, as a medicinal product, of an active ingredient or combination of active ingredients. ( 57 )

53.

In particular, paragraph 11 of the Explanatory Memorandum reads as follows: ‘The proposal for a Regulation therefore concerns only new medicinal products. It does not involve granting a certificate for all medicinal products that are authorised to be placed on the market. Only one certificate may be granted for any one product, a product being understood to mean an active substance in the strict sense. Minor changes to the medicinal product such as a new dose, the use of a different salt or ester or a different pharmaceutical form will not lead to the issue of a new certificate’. ( 58 )

54.

That point seems to echo the first subparagraph of paragraph 6 of the Explanatory Memorandum, which states: ‘Over about the last 10 years there has been a fall in the number of molecules of European origin that have reached the research and development stage …’ The second subparagraph of paragraph 5 of that document had, in that regard, emphasised the risks associated with the research and development activities necessary for the commercial exploitation of new active substances: ‘Out of a total of about 10000 substances synthesised by a research laboratory, a few hundred will be selected for the filing of patents out of which only one to three will actually be authorised to be placed on the market’. ( 59 )

55.

Moreover, paragraph 35 of the Explanatory Memorandum states: ‘It occurs very often that one and the same product is successively granted several authorisations to be placed on the market, namely each time a modification is made affecting the pharmaceutical form, dose, composition, indications, etc. In such a case, only the first authorisation for the product to be placed on the market in the Member State in which the application is presented is taken into account for the purposes of the proposal for a Regulation …’ The third subparagraph of paragraph 36 of that document goes on to clarify that ‘although one and the same product may be the subject of several patents and several authorisations to be placed on the market in one and the same Member State, the supplementary protection certificate will only be granted for that product on the basis of a single patent and a single authorisation to be placed on the market, namely the first chronologically given in the State concerned’. ( 60 )

56.

Abraxis relies, however, on paragraph 11, already cited, and on paragraphs 12 and 29 of the Explanatory Memorandum in support of an alternative teleological reading, according to which Regulation No 469/2009 seeks to stimulate all pharmaceutical research giving rise to an invention which is patented and incorporated into a medicinal product that has been granted a new marketing authorisation. Abraxis states that, according to Neurim, ( 61 ) that general consideration provides, where a previously authorised product is covered by a new marketing authorisation for a use falling within the scope of the protection conferred by the basic patent, justification for granting that product an SPC the scope of which will be limited to that of that patent. The concept of ‘use’, or ‘application’, within the meaning of that judgment, covers any type of invention without distinction, whether it concerns a formulation, a manufacturing process or a therapeutic indication of a known product. Consequently, Article 3(d) of Regulation No 469/2009 does not preclude the grant of an SPC for the new formulation, intended for a known therapeutic use, of an active ingredient already covered by an earlier marketing authorisation.

57.

In my view, that argument does not stand up to a detailed analysis of the Explanatory Memorandum as a whole and of the paragraphs on which Abraxis relies in particular.

58.

In the first place, paragraph 29 of that document states: ‘The purpose of the expression “product protected by a patent” is to specify what types of invention may be used as a basis for a certificate. The proposal does not provide for any exclusions. In other words, all pharmaceutical research, provided that it leads to a new invention that can be patented, whether it concerns a new product, a new process for obtaining a new or known product, a new application of a new or known product, or a new combination of substances containing a new or known product, must be encouraged, without any discrimination, and must be able to be given a supplementary certificate of protection provided that all of the conditions governing the application of the proposal for a Regulation are fulfilled (my empahasis).’

59.

