Opinion of the Advocate General — ECLI:EU:C:2020:34
Date: 2020-01-23
Language of the case: French
Subject matter: Intellectual, industrial and commercial property;Approximation of laws
Procedure: Reference for a preliminary ruling
Origin: France

summary of product characteristics that it is undisputed that the active 
ingredient of that medicinal product is ciclosporin [also spelled ‘cyclosporine’ and 
cyclosporin’]. It has the form of an emulsion (eye drops) containing 1 mg of 
ciclosporin per ml. It is administered in a dose of one drop in the eye and treats 
severe keratitis in adult patients with dry eye disease that has not improved despite 
treatment with tear substitutes, consisting of inflammation of the cornea, the front 
part of the eye.  
SANTEN 
 
3 
On 3 June 2015, on the basis of the patent and MA referred to above, SANTEN 
filed application No 15C0040 for a supplementary protection certificate (SPC) for 
a product called ‘ciclosporine collyre en émulsion’ [‘ciclosporin eye drops, 
emulsion’].  
On 26 August 2015, in response to observations by the INPI, it renamed the 
product under the SPC ‘Ciclosporin for use in the treatment of keratitis’. 
2 On 23 December 1983, a marketing authorisation had been granted for a 
medicinal product Sandimmun that already had ciclosporin as its active 
ingredient. That medicinal product was presented in the form of an oral solution 
containing 100 mg/ml of ciclosporin. It had several therapeutic indications, both 
in preventing the rejection of solid organ and bone marrow grafts and 
non-transplant indications including the treatment of endogenous uveitis, an 
inflammation of some or all of the uvea, the middle part of the eye.  
3 By a decision of 6 October 2017, the director of the INPI rejected that application 
for an SPC. 
4 By a declaration of 3 November 2017, SANTEN brought an action against that 
decision of the director of the INPI and on 1 December 2017 filed its first 
submissions. 
By registered letters of 22 January 2018, SANTEN and the director of the INPI 
were called to attend the hearing of 19 June 2018. 
5 In its most recent submissions, served on 17 May 2018, SANTEN applied to the 
Court of Appeal as follows: 
Principal claims: 
• To hold that the director of the INPI erred in rejecting SANTEN’s SPC 
application No 15C0040. 
• To annul the decision of 6 October 2017 of the director of the INPI;  
• To order the director of the INPI to grant SPC No 15C0040; [Or. 4]  
In the alternative: 
• To refer the following question to the Court of Justice of the European 
Union for a preliminary ruling: 
‘Interpreting Article 3 of the SPC Regulation [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 (codified version) (OJ 
2009 L 152, p. 1], where a marketing authorisation (A) has been granted for a 
medicinal product containing an active ingredient, must Article 3(d) be interpreted 
REQUEST FOR A PRELIMINARY RULING OF 9.10.2018 — CASE C-673/18 
 
4  
as precluding the grant of an SPC based on a later authorisation (B) for a different 
application of the same product where: 
(i) the limits of the protection conferred by the basic patent extend not only to 
the second therapeutic application but also to a new formulation; 
(ii) the earlier marketing authorisation was granted for a medicinal product for 
human use for a specific indication and the later marketing authorisation was also 
granted for a medicinal product for human use?’ 
• To stay proceedings pending the preliminary ruling by the Court of Justice 
  
[...]. 
6 On 21 March 2018, the director of the INPI filed a pleading applying that the 
action be dismissed. 
7 The case, in which oral arguments were submitted at the hearing on 19 June 2018, 
was adjourned [...] to the hearing of 3 July 2018 so that the director of the INPI 
and SANTEN could make submissions on the wording of any question to be 
referred for a preliminary ruling. 
8 In his written pleadings served on 26 June 2018, the director of the INPI stated 
that he did not object to [the referral of questions] for a preliminary ruling, for 
which he proposed the following wording: 
‘1. Where the MA relied upon in support of an application for an SPC is not the 
first MA granted for the product, on the basis of what criteria can a “new 
therapeutic use” justifying grant of the SPC be established? In particular, in the 
light of the objectives of Regulation (EC) No 469/2009 of establishing a balanced 
system taking into account all the interests at stake, including those of public 
health, must the notion of a “new therapeutic use” be assessed according to stricter 
criteria than those for assessing the patentability of the invention? 
2. Where an earlier marketing authorisation (A) has been granted for a 
medicinal product containing an active ingredient, must Article 3(d) be interpreted 
as precluding the grant of an SPC based on a later marketing authorisation (B) for 
a medicinal product using the same active ingredient but authorised for a different 
indication, where: 
(i) the protection conferred by the basic patent covers a specific 
formulation of the active ingredient and is not used by the medicinal 
product to which the authorisation (A) relates;  
(ii) the protection conferred by the basic patent is not limited to a 
specific therapeutic indication but covers the new formulation as such; 
[Or. 5]  
SANTEN 
 
