Opinion of the Advocate General — ECLI:EU:C:2024:472
Date: 2024-06-06
Language of the case: English;Finnish
Procedure: Reference for a preliminary ruling
Origin: Finland;Ireland

Summary C-119/22 – 1 
Case C-119/22 
Summary of the request for a preliminary ruling pursuant to Article 98(1) of 
the Rules of Procedure of the Court of Justice 
Date lodged: 
17 February 2022 
Referring court: 
Markkinaoikeus (Finland) 
Date of the decision to refer: 
17 February 2022 
Applicants: 
Teva B.V. 
Teva Finland Oy 
Defendant: 
Merck Sharp & Dohme Corp. 
  
Subject matter of the main proceedings 
Request for a preliminary ruling – Article 267 TFEU – Convention on the 
Grant of European Patents – Regulation (EC) No 469/2009 concerning the 
supplementary protection certificate for medicinal products – Declaration of 
invalidity of a supplementary protection certificate 
Subject matter and legal basis of the request 
The dispute concerns an action for a declaration of invalidity of a supplementary 
protection certificate granted in Finland on the basis of Article 3(a), (c) and (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 (hereinafter also referred to as ‘the SPC Regulation’). 
EN 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-119/22 
 
2  
The case concerns, in particular, the interpretation of Article 3(c) of the SPC 
Regulation. 
Questions referred for a preliminary ruling 
1. What criteria must be applied to determine when a product has not already 
been granted a supplementary protection certificate within the meaning of 
Article 3(c) 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 (‘SPC Regulation’)? 
2. Must the assessment of the condition set out in Article 3(c) of the SPC 
Regulation be regarded as being different from the assessment of the 
condition set out in Article 3(a) of that regulation, and if so, in what way? 
3. Must the statements on the interpretation of Article 3(a) of the SPC 
Regulation in the judgments of the Court in Case C-121/17 and Case 
C-650/17 be regarded as relevant to the assessment of the condition in 
Article 3(c) of the SPC Regulation and, if so, in what way? In that 
connection, particular attention should be paid to the statements made in 
those judgments regarding Article 3(a) of the SPC Regulation, specifically: 
– the essential meaning of patent claims; and 
– the assessment of the case from the point of view of a person skilled in 
the art and in the light of the prior art at the filing date or priority date 
of the basic patent. 
4. Are the concepts ‘core inventive advance’, ‘central inventive step’ and/or 
‘subject matter of the invention’ of the basic patent relevant to the 
interpretation of Article 3(c) of the SPC Regulation and, if any or all of 
those concepts are relevant, how are they to be understood for purposes of 
interpreting Article 3(c) of the SPC Regulation? For the purposes of 
applying those concepts, does it make any difference whether the product in 
question consists of a single active ingredient (‘mono-product’) or a 
combination of active ingredients (‘combination product’) and, if so, in what 
way? How is the latter question to be assessed in a case in which the basic 
patent contains, on the one hand, a patent claim for a mono-product and, on 
the other hand, a patent claim for a combination product, the latter patent 
claim relating to a combination of active ingredients consisting of the active 
ingredient of the mono-product plus one or more active ingredients from the 
known prior art? 
TEVA AND TEVA FINLAND 
 
3 
Provisions of European Union law relied on 
Convention on the Grant of European Patents of 5 October 1973, signed in 
Munich, Article 69, and the Protocol on the Interpretation of Article 69 of the 
Convention 
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, Articles 1, 3 and 7 
Case-law of the Court relied on 
Judgment of 12 December 2013, Actavis Group PTC and Actavis UK (C-443/12, 
EU:C:2013:833). 
Judgment of 12 December 2013, Georgetown University (C-484/12, 
EU:C:2013:828). 
Judgment of 12 March 2015, Actavis Group PTC and Actavis UK (C-577/13, 
EU:C:2015:165, paragraphs 33, 37 to 38). 
Judgment of 25 July 2018, Teva UK and Others (C-121/17, EU:C:2018:585). 
Judgment of 30 April 2020, Royalty Pharma Collection Trust (C-650/17, 
EU:C:2020:327, paragraphs 31 to 32). 
Provisions of national law relied on 
Patenttilaki (550/1967, Law on patents No 550/1967), Paragraph 39 
Succinct presentation of the facts and procedure in the main proceedings 
1 The company Merck Sharp & Dohme Corp. (hereinafter also referred to as 
‘MSD’) was granted supplementary protection certificate No 342 in Finland. The 
application which led to the grant of the supplementary protection certificate in 
question was based on European patent No FI/EP 1 412 357, granted to MSD and 
later validated in Finland, and on the following marketing authorisations granted 
to MSD: EU/1/08/455/001-014 in respect of the product Janumet, 
EU/1/08/456/001-014 in respect of the product Velmetia and EU/1/08/457/001-
014 in respect of the product Efficib. 
Basic patent 
2 It is common ground that the application leading to the grant of supplementary 
protection certificate No 342 was based on European patent No FI/EP 1 412 357 
(‘basic patent’), granted to MSD and later validated in Finland. 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-119/22 
 