Understood in its entirety, that paragraph reflects, it seems to me, the principle that the concept of ‘basic patent’ defined in Article 1(c) of Regulation No 469/2009, which is referred to by Article 3(a) thereof, or of ‘patent’ within the meaning of Article 2 is not limited to patents which protect a product as such. That concept includes patents relating to a process for the manufacture of a known product or to an application of it. ( 62 ) Accordingly, the scope of that regulation, as defined in Article 2 thereof, does not exclude a product which, without being patented as such, is covered by a patent which protects an invention relating to a process to obtain that product or an application of it. The condition laid down in Article 3(a) of that regulation is also fulfilled in such a situation. However, the SPC may only be granted provided that the other conditions set out in that article are fulfilled. They include the condition, in Article 3(d) of that regulation, that the marketing authorisation relied upon in support of the SPC application must be the first marketing authorisation for the product at issue.

60.

It is also to that effect that paragraph 12 of the Explanatory Memorandum should be understood, in that it states: ‘The proposal is not confined to new products only. A new process for obtaining the product or a new application of the product may also be protected by a certificate. All research, whatever the strategy or final result, must be given sufficient protection.’ ( 63 )

61.

In that regard, I would note that, although patent law is not harmonised at EU level, ( 64 ) all the Member States have acceded to the European Patent Convention. ( 65 ) This makes it possible to patent, inter alia, ‘substances or combinations of substances’, without those substances or combinations being limited to active ingredients and combinations of active ingredients. ( 66 ) Moreover, Article 54(4) and Article 54(5) of the EPC provide for the patentability, respectively, of the first therapeutic uses of known substances and the second therapeutic uses (or subsequent therapeutic uses) of such substances. ( 67 )

62.

According to the case-law of the European Patent Office (EPO), the concept of ‘use’ (for which the term ‘application’ is used as a synonym), ( 68 ) within the meaning of Article 54(5) of the EPC, does not refer only to the use of a known product for a new therapeutic indication. That concept also covers applications of such a product for a known therapeutic indication when other features of those applications are new and inventive, for example, the dosage or route of administration. ( 69 )

63.

In my view, Article 3(d) of Regulation No 469/2009 nevertheless precludes the grant of an SPC on the basis of a patent protecting a second therapeutic application of a known product or a new formulation of that product for a therapeutic application already covered by an earlier marketing authorisation. By definition, the known product covered by such a patent is not a product placed on the market for the first time for the purposes of that provision. Although the condition set out in Article 3(a) of that regulation could, in principle, be fulfilled in such a situation, the condition provided for in Article 3(d) of that regulation is not fulfilled.

64.

Abraxis points out, however, that Article 54(5), as currently worded, was added to the European Patent Convention only at the time of its 2000 revision, that is to say after the adoption of Regulation No 1768/92. Abraxis infers from this that inventions relating to the second and subsequent therapeutic uses of known products should now also benefit from the protection of the SPC regime in order to reflect that change. ( 70 ) That argument does not convince me, since such inventions were already regarded as patentable in accordance with the EPO case-law established as early as 1984. ( 71 ) That development was therefore not a new contextual factor which the legislature failed to anticipate when adopting Regulation No 1768/92 or, a fortiori, Regulation No 469/2009. As noted by the United Kingdom Government, the order in Yissum ( 72 ) had previously also concerned a situation in which the basic patent protected the second therapeutic use of a known active ingredient.

65.

In short, paragraphs 12 and 29 of the Explanatory Memorandum mean that any patent which protects either a product as such, or a manufacturing process or an application of a known product, may be relied upon as a basic patent in support of an SPC application. It cannot, however, be extrapolated from this that any invention protected by such a patent may be covered by an SPC where the marketing authorisation relied upon for that purpose, although it is the first to fall within the scope of the protection conferred by the patent, is not the first marketing authorisation for the product at issue.

66.

In the second place, paragraph 11 of the Explanatory Memorandum, read as a whole, is, in my view, intended to make clear that such changes to the medicinal product do not justify the grant of an SPC in that they do not modify the active ingredients and thus do not lead to the creation of a new product. This is particularly true of changes in relation to obtaining a new salt, ester or other derivative of the active ingredient — which constitute different forms of the ‘active moiety’ of that active ingredient. ( 73 ) That consideration also underlies the case-law of the Court according to which an SPC covering an active ingredient also protects the derivatives of that active ingredient provided that they are protected by the basic patent, ( 74 ) it being understood that those derivatives are not then considered to be distinct active ingredients. However, in the event that the derivative obtained itself constitutes a new active ingredient which is the subject of a specific patent, an SPC could be granted for that derivative.

