This post is an attempt to provide salient information on Case C-794/25
Referring court
Østre Landsret, Denmark (High Court of Eastern Denmark)
Parties to the main proceedings1
Applicant/Appellant: Stada Arzneimittel AG
Defendant/Respondent: Takeda Pharmaceuticals USA, Inc., Takeda Pharmaceutical Company Ltd.
Product concerned1
Lisdexamfetamine (also known as LDX) is a so-called derivative (more specifically, a therapeutic prodrug) of the active ingredient dexamfetamine (also known as DEX).
Takeda’s medicinal product to which the Supplementary Protection Certificate (SPC) at issue and the underlying marketing authorisation relates, is marketed by Takeda under the product name/trademark Elvanse (which contains lisdexamfetamine dimesylate).
About the companies1
Stada Arzneimittel AG (‘Stada’) is a pharmaceutical company in Germany which manufactures, markets and sells generic medicinal products.
Takeda Pharmaceuticals USA, Inc. and Takeda Pharmaceutical Company Ltd. (‘Takeda’) are companies belonging to a pharmaceutical group headquartered in Japan. The group develops, manufactures, markets and sells medicinal products.
Background to the case1
| Date | Event | |
|---|---|---|
| 1 June 2004 | Takeda filed the European application for its basic patent, titled “Abuse resistant amphetamine compounds” (registered in Denmark as DK/EP 1644019 T4). The patent protects L-lysine-d-amphetamine (lisdexamfetamine), a therapeutic prodrug designed to reduce amphetamine abuse. | |
| 16 December 2012 | The UK MHRA, acting as the Reference Member State (RMS) under the EU decentralised procedure, issued its Day 210 Final Assessment Report, determining lisdexamfetamine to be a “new active substance” considering the requirements of Article 10.2.b of Directive 2001/83/EC and of the CHMP reflection paper on new active substance designation (EMA/651649/2010). | The basis for the UK marketing authorisation included the ‘RMS Day 210 Final Assessment Report’ of 16 December 2012, which states amongst other things: The application had been submitted under Article 8.3 as a new active substance. The current legislation, Article 10.2.b of Directive 2001/83/EC, as amended, states that the different salts, esters, ethers, isomers, mixture of isomers, complexes or derivatives of an active substance shall be considered to be the same active substance unless they differ significantly in properties with regard to safety and/or efficacy. In such cases additional information providing proof of the safety and/or efficacy of the various salts, esters or derivatives of an authorised active substance must be supplied by the applicant. The applicant provided a package of documentation to support their position that lisdexamfetamine is considered to be a new active substance. |
| 1 February 2013 | The UK MHRA granted the first marketing authorization for Takeda’s product, marketed under the name Elvanse (lisdexamfetamine dimesylate). | |
| 14 February 2013 | The Danish regulatory authority granted a marketing authorisation for Elvanse, with Denmark as a Concerned Member State (CMS). | |
| 12 August 2013 | Takeda application for the Supplementary Protection Certificate (SPC) at issue was submitted to the Danish Patent and Trademark Office and was granted on 6 June 2018. (See further information below. | |
| 7 September 2017 | An independent scientific study by Dolder et al. was published in Frontiers in Pharmacology, analysing the pharmacokinetics and pharmacodynamics of lisdexamfetamine compared with D-amphetamine in healthy subjects. Note: The study above is referred to in the section following this table titled Some of the important arguments concerning this case | |
| 6 June 2018 | The Danish Patent and Trademark Office granted Takeda Supplementary Protection Certificate CR 2013 00043 for the product “Lisdexamfetamine, possibly in the form of a mesylate or hydrochloride salt thereof”, scheduled to enter into force on 2 June 2024 and expire on 1 February 2028. The certificate at issue was granted on the basis of Takeda’s Danish patent DK/EP 1644019 T4. | |
| 26 October 2023 | Stada brought an action against Takeda before the Danish Maritime and Commercial Court seeking a declaration that Takeda’s Danish SPC is invalid. | |
| 4 June & 8 August 2024 | German courts (the Federal Patent Court and Regional Court, Düsseldorf) sided with Stada and generic manufacturers, conducting an independent assessment and declared Takeda’s German SPC for Elvanse invalid. | |
| 18 February 2025 | In contrast, the Danish Maritime and Commercial Court dismissed Stada’s action, upholding Takeda’s SPC. Similar upholdings occured in Sweden and Switzerland. In Denmark, Stada promptly appealed the decision to the High Court of Eastern Denmark. | |
| 5 December 2025 | Stada repeated its claim that the Takeda SPC at issue should be declared invalid The High Court of Eastern Denmark officially stayed its proceedings and referred the case to the European Court of Justice (CJEU) for a preliminary ruling. |
Some of the important points/arguments concerning this case1
Like the case before the Maritime and Commercial Court, the appeal case concerns, in particular, whether lisdexamfetamine can be, and is, the product covered by the certificate at issue under the SPC Regulation, or whether it is in fact dexamfetamine that is the product protected under the regulation.