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3 The English title of that basic patent is ‘Beta-amino-tetrahydroimidazo(1,2-
a)pyrazines and -tetrahydrotriazolo(4,3-a)pyrazines as dipeptidyl peptidase 
inhibitors for the treatment or prevention of diabetes’. The basic patent contains a 
total of 30 patent claims, of which the following are the most relevant to the 
present case: 
– independent Claim 1, which is a product claim relating to a compound, 
drafted in the form of a Markush formula; 
– independent Claim 15, which is a product claim relating to a compound, 
wherein the compound is selected from a group consisting of 33 different 
compounds, represented in the form of chemical structural formulae, or a 
pharmaceutically acceptable salt thereof; 
– Claim 20 of the patent, which is a product claim relating to a combination, 
wherein the combination consists of 
1) a compound according to any one of Claims 1 to 15, or a 
pharmaceutically acceptable salt thereof, and 
2) one or more other compounds selected from a group of compounds 
listed in that claim; 
– Claim 25, which is a product claim relating to a pharmaceutical 
composition, wherein the pharmaceutical composition comprises 
1) a compound according to any one of Claims 1 to 15, or a 
pharmaceutically acceptable salt thereof, 
2) one or more compounds selected from a group of compounds listed in 
that claim, and 
3) a pharmaceutically acceptable carrier. 
– Claim 26, which is a product claim relating to a compound, wherein the 
compound is selected from a group consisting of five different compounds 
according to Claim 15 of the patent, represented in the form of chemical 
structural formulae, or a pharmaceutically acceptable salt thereof; 
– Claim 28, which is a product claim relating to a compound, and comprising 
only one compound, represented in the form of a chemical structural 
formula, or a pharmaceutically acceptable salt thereof; 
– Claim 30, which is a product claim relating to a pharmaceutical composition 
as claimed in Claim 25, wherein the pharmaceutical composition comprises 
a compound according to any one of Claims 1 to 15 or a pharmaceutically 
acceptable salt thereof, metformin, and a pharmaceutically acceptable 
carrier. 
TEVA AND TEVA FINLAND 
 
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4 It is common ground in the present case 
– that the Markush formula within the meaning of independent Claim 1 of the 
basic patent comprises a large number of different compounds; 
– that that formula comprises, inter alia, a compound that later became known 
as sitagliptin; 
– that the seventh chemical structural formula in independent Claim 15 
represents a compound that later became known as sitagliptin; 
– that the fourth chemical structural formula in Claim 26 represents a 
compound that later became known as sitagliptin; 
– that the sole structural formula according to Claim 28 is a compound that 
later became known as sitagliptin; 
– that, as one of the DP-IV inhibitors referred to above, the basic patent refers 
to a compound that later became known as sitagliptin. 
5 In the ‘Summary of the invention’ section of the description of the basic patent, it 
is stated that the invention according to the basic patent is directed to compounds 
which are inhibitors of the dipeptidyl peptidase-IV enzyme (‘DP-IV inhibitors’) 
and which are useful in the treatment or prevention of diseases in which the 
dipeptidyl peptidase-IV enzyme is involved, such as diabetes and particularly type 
2 diabetes. Furthermore, it is also stated in that section that the invention is also 
directed to pharmaceutical compositions comprising those compounds and the use 
of those compounds and compositions in the prevention or treatment of such 
diseases in which the dipeptidyl peptidase-IV enzyme is involved. 
6 The basic patent states that DP-IV inhibitors can be used, alone or in combination 
with other compounds, to treat diabetes, for example. In the light of expert 
evidence adduced in the case, Claims 20 and 25 of the basic patent list as such 
other compounds, inter alia, all compounds used in the treatment of diabetes at 
that time. One of the groups of other compounds referred to in Claims 20 and 25 
of the basic patent are biguanides, which, in the light of the expert evidence 
adduced in the case, comprised, in essence, two compounds as at the priority date 
of the basic patent, one of which was metformin, a compound which at that time 
had already been used for decades in the treatment of diabetes, and the other of 
which was phenformin, the use of which as a medicinal product for human use 
was associated with known safety risks, according to the expert evidence adduced 
in the case. 
7 Metformin is expressly referred to in Claim 30 of the basic patent as the second 
compound of the pharmaceutical composition referred to in that claim. 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-119/22 
 