67.

It is, in my opinion, from that perspective that it is necessary to understand recital 14 of Regulation No 1610/96, which Abraxis relies upon in order to establish the validity of the scope of protection of the basic patent test. That recital — which according to recital 17 of that regulation is also valid for the interpretation in particular of Article 3 of Regulation No 469/2009 — states that ‘the issue of a certificate for a product consisting of an active substance does not prejudice the issue of other certificates for derivatives (salts and esters) of the substance, provided that the derivatives are the subject of patents specifically covering them’.

68.

Indeed, a reading of recital 14 of Regulation No 1610/96 in the light of Article 1(8) and Article 3(d) of that regulation highlights that an SPC may be granted only on the basis of the first marketing authorisation covering an active ingredient or combination of specific active ingredients. ( 75 ) In those circumstances, that recital can be understood only as meaning that a derivative of an active ingredient already covered by an SPC may, where that derivative is specifically claimed by a patent, be the subject of another SPC, in so far as it is itself considered to be a new and distinct active ingredient. ( 76 ) That recital in no way suggests that any new formulation of a previously authorised active ingredient may be the subject of an SPC provided that it is covered by a basic patent.

69.

It follows from all the foregoing considerations that the intention of the legislature, in establishing the SPC regime, was to protect not all pharmaceutical research sufficiently innovative to give rise to the grant of a patent and the marketing of a new medicinal product, but only research leading to the placing on the market for the first time of an active ingredient or a combination of active ingredients as a medicinal product. That research must be encouraged whatever its purpose, regardless of whether it concerns the product itself or a process to obtain or therapeutic use of that product.

70.

The approach adopted by the legislature inevitably denies the protection of an SPC to certain inventions, such as the formulation of nab-paclitaxel, which, although they concern a previously authorised product, constitute genuine therapeutic advances ( 77 ) and are subject to a considerable erosion of the effective duration of the patent by reason of the procedures to be carried out before commercial exploitation is possible. ( 78 ) In my view, however, that finding does not justify the creation by judicial decision of a test departing from the wording of Article 3(d) of Regulation No 469/2009 and from the intention of the legislature, on the basis of a different conception of the way in which it is appropriate to pursue the objectives of stimulating innovation and striking a balance between all the interests involved in the field of medicinal products. The following considerations strengthen my conviction in that regard.

71.

In the first place, the actual impact of the SPC regime on innovation requires delicate economic assessments involving the consideration of a multiplicity of factors. ( 79 ) In that regard, although the argument put forward by Abraxis is based on the premiss that extending the scope of the protection conferred by the SPC would necessarily favour research into innovative medicinal products in the European Union, the accuracy of that premiss is disputed.

72.

In particular, according to some recent studies, the grant of SPCs on the basis of marketing authorisations for medicinal products comprising active ingredients which have all been previously authorised may amplify a tendency, observed in the pharmaceutical industry, to concentrate research efforts on safer and more marginal innovations (‘incremental innovations’) rather than on risky innovations leading to real therapeutic breakthroughs (‘fundamental innovations’). ( 80 )

73.

Moreover, the authors of the Max Planck Report argue that the decline in the research and development of new molecules in Europe, which the introduction of the SPC regime was aimed at remedying, was due to the particularly risky nature of those activities and the onerous nature of the pre-clinical tests and clinical trials necessary for the first placing on the market of an active ingredient. In the light of those factors, the effective duration of the patent was insufficient to ensure the continued profitability of that type of activity. However, the existence of such a market failure has not been documented as regards the research and development of new therapeutic applications of known active ingredients. ( 81 )

74.

