1.

This request for a preliminary ruling, lodged with the Court Registry on 8 March 2017 by the High Court of Justice (England and Wales), Chancery Division (Patents Court) (United Kingdom) concerns the interpretation of Article 3(a) 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. ( 2 )

2.

The request has been made in proceedings brought by Teva UK Ltd, Accord Healthcare Ltd, Lupin Ltd, Lupin (Europe) Ltd and Generics (UK), trading as ‘Mylan’, against Gilead Sciences Inc. (‘Gilead’). In the main proceedings, the applicants are challenging the validity of Gilead’s supplementary protection certificate (‘SPC’) SPC/GB05/041 for a product described in the SPC as a ‘composition containing both Tenofovir disoproxil, optionally in the form of a pharmaceutically acceptable salt, hydrate, tautomer or solvate, together with Emtricitabine’. The product covered by the SPC is an anti-retroviral medication used in the treatment of human immunodeficiency virus (HIV) and is marketed by Gilead under the trade mark Truvada.

3.

Gilead claims that the product covered by the SPC is ‘protected’ within the meaning of Article 3(a) of Regulation No 469/2009 by a European patent but the applicants in the main proceedings dispute that claim. The latter therefore contend that the SPC does not comply with Article 3(a) of that regulation.

4.

The request for a preliminary ruling affords the Court a further opportunity to rule on the thorny issue of the criteria for determining whether an active ingredient ( 3 ) or combination of active ingredients of a medicinal product is ‘protected by a basic patent in force’ within the meaning of Article 3(a) of Regulation No 469/2009. ( 4 )

5.

Recitals 4, 5, 9 and 10 of Regulation No 469/2009 read as follows:

…

6.

Article 1 of that regulation, headed ‘Definitions’, provides:

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

…’

7.

Article 3 of Regulation No 469/2009, headed ‘Conditions for obtaining a certificate’, provides:

‘A certificate 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:

8.

Under the heading ‘Extent of protection’, Article 69 of the Convention on the Grant of European Patents, signed in Munich on 5 October 1973, in the version applicable at the material time in the main proceedings (‘the EPC’), is worded as follows:

‘(1)   The extent of the protection conferred by a European patent or a European patent application shall be determined by the claims. Nevertheless, the description and drawings shall be used to interpret the claims.

(2)   For the period up to grant of the European patent, the extent of the protection conferred by the European patent application shall be determined by the claims contained in the application as published. However, the European patent as granted or as amended in opposition, limitation or revocation proceedings shall determine retroactively the protection conferred by the application, in so far as such protection is not thereby extended.’

9.

Article 1 of the Protocol on the Interpretation of Article 69 of the EPC, which forms an integral part of the convention in accordance with Article 164(1) thereof, provides as follows in relation to Article 69:

‘Article 69 should not be interpreted as meaning that the extent of the protection conferred by a European patent is to be understood as that defined by the strict, literal meaning of the wording used in the claims, the description and drawings being employed only for the purpose of resolving an ambiguity found in the claims. Nor should it be taken to mean that the claims serve only as a guideline and that the actual protection conferred may extend to what, from a consideration of the description and drawings by a person skilled in the art, the patent proprietor has contemplated. On the contrary, it is to be interpreted as defining a position between these extremes which combines a fair protection for the patent proprietor with a reasonable degree of legal certainty for third parties.’

10.

Article 83 of the EPC, headed ‘Disclosure of the invention’, states as follows:

‘The European patent application shall disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art.’

11.

Article 84 of the EPC, headed ‘Claims’, provides that ‘the claims shall define the matter for which protection is sought. They shall be clear and concise and be supported by the description.’

12.

Article 69 of the EPC and the Protocol on its interpretation were given effect in the United Kingdom by section 125(1) and (3) of the Patents Act 1977 (‘the Patents Act 1977’).

13.

Under the heading ‘Extent of invention’, section 125 of the Patents Act 1977 provides:

‘(1)   For the purposes of this Act an invention for a patent for which an application has been made or for which a patent has been granted shall, unless the context otherwise requires, be taken to be that specified in a claim of the specification of the application or patent, as the case may be, as interpreted by the description and any drawings contained in that specification, and the extent of the protection conferred by a patent or application for a patent shall be determined accordingly.