5 
(iii)  the later marketing authorisation (B) is limited to a therapeutic 
indication different from the therapeutic indications for which an 
earlier marketing authorisation (A) was granted; 
(iv) the earlier marketing authorisation (A) was granted for a 
medicinal product for human use for a specific therapeutic indication 
and the marketing authorisation (B) was also granted for a medicinal 
product for human use? 
(v) the basic patent relied upon in support of the application for an 
SPC protects use of the formulation to treat not only the disease 
referred to in the therapeutic indications in the MA relied upon in 
support of the application, but also to treat a disease referred to in the 
therapeutic indications of the earlier MA.’ 
9 On 29 June 2016, SANTEN served its submissions containing the following 
proposed wording of the question for a preliminary ruling: 
‘Where an earlier marketing authorisation (A) has been granted for a medicinal 
product containing an active ingredient, must Article 3(d) be interpreted as 
precluding the grant of an SPC based on a later marketing authorisation (B) for a 
medicinal product using the same active ingredient but authorised for a different 
indication, where: 
(i) the protection conferred by the basic patent covers a specific 
formulation that is not the formulation used by the medicinal product 
to which the authorisation (A) relates, meaning that the SPC would not 
prevent exploitation of the previously authorised medicinal product; 
(ii) the protection conferred by the basic patent is not limited to a 
specific therapeutic indication but covers the new formulation as such; 
(iii)  the later marketing authorisation (B) is limited to a therapeutic 
indication different from the therapeutic indications for which the 
earlier marketing authorisation (A) was granted; 
(iv) the earlier marketing authorisation (A) was granted for a 
medicinal product for human use for a specific therapeutic indication 
and the marketing authorisation (B) was also granted for a medicinal 
product for human use?’ 
10 [...]. [Or. 6] 
ACCORDINGLY 
11 In order to reject SANTEN’s application for a supplementary protection certificate 
for the medicinal product Ikervis the director of the INPI took the view that the 
marketing authorisation of 19 March 2015 was not the first marketing 
REQUEST FOR A PRELIMINARY RULING OF 9.10.2018 — CASE C-673/18 
 
6  
authorisation, within the meaning of Article 3(d) of Regulation (EC) 
No 469/2009, for the active ingredient ‘ciclosporin’ in so far as a marketing 
authorisation had already been granted on 23 December 1983 for the medicinal 
product Sandimmun that also had ciclosporin as its active ingredient. 
He added that the requirements in the Court of Justice’s judgment of 19 July 2012 
[Neurim Pharmaceuticals (1991) Ltd v Comptroller-General of Patents, 
(C-130/11, EU:C:2012:489)], on which SANTEN relies to argue that the 
medicinal product Ikervis included a new application of ciclosporin enabling a 
new SPC to be granted, seemed to him not to be satisfied since, first, the basic 
patent relied upon protected not only a new application of ciclosporin (claims 23 
to 24) but also and primarily an ophthalmic oil-in-water submicron type emulsion 
containing an active substance, including ciclosporin (claims 1 to 21 and 25 to 
26); furthermore and in any event, according to the director, it had not been shown 
that the medical application in the MA for the proprietary product Ikervis 
amounted to a new therapeutic application within the meaning of the Neurim 
case-law, compared with the proprietary product Sandimmun, since both 
concerned the treatment of inflammations in the field of ophthalmology. 
In his pleading of 21 March 2018, he contends that the grant of an SPC, designed 
as an exceptional recompense for innovative medicinal products, requires several 
conditions to be satisfied. The Court of Justice, he submits, having interpreted 
restrictively the concept ‘product’, the active ingredient of a medicinal product, 
excluding considerations relating to its form, dosage, posology and therapeutic 
indications, in Neurim nuanced its case-law by allowing that, under certain 
circumstances, an MA, where it is not the first for the product, may nevertheless 
satisfy Article 3(d) if it is the first MA for a new medical use of the product falling 
within the limits of the protection conferred by the basic patent. According to the 
director, since that Court gave no indication of what the notion of a new 
therapeutic indication encompasses, it has been understood differently by the 
offices in the various EU Member States: the Netherlands office has confined the 
concept strictly to the situation in the Neurim case (an MA for human use as 
opposed to a veterinary MA) whereas the UK court has even wondered whether 
that concept should include new formulations of known products. 
The French institution aims to take a measured approach in applying the Neurim 
case-law. 
It is of the view, first, that the basic patent must have the same scope as the MA 
relied upon and, therefore, that scope must be limited to the new medical use 
corresponding to the therapeutic indication in that MA; that is the situation on the 
facts in Neurim; it is not the situation, it contends, in the present case, since the 
basic patent protects both a product, that is to say an ophthalmic emulsion in 
which the active substance is ciclosporin (claim 21), and the use of that emulsion 
to prepare an ophthalmic composition to treat numerous eye diseases that are 
referred to expressly, including not only keratitis but also, indeed, uveitis (claim 
24). [Or. 7] 
SANTEN 
 
