1 The present request for a preliminary ruling 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 (OJ 2009 L 152, p. 1).
2 The request has been made in proceedings between Royalty Pharma Collection Trust (‘Royalty Pharma’) and the Deutsches Patent- und Markenamt (German Patent and Trade Mark Office, Germany) (‘the DPMA’) concerning the DPMA’s refusal to issue a supplementary protection certificate (‘the SPC’) for sitagliptin used for the treatment of diabetes mellitus.
3 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 to the dispute in the main proceedings, (‘the EPC’), stipulates 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.’
4 Article 1 of the Protocol on the Interpretation of Article 69, which forms an integral part of the EPC, pursuant to Article 164(1) of the latter, provides: ‘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.’
5 Recitals 3 to 5, 7, 9 and 10 of Regulation No 469/2009 state as follows: ‘(3) Medicinal products, especially those that are the result of long, costly research, will not continue to be developed in the [European Union] and in Europe unless they are covered by favourable rules that provide for sufficient protection to encourage such research. (4) At the moment, the period that elapses between the filing of an application for a patent for a new medicinal product and authorisation to place the medicinal product on the market makes the period of effective protection under the patent insufficient to cover the investment put into the research. (5) This situation leads to a lack of protection which penalises pharmaceutical research. … (7) A uniform solution at [EU] level should be provided for, 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 [European Union] and thus directly affect the functioning of the internal market. … (9) The duration of the protection granted by the [SPC] should be such as to provide adequate effective protection. For this purpose, the holder of both a patent and [an SPC] should be able to enjoy an overall maximum of 15 years of exclusivity from the time the medicinal product in question first obtains authorisation to be placed on the market in the [European Union]. (10) All the interests at stake, including those of public health, in a sector as complex and sensitive as the pharmaceutical sector should nevertheless be taken into account. For this purpose, the [SPC] cannot be granted for a period exceeding five years. The protection granted should furthermore be strictly confined to the product which obtained authorisation to be placed on the market as a medicinal product.’
6 Article 1 of that regulation provides: ‘For the purposes of this Regulation, the following definitions shall apply: (a) “medicinal product” means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals; (b) “product” means the active ingredient or combination of active ingredients of a medicinal product; (c) “basic patent” means a patent which protects a product as such, a process to obtain a product or an application of a product, and which is designated by its holder for the purpose of the procedure for grant of [an SPC]; …’
7 Article 3 of that regulation, entitled ‘Conditions for obtaining [an SPC]’, provides: ‘[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: (a) the product is protected by a basic patent in force; (b) a valid authorisation to place the product on the market as a medicinal product has been granted …; (c) the product has not already been the subject of [an SPC]; (d) the authorisation referred to in point (b) is the first authorisation to place the product on the market as a medicinal product.’
8 Article 4 of that regulation, entitled ‘Subject matter of protection’, provides: ‘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].’
9 Under Article 5 of Regulation No 469/2009, relating to the ‘effects of the [SPC]’: ‘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.’
10 Under the heading ‘Duration of the [SPC]’, Article 13 of that regulation provides paragraph 1: ‘The [SPC] shall 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 [European Union], reduced by a period of five years.’
11 Royalty Pharma is the proprietor of European patent (DE) EP 1084705 (‘the basic patent at issue in the main proceedings’), applied for on 24 April 1997. That patent discloses a method for lowering blood sugar levels in mammals through the administration of inhibitors of the enzyme dipeptidyl peptidase IV (‘DP IV’), which contributes to the regulation of blood sugar levels.
12 Sitagliptin belongs to the group of DP IV inhibitors. That product was developed by a licensee of the basic patent at issue in the main proceedings after the date on which the application for that patent was filed. That licensee obtained a new patent covering sitagliptin, which served as the basic patent for the grant of an SPC.
13 On 17 December 2014, Royalty Pharma filed an application for an SPC for sitagliptin with the DPMA, on the basis of the basic patent at issue in the main proceedings and of an authorisation to place a medicinal product on the market (‘MA’) issued on 21 March 2007 by the European Medicines Agency (EMA) for the medicinal product marketed under the name ‘Januvia’.
14 That application was rejected by the DPMA on 12 April 2017, on the ground that the condition laid down in Article 3(a) of Regulation No 469/2009 had not been satisfied. The DPMA stated that, although sitagliptin does indeed satisfy the functional definition of the DP IV inhibitor in the claims of the basic patent at issue in the main proceedings, that patent does not contain any specific disclosure of that product whatsoever, with the result that the precise active ingredient was not provided to the expert.