…

(3)   The Protocol on the Interpretation of Article 69 of the European Patent Convention (which Article contains a provision corresponding to subsection (1) above) shall, as for the time being in force, apply for the purposes of subsection (1) above as it applies for the purposes of that Article.’

14.

Gilead is a pharmaceutical company which markets an antiretroviral medicinal product indicated for the treatment of persons infected with HIV, under the name Truvada. That medicinal product contains two active ingredients, tenofovir disoproxil (‘TD’) and emtricitabine. ( 5 ) It was granted marketing authorisation (‘MA’) in 2005 by the European Medicines Agency (EMA).

15.

Gilead holds European patent No EP 0 915894 (‘the basic patent’). That patent, which was applied for on 25 July 1997 with a claimed priority date of 26 July 1996, was granted on 14 May 2003 and expired on 24 July 2017. It covers, in general terms, a series of molecules which are helpful in the therapeutic treatment of a number of viral infections in humans and animals, in particular HIV.

16.

The ‘Summary of the Invention’ states that the invention provides compounds in accordance with two Markush formulae, formula (1a) and formula (1), and methods for preparing such compounds.

17.

Claim 1 is a claim to compounds of formula (1a) and claim 2 is a claim to compounds of formula (1). Claims 3 to 24 are dependent compound claims which get progressively narrower in scope.

18.

Claim 25 is an independent compound claim to TD.

19.

Claim 27 is in the following terms:

‘A pharmaceutical composition comprising a compound according to any one of claims 1 to 25 together with a pharmaceutically acceptable carrier and optionally other therapeutic ingredients.’ ( 6 )

20.

Claims 28 to 33 are method claims.

21.

In 2008, Gilead was granted SPC SPC/GB05/041 on the basis of claim 27 of the basic patent and the MA obtained for Truvada. The SPC relates to a ‘composition containing [TD], optionally in the form of a pharmaceutically acceptable salt, hydrate, tautomer or solvate, together with Emtricitabine’. ( 7 )

22.

The applicants in the main proceedings, who intended to market generic versions of Truvada on the UK market once the basic patent had expired, brought proceedings before the referring court disputing the validity of that SPC.

23.

In support of their action, the applicants in the main proceedings argue essentially that, in order for Article 3(a) of Regulation No 469/2009 to be satisfied, the product in question must be ‘specified in the wording of the claims’ ( 8 ) and, where the claim contains a functional definition, it must ‘relate, implicitly but necessarily and specifically’ to that product. ( 9 ) They observe that emtricitabine is not specified anywhere in the wording of claim 27 and that the words ‘other therapeutic ingredients’ do not specify any active ingredient, whether structurally, functionally or otherwise. ‘On the contrary, they cover a virtually unlimited range of active ingredients for the treatment of many diseases. Indeed, emtricitabine was not approved for clinical use until seven years after the priority date of the Patent and there is no evidence that it was known to be efficacious at that date.’

24.

The applicants in the main proceedings also contend that claim 27 does not require the presence of any ‘other therapeutic ingredients’ since such ingredients are only ‘optionally’ present. According to the applicants, ‘it is clear from the case-law of the [Court] that it is not enough that a claim to “A composition comprising compound A” would be infringed due to the presence of A in a combination product consisting of A and B. There is no distinction between such a claim and a claim to “A composition consisting of compound A and optionally other active ingredients”’.

25.

Gilead asserts that in order for Article 3(a) of Regulation No 469/2009 to be satisfied, it is necessary and sufficient that the product in question falls within the scope of protection of at least one claim of the basic patent applying the Extent of Protection Rules. ( 10 ) It takes the view that the combination of TD and emtricitabine does fall within the scope of protection of claim 27 of the patent under Article 69 of the EPC and under the Protocol on interpretation.

26.

