Santen v Directeur général de l'INPI (CJEU, C-673/18, 2020)

Dhenne Avocats · 11 October 2026

Our analysis

Summary

On a reference from the Paris Court of Appeal (cour d’appel de Paris), the Grand Chamber held that Article 3(d) of Regulation 469/2009 precludes a marketing authorisation from being regarded as the first authorisation where it covers a new therapeutic application of an active ingredient, or combination of active ingredients, that has already been authorised for a different therapeutic application (para 61 and operative part). It departed from paragraph 27 of Neurim, under which the first authorisation was assessed within the limits of the protection conferred by the basic patent (para 53). Patents for a new therapeutic application of a known active ingredient can no longer support an SPC once that ingredient has been authorised as a medicinal product.

Facts and procedure

Santen holds a European patent filed on 10 October 2005 protecting an ophthalmic emulsion whose active ingredient is ciclosporin (para 13). On 19 March 2015 a marketing authorisation was granted for Ikervis, containing ciclosporin, for the treatment of severe keratitis in adults with dry eye disease (para 14). On 3 June 2015 Santen applied for an SPC for « ciclosporin for use in the treatment of keratitis » (para 15). The Director General of INPI refused it on 6 October 2017 on account of a French authorisation of 23 December 1983 for Sandimmun, an oral solution containing ciclosporin intended in particular to prevent graft rejection (paras 15 and 16). On appeal, the Paris Court of Appeal, which relied on Neurim (para 18), referred two questions by decision of 9 October 2018. The Court dismissed the plea of inadmissibility raised by the Netherlands Government (paras 24 to 31).

The applicable law

The dispute concerns Articles 1(b) and 3(d) of Regulation 469/2009. The Court relied on the concept of active ingredient developed in Massachusetts Institute of Technology and Forsgren, which requires a therapeutic effect of its own (para 42), on Article 4, which extends protection to any authorised use of the product (paras 43 and 44), and on the 1990 Explanatory Memorandum, under which the product means the active substance in the strict sense (para 45). It also referred to recital 10 of the Regulation (para 57).

Question

Can an authorisation covering a new therapeutic application of an active ingredient already authorised for a different application be the first authorisation within the meaning of Article 3(d)?

Decision

The Court reformulated the questions, which rested on the premise of Neurim (paras 34 to 37). The product is defined by the active ingredient, irrespective of the therapeutic application protected by the patent; a new application does not turn a known active ingredient into a distinct product (paras 46 and 47). The first authorisation of the product is therefore that of the first medicinal product containing the active ingredient, whatever its therapeutic application (para 51, citing Abraxis). Confining the concept to the first authorisation within the basic patent would undermine the strict definition of the product, so that, contrary to paragraph 27 of Neurim, the limits of the protection conferred by the patent are not to be taken into account (paras 52 and 53). That reading serves the aim of protecting research leading to the first placing on the market of an active ingredient as a medicinal product (paras 54 to 57) and preserves the simplicity and predictability of a uniform scheme, which distinctions between therapeutic applications would jeopardise (para 59). The premise adopted by the referring court must be set aside (para 60).

Key points for practice

• The product under Article 1(b) does not depend on the therapeutic application (paras 46 and 47).
• The first authorisation is assessed by reference to the active ingredient, without regard to the limits of the protection of the basic patent (paras 51 to 53).
• Having reformulated the reference, the Court neither defined the concept of a different application nor answered the second question separately (paras 36 and 37).
• Practical point: any earlier authorisation for the same active ingredient, however old and whatever its form or indication, bars an SPC based on a new therapeutic application; the full regulatory history of the active ingredient should be checked before filing (para 60).

Provisions applied

Regulation (EC) No 469/2009

Arts 1(b), 3(d) and 4

Case law cited

Neurim Pharmaceuticals (1991) (C-130/11); Synthon (C-195/09); Wightman and Others (C-621/18); Coman and Others (C-673/16); Massachusetts Institute of Technology (C-431/04); Abraxis Bioscience (C-443/17); Forsgren (C-631/13); Pharmacia Italia (C-31/03)

Related decisions

• Neurim, CJEU, 19 July 2012, whose paragraph 27 the Court departed from (para 53).
• Abraxis, CJEU, 21 March 2019, cited on the concept of first authorisation (para 51).
• Forsgren, CJEU, 15 January 2015, cited on the concept of active ingredient (para 42).

Prepared by Dhenne Avocats from the text of the decision (EUR-Lex, English version), consulted on 11 October 2026. Only the official text is authoritative.