Without taking any position in that debate, which would be beyond the scope of my duties, the existence of such a debate induces me to exercise prudence before drawing general conclusions on the adequacy or otherwise of the system adopted by the legislature with the objective of encouraging pharmaceutical research within the European Union.

75.

In the second place, and in any event, it must be borne in mind that, by adopting the SPC regime, the legislature intended to achieve that objective in a manner which struck a balance between all the interests involved. That intention resulted in a general compromise between those various interests, under which certain patented inventions, namely those leading to the first placing on the market of an active ingredient or a combination of active ingredients as a medicinal product, may benefit from an SPC. Only the legislature has the power to change the weighting of the interests involved if it considers that, in the current context, the balance sought is no longer maintained by the system in place, in the light of developments in the pharmaceutical research sector.

76.

Moreover, the compromise made by the legislature under the SPC regime is part of a broader legislative framework providing for varies types of incentives for research into new medicinal products. They include, in addition to intellectual property rights, legislative incentives such as the protection of data derived from pre-clinical tests and clinical trials ( 82 ) as well as the market exclusivity conferred by a marketing authorisation. ( 83 )

77.

In the third place, paragraph 16 of the Explanatory Memorandum states that the legislature intended to create a simple, transparent system which could easily be applied by the national patent offices responsible for granting SPCs. The rule that only the first marketing authorisation for the product may be relied upon in support of an SPC application contributes to the pursuit of that objective. As, in essence, the United Kingdom Government, the Hungarian and Netherlands Governments, and also the Commission, have pointed out, to place on the national patent offices the burden of verifying whether the earlier marketing authorisations for the product fall within the scope of the protection conferred by the basic patent would depart from the logic governing that system.

78.

In the fourth place, the literal interpretation of Article 3(d) of Regulation No 469/2009 cannot be dismissed on the basis of the objective of compensating for the delay in the commercial exploitation of a patented invention on account of the procedures necessary to obtain a marketing authorisation.

79.

I would point out in that regard that a medicinal product containing a new active ingredient or a new combination of active ingredients must be authorised at the end of the procedure based on Article 8(3) of Directive 2001/83. ( 84 ) That procedure involves the submission of a full application for marketing authorisation, including the results of pre-clinical tests and clinical trials establishing the efficacy and safety of that medicinal product. ( 85 ) However, the marketing authorisation for a medicinal product which contains an active ingredient or a combination of active ingredients included in a reference medicinal product (when it does not constitute a generic of the latter medicinal product) ( 86 ) may be obtained at the end of the ‘hybrid’ procedure provided for in Article 10(3) of that directive. That procedure allows the applicant for marketing authorisation, upon the expiry of the period of protection of the data derived from the pre-clinical tests and clinical trials provided in the submission of a marketing authorisation dossier for the reference medicinal product, to use those data without demonstrating independently the effectiveness and safety of the active ingredient. The applicant need then himself produce only the results of pre-clinical tests and clinical trials covering the changes made to the medicinal product at issue — concerning, in particular, the formulation or the therapeutic indications — by comparison with the reference medicinal product. ( 87 )

80.

However, certain medicinal products, such as Abraxane, containing a new formulation of a known active ingredient differ to such an extent from other medicinal products containing that active ingredient that their authorisation is subject to the procedure laid down in Article 8(3) of Directive 2001/83. ( 88 ) In the light of that consideration, Abraxis submits that the objective referred to in point 78 of this Opinion justifies conferring on the new formulation of a known active ingredient the protection of an SPC where the placing on the market of a medicinal product containing that formulation required the grant of a new marketing authorisation under the same conditions as a medicinal product containing a new active ingredient.

81.