The referring court considers that, notwithstanding the many judgments delivered by the Court of Justice on interpretation of Article 3(a) of Regulation No 469/2009, ( 11 ) the meaning to be given to that article ‘remains unclear’. The referring court asserts that the need to make a reference to the Court of Justice is confirmed by the divergent decisions that have been reached around Europe as to the availability of an SPC on the facts of the present case and by the differing interpretations of Article 3(a) of Regulation No 469/2009 that have been adopted in the case-law of the national courts. ( 12 )

27.

The referring court states that it is not sufficient that the product falls within at least one claim of the basic patent and that ‘more is required’. The judgments of 12 December 2013, Actavis Group PTC and Actavis UK (C‑443/12, EU:C:2013:833), of 12 December 2013, Eli Lilly and Company (C‑493/12, EU:C:2013:835), and of 12 March 2015, Actavis Group PTC and Actavis UK (C‑577/13, EU:C:2015:165), suggest that, in order to determine whether a ‘product is protected by a basic patent’, ‘the subject matter of the invention covered by the basic patent’ or the ‘core inventive advance’ must also be taken into consideration. However, the referring court submits, those judgments do not make clear the meaning and scope of those new tests, or even whether they apply to interpretation of Article 3(a) of Regulation No 469/2009. ( 13 )

28.

According to the referring court, the product must contain an active ingredient, or a combination of active ingredients, which embodies the inventive advance (or technical contribution) of the basic patent. ( 14 )

29.

In the present case, the referring court notes that emtricitabine is not mentioned in the basic patent at issue. Nor is there any evidence that emtricitabine was known to be efficacious for the treatment of HIV on the priority date claimed by that patent. In view of those considerations, the referring court hesitates to find that the TD/emtricitabine combination is protected by the basic patent within the meaning of Article 3(a) of Regulation No 469/2009, especially as the criteria laid down in the case-law provide but little clarification for the purpose of resolving that question.

30.

In those circumstances, the High Court of Justice (England and Wales), Chancery Division (Patents Court) decided to stay the proceedings and to refer the following question to the Court of Justice for a preliminary ruling:

‘What are the criteria for deciding whether “the product is protected by a basic patent in force” in Article 3(a) of Regulation No 469/2009.’

31.

The referring court included with its request for a preliminary ruling a request for the case to be decided under the expedited procedure pursuant to Article 105(1) of the Court’s Rules of Procedure. ( 15 ) The Court of Justice refused that request by order of 4 April 2017. ( 16 )

32.

The applicants in the main proceedings, Gilead, the United Kingdom Government, the Greek and Netherlands Governments and the European Commission submitted written observations.

33.

The applicants in the main proceedings, Gilead, the United Kingdom Government, the Greek and Latvian Governments and the Commission presented oral argument at the hearing on 20 February 2018.

34.

The applicants in the main proceedings contend that the Court of Justice had answered substantially the same question concerning Article 3(a) of Regulation No 469/2009 in its judgment of 24 November 2011, Medeva (C‑322/10, EU:C:2011:773). In their view, that article must be interpreted as precluding the grant of an SPC relating to active ingredients which are not specified in the wording of the claims of the basic patent relied on in support of the SPC application.

35.

According to the applicants in the main proceedings, the Court’s case-law subsequent to that judgment has restated the same criteria and given the same reasons for adopting it. They maintain that it is plain, in the present case, that the SPC does not satisfy the requirements under Article 3(a) of Regulation No 469/2009, because emtricitabine is not referred to anywhere in the patent, whether by name, by reference to its chemical structure or otherwise.

36.

The applicants in the main proceedings also contend that it ‘is clear that the scope of protection of claim 27 is not limited to a pharmaceutical composition containing two (or more) therapeutic ingredients, but extends to a pharmaceutical composition containing a single therapeutic ingredient consisting of a compound falling within claims 1 to 25. As the referring court held, the presence or absence of another therapeutic ingredient is irrelevant to any assessment of whether a pharmaceutical composition falls within claim 27, and thus to whether dealings in such a pharmaceutical composition infringe that claim of the patent.’

37.

