Order;Summary — ECLI:EU:C:2024:627
Date: 2024-07-16
Language of the case: Hungarian
Court formation: Eighth Chamber
Subject matter: Intellectual, industrial and commercial property;Approximation of laws
Procedure: Reference for a preliminary ruling
Origin: Hungary

Translation C-181/24 – 1 
Case C-181/24 
Request for a preliminary ruling 
Date lodged: 
6 March 2024 
Referring court: 
Fővárosi Törvényszék (Hungary) 
Date of the decision to refer: 
27 February 2024 
Applicant: 
Genmab A/S 
  
Fővárosi Törvényszék (Budapest High Court, Hungary) 
[…] 
In non-contentious proceedings initiated by the applicant Genmab A/S ([…] 
Valby, Denmark) and seeking the modification of decision […] of the Szellemi 
Tulajdon Nemzeti Hivatala (National Intellectual Property Office, Hungary; ‘the 
Office’) refusing an application to grant a supplementary protection certificate, the 
Fővárosi Törvényszék (Budapest High Court) makes the following 
Order: 
The Fővárosi Törvényszék (Budapest High Court) is initiating a preliminary 
ruling procedure before the Court of Justice of the European Union and refers the 
following question to the Court: 
i. Must Article 3(b) 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 be interpreted as meaning that a 
marketing authorisation predating the marketing authorisation appearing in 
the application for a supplementary protection certificate and referring to the 
same product must be regarded as the first marketing authorisation for the 
purposes of that regulation, even where that prior marketing authorisation 
was withdrawn prior to the submission of the application for the certificate? 
EN 
REQUEST FOR A PRELIMINARY RULING OF 27. 2. 2024 – CASE C-181/24 
 
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[Matters of national procedural law] 
Grounds 
Facts of the case and arguments of the parties 
1 The applicant is the holder of the European patent with registration number EP 
3 284 753 B1 and the title ‘human monoclonal antibodies against CD20 for use in 
the treatment of multiple sclerosis’, validated in Hungary with registration number 
E046695 (‘the basic patent’). 
2 The applicant used the basic patent for the first time in the medicinal product 
called ‘Arzerra’, which contains the active ingredient ofatumumab and is 
indicated for the treatment of previously untreated chronic lymphocytic 
leukaemia. On 21 April 2010, the medicinal product obtained marketing 
authorisation number EU/1/10/625 (‘the prior marketing authorisation’). 
3 On 27 February 2019, the applicant had that marketing authorisation withdrawn. 
4 On 29 March 2021, the applicant [obtained] marketing authorisation number 
EU/1/21/1532 for the medicinal product ‘Kesimpta’, which also contains the 
active ingredient ofatumumab and is indicated for the treatment of relapsing-
remitting multiple sclerosis (RRMS) (‘the subsequent marketing authorisation’). 
5 On 7 July 2021, the applicant, pursuant to 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 (‘the SPC 
Regulation’), applied to the National Intellectual Property Office for a 
supplementary protection certificate for the above-mentioned patent (‘the SPC’ or 
‘the certificate’). In its application, it gave the name of the active ingredient 
‘ofatumumab’ as the name of the product (as the title of the certificate). It attached 
authorisation number EU/1/21/1532 to its application as the first authorisation to 
place that product on the market; that is, the subsequent marketing authorisation. 
6 The Office examined the application and concluded that it did not satisfy the 
requirements of Article 3(d) of the SPC Regulation. For that reason, by means of 
decision […] it refused the application for a supplementary protection certificate. 
7 According to the reasons given for the decision, the active ingredient of Arzerra 
and Kesimpta, ofatumumab, is the same. The only difference between the two 
medicinal products lies in their therapeutic indications, with Azerra being 
indicated for the treatment of previously untreated chronic lymphocytic 
leukaemia, while Kesimpta is indicated for the treatment of relapsing multiple 
sclerosis in adult patients. The applicant had, on 21 April 2010, already obtained 
the marketing authorisation for the medicinal product called Arzerra and, 
consequently, the subsequent marketing authorisation which was attached to the 
application is not the first authorisation to place the product on the market as a 
GENMAB 
 