15 Thus, according to the DPMA, the subject matter of the protection afforded by that patent does not correspond to the medicinal product subsequently developed and marketed under the name ‘Januvia’. It would therefore, it held, be contrary to the objectives of Regulation No 469/2009 to grant an SPC for a product which has not been disclosed by the basic patent at issue in the main proceedings.
16 Royalty Pharma brought an action against that decision before the Bundespatentgericht (Federal Patent Court, Germany). It submits that it is not necessary, in order for a product to be afforded the protection conferred by a basic patent in force, that that patent should indicate the chemical name or structure of the protected active ingredient, since the description of the functional characteristics of that active ingredient is sufficient for that purpose. It submits that sitagliptin satisfies the functional definition of a category of active ingredient referred to in the basic patent at issue in the main proceedings. In its view, any DP IV inhibitor to treat diabetes mellitus comes within ‘the core of the patented invention’ at issue in the main proceedings, which covers all the specific compounds satisfying that definition. The Court of Justice, it submits, has not interpreted Article 3 of Regulation No 469/2009 as meaning that the grant of an SPC for an active ingredient is subject to the condition that that active ingredient be indicated in its individualised form in the claims of the basic patent. Moreover, the Court has pointed out the importance of ‘the core inventive advance’.
17 Royalty Pharma also observes that the courts of the United Kingdom interpret the case-law of the Court of Justice to that effect. It states that there are, however, differences of interpretation between the Member States, which are liable to persist if the Court does not clarify that point.
18 The Bundespatentgericht (Federal Patent Court) notes that the Court of Justice has held that, for the purposes of interpreting Article 3(a) of Regulation No 469/2009, regard must be had to the subject matter of protection of the basic patent, which must be determined by interpreting the claims of that patent. In this respect, it finds, the claims have the dual function of defining the subject matter of the protection conferred by the patent and of determining the extent of that protection, which goes beyond that subject matter. The referring court understands the Court’s case-law as meaning that, for the purposes of interpreting that article, account should be taken of the subject matter of the protection and not of the extent of that protection. Thus, an active ingredient will satisfy the condition laid down by that article only if that active ingredient is described in such a specific way in the claims of the basic patent as to make it clear that it forms part of the subject matter of the protection afforded by that patent.
19 Contrary to Royalty Pharma’s assertions, the referring court states that the concept of ‘core inventive advance’ is not relevant for the interpretation of Article 3(a) of Regulation No 469/2009. Similarly, the decision of the Bundesgerichtshof (Federal Court of Justice, Germany) of 11 September 2013 (X ZB 8/12) on DP IV inhibitors does not provide an answer on the interpretation of that article, but merely specifies the requirement of sufficient description where a functional definition is used in the claims of a patent.
20 That being the case, the referring court notes the fundamental differences existing between the Member States as to the interpretation of the criteria defined in the case-law of the Court relating to Article 3(a) of Regulation No 469/2009. The referring court mentions, inter alia, the interpretation adopted by the High Court of Justice (England and Wales), Chancery Division (Patents Court) in this connection, for which the concept of ‘core inventive advance’ is applicable to Article 3(a) of Regulation No 469/2009.
21 In those circumstances, the Bundespatentgericht (Federal Patent Court) decided to stay the proceedings and to refer the following questions to the Court of Justice for a preliminary ruling: ‘(1) Is a product protected by a basic patent in force pursuant to Article 3(a) of Regulation [No 469/2009] only if it forms part of the subject matter of protection defined by the claims and is thus provided to the expert as a specific embodiment? (2) Is it not therefore sufficient for the requirements of Article 3(a) of Regulation [No 469/2009] if the product in question satisfies the general functional definition of a class of active ingredients in the claims, but is not otherwise indicated in individualised form as a specific embodiment of the method protected by the basic patent? (3) Is a product not protected by a basic patent in force under Article 3(a) of Regulation [No 469/2009] if it is covered by the functional definition in the claims, but was developed only after the filing date of the basic patent as a result of an independent inventive step?’
22 Following the delivery of the judgment of 25 July 2018, Teva UK and Others (C‑121/17, EU:C:2018:585), the Court asked the Bundespatentgericht (Federal Patent Court) whether, in the light of that judgment, it wished to maintain its request for a preliminary ruling and, if so, on what grounds.