Gilead argues that a product is protected by a basic patent in force, in accordance with Article 3(a) of Regulation No 469/2009, if the product falls within the scope of protection of a claim of the basic patent in force, as determined in accordance with Article 69 of the EPC or national legislation derived from that article. Gilead submits that there is no further or additional requirement under EU law. In its view, the approach advocated by the referring court must be rejected because it has no basis in Regulation No 469/2009, is inconsistent with the case-law of the Court of Justice, and has been proposed in the past by the referring court and rejected by the Court of Justice.

38.

The United Kingdom Government points out that in paragraph 41 of the judgment of 12 December 2013, Actavis Group PTC and Actavis UK (C‑443/12, EU:C:2013:833), the Court stated that ‘the basic objective of Regulation No 469/2009 is to compensate for the delay to the marketing of what constitutes the core inventive advance that is the subject of the basic patent …’. The United Kingdom of Great Britain and Northern Ireland submits that this ‘core inventive advance’ test is a workable approach which properly reflects the balance between the competing interests underlying Regulation No 469/2009 because it does not require national intellectual property offices to undertake an assessment of inventive step akin to assessing the validity of the contested patent. That government notes that the referring court has suggested that ‘technical contribution’ can be taken as equivalent to identifying an ‘inventive advance’. Nevertheless, according to the United Kingdom Government, some care is needed in linking these concepts, because the term ‘technical contribution’ arises in a number of different contexts in the case-law of the Boards of Appeal of the European Patent Office (EPO) and it is likely to lead to confusion and legal uncertainty if the test to be applied under Regulation No 469/2009 is tied too closely to that case-law. ( 17 )

39.

The United Kingdom Government is therefore of the view that the appropriate test comprises three stages as follows:

40.

The Netherlands Government takes the view that a ‘product is protected by a basic patent in force’ within the meaning of Article 3(a) of Regulation No 469/2009 if the product is specified in the claims of the basic patent. According to that government, the product is so specified if a person skilled in the art would have recognised, both in the light of the description and of that person’s general knowledge as at the priority date, that the active ingredient for which a supplementary certificate is sought is among the substances mentioned in the claims. However, according to the Netherlands Government, in order to determine whether a combination product (in this instance, the combination of TD and emtricitabine) is protected by a basic patent in force, the combination product must also be capable of being regarded as the core inventive advance. ( 18 )

41.

In the present case, the Netherlands Government considers that what is therefore required is not only that a person skilled in the art should recognise that the expression ‘other therapeutic ingredients’ mentioned in claim 27 refers to emtricitabine. It is also necessary, according to that government, to assess whether that ingredient, in combination with the active ingredient TD, is the subject of the invention covered by the patent. If the combination of TD and emtricitabine does not form part of the core inventive advance, according to the Netherlands Government the condition under Article 3(a) of Regulation No 469/2009 is not satisfied.

42.

The Greek Government contends that it is clear from the Court’s case-law that in the case of a combination medicinal product composed of at least two active ingredients, as with the product at issue, ( 19 ) in order for an SPC to be granted, the inventive advance of the patent must form part of the combination, as referred to in the claims of the patent. Therefore, in a case such as the present one, no SPC is to be granted for a medicinal product consisting of an active ingredient or a combination of active ingredients which does not embody the inventive advance of the basic patent.

43.

At the hearing on 20 February 2018, the Latvian Government contended that the expression ‘protected by a basic patent in force’ within the meaning of Article 3(a) of Regulation No 469/2009 had to be interpreted strictly in order to meet the objectives of that regulation and to protect not only the interests of manufacturers of patented pharmaceutical products, but also those of manufacturers of generic medicinal products and consumers. That government argues that the active ingredient must be clearly mentioned in the claims of the basic patent, as interpreted in accordance with Article 69 of the EPC. However, the Latvian Government does not believe that criterion to be sufficient. In its view, there must be an additional test, that is to say, whether the active ingredient in question constitutes the core inventive advance of the basic patent. According to that government, in the case of a combination of active ingredients, that combination must constitute the core inventive advance.