3 
medicinal product in Hungary. The Office noted that, in accordance with the 
judgments of the Court of Justice of the European Union of 21 March 2019, 
Abraxis Bioscience (C-443/17, EU:C:2019:238), and of 9 July 2020, Santen 
(C-673/18, EU:C:2020:531), in order to determine which of the marketing 
authorisations is to be regarded as the first authorisation to place the product on 
the market as a medicinal product for the purposes of Article 3(d) of the SPC 
Regulation, importance is to be attached not to the different indications, but rather 
to the fact that the active ingredient is identical. In this particular case, it is the 
prior marketing authorisation granted for Arzerra. Consequently, the authorisation 
relating to the medicinal product Kesimpta is not the first authorisation for the 
product ofatumumab and, therefore, the application does not comply with 
Article 3(d) of the SPC Regulation. 
8 In the opinion of the Office, the prior marketing authorisation is to be regarded as 
the first authorisation for the purposes of Article 3(d) of the SPC Regulation, 
despite the fact that it was withdrawn on 27 February 2019 and that, consequently, 
at the time when the application for the certificate was submitted, the 
authorisation to place Kesimpta on the market was the only valid marketing 
authorisation in respect of the product ofatumumab. The Office maintains that it is 
immaterial whether, at the time when the application was submitted, the prior 
authorisation was or was not valid, because, when assessing in what case a 
particular marketing authorisation may be regarded as the first authorisation, the 
only thing that matters is the definition of the ‘product’. If it were necessary to 
take into consideration the question of whether the first authorisation did or did 
not remain valid at the time when the application was submitted, the Court of 
Justice would, in any event, have also included that point in its analysis. 
Accordingly, the Office considers the applicant’s interpretation, whereby, in 
accordance with Article 3(b) and (d) of the SPC Regulation, the authorisation that 
was valid at the date of the application is to be regarded as the first authorisation, 
to be incorrect, since such an interpretation cannot be deduced either from the 
wording of the SPC Regulation or from the above-mentioned judgments of the 
Court of Justice. 
9 In these non-contentious proceedings, the applicant wishes the referring court to 
modify the above-mentioned decision of the Office and grant the supplementary 
protection certificate. 
10 The applicant maintains that, in accordance with Article 3(b) and (d) of the SPC 
Regulation, the authorisation that was valid at the date of the application is to be 
regarded as the first authorisation. Consequently, the Office incorrectly concluded 
that the first authorisation for the product ofatumumab was the authorisation 
relating to Arzerra, which was no longer valid at the date of the application, and 
not that relating to the medicinal product Kesimpta, which was valid at that date. 
11 In the opinion of the applicant, the Office incorrectly considered the judgments in 
Abraxis and Santen to have relevance to this question, since neither of them dealt 
with the matter of the validity of the prior marketing authorisation and, therefore, 
REQUEST FOR A PRELIMINARY RULING OF 27. 2. 2024 – CASE C-181/24 
 
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the relevant provisions of the SPC Regulation were not interpreted from that 
perspective. The Court of Justice did not need to consider that question, since, in 
those cases, the conflicting marketing authorisations were [both] valid. What sets 
this case apart is that, unlike the situation [in the above-mentioned cases], the 
prior marketing authorisation was not valid at the date of submission of the 
application for a supplementary protection certificate. 
12 According to the applicant, Article 3(b) and (d) of the SPC Regulation requires a 
marketing authorisation which is valid at the date of submission of the application 
for a supplementary protection certificate. Given that point (d) of Article 3 refers 
to point (b) of the same article, it is important to have an accurate translation of 
that article in order to be able to interpret it, since, currently, the Hungarian 
version of Article 3(b) and (d) of that regulation does not correspond to the 
original and authentic English version, according to which: 
‘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: 
(b) a valid authorisation to place the product on the market as a medicinal 
product has been granted in accordance with Directive 2001/83/EC or 
Directive 2001/82/EC, as appropriate; 
(d) the authorisation referred to in point (b) is the first authorisation to place the 
product on the market as a medicinal product.’ 
13 The applicant maintains that, in the German and French versions of the article, the 
equivalent of the English term ‘valid’ – gültig and validité, respectively – appears, 
while, in the Hungarian version, no equivalent term is used. Taking the English 
wording into consideration, Article 3(d) specifies that, at the date of the 
application, the authorisation referred to in point (b) must be the first authorisation 
to place the product on the market as a medicinal product. For its part, Article 3(b) 
provides that the authorisation to place the product on the market as a medicinal 
product must be valid. 
14 The applicant emphasises that the authorisation for Kesimpta is the first relevant 
authorisation for the purposes of Article 3(d) of the SPC Regulation, since, at the 
date of the application, it was the only and, therefore, the first valid authorisation 
in Hungary for the active ingredient ofatumumab as a medicinal product. 
Relevant national law 
15 In accordance with paragraph 22/A(1) of the a találmányok szabadalmi oltalmáról 
szóló 1995. évi XXXIII. törvény (Law No XXXIII of 1995 on patent protection of 
inventions), inventions are to enjoy supplementary protection in the cases, under 
the conditions and for the duration provided for in the European Community 
regulations, once the protection conferred by the patent ends on expiry of the 
period of protection. 
GENMAB 
 
