CJEU to revisit Santen doctrine: German court challenges SPC interpretation for veterinary medicinal products

Intellectual property rights created by European Union regulations (such as supplementary protection certificates (SPC)) can give rise to difficult legal issues when National Courts are required to interpret these regulations. Given the risk of divergent interpretations by the EU Member States in respect of the SPC Regulation, the referral of a preliminary ruling under Article 267 of the Treaty on the Functioning of the European Union is a convenient mechanism for obtaining a uniform interpretation. It should be noted that SPCs are not covered by international conventions, like TRIPs or the Paris Union Convention.

The German Federal Patent Court's challenge to Santen

In January 2026, the German Federal Patent Court (BPatG) requested a preliminary ruling that will require the CJEU to revisit the Santen doctrine. This doctrine arises from the judgment of the Grand Chamber of the CJEU of 9 July 2020, Santen SAS and Directeur général de l’Institut national de la Propriété Industrielle (Case C-673/18) (Santen) concerning the interpretation of Article 3(d) of Regulation (EU) No 469/2009 on SPCs for medicinal products (SPC Regulation). Briefly, the BPatG has referred to the CJEU the issue of whether the Santen doctrine applies in cases where the SPC concerns veterinary medicinal products that have previously been authorised for human use, or whether the Court should return to the doctrine applied in Neurim Pharmaceuticals (1991) Ltd and Comptroller-General of Patents, C-130/11) (Neurim) that was overturned in Santen. 

The BPatG stated that it considers the Neurim doctrine to be correct and that it also applies when a medicinal product is initially authorised for use in humans and subsequently authorised for use in horses. In this case the first marketing authorisation (MA) was for the treatment of asthma in humans and the second MA was for the treatment of horses. While Neurim was the other way round (the first MA concerned melatonin used to regulate reproduction in sheep and the second MA concerned melatonin for treating sleep disorders in humans), the BPatG held: 

The applicant's view that, in the present case, the 'Neurim' decision should be upheld seems correct from the point of view of this Chamber. It is true that the Patent Division correctly assumed that the Court of Justice of the European Union, in the 'Santen' judgment, had expressly abandoned its previous case law, according to which a first authorisation within the meaning of the Regulation had to be taken as the starting point when a subsequent authorisation was granted for the same active ingredient but for a different therapeutic indication (CJEU, loc. cit., paragraphs 51 to 53). However, it must be borne in mind that the 'Neurim' and 'Santen' judgments were based on very different facts. In the opinion of this Chamber, the different legal requirements for the authorisation procedures for medicinal products for human and veterinary use preclude the two groups of cases, namely subsequent authorisation for a new indication for a medicinal product for human use which has already been authorised, on the one hand, and subsequent authorisation relating to the first marketing of the product as a medicinal product for human or veterinary use, on the other, from being treated in the same way. (14 W (pat) 28/23, 12 December 2025 (published on 9 January 2025)

The evolution from Neurim to Santen

In Neurim, the Fourth Chamber of the CJEU ruled that Articles 3 and 4 of the SPC Regulation must be interpreted as meaning that the existence of a prior MA obtained for a veterinary medicinal product does not preclude the grant of a SPC in respect of a human medicinal product for a different indication. 

Article 3(d) of the SPC Regulation provides that the relevant MA is the first authorisation to place the product on the market. The Court found that an MA will be the first authorization for the purposes of Article 3(d) if the human product falls within the scope of the claims of the basic patent relied upon for the SPC application.  The distinction between human and veterinary medicinal products was also deemed necessary as a matter of fairness, so that a medicinal product for human use that had undergone significant testing could benefit from the extension of protection afforded by the SPC. As the saying goes, 'hard cases make bad law'.

This test was subsequently overturned in Santen (see bold text):

52  Well, to consider that the concept of 'first authorisation to place the product on the market as a medicinal product' within the meaning of Article 3(d) of Regulation No.^o 469/2009 refers exclusively to the first marketing authorisation falling within the scope of protection of the basic patent relied on as the basis for the SPC application would necessarily lead to questioning that strict definition of the concept of 'product' within the meaning of Article 1(b) of that Regulation, since, as indicated in Article 1(c) of that regulation, it is possible that the basic patent in question covers only one therapeutic application of a given product. If that were the case, that therapeutic application could justify the grant of an SPC even though the same active ingredient, or the same composition of active ingredients, is the subject of another therapeutic application already known and which has given rise to a previous marketing authorisation.

53 It follows that, contrary to what the Court of Justice stated in paragraph 27 of the Neurim judgment, in order to define the concept of 'first authorisation to place on the market as a medicinal product' within the meaning of Article 3(d) of Regulation 469/2009, it is not appropriate to take into account the scope of protection of the basic patent.

54 Similarly, an analysis of the objectives of Regulation No 469/2009 confirms that interpretation.

55 Thus, it follows from paragraph 11 of the explanatory memorandum referred to in paragraph 45 of this judgment that, in establishing the SPC system, the intention of the EU legislature was to promote the protection not of any pharmaceutical research leading to the grant of a patent and the marketing of a new medicinal product, but of research leading to the first marketing of an active ingredient or a combination of active ingredients as a medicinal product (see, to that effect, the judgment of 21 March 2019, Abraxis Bioscience, C-443/17, EU:C:2019:238, paragraph 37).

Will the Santen doctrine change?

There is currently little indication that the CJEU will depart from the Santen doctrine.

Firstly, Santen was a decision of the Grand Chamber (thirteen judges took part in the deliberation), while Neurim was heard by the Fourth Chamber. As a result of this, the Santen ruling has been applied consistently by the courts of the Member States. Shortly after Santen, the preliminary ruling requested by the Swedish Supreme Court (Case C-354/19) on the possible granting of a new SPC for canakinumab for a new MA for the treatment of rheumatoid arthritis was withdrawn (canakinumab was originally authorised for cryopyrin-associated periodic syndrome). Similarly, the Administrative Chamber of the District Court of The Hague refused to grant an SPC for ciclesonide because of the earlier MA for human use in respect of the same active ingredient (judgment 14 May 2025).

Secondly, Santen rejected the test in Neurim (as identified in the extract above, particularly paragraphs 52 and 53) on the basis that it was inappropriate to take into account the scope of protection of the basic patent to determine the 'first authorisation’ for the purposes of Article 3(d).  

It should be remembered that there is a different data exclusivity regime for veterinary medicinal products (Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products). This disparity between the regimes for medicinal products for human use and veterinary use is not reflected in the SPC Regulation (Article 2 of Regulation 469/2009 stipulates that the Regulation applies to both human and veterinary medicinal products).

Furthermore, Neurim was an unusual case in which a veterinary medicinal product was converted for human use. This was unusual because the relatively greater investment required to develop human medicinal products, means that these products are more often used to develop animal products. Other examples include fluoxetine, loop diuretics, amlodipine, ACE inhibitors and spironolactone. In the case of ciclesonide, the indication for the veterinary product is the same as the human product.

For these reasons, we expect that the CJEU will respond to the request for a preliminary ruling by reaffirming the Santen decision. 

Despite this, several authors (and the BPatG) consider that the legislative intention underlying the SPC Regulation requires a change to the Santen doctrine. The BPatG’s decision is clearly a relevant preliminary ruling that highlights the crucial role of the CJEU in determining the availability of SPCs for medicinal products.