44.

The Commission points out that in paragraph 28 of the judgment of 24 November 2011, Medeva (C‑322/10, EU:C:2011:773), the Court of Justice held that ‘Article 3(a) of Regulation No 469/2009 [had to] be interpreted as precluding the competent industrial property office of a Member State from granting a SPC relating to active ingredients which are not specified in the wording of the claims of the basic patent relied on in support of the SPC application.’

45.

According to the Commission, claim 27 is unduly broad, open-ended and generic in its drafting. In its view, whilst that wording might have sufficed under proper scrutiny in the era of the judgment of 16 September 1999, Farmitalia (C‑392/97, EU:C:1999:416), under the Extent of Protection Rules, it would not meet the standard laid down in the Court’s more recent case-law.

46.

The Commission submits in that regard that the terms ‘comprising’ and ‘optionally’ militate against that standard as they are by choice broad and open-ended.

47.

As regards the referring court’s proposed core inventive advance test and whether or not it can be applied for the purposes of Article 3(a) of Regulation No 469/2009, the Commission submits that it could be argued that the Court has already alluded to that test in paragraph 41 of its judgment of 12 December 2013, Actavis Group PTC and Actavis UK (C‑443/12, EU:C:2013:833). It notes that that judgment relates, however, to Article 3(c) of Regulation No 469/2009 in a context where an earlier SPC had been issued to the applicant for the same product and a second SPC was requested for a combination that included that product. The Commission adds that the Court declined to answer the first question in that case, which related to Article 3(a) of that regulation.

48.

The reason given for adopting Regulation No 469/2009 is that the period of effective protection under a patent is insufficient to cover the investment put into pharmaceutical research and the regulation therefore seeks to make up for that insufficiency by creating an SPC for medicinal products. ( 20 )

49.

Regulation No 469/2009 establishes a uniform solution at European Union level by creating an SPC which may be obtained by the holder of a national or European patent under the same conditions in each Member State, thereby preventing the heterogeneous development of national laws leading to further disparities which would be likely to create obstacles to the free movement of medicinal products within the Union. ( 21 )

50.

Indeed, Article 2 of Regulation No 469/2009 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 licensing procedure ( 22 ) may, under the terms and conditions provided for in that regulation, be the subject of an SPC.

51.

Article 3 of Regulation No 469/2009 accordingly lays down four cumulative requirements for obtaining an SPC. Only the first requirement, laid down in Article 3(a) of that regulation, that the product must be ‘protected by a basic patent in force’, is at issue in the present case.

52.

Under Article 5 of Regulation No 469/2009, any SPC confers the same rights as conferred by the basic patent and is subject to the same limitations and the same obligations.

53.

Article 13(1) of Regulation No 469/2009 provides that the SPC is to take effect at the end of the lawful term of the basic patent for a period equal to the period which elapsed between the date on which the application for a basic patent was lodged and the date of the first authorisation to place the product on the market in the Union, reduced by a period of five years. Article 13(2) of Regulation No 469/2009 states that ‘notwithstanding paragraph 1, the duration of the certificate may not exceed five years from the date on which it takes effect’. ( 23 )

54.

As stated in paragraph 32 of the judgment of 24 November 2011, Medeva (C‑322/10, EU:C:2011:773), and given that, under Article 5 of Regulation No 469/2009, any SPC confers the same rights as conferred by the basic patent and is subject to the same limitations and the same obligations, it follows that Article 3(a) of Regulation No 469/2009 precludes an SPC being issued where it relates to active ingredients which are not specified ( 24 )in the wording of the claims in that basic patent. ( 25 )

55.

In paragraph 30 of the order of 25 November 2011, Daiichi Sankyo (C‑6/11, EU:C:2011:781) the Court also held that ‘Article 3(a) of Regulation No 469/2009 must be interpreted as precluding the competent industrial property office of a Member State from granting an SPC relating to active ingredients which are not identified in the wording of the claims of the basic patent relied on in support of the SPC application.’ ( 26 )

56.

To my mind, the terms ‘specify’ and ‘identify’ are synonyms that the Court of Justice uses interchangeably.