Both the wording of Article 3(d) of Regulation No 469/2009 and the case-law of the Court prevent me from concurring with that view. Indeed, that provision does not set out any criterion relating to the type of procedure followed for the purpose of obtaining a marketing authorisation. In accordance with that wording, the Court held in Neurim that Article 8(3) of Directive 2001/83, the subject matter of which is purely procedural, cannot affect the assessment of the substantive conditions which are laid down by Regulation No 469/2009. ( 89 ) Accordingly, the scope of Article 3(d) of that regulation does not depend on whether or not a full application for marketing authorisation has been required.

82.

However, since the placing on the market of medicinal products containing a new product, within the meaning of Article 1(b) of Regulation No 469/2009, unlike the placing on the market of medicinal products consisting of new formulations of previously authorised products, necessarily requires the submission of a complete marketing authorisation dossier, that fact may help to explain the legislative choice to confine the benefit of the SPC to products placed on the market for the first time. In that regard, as is apparent from Synthon, ( 90 ) the protection conferred by the SPC is intended to offset the time taken to obtain a marketing authorisation, which requires ‘long and demanding testing of the safety and efficacy of the medicinal product concerned’. According to that explanation, the legislature sought to promote basic innovation, which requires particularly risky research and the commercial exploitation of which entails a particularly onerous authorisation procedure, while ensuring the simplicity and transparency of the SPC regime. To that end, the legislature used the fact that the active ingredient or combination of active ingredients was new as a ‘proxy’ to demonstrate the existence of such innovation. ( 91 )

83.

From that perspective, although the authorisation of certain new formulations of known products is itself also subject to the procedure based on Article 8(3) of Directive 2001/83, the exclusion of the benefit of the SPC for such inventions appears to be inherent both in striking the overall balance sought by the legislature between the interests involved and in the functioning of the SPC regime, which the legislature intended to be simple and predictable.

84.

It is ultimately for the legislature, if it deems it appropriate, to modify the system so as to protect all patented inventions whose commercial exploitation requires the submission of a full application for marketing authorisation under that provision, or even to favour more generally all research leading to the placing on the market of a medicinal product incorporating for the first time a patented invention. Likewise, it is solely within the discretion of the legislature to choose the approach to be adopted in order to implement such a modification and, in particular, the provision or provisions of Regulation No 469/2009 which should be amended for that purpose. I note in that regard that, in the context of the ongoing review procedure, the Commission has not proposed any amendment to Article 3 or Article 1(b) of that regulation. ( 92 )

85.

Having regard to all the foregoing considerations, I take the view that neither the objectives pursued by Regulation No 469/2009 nor its context supports an interpretation which departs from the wording of Article 3(d).

86.

That finding leads me to propose the abandonment of the scope of protection of the basic patent test and a return to a literal interpretation of Article 3(d) of Regulation No 469/2009, in the light of Article 1(b) of that regulation. I am of the view that the restrictive reading by the Court, in its settled case-law, of the concept of ‘product’, within the meaning of Article 1(b) of that regulation, cannot be circumvented by means of a broad interpretation of the concept of ‘first authorisation to place the product on the market as a medicinal product’, within the meaning of Article 3(d) of that regulation.

87.

My proposal means, inter alia, that the latter provision precludes the grant of an SPC in a situation, such as that at issue in the main proceedings, where the marketing authorisation relied upon in the SPC application, although the first to fall within the scope of a basic patent protecting the new formulation of a known active ingredient, is not the first marketing authorisation for that active ingredient.

88.

In the alternative, and in the event that the Court does not wish to adopt such an approach, I shall examine below the options which might allow it to limit the application of the scope of protection of the basic patent test to specific situations.

89.

In the first place, the United Kingdom Government and the Commission, in its written observations, take the view, in essence, that the scope of protection of the basic patent test applies where the invention protected by the patent at issue concerns a new therapeutic use of a known product. ( 93 ) Such a factual background characterised the cases which gave rise to Neurim and to the order in Yissum. ( 94 ) On the other hand, Article 3(d) of Regulation No 469/2009 precluded the grant of an SPC in situations where, as in particular in the case giving rise to Massachusetts Institute of Technology ( 95 ) or in the case in the main proceedings, the marketing authorisation at issue is the first to fall within the scope of a basic patent which protects a new formulation of a known product for a known therapeutic use of that product.