7 
It asserts, secondly, that for it to be possible to grant an SPC, the MA relied upon 
must relate to an indication within a new therapeutic scope, in the sense of a new 
proprietary medical product, compared with the earlier MA, or a medicinal 
product in which the active ingredient acts differently from how it acts in the 
medicinal product to which the first MA relates. In the present case, in so far as 
both MAs were for the treatment of inflammation of parts of the human eye, using 
the same mechanism of action of ciclosporin, no new medicinal use has been 
sufficiently demonstrated. 
12 SANTEN is seeking annulment of the decision of 6 October 2017 and, in the 
alternative, a [reference for a] preliminary ruling. 
According to SANTEN, the application of the active substance ciclosporin is 
different, within the meaning of Neurim, in the Sandimmun and Ikervis 
proprietary medicines because: 
- none of the earlier formulations of the proprietary medicine Sandimmun is the 
oil-in-water emulsion in claim no 1 of the basic patent relied upon for the Ikervis 
SPC; 
- the Sandimmun and Ikervis proprietary medicines do not have the same 
therapeutic indication and treat different diseases; although in both instances 
ciclosporin has an anti-inflammatory function, amongst others, it is to treat 
different parts of the eye and different conditions; 
- their posology and means of administration are different and the two proprietary 
medicines are not interchangeable. 
SANTEN further asserts that the Neurim ruling does not contain any of the 
limitations that the director of the INPI is trying to include in it: 
- the ruling is not confined to claims in the application but also covers basic 
patents protecting a new formulation; 
- the principles it lays down are not confined to factual situations in which the first 
use was veterinary and the second human; 
- it does not, according to SANTEN, require the basic patent to be limited to the 
new use. 
13 According to Article 3, ‘Conditions for obtaining a certificate’, of Regulation 
(EC) No 469/2009 of 6 May 2009 concerning the supplementary protection 
certificate for medicinal products: 
‘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: 
REQUEST FOR A PRELIMINARY RULING OF 9.10.2018 — CASE C-673/18 
 
8  
(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 in accordance with Directive 2001/83/EC or 
Directive 2001/82/EC, as appropriate; 
(c) the product has not already been the subject of a certificate; 
(d) the authorisation referred to in (b) is the first authorisation to place the 
product on the market as a medicinal product.’ [Or. 8] 
The Court of Justice held as follows in its judgment of 19 July 2012, Neurim 
(C-130/11, EU:C:2012:489): 
‘Articles 3 and 4 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, in a case such as that in the main proceedings, the mere existence of an 
earlier marketing authorisation obtained for a veterinary medicinal product 
does not preclude the grant of a supplementary protection certificate for a 
different application of the same product for which a marketing 
authorisation has been granted, provided that the application is within the 
limits of the protection conferred by the basic patent relied upon for the 
purposes of the application for the supplementary protection certificate.’ 
14 In the present case, it is common ground that the application for supplementary 
protection certificate no 1 5C0040, for the product renamed ‘ciclosporin for use in 
the treatment of keratitis’, meets the requirements in Article 3(a), (b) and (c) 
above. 
That product is protected by patent EP 306, which expires on 11 October 2025, in 
claims 1 (ophthalmic oil-in-water submicron type emulsion ...), 21 (... wherein the 
active substance is cyclosporin A ...) and 24 (… for the preparation of an 
ophthalmic composition for treating ocular conditions such as ... keratitis …) of 
that patent. 
As the medicinal product known as Ikervis, it obtained Community marketing 
authorisation No EU/1/15/1990 on 19 March 2015. 
It has not already been the subject of a supplementary protection certificate. 
15 In contrast, it is also common ground that ciclosporin, the active ingredient of the 
medicinal product Ikervis, had already been the subject of a marketing 
authorisation, on 23 December 1983, as the medicinal product Sandimmun. 
SANTEN nevertheless argues that this earlier authorisation does not preclude the 
grant of the SPC in question in so far as Neurim permits such a grant: 
SANTEN 
 