57.

The Court has therefore emphasised the key role played by the claims for the purposes of determining whether a product is protected by a basic patent within the meaning of Article 3(a) of Regulation No 469/2009.

58.

The Court of Justice has clearly ruled that the rules for determining what is protected by a basic patent for the purpose of Article 3(a) of Regulation No 469/2009 are those relating to the extent of the invention covered by such a patent, as distinct from those relating to infringement proceedings. ( 27 )

59.

As a simple illustration of the difference between the rules relating to the extent of the invention and those relating to infringement proceedings, a medicinal product composed of active ingredients A+B would infringe a patent and give rise to infringement proceedings even if the claims of the patent related only to active ingredient A.

60.

On the other hand, it is clear that active ingredient B, which is not specified anywhere in the claims, does not fall within the extent of the invention and is not ‘protected’ by the patent in question within the meaning of Article 69 of the EPC and the Protocol on its interpretation and of Article 125 of the Patents Act 1977.

61.

Indeed, although Regulation No 469/2009 is intended to establish a uniform solution at Union level by creating an SPC which may be obtained by the holder of a national or European patent under the same conditions in each Member State, the Court has nevertheless held that, since patent law is not harmonised at Union level, the extent of patent protection can be determined only in the light of the non-European Union rules governing patents. ( 28 )

62.

In paragraph 40 of the judgment of 12 December 2013, Eli Lilly and Company (C‑493/12, EU:C:2013:835), the Court held that it had no jurisdiction to interpret the provisions of the EPC, since, unlike the Member States, the European Union has not acceded to the convention and the Court could not, therefore, provide further guidance to the referring court concerning the manner in which it should determine the extent of the claims of a patent issued by the EPO.

63.

To my mind, it is that tension between two separate legal regimes that characterises the SPC system set up by Regulation No 469/2009 and gives rise to difficulties in interpreting and applying certain provisions of that regulation, in particular Article 3(a). ( 29 )

64.

The question being asked in this case is whether it is sufficient that a product falls within at least one claim of the basic patent under the Extent of Protection Rules applicable to the patent in order to be a product protected by a basic patent within the meaning of Article 3(a) of Regulation No 469/2009, or whether other additional criteria must be applied.

65.

To resolve that doubt, the referring court proposes that it should be ascertained not only whether the product falls within at least one claim of the basic patent under the Extension of Protection Rules, but also whether the product embodies the inventive advance of the basic patent.

66.

That question has arisen in response to certain guidance provided in the Court’s case-law subsequent to the judgment of 24 November 2011, Medeva (C‑322/10, EU:C:2011:773).

67.

In paragraph 41 of its judgment of 12 December 2013, Actavis Group PTC and Actavis UK (C‑443/12, EU:C:2013:833), the Court held that ‘the basic objective of Regulation No 469/2009 [was] to compensate for the delay to the marketing of what constitutes the core inventive advance that is the subject of the basic patent’. ( 30 )

68.

It should be noted, however, that that judgment is not relevant in the present case because it concerns only Article 3(c) of Regulation No 469/2009, which is not at issue in the present case, ( 31 ) the Court having stated clearly that there was no need to rule on the question referred in that case relating to Article 3(a) of that regulation.

69.

In the case which gave rise to the judgment of 12 December 2013, Eli Lilly and Company (C‑493/12, EU:C:2013:835), the Court was asked whether Article 3(a) of Regulation No 469/2009 must be interpreted as meaning that, in order for an active ingredient to be regarded as ‘protected by a basic patent in force’ within the meaning of that provision, the active ingredient must be identified in the claims of the patent by a structural formula, or whether the active ingredient may also be considered to be protected where it is covered by a functional formula ( 32 ) in the patent claims.

70.