90.

In the light of the foregoing, that interpretation remains at odds with the wording and objectives of Regulation No 469/2009. Moreover, the interested parties have not presented arguments capable of justifying a distinction between, on the one hand, inventions relating to a new therapeutic use of an already authorised active ingredient (where appropriate, in a new formulation) and, on the other hand, inventions relating to a new formulation of such an active ingredient for a known therapeutic use. I am also struggling to find such arguments.

91.

First of all, neither the wording of the regulation nor the Explanatory Memorandum suggests that the legislature intended to favour research into new therapeutic applications for a known active ingredient over research into new formulations of such an active ingredient already covered by a marketing authorisation which enhance its efficacy or safety for known therapeutic indications. ( 96 )

92.

Next, it is difficult to justify and apply such a distinction from the perspective of patent law. Indeed, I would point out that under the European Patent Convention, as interpreted by the EPO, any new formulation of a known active ingredient, as well as any second or subsequent therapeutic application of such an active ingredient, whether or not it permits a new therapeutic indication, is capable of being patented. ( 97 )

93.

Lastly, it cannot be presumed, without a more in-depth examination of an economic and scientific nature, that the merits and risks associated with research and development concerning a new therapeutic use of a known active ingredient would exceed, in general at least, those involved in the research and development of a new formulation of such an active ingredient intended to improve its efficacy or safety for known therapeutic indications. ( 98 ) In particular, applications for marketing authorisation covering a new formulation of a previously authorised product, a new therapeutic indication for that product or a combination of both may, in principle at the very least, benefit from the hybrid procedure provided for in Article 10(3) of Directive 2001/83. ( 99 )

94.

In the second place, the Czech and Netherlands Governments have proposed confining the scope of Neurim to the specific cases in which the marketing authorisation relied upon in the SPC application, although not the first to cover the active ingredient at issue, is the first marketing authorisation for that active ingredient for the therapeutic use protected by the basic patent and as a human medicinal product.

95.

In support of that line of argument, the Netherlands Government submits that the first placing on the market of a human medicinal product containing a given active ingredient, even though it has already been authorised as a veterinary medicinal product, necessarily requires the submission of a marketing authorisation dossier similar to that of a human medicinal product containing an active ingredient that has never been authorised.

96.

In my opinion, on the one hand, that approach is not in keeping with the wording of the provisions of Regulation No 469/2009. Indeed, as the Court has already found in Pharmacia Italia, ( 100 ) that regulation does not distinguish in principle between marketing authorisations granted for human medicinal products and those for veterinary medicinal products. ( 101 ) In particular, the definition of ‘medicinal product’ in Article 1(a) of the regulation includes substances that can be administered to humans or to animals. Similarly, Article 2 of Regulation No 469/2009 provides that the regulation applies without distinction to any product protected by a patent and subject to an administrative authorisation procedure under either Directive 2001/83 or Directive 2001/82. However, the legislature did not consider it appropriate to provide, in Article 3(d) of Regulation No 469/2009, that the marketing authorisation relied upon in support of the SPC application must be the first marketing authorisation covering the product at issue for a given (human or animal) population.

97.

Moreover, the fact that the grant of the marketing authorisation relied upon in support of the SPC application required the submission of a complete dossier under Article 8(3) of Directive 2001/83 is not, I would point out, a decisive criterion for the purpose of the grant of an SPC. That fact is, at most, one of the reasons capable of explaining the choice of the legislature to restrict the benefit of the SPC to active ingredients or combinations of active ingredients placed on the market for the first time. ( 102 )

98.

However, in the alternative, and in the event that the Court does not adopt the principal interpretation which I have put forward, the interpretation advocated by the Czech and Netherlands Governments has certain advantages which lead me to propose that it be endorsed by the Court.