9 
- for a different application of the same product; 
- provided that application is within the limits of the protection conferred by the 
basic patent. 
SANTEN and the director of the INPI disagree on the interpretation to be given to 
those concepts. 
16 It is apparent from the evidence produced and the clarifications given that both 
medicinal products relate to the treatment of inflammation of parts of the eye in 
humans, using the same anti-inflammatory mechanism of ciclosporin. 
However, they differ in their therapeutic indications and in factors relating to their 
formulation, dosage and posology. [Or. 9] 
First of all, Sandimmun has several therapeutic indications, both in preventing the 
rejection of solid organ and bone marrow grafts and non-transplant indications 
including the treatment of endogenous uveitis, an inflammation of some or all of 
the uvea, the middle part of the eye. Ikervis can be used to treat severe keratitis in 
adult patients with dry eye disease that has not improved despite treatment with 
tear substitutes, consisting of inflammation of the cornea, the front part of the eye. 
It is not disputed that these are different diseases, affecting different parts of the 
eye.  
Further, the proprietary medicine Sandimmun is presented as an oral solution 
containing 100 mg/ml of ciclosporin. To treat endogenous uveitis it is 
recommended that 5mg/kg/day be administered orally in 2 separate doses. The 
proprietary medicine Ikervis is in the form of an emulsion (eye drops) containing 
1 mg of ciclosporin per ml. It is administered in a dose of one drop in the eye.  
The director of the INPI argues that the concept of a different application within 
the meaning of Neurim should be interpreted strictly. Whilst not going so far as to 
claim that it should mean only the situation where an application for human use 
follows a veterinary application, the MA relied upon should relate to an indication 
falling within the new therapeutic scope, in the sense of a new proprietary 
medicine, compared with the earlier MA, or a medicinal product in which the 
active ingredient acts differently from how it acts in the medicinal product to 
which the first MA relates. In his draft question for a preliminary ruling, he 
suggests enquiring whether, in the light of the objectives of Regulation (EC) 
No 469/2009 of establishing a balanced system taking into account all the interests 
at stake, including those of public health, the notion of a ‘new therapeutic use’ 
should be assessed according to stricter criteria than those for assessing the 
patentability of the invention. 
SANTEN asserts, conversely, that the notion of a different application within the 
meaning of Neurim should be interpreted broadly, that is to say, as including not 
only different therapeutic indications and diseases, but also different formulations, 
posologies and means of administration. 
REQUEST FOR A PRELIMINARY RULING OF 9.10.2018 — CASE C-673/18 
 
10  
In so far as that concept of a different application cannot be interpreted with 
certainty, as is necessary in order to resolve the dispute, by reading the Neurim 
judgment, the Court of Appeal finds it appropriate for that purpose to refer for a 
preliminary ruling a question worded in accordance with the operative part of this 
decision. 
17 Secondly, the director of the INPI is uncertain of what link there should be 
between the different application thus defined and the basic patent. In his decision 
of 19 July 2012, he found that the basic patent relied upon protects not only a new 
application of ciclosporin (claims 23 to 24) but also and primarily a submicron 
oil-in-water ophthalmic emulsion containing an active substance, including 
ciclosporin (claims 1 to 21 and 25 to 26). In his pleading he argues, slightly 
differently, that the basic patent must have the same scope as the MA relied upon 
and, therefore, that scope must be limited to the new medical use corresponding to 
the therapeutic indication in that MA. 
Since it is still necessary to answer that question in order to resolve the dispute, it 
is still appropriate to refer for a preliminary ruling a question worded in 
accordance with the operative part of this decision. 
The proceedings will be stayed until the Court of Justice has ruled on that 
question. [Or. 10] 
ON THOSE GROUNDS 
18 The Court of Appeal, ruling inter partes, 
Refers the following questions to the Court of Justice of the European Union for a 
preliminary ruling: 
‘1 — Must the concept of a ‘different application’ within the meaning of the 
judgment of 19 July 2012, Neurim (C-130/11, EU:C:2012:489), be interpreted 
strictly, that is to say: 
- as limited only to the situation where an application for human use follows a 
veterinary application; 
- or as relating to an indication within a new therapeutic scope, in the sense of a 
new proprietary medical product, compared with the earlier marketing 
authorisation, or a medicinal product in which the active ingredient acts 
differently from how it acts in the medicinal product to which the first marketing 
authorisation related; 
- or more generally, in the light of the objectives of Regulation (EC) No 469/2009 
of establishing a balanced system taking into account all the interests at stake, 
including those of public health, must the concept of a “new therapeutic use” be 
assessed according to stricter criteria than those for assessing the patentability of 
the invention; 
SANTEN 
 
11 
- or must it on the other hand be interpreted broadly, that is to say, as including 
not only different therapeutic indications and diseases, but also different 
formulations, posologies and/or means of administration? 
2 — Does the expression “[application] within the limits of the protection 
conferred by the basic patent” within the meaning of the judgment [of the Court of 
Justice] of 19 July 2012, Neurim (C-130/11, [EU:C:2012:489]), mean that the 
scope of the basic patent must be the same as that of the marketing authorisation 
relied upon and, therefore, be limited to the new medical use corresponding to the 
therapeutic indication of that marketing authorisation?’. 
Stays the proceedings brought by SANTEN pending the ruling of the Court of 
Justice 
 
[procedural references omitted]