6  
8 None of the claims of the basic patent, taken alone, discloses a pharmaceutical 
composition consisting of a compound which later became known as sitagliptin 
and metformin. 
Marketing authorisations 
9 In the first place, MSD was granted marketing authorisation, under No 
EU/1/07/383/001-018, for a product called Januvia, which contains sitagliptin as 
the only active ingredient. 
10 MSD subsequently received marketing authorisations for a product called Janumet 
under No EU/1/08/455/001-014, for a product called Velmetia under No 
EU/1/08/456/001-014 and for a product called Efficib under No EU/1/08/457/001-
014, all containing, as a combination of active ingredients, sitagliptin and 
metformin hydrochloride, which is a pharmaceutically acceptable salt of 
metformin. 
11 It is common ground in the present case that sitagliptin was the first active 
ingredient in the DP-IV class of inhibitors to receive marketing authorisation. 
Supplementary protection certificates 
12 MSD was first granted supplementary protection certificate No 343 on 13 March 
2012 on the basis of the basic patent and the marketing authorisation for the 
product Januvia. The title of that supplementary protection certificate is 
‘Sitagliptin, optionally in the form of a pharmaceutical salt’. 
13 In addition, on 20 March 2012, MSD was granted supplementary protection 
certificate No 342 on the basis of the basic patent and the marketing authorisation 
for the product Janumet, which is the subject of the action for a declaration of 
invalidity at issue in the present case. The title of that supplementary protection 
certificate is ‘Sitagliptin, optionally in the form of a pharmaceutically acceptable 
salt, in particular monophosphate, plus metformin, optionally in the form of a 
pharmaceutically acceptable salt, in particular the hydrochloride’. Supplementary 
protection certificate No 342 is valid until 8 April 2023. 
The essential arguments of the parties in the main proceedings 
Forms of order sought by the parties 
Teva B.V. and Teva Finland Oy 
14 Teva B.V. and Teva Finland Oy (hereinafter also referred to collectively as 
‘Teva’) brought an action before the Markkinaoikeus (Market Court) against MSD 
for a declaration of invalidity of supplementary protection certificate No 342 
granted in Finland. Teva bases its action on the allegation that supplementary 
TEVA AND TEVA FINLAND 
 
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protection certificate No 342 was granted in breach of Article 3(a), (c) and (d) of 
the SPC Regulation. 
15 Teva submits that: 
– first, supplementary protection certificate No 342 was granted in breach of 
Article 3(a) of the SPC Regulation, since European patent FI/EP 1 412 357, 
granted to MSD and subsequently validated in Finland, does not protect the 
combination of active ingredients under supplementary protection certificate 
No 342 in the manner referred to in Article 3(a) of the SPC Regulation; 
– supplementary protection certificate No 342 was granted in breach of 
Article 3(c) of the SPC Regulation. The fact that supplementary protection 
certificate No 343 had already been granted in Finland on the basis of 
European patent No FI/EP 1 412 357 must be regarded as precluding the 
grant of a certificate for the combination of active ingredients covered by 
supplementary protection certificate No 342; 
– supplementary protection certificate No 342 was granted in breach of 
Article 3(d) of the SPC Regulation, since the marketing authorisation on 
which the application leading to the grant of supplementary protection 
certificate No 342 was based was not the first authorisation to place the 
combination of active ingredients covered by supplementary protection 
certificate No 342 on the market as a medicinal product. 
Merck Sharp & Dohme Corp. 
16 MSD opposes the form of order sought by Teva and requests that the action be 
dismissed. MSD disputes that supplementary protection certificate No 342 was 
granted in breach of Article 3(a), (c) or (d) of the SPC Regulation. 
17 MSD submits that: 
– European patent FI/EP 1 412 357, granted to it and subsequently validated in 
Finland, does protect the combination of active ingredients under 
supplementary protection certificate No 342 in the manner referred to in 
Article 3(a) of the SPC Regulation; 
– Article 3(c) of the SPC Regulation must also be regarded as being complied 
with in relation to the grant of supplementary protection certificate No 342. 
Article 3(c) of the SPC Regulation does not preclude the grant of a 
certificate for the combination of active ingredients covered by 
supplementary protection certificate No 342, even if a supplementary 
protection certificate had previously been granted on the basis of the same 
patent for an active ingredient which constitutes one of the two compounds 
of the combination of active substances under supplementary protection 
certificate No 342; 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-119/22 
 