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[According to point 2 of that paragraph], detailed rules for implementing the 
European Community regulations referred to in point 1 are to be laid down in 
specific legislation. 
16 The Hungarian version of Articles 3 and 4 of the SPC Regulation are worded as 
follows: 
‘3. cikk 1 
(1) A termékre tanúsítványt kell adni, ha abban a tagállamban, amelyben a 7. 
cikk szerinti bejelentést benyújtották, a bejelentés napján 
a) a termék hatályos alapszabadalom oltalma alatt áll; 
b) a termék gyógyszerként történő forgalomba hozatalát – az esettől függően – 
a 2001/83/EK irányelv vagy a 2001/82/EK irányelv szerint engedélyezték; 
c) a termékre még nem adtak tanúsítványt; 
d) a b) pontban említett engedély a termék gyógyszerként történő forgalomba 
hozatalára vonatkozó első engedély. 
4. cikk 2 
Az alapszabadalom által biztosított oltalom keretein belül a tanúsítvány révén 
nyújtott oltalom csak a forgalombahozatali engedély szerinti termékre, illetve a 
termék gyógyszerként történő olyan alkalmazásaira terjed ki, amelyeket a 
tanúsítvány megszűnése előtt engedélyeztek.’ 
Regarding the need to request a preliminary ruling 
17 The European patent system also allows the patent protection of inventions, 
essentially consisting in the protection of innovative technical solutions related to 
the therapeutic application of a known active ingredient; in particular, the 
protection of a more recent formulation of a preparation containing the active 
ingredient or the protection of the use of the active ingredient in a new medical 
indication. 
18 Consequently, the situation in which medicinal products go into circulation with 
an identical active ingredient and only differing as regards other technical 
 
1 Translator's note: the Hungarian version of Article 3 is reproduced here, because the request for 
a preliminary ruling hinges on the existence of possible differences between that language 
version and others, in particular, the English version. The wording of the Hungarian version is 
similar to that of the other versions, except that no Hungarian term equivalent to ‘valid’ appears 
in point (b). 
2 Translator's note. For the same reasons as those set out in note 1, the Hungarian version of 
Article 4 is reproduced here. 
REQUEST FOR A PRELIMINARY RULING OF 27. 2. 2024 – CASE C-181/24 
 
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characteristics, in particular their formulations or their indications, is well known 
in the pharmaceutical industry. Such medicinal products go into circulation in a 
staggered fashion over time, as and when they are developed. Therefore, the 
authorisations to place those medicinal products on the market, granted at 
different times, are valid at the same time; the relevant composition of such 
medicinal products is identical as regards the nature of the active ingredient and 
they only differ in respect of other technical characteristics, specifically the nature 
of the formulation of the medicinal product or the nature of its indication. 
19 Given that, in accordance with Article 3 of the SPC Regulation, a supplementary 
protection certificate may be granted for those products which, as a medicinal 
product, have obtained an authorisation to be placed on the market in accordance 
with Directive 2001/83/EC or Directive 2001/82/EC, as appropriate, and where 
that authorisation is the first authorisation to place the product on the market as a 
medicinal product, the question arises of which of the marketing authorisations for 
medicinal products containing an identical active ingredient and which, in view of 
the characteristics set out above, are valid simultaneously is to be regarded as the 
first authorisation for the purposes of the SPC Regulation. 
20 The Court of Justice set out its legal interpretation with regard to this question, 
inter alia, in its judgments of 21 March 2019, Abraxis Bioscience (C-443/17, 
EU:C:2019:238), and of 9 July 2020, Santen (C-673/18, EU:C:2020:531), both 
cases relating to medicinal products placed on the market with an identical active 
ingredient, in the case of the product analysed in the first of those cases, on the 
basis of its new formulation and, in the case of the product analysed in the second 
of those cases, on the basis of its new indication. 
21 The ruling given in the judgment in Santen, the facts of which bear greater 
similarity to those of the present case, states: ‘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 must 
be interpreted as meaning that a marketing authorisation cannot be considered to 
be the first marketing authorisation, for the purpose of that provision, where it 
covers a new therapeutic application of an active ingredient, or of a combination 
of active ingredients, and that active ingredient or combination has already been 
the subject of a marketing authorisation for a different therapeutic application.’ 
22 The facts of the present case are similar to those of the main proceedings in 
Santen. However, the referring court considers them to differ in one essential 
respect. 
23 In the main proceedings in Santen, at the date of submission of the application for 
a supplementary protection certificate there were at least two valid marketing 
authorisations for medicinal products with an identical active ingredient and 
which were only distinguished by their indications. In the present case, there are 
also two relevant marketing authorisations, relating to medicinal products 
containing the same active ingredient (ofatumumab): the first is the marketing 
GENMAB 
 