99.

First, the regulatory argument put forward by the Netherlands Government seems to me, in spite of its limits, to be relevant in the light of the objective, pursued by Regulation No 469/2009, of compensating for the erosion of the protection conferred by a patent by reason of the length of the authorisation procedures for a new medicinal product constituting a basic innovation.

100.

In that connection, I would point out that Directive 2001/83 does not permit use of the hybrid procedure on the basis of a reference veterinary medicinal product. ( 103 ) Consequently, the first placing on the market of a human medicinal product containing a particular active ingredient, even when that active ingredient is already authorised for veterinary use, is always subject to the submission of a full application for marketing authorisation under Article 8(3) of that directive. It therefore involves the same procedures as those required for the first placing on the market of a medicinal product composed of an active ingredient that has never been authorised for veterinary or human use, which is not necessarily the case with the first marketing authorisation covering a new therapeutic indication of a product previously authorised as a human medicinal product.

101.

Moreover, where an invention leads to the first placing on the market of a product for a particular therapeutic indication and as a human medicinal product, it does not seem unreasonable to me to consider that that invention may, in principle, be regarded as a basic therapeutic advance. Thus, although the legislature did not specifically envisage the particular, and probably exceptional, kind of situations at issue in Neurim, the pursuit of the objectives referred to by that regulation would imply that the benefit of the SPC extends to such situations.

102.

Secondly, that solution would promote the coherence of the Court’s case-law by allowing Neurim to coexist alongside the judgments relating to the interpretation of the concept of ‘product’, within the meaning of Regulation No 469/2009, and the order in Yissum. ( 104 )

103.

That order covers situations in which the first marketing authorisation for an active ingredient concerns a therapeutic indication in human medicine and the second marketing authorisation for that active ingredient, although the first to cover a new therapeutic use protected by the basic patent, also relates to a human medicinal product. Those situations are, according to the interpretation of the Czech and Netherlands Governments, excluded from the scope of the test set out in Neurim. Article 3(d) of Regulation No 469/2009 therefore precludes the grant of an SPC in such situations.

104.

I would add, for the sake of completeness, that Pharmacia Italia, ( 105 ) in which the Court refused to establish the intended use of the medicinal product as the decisive factor for the grant of an SPC, dealt with a situation in which both the first marketing authorisation for the active ingredient at issue, which covers a veterinary medicinal product, and the second marketing authorisation for that active ingredient, which concerns a human medicinal product, fall within the scope of the same basic patent protecting that active ingredient as such. In that situation, as has been emphasised by Abraxis and by the United Kingdom Government, the application of the scope of protection of the basic patent test would in any event lead to the rejection of the SPC application.

105.

In the light of those considerations, I propose that the Court, in the alternative, hold that the scope of protection of the basic patent test applies only where a product previously authorised pursuant to Directive 2001/82 for a therapeutic indication in veterinary medicine is subsequently granted a marketing authorisation under Directive 2001/83 for a new therapeutic indication in human medicine. In such a situation, Article 3(d) of Regulation No 469/2009 does not preclude the grant of an SPC on the basis of that marketing authorisation, provided it is the first to fall within the scope of the protection conferred by the basic patent relied upon in support of the SPC application.

106.

In the light of all the foregoing considerations, I propose that the Court give the following answer to the question referred by the High Court of Justice (England & Wales), Chancery Division (Patents Court), United Kingdom:

Article 3(d) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products precludes the grant of such a certificate where the marketing authorisation relied upon in support of the application for a supplementary protection certificate under Article 3(b) of that regulation is not the first marketing authorisation for the active ingredient or combination of active ingredients at issue as a medicinal product. This is so even in a situation, such as that at issue in the main proceedings, where the marketing authorisation relied upon is the first to cover the formulation protected by the basic patent relied upon in support of the application for a supplementary protection certificate under Article 3(a) of that regulation.