23 By letter of 21 August 2018, the Bundespatentgericht (Federal Patent Court) informed the Court that it was maintaining that request, arguing, in essence, that there is a need to promote uniform practice at Member-State level in the various situations described in Article 3(a) of Regulation No 469/2009. It stated, however, that it is not clear from the judgment of 25 July 2018, Teva UK and Others (C‑121/17, EU:C:2018:585), read in the light of the earlier case-law of the Court and the Opinion of the Advocate General in the case which gave rise to that judgment, whether the concept of ‘core inventive advance’ is of any relevance for the purposes of interpreting Article 3(a) of Regulation No 469/2009. The Court, it submitted, should therefore provide further clarification on that point.
24 By a letter lodged at the Court Registry on 23 September 2019, Royalty Pharma requested that the oral procedure be reopened pursuant to Article 83 of the Rules of Procedure of the Court of Justice.
25 In support of its request, Royalty Pharma puts forward two arguments. First, it contends, the Advocate General based his Opinion on an incorrect account of the facts, in so far as, in point 14 of that Opinion, he stated that Royalty Pharma had filed an SPC application for sitagliptin on the basis of basic patent EP 1412357, at issue in the judgment of 8 December 2011, Merck Sharp & Dohme (C‑125/10, EU:C:2011:812), whereas that application was based on basic patent EP 1084705. Second, it contends, the Advocate General departed from the case-law arising from the judgment of 25 July 2018, Teva UK and Others (C‑121/17, EU:C:2018:585).
26 In this regard, it is a matter of settled case-law that the Court may, of its own motion, on a proposal from the Advocate General, or at the request of the parties, order the reopening of the oral procedure under Article 83 of its Rules of Procedure if it considers that it lacks sufficient information or that the case must be decided on the basis of an argument which has not been debated between the parties or that one of the parties has submitted a new fact which is of such a nature as to be a decisive factor for the decision of the Court. By contrast, neither the Statute of the Court of Justice of the European Union nor the Rules of Procedure make provision for the parties to submit observations in response to the Advocate General’s Opinion (judgment of 21 March 2019, Abraxis Bioscience, C‑443/17, EU:C:2019:238, paragraph 16 and the case-law cited).
27 With regard to factual errors which should be corrected, these are not of such a nature as to have a decisive influence on the decision adopted by the Court in the context of a request for a preliminary ruling and, therefore, to justify a reopening of the oral part of the procedure. With regard to the argument relating to the Advocate General’s own interpretation of the judgment of 25 July 2018, Teva UK and Others (C‑121/17, EU:C:2018:585), it must be noted that, by that argument, Royalty Pharma is in fact seeking to respond to certain points of the Advocate General’s Opinion. However, it follows from the case-law cited in the preceding paragraph of the present judgment that there is no provision in the texts governing procedure before the Court for the lodging of such observations.
28 Moreover, the Court considers, after hearing the Advocate General, that it has sufficient information to answer the questions raised by the referring court and that all the arguments necessary for the determination of the present case have already been debated in the course of the proceedings.
29 Consequently, the request to have the oral procedure reopened must be rejected.
30 As a preliminary point, it should be noted that, as stated in paragraph 23 of the present judgment, the referring court decided to maintain its request for a preliminary ruling in order to obtain further clarification as to the scope of the judgment of 25 July 2018, Teva UK and Others (C‑121/17, EU:C:2018:585), for the purposes of resolving the dispute in the main proceedings. More specifically, that court is uncertain whether the concept of ‘core inventive advance’ is relevant for the purposes of interpreting Article 3(a) of Regulation No 469/2009. The referring court notes that, in that judgment, the Court ruled without addressing Advocate General Wathelet’s criticism in his Opinion in Teva UK and Others (C‑121/17, EU:C:2018:278), particularly in point 73 of that Opinion, on the use of that concept for the purpose of determining the subject matter of protection conferred by a basic patent. The referring court infers from this that, by not expressly ruling out the application of that concept, for the purposes of assessing whether a combination of active ingredients could be afforded the protection conferred by a basic patent in force, the Court may have implicitly affirmed that concept. The referring court also states that the questions relating to the concept of ‘core inventive advance’ give rise to numerous divergences in the interpretation of Article 3(a) of Regulation No 469/2009 as between the competent national courts and the authorities.