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– the granting of supplementary protection certificate No 342 cannot be 
considered to have infringed Article 3(d) of the SPC Regulation either. The 
marketing authorisation on which the application leading to the grant of 
supplementary protection certificate No 342 was based was the first 
authorisation to place the combination of active ingredients covered by 
supplementary protection certificate No 342 on the market as a medicinal 
product. 
Succinct presentation of the reasoning in the request for a preliminary ruling 
18 The Court has given several preliminary rulings on the interpretation of 
Article 3(a) of the SPC Regulation over the last two decades. The interpretation of 
that provision will have been significantly clarified by the judgments of the Court 
in Case C-121/17 in July 2018 and in Case C-650/17 in April 2020. 
19 In addition, the Court has given two preliminary rulings on the interpretation of 
Article 3(d) of the SPC Regulation in the last two years (judgment of 21 March 
2019, Abraxis Bioscience, C-443/17, EU:C:2019:238, and judgment of 9 July 
2020, Santen, C-673/18, EU:C:2020:531). 
20 As regards Article 3(c) of the SPC Regulation, on the other hand, the Court gave 
its most recent preliminary rulings in its judgments in Case C-443/12 and Case 
C-484/12 of December 2013 and in Case C-577/13 of March 2015. 
21 As regards the latter judgment in particular, it should be emphasised that, as 
explained above, the Court’s decision concerned the interpretation of both 
Article 3(a) and Article 3(c) of the SPC Regulation. 
22 In the light of the foregoing, the question already arises, in a general manner, as to 
whether the Court’s case-law on Article 3(a) of the ESC Regulation in its 
judgments in Cases C-121/17 and C-650/17 must be regarded as being relevant to 
the interpretation of Article 3(c) of the SPC Regulation, and, if so, in what way. 
23 With regard to the abovementioned preliminary rulings, it should be noted that, in 
the judgment of the Court in Case C-443/12, which concerned the interpretation of 
Article 3(c) of the SPC Regulation, reference was made, on the one hand, to [in 
the German language version] ‘die zentrale erfinderische Tätigkeit’ [literally: ‘the 
central inventive advance’] of the basic patent (paragraph 30; ‘l’activité inventive 
centrale’ in French and ‘the core inventive advance’ in English) and, on the other 
hand, to the ‘Kern der erfinderischen Tätigkeit’ [literally: ‘core inventive 
advance’] of the basic patent (paragraph 41; ‘le cœur de l’activité inventive’ in 
French, but once again ‘the core inventive advance’ in English). In the Court’s 
judgment in Case C-577/13, concerning the interpretation of Article 3(a) and (c) 
of the SPC Regulation, reference was made, in turn, to the ‘subject matter of the 
invention’ of the basic patent. In the Court’s judgment in Case C-650/17, 
concerning the interpretation of Article 3(a) of the SPC Regulation, it was stated, 
TEVA AND TEVA FINLAND 
 
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in turn, that the concept of ‘core inventive advance’ of the basic patent is not 
relevant in the context of Article 3(a) of the SPC Regulation. 
24 Furthermore, the question arises as to whether the concepts of ‘central inventive 
step’, ‘core inventive step’ and ‘subject matter of the invention’ are still relevant 
to the interpretation of Article 3(c) of the SPC Regulation and, if so, how those 
concepts are to be understood in the context of the interpretation of Article 3(c) of 
the SPC Regulation. In particular, the question arises as to how those terms are to 
be regarded as being different – if they are considered to be different – and how 
they are to be understood in the case of a product consisting of a single active 
ingredient (‘mono-product’), on the one hand, and in the case of a product 
consisting of a combination of active ingredients (‘combination product’), on the 
other hand. 
25 The need for uniform application of EU law and the need to obtain a preliminary 
ruling in the present case is underlined by the fact that proceedings relating to a 
declaration of invalidity of supplementary protection certificates similar to that at 
issue in the present case which were granted in other Member States of the 
European Union are pending in several other Member States of the European 
Union.