Paragraph 44 of the same judgment of 12 December 2013, Eli Lilly and Company (C‑493/12, EU:C:2013:835), indicates that ‘where the active ingredient is covered by a functional formula ( 33 ) in the claims of a patent issued by the EPO, Article 3(a) of that regulation does not, in principle, preclude the grant of an SPC for that active ingredient, on condition that it is possible to reach the conclusion on the basis of those claims, interpreted inter alia in the light of the description of the invention, as required by Article 69 of the EPC and the Protocol on the interpretation of that provision, that the claims relate, implicitly but necessarily and specifically, to the active ingredient in question, which is a matter to be determined by the referring court.’ ( 34 )

71.

Lastly, in paragraph 38 of the judgment of 12 March 2015, Actavis Group PTC and Actavis UK (C‑577/13, EU:C:2015:165), the Court held that ‘in order for a basic patent to protect “as such” an active ingredient within the meaning of Articles 1(c) and 3(a) of Regulation No 469/2009, that active ingredient [had to] constitute the subject matter of the invention ( 35 )covered by that patent.’ ( 36 )

72.

To my mind, it is clear from the Court’s case-law, in particular the judgments of 24 November 2011, Medeva (C‑322/10, EU:C:2011:773), of 12 December 2013, Eli Lilly and Company (C‑493/12, EU:C:2013:835), and of 12 March 2015, Actavis Group PTC and Actavis UK (C‑577/13, EU:C:2015:165), that the only means of determining whether a basic patent protects an active ingredient within the meaning of Article 3(a) of Regulation No 469/2009 is to be found only in the wording, or interpretation of the wording, of the claims of the patent granted, and nowhere else. ( 37 )

73.

Any other additional criterion, such as the requirement proposed by the referring court that the active ingredient embody ‘the inventive advance of the patent’ runs the risk, in my view, of giving rise to confusion with the criteria for determining whether an invention is patentable. ( 38 ) The question whether a product is protected by a patent within the meaning of Article 3(a) of Regulation No 469/2009 is not the same as the question whether that product is patentable, which is a matter exclusively for national or treaty law.

74.

Nevertheless, merely because a substance might fall within the protection of the claims of a patent under Article 69 of the EPC and the Protocol on its interpretation and the provisions of relevant national law, such as Article 125 of the Patents Act 1977, does not necessarily imply that that substance is a product protected by a patent within the meaning of Article 3(a) of Regulation No 469/2009.

75.

Indeed, the fact that a substance or combination of substances falls within the scope of protection of a patent, in particular under Article 69 of the EPC and the Protocol on its interpretation and the provisions of relevant national law is a necessary but not sufficient condition for it to be a product protected by a patent within the meaning of Article 3(a) of Regulation No 469/2009.

76.

As patents often contain a range of claims varying in their degree of specificity or abstraction, ( 39 ) the real question which arises in the present case is with what degree of specificity or abstraction a product is ‘specified’ in the claims of the basic patent within the meaning of Article 3(a) of Regulation No 469/2009.

77.

In paragraph 39 of its judgment of 12 December 2013, Eli Lilly and Company (C‑493/12, EU:C:2013:835), the Court held that it is not always necessary for the purposes of Article 3(a) of Regulation No 469/2009 that the active ingredient be referred to literally by its name or chemical structure in the claims of a basic patent and that a functional definition of an active ingredient in the claims of a basic patent could, in certain circumstances, be sufficient. ( 40 )

78.

On the other hand, it is apparent from paragraphs 36 to 39 and 41 of the judgment of 12 March 2015, Actavis Group PTC and Actavis UK (C‑577/13, EU:C:2015:165), that the fact that a basic patent contains a claim relating to a specifically named active ingredient may, in certain circumstances, not be sufficient.

79.

However, that judgment should be read with caution given the singular facts it dealt with. The active ingredient at issue was not in fact specified in the patent as initially granted. A new claim relating to that active ingredient was purportedly added to the basic patent retrospectively after it had been granted, following a procedure to amend the basic patent, ( 41 ) with the intention, in my view, of obtaining an SPC.

80.

As I indicated in point 74 of this Opinion, it is not sufficient merely that a product falls within the scope of protection of a patent ( 42 ) for it to be regarded as a protected product within the meaning of Article 3(a) of Regulation No 469/2009. It is common knowledge that claims are often (deliberately and ingeniously) drafted in broad, ( 43 ) vague, generic and stereotypical ( 44 ) terms so that they cover multiple substances.