If the product covered by the certificate at issue is deemed to be lisdexamfetamine (which is Takeda’s view), it is both common ground and quite clear that the conditions for granting the certificate have been met and that it is valid. If, on the other hand, the product is deemed to be dexamfetamine (which is Stada’s view), the conditions have not been met and the certificate at issue is invalid.
The decisive issue is therefore whether, for the purposes of Article 3 of the SPC Regulation, the ‘product’ within the meaning Article 1(b) thereof is lisdexamfetamine or whether it is in fact dexamfetamine.
As it did before the Maritime and Commercial Court, in the appeal Stada refers, in support of its claim that the active ingredient (and thus the product) is dexamfetamine, to an article by Dolder et al. in Frontiers in Pharmacology: Pharmacokinetics and Pharmacodynamics of Lisdexamfetamine Compared with D-Amphetamine in Healthy Subjects. The article was published on 7 September 2017, that is to say after the marketing authorisation of February 2013 – on which the certificate at issue is based – was granted.
Stada also claims that the High Court of Eastern Denmark should order an expert report on the therapeutic difference between lisdexamfetamine and dexamfetamine.
Takeda specific points/arguments1
- Takeda opposes the commissioning of an expert report.
- Takeda argues that it follows from a general EU-law principle that there are limitations on the courts’ review of the technical scientific assessment on which the medicinal products authorities base the grant of the marketing authorisation.
- Therefore, in a case before a national court such as the present case, information that post-dates the granting of the marketing authorisation cannot be taken into account. For the same reason, no evidential weight can be attached to the article by Dolder et al.
The High Court of Eastern Denmark referred two central questions to the CJEU. You can view the request for a preliminary ruling here.
The simple version of the two questions referred to the CJEU
- The Product Test: Under what conditions must a derivative (such as a prodrug like
lisdexamfetamine) of an active ingredient (such as dexamfetamine) be considered an
independent active ingredient, and thus a “product” under the SPC Regulation? Specifically, is it enough if (a) the derivative itself is independently protected by a patent, or (b) it was classified as a “new active substance” by regulatory authorities during a marketing authorization procedure? If neither is sufficient, what conditions must it satisfy? - The Scope of Judicial Review: Are there limitations on how deeply a national court can
review the validity of an SPC? Takeda argues that courts must defer to the complex technical and scientific assessments made by regulatory authorities. Stada counters that courts have full jurisdiction and can look at evidence that came to light after the marketing authorization was granted (such as the 2017 Dolder scientific article).
The complete version of the two questions referred to the CJEU
1. Must a derivative, such as lisdexamfetamine, of an active ingredient, such as dexamfetamine, in accordance with the Opinion of Advocate General Henrik Saugmandsgaard Øe of 13 December 2018 in Case C-443/17,(1)Abraxis Bioscience LLCv Comptroller General of Patents, footnote 76, be considered to be an independent active ingredient, which thus comes within the concept of ‘product’ within the meaning of Article 1(b) of Regulation (EC) No 469/2009(2)of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (SPC Regulation), if:
(a) the derivative itself is protected by a patent or
(b) the derivative in connection with the grant of a marketing authorisation is considered to be a new active substance within the meaning of Article 10(2)(b) of Directive 2001/83/EC(3)of the European Parliament and of the Council of 6 November 2001 (consolidated version) on the Community code relating to medicinal products for human use (Medicinal Products Directive)?
If the fact that a derivative such as lisdexamfetamine enjoys independent patent protection or is classified as a new active substance under Article 10(2)(b) of the Medicinal Products Directive does not mean that it must be considered to be an independent active ingredient, what conditions must a derivative, such as lisdexamfetamine, of an active ingredient satisfy in order to be considered to be an independent active ingredient coming within the concept of ‘product’ within the meaning of Article 1(b) of the SPC Regulation?
2. Are there any limitations on judicial review by a court of a Member State in a case such as the present case concerning the alleged invalidity of a supplementary protection certificate, including limitations similar to those referred to in the judgment of the General Court of 5 May 2021 in Case T-611/18,(4)Pharmaceutical Works Polpharma S.Av European Medicines Agency (EMA)ECLI:EU:T:2021:241, paragraphs 164 to 172, which concerned judicial review by the General Court and the Court of Justice in cases regarding applications for marketing authorisation for medicinal products?
References
1. Case C-794/25, InfoCuria
Further reading
Pro = Active? CJEU asked to decide, May 2026, HGF