31 In this regard, it should be observed that, in its reply to the question raised in the case which gave rise to the judgment of 25 July 2018, Teva UK and Others (C‑121/17, EU:C:2018:585, paragraphs 34 and 35), the Court did not employ the concept of ‘core inventive advance’, even though the referring court called on it to do so in its request for a preliminary ruling. On the contrary, in that judgment, the Court recalled the key role played by the claims, under Article 69 of the EPC and Article 1 of the Protocol on the Interpretation of Article 69, thus confirming that the subject matter of the protection conferred by an SPC must be restricted to the technical specifications of the invention covered by the basic patent, such as claimed in that patent (judgment of 25 July 2018, Teva UK and Others, C‑121/17, EU:C:2018:585, paragraph 46), and not extend to the ‘core inventive advance’.
32 In so doing, the Court clearly relied on an interpretation of Article 3(a) of Regulation No 469/2009, in the context of which the concept of ‘core inventive advance’ is not relevant.
33 By its first and second questions, which it is appropriate to examine together, the referring court asks, in essence, whether Article 3(a) of Regulation No 469/2009 must be interpreted as meaning that a product is protected by a basic patent in force, within the meaning of that provision, if it satisfies a general functional definition used by one of the claims of the basic patent and necessarily comes within the scope of the invention covered by that patent, but is not otherwise indicated in individualised form as a specific embodiment of the method of that patent.
34 In that regard, it should be borne in mind that the Court has consistently 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 that provision (judgment of 25 July 2018, Teva UK and Others, C‑121/17, EU:C:2018:585, paragraph 34 and the case-law cited).
35 So far as the European patent, in particular, is concerned, it should be noted that, pursuant to Article 69 of the EPC, the extent of the protection conferred is determined by the claims conferred by such a patent. The information in Article 1 of the Protocol on the Interpretation of Article 69 of the EPC states that those claims must ensure both a fair protection for the patent proprietor and a reasonable degree of legal certainty for third parties. Thus, they must not serve merely as a guideline, nor can they be interpreted as meaning that the extent of the protection conferred by a patent is that defined by the narrow, literal meaning of the wording used in the claims (judgment of 25 July 2018, Teva UK and Others, C‑121/17, EU:C:2018:585, paragraph 35).
36 In this respect, the Court has held that Article 3(a) of Regulation No 469/2009 does not, in principle, preclude an active ingredient which is given a functional definition in the claims of a basic patent issued by the European Patent Office from being regarded as protected by the patent, on condition, however, that it is possible, on the basis of those claims as interpreted in, inter alia, the light of the description of the invention, as required under Article 69 of the EPC and the Protocol on the Interpretation of that provision, to conclude that the claims relate implicitly but necessarily and specifically to the active ingredient in question (judgment of 25 July 2018, Teva UK and Others, C‑121/17, EU:C:2018:585, paragraph 36 and the case-law cited).
37 The Court inferred from this that, in order to ascertain whether a particular product is protected by a basic patent in force, within the meaning of Article 3(a) of Regulation No 469/2009, it is necessary to ascertain, where that product is not expressly mentioned in the claims of that patent, whether that product is necessarily and specifically covered by one of those claims. To that end, two cumulative conditions must be satisfied. First, the product must, from the point of view of a person skilled in the art and in the light of the description and drawings of the basic patent, necessarily come under the invention covered by that patent. Second, the person skilled in the art must be able to identify that product specifically in the light of all the information disclosed by that patent, on the basis of the prior art at the filing date or priority date of the patent concerned (see, to that effect, judgment of 25 July 2018, Teva UK and Others, C‑121/17, EU:C:2018:585, paragraph 52).
38 In the case in the main proceedings, it is apparent from the order for reference that, although the claims of the basic patent do not refer expressly to sitagliptin, the latter meets the functional definition used by one of the claims of that patent. In those circumstances, subject to verifications to be carried out by the referring court, sitagliptin, as a DP IV inhibitor, necessarily comes within the scope of the invention covered by the basic patent and, therefore, the first condition laid down in the judgment of 25 July 2018, Teva UK and Others (C‑121/17, EU:C:2018:585), is satisfied.
39 By contrast, doubts may be expressed as to whether sitagliptin, which is not individually identified in the specification of the basic patent at issue in the main proceedings, satisfies the second of the two cumulative conditions identified in paragraph 37 of the present judgment. More specifically, the referring court’s doubts concern, in essence, whether, by reference to the filing date or priority date of the basic patent, and in the light of all the information disclosed by that patent, sitagliptin is specifically identifiable by a person skilled in the art even though it is not individualised as a specific embodiment in the specification of the basic patent. The referring court thus seeks to determine the level of disclosure of the product that is required by Article 3(a) of Regulation No 469/2009.