81.

To my mind, a product is protected by a patent within the meaning of Article 3(a) of Regulation No 469/2009 if, on the priority date of the patent, it would have been obvious to a person skilled in the art that the active ingredient in question was specifically and precisely identifiable in the wording of the patent claims. In the case of a combination of active ingredients, each active ingredient must be specifically, precisely and individually identifiable ( 45 ) in the wording of the patent claims.

82.

The name of the active ingredient or its chemical composition does not need to be referred to expressly in the claims, ( 46 ) provided that the active ingredient is specifically and precisely identifiable as at the priority date of the patent.

83.

If, for example, a substance claimed in a patent consists of several variants, ( 47 ) the product protected by the patent within the meaning of Article 3(a) of Regulation No 469/2009 does not necessarily encompass all those variants. As at the priority date of the patent, a variant must be specifically and precisely identifiable in the wording of the patent claims in order for it to be ‘a product protected by the patent’ within the meaning of Article 3(a) of Regulation No 469/2009. ( 48 )

84.

In paragraph 35 of the judgment of 12 March 2015, Actavis Group PTC and Actavis UK (C‑577/13, EU:C:2015:165), the Court held that ‘the objective pursued by Regulation No 469/2009 [was] not to compensate the holder fully for the delay to the marketing of his invention or to compensate for such delay in connection with the marketing of that invention in all its possible commercial forms, including in the form of combinations based on the same active ingredient’. ( 49 )

85.

In the main proceedings, it is common ground that the active ingredient emtricitabine is not expressly named in the claims of the basic patent.

86.

However, it is apparent from the request for a preliminary ruling that Gilead obtained the SPC in question in the main proceedings for an anti-viral medicinal product containing two active ingredients, namely TD and emtricitabine, on the basis of claim 27 of the basic patent. That claim in fact refers to a pharmaceutical composition ‘comprising’ a compound according to any one of claims 1 to 25, that is to say, in the present case, TD under claim 25, and ‘optionally other therapeutic ingredients.’

87.

To my mind, and subject to verification by the referring court, as the active ingredient emtricitabine is claimed solely through the use of completely indeterminate expressions such as ‘comprising’ and ‘optionally other therapeutic ingredients’, ( 50 ) terms which may cover multiple substances that are not specifically and precisely identifiable on the priority date of the patent, ( 51 ) the combination containing the active ingredients TD and emtricitabine, that is to say, the medicinal product marketed under the name Truvada, is not protected by the basic patent within the meaning of Article 3(a) of Regulation No 469/2009, even though that combination may fall within the protection of claim 27 of the patent at issue in the main proceedings under Article 69 of the EPC and the Protocol on its interpretation and section 125 of the Patents Act 1977.

88.

It would appear, subject once again to verification by the referring court, that, on 26 July 1996, the claimed priority date of the patent at issue in the main proceedings, it would not have been obvious to a person skilled in the art that the active ingredient emtricitabine was specifically and precisely identifiable in the wording of the claims of that patent.

89.

In the light of all the foregoing, I propose that the Court should answer the question referred for a preliminary ruling by the High Court of Justice (England and Wales), Chancery Division (Patents Court) (United Kingdom) as follows:

Article 3(a) 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 a supplementary protection certificate relating to active ingredients which are not specified in the wording of the claims of the basic patent. The fact that a substance or combination of substances falls within the scope of protection of the basic patent is a necessary, but not sufficient, requirement for it to constitute a product protected by a patent within the meaning of Article 3(a) of Regulation No 469/2009. A product is protected by a patent within the meaning of Article 3(a) of that regulation if, on the priority date of the patent, it would have been obvious to a person skilled in the art that the active ingredient in question was specifically and precisely identifiable in the wording of the claims of the basic patent. In the case of a combination of active ingredients, each active ingredient in that combination must be specifically, precisely and individually identifiable in the wording of the claims of the basic patent.