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authorisation granted on 21 April 2010 for the medicinal product called Arzerra 
and indicated for the treatment of chronic lymphocytic leukaemia; the second is 
the marketing authorisation granted by the specialist authority on 29 March 2021 
for the medicinal product Kesimpta, indicated for the treatment of RRMS. 
24 The difference between the facts of the two cases lies in the fact that, in the 
present proceedings, the holder, on 27 February 2019, withdrew the marketing 
authorisation relating to the medicinal product called Arzerra, prior to submitting 
the application for a supplementary protection certificate, on 7 July 2021. That is, 
whereas in the main proceedings in Santen there was more than one valid 
marketing authorisation at the time when the application for the supplementary 
protection certificate was submitted, in the present case there is only one valid 
authorisation: the marketing authorisation relating to the medicinal product 
Kesimpta. 
Regarding the question referred for a preliminary ruling 
25 In the Santen case, due to the different factual context, the Court of Justice did not 
address the question of how, in applying Article 3(b) and (d) of the SPC 
Regulation, the decision-making authority should deal with a situation in which 
the product to which the application relates has, at different times, obtained 
authorisation to be placed on the market as a medicinal product and, in which, at 
the time when the application for the supplementary protection certificate was 
submitted, the earlier authorisation in that series of authorisations was no longer 
valid, as a consequence of having been withdrawn. 
26 The Office and the applicant interpret the EU law on this question differently. 
Accordingly, they disagree as to whether, in deciding regarding the application 
[for a supplementary protection certificate], the marketing authorisation for a 
medicinal product which contains the product and which is unequivocally earlier 
and the first in time, but which is no longer valid at the time when the application 
for the supplementary protection certificate is submitted, may be taken into 
consideration and, if it can be, whether that authorisation can be regarded as the 
first authorisation to place the product on the market as a medicinal product for 
the purposes of the application of Article 3(b) and (d) of the SPC Regulation. 
27 The referring court notes that the Hungarian translation of Article 3(b) of the SPC 
Regulation does not correspond exactly to the English wording of the provision, 
since, in the Hungarian version, it is not possible to identify, unequivocally, any 
expression corresponding to the attribute ‘valid’ which describes the marketing 
authorisation and appears in the English version. 
28 However, based on the English version, the provision could possibly be 
interpreted, as the applicant does, to mean that, in the procedure for granting the 
supplementary protection certificate, it is necessary to examine only the marketing 
authorisation which is valid at the date of the application – and which is, in that 
sense, ‘valid’. Should such an interpretation be acceptable, the prior marketing 
REQUEST FOR A PRELIMINARY RULING OF 27. 2. 2024 – CASE C-181/24 
 
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authorisation, which is not in effect at the time of the application for the 
supplementary protection certificate, could not be regarded as the first 
authorisation to place the product on the market as a medicinal product for the 
purposes of Article 3(b) and (d) of the SPC Regulation. 
29 In addition to the literal interpretation, that conclusion may also be arrived at by 
means of a teleological interpretation which, together with the facts at issue, takes 
account of the fact that, at the time when the application for the supplementary 
protection certificate is submitted, there are not in fact various medicinal products 
on the market containing the same active ingredient, having entered the market in 
a staggered fashion on the basis of their indication, their formulation and other 
characteristics, but rather there is a single medicinal product in which the product 
which the supplementary protection certificate is intended to protect is used. The 
present case may be understood from the perspective of the active ingredient 
ofatumumab, the use of which proved to be ineffective in an earlier indication 
(Arzerra), only ‘finding’ the medical indication that would allow it to acquire the 
status of a product suitable to be placed on the market after that failed test. Such 
an approach may not be contrary to the intention of the legislature, as expressed in 
paragraph 55 of the judgment of 9 July 2020, Santen (C-673/18, EU:C:2020:531), 
which states that the EU legislature intended, in establishing the SPC regime, to 
protect not all pharmaceutical research giving rise to the grant of a patent and the 
marketing of a new medicinal product, but to protect research leading to the first 
placing on the market of an active ingredient or a combination of active 
ingredients as a medicinal product. 
30 Accordingly, in order to give a correct ruling in the present case, the referring 
court asks the Court of Justice for a useful response to the question of whether, for 
the purposes of the application of Article 3(b) and (d) of the SPC Regulation, an 
authorisation to place a product on the market which is no longer valid at the time 
when the application for the supplementary protection certificate is submitted 
must be taken into consideration and, if so, whether such an authorisation, in so 
far as it predates the marketing authorisation which appears in the application, 
may be regarded as the first authorisation to place the product on the market as a 
medicinal product. 
31 [Matters of national procedural law] 
Budapest, 27 February 2024. 
[…] [signatures]