40 In order to determine whether the second condition referred to in paragraph 37 of the present judgment is satisfied, it is, more specifically, for the referring court to ascertain whether the subject matter of the SPC concerned is within the limits of what a person skilled in the art is objectively able, at the filing date or priority date of the basic patent, to infer directly and unequivocally from the specification of that patent as filed, based on that person’s general knowledge in the relevant field at the filing date or priority date, and in the light of the prior art at the filing date or priority date.
41 It follows that, even where the product which is the subject of the SPC is not in individualised form as a specific embodiment of the method of that patent, the grant of an SPC is not, in principle, excluded.
42 In so far as, where the product is not explicitly disclosed by the claims of the basic patent, but is covered by a general functional definition, such as that used by the basic patent at issue in the main proceedings, a person skilled in the art must be able to infer directly and unambiguously from the specification of the patent as filed that the product which is the subject of the SPC comes within the scope of the protection afforded by that patent.
43 It follows from the foregoing that the answer to the first and second questions is that Article 3(a) of Regulation No 469/2009 must be interpreted as meaning that a product is protected by a basic patent in force, within the meaning of that provision, if it corresponds to a general functional definition used by one of the claims of the basic patent and necessarily comes within the scope of the invention covered by that patent, but is not otherwise indicated in individualised form as a specific embodiment of the method of that patent, provided that it is specifically identifiable, in the light of all the information disclosed by that patent, by a person skilled in the art, based on that person’s general knowledge in the relevant field at the filing date or priority date of the basic patent and on the prior art at that date.
44 By its third question, the referring court asks whether Article 3(a) of Regulation No 469/2009 must be interpreted as meaning that a product is not protected by the basic patent in force, within the meaning of that provision, if, although it is covered by the functional definition in the claims of that patent, it was developed after the filing date of the application for the basic patent, following an independent inventive step.
45 In that regard, it must be observed that, for the purposes of applying the condition laid down by Article 3(a) of Regulation No 469/2009, the subject matter of the protection conferred by the basic patent must be determined at the filing date or priority date of that patent. Were the results from research which took place after the filing date or priority date of that patent to be taken into account, an SPC could enable its holder unduly to enjoy protection for those results, even though they were not known on one or other of those dates.
46 The Court has stated that it is not the purpose of the SPC to extend the protection conferred by the basic patent beyond the invention which that patent covers. It would be contrary to the objective of Regulation No 469/2009, according to which the grant of the additional period of exclusivity by the use of SPCs is intended to encourage research and, to that end, to ensure that the investments made in such research are covered, to grant an SPC for a product which is not covered by the invention which is the subject of the basic patent, inasmuch as such an SPC would not relate to the results of the research claimed under that patent (see, to that effect, judgment of 25 July 2018, Teva UK and Others, C‑121/17, EU:C:2018:585, paragraphs 39 and 40).
47 It follows that a product which is the subject of an SPC or an SPC application, and which was developed after the filing date or priority date of the basic patent, following an independent inventive step, cannot be regarded as coming within the scope of the subject matter of the protection conferred by that patent.
48 The fact that such a product comes under the functional definition given in the claims of the basic patent cannot invalidate that interpretation. As is apparent from the answer to the first and second questions, a product can be regarded as being protected by a basic patent in force, within the meaning of Article 3(a) of Regulation No 469/2009, only if, from the point of view of a person skilled in the art, based on that person’s general knowledge in the relevant field at the filing date or priority date of that patent, and on the basis of the prior art at that date, that product is specifically identifiable in the light of all the information disclosed by that patent.
49 However, that is not the case for a product which was developed after the filing date or priority date of the basic patent, following an independent inventive step.
50 In the light of the foregoing, the answer to the third question is that Article 3(a) of Regulation No 469/2009 must be interpreted as meaning that a product is not protected by a basic patent in force, within the meaning of that provision, if, although it is covered by the functional definition given in the claims of that patent, it was developed after the filing date of the application for the basic patent, following an independent inventive step.
51 Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the national court, the decision on costs is a matter for that court. Costs incurred in submitting observations to the Court, other than the costs of those parties, are not recoverable.