Factual and Procedural Background
This was a statutory appeal by the Plaintiff against the Defendant’s refusal of a supplementary protection certificate (SPC) for Mavenclad, a human medicinal product containing cladribine. Mavenclad was protected by a basic patent concerning a pulsed dosage regimen for relapsing-remitting multiple sclerosis. Cladribine had previously been authorised in Litak for hairy cell leukaemia. [1][2][3]
The Plaintiff applied for an SPC in February 2018. The Defendant refused the application in September 2025 because the Litak marketing authorisation was an earlier authorisation for the same active ingredient, contrary to Article 3(d) of Regulation (EC) No. 469/2009. [4][5]
The High Court conducted a full rehearing on the materials before the Defendant. The Plaintiff sought to have the refusal set aside, an SPC granted, or alternatively a reference made to the Court of Justice of the European Union (CJEU). [6][7]
Legal Issues Presented
- Whether an SPC could be granted for a second medicinal use involving a known active ingredient but a new dosage regimen. [3]
- Whether the earlier Litak authorisation prevented Mavenclad’s authorisation from being the first marketing authorisation under Article 3(d) of Regulation (EC) No. 469/2009. [5][8]
- Whether the CJEU’s decision in Santen permitted or required refusal of the SPC despite the different therapeutic use and dosage regimen. [9][10]
- Whether the alleged uncertainty in the CJEU authorities required a preliminary reference. [6][11]
Arguments of the Parties
Plaintiff’s Arguments
- A strict interpretation of “product” as meaning only the active ingredient would improperly exclude second medicinal use inventions from SPC protection, and Santen had been misapplied. [12]
- The approach should account for patent-law rules identifying the subject matter protected by the basic patent, as discussed in Teva UK Ltd v. Gilead Sciences Inc. and Merck Sharp & Dohme v. Clonmel Healthcare. [13]
- The Regulation’s purpose required correspondence between the authorised product and the invention protected by the basic patent, including compensation for time spent obtaining Mavenclad’s authorisation. [14]
- The Mavenclad dosage regimen produced pharmacological, immunological and metabolic effects distinct from those associated with Litak, justifying treatment of the product as different. [15][16][17]
- The CJEU should be asked to clarify an alleged conflict between Neurim and Santen. [18][6]
Defendant’s Arguments
- The appeal should be dismissed because Santen clearly required the earlier authorisation for cladribine to be treated as the first authorisation for the product. [19]
- The Article 1(b) definition of “product” and Article 3(d) required focus on the active ingredient, not its therapeutic use or dosage regimen. [20][21]
Table of Precedents Cited
| Precedent |
Rule or Principle Cited For |
Application by the Court |
| Carrickdale Hotel v. Controller of Patents [2004] 3 I.R. 410 |
The applicable standard in an appeal of this type. |
The appeal involved a full rehearing rather than error-based review. [7] |
| Diesel SPA v. Controller of Patents [2023] 1 I.R. 1 |
The standard of review on appeal. |
The Court was entitled to reach its own conclusion on the materials before the Defendant. [7] |
| Fitzgibbon v. Law Society of Ireland [2015] 1 I.R. 516 |
The standard of review in the relevant appellate context. |
The Court applied the agreed full-rehearing approach. [7] |
| Warner-Lambert Co LLC v. Generics (UK) Ltd (t/a Mylan) [2019] 3 All ER 95 |
The history and rationale of second medicinal use patents. |
The Court used the discussion to explain that novelty may lie in a purpose-limited process or use rather than the known active ingredient. [22][23] |
| Case C-31/03 Pharmacia Italia SPA |
The first authorisation and “product” concepts were treated uniformly, without distinguishing intended use or human and veterinary use. |
The reasoning supported the conclusion that an earlier authorisation for the same active ingredient could prevent a later SPC. [24][25][26] |
| Case C-431/04 Massachusetts Institute of Technology |
“Product” means an active ingredient or combination of active ingredients; non-therapeutic excipients are excluded. |
The case supported a strict interpretation of “active ingredient” and “product.” [27][28][29] |
| Case C-202/05 Yissum Research and Development Company of the Hebrew University of Jerusalem v. Comptroller General of Patents |
A second therapeutic use does not form part of the definition of “product.” |
The Court relied on the case as part of the pre-existing strict approach later reaffirmed in Santen. [30][31][32] |
| Case C-322/10 Medeva BV v. Comptroller of Patents |
The SPC regime provides a uniform EU solution; Article 3(a) concerns protection by the basic patent. |
The Court distinguished the Article 3(a) inquiry from the separate Article 3(d) inquiry. [33][34][35] |
| Case C-130/11 Neurim Pharmaceuticals (1991) Ltd v. Comptroller-General of Patents |
An earlier authorisation for a different veterinary use was held not necessarily to prevent an SPC for a new therapeutic application. |
The Court held that Santen had overturned, or substantially restricted, this approach. [36][37][38] |
| Case C-443/12 Actavis UK Ltd v. Sanofi |
Article 3(c) may prevent multiple SPCs connected with the same product under one basic patent. |
The case illustrated the Regulation’s concern with avoiding overlapping or repeated protection. [39][40] |
| C-121/17 Teva UK Ltd v. Gilead Sciences Inc. |
Whether a product is protected by a basic patent is determined by patent-law rules and the patent claims. |
The Court accepted that this principle applies to Article 3(a), but held that Article 3(d) is governed separately by Santen. [40][41][42][43] |
| Case C-443/17 Abraxis Bioscience LLC v. Comptroller General of Patents |
A new formulation of an old active ingredient is not a distinct product where the carrier has no therapeutic effect; an earlier authorisation for the active ingredient prevents reliance on the later formulation authorisation. |
The case reinforced the narrow and predictable interpretation of “product” and Article 3(d). [44][45][46][47] |
| Case C-673/18 Santen SAS v. Directeur général de l’Institut national de la propriété industrielle |
A new therapeutic use does not make the same active ingredient a distinct product, and a later authorisation for that use is not the first authorisation if the ingredient was previously authorised. |
The Court treated Santen as clear and binding. Because cladribine had previously been authorised in Litak, Mavenclad could not satisfy Article 3(d). [47][48][49][42][21] |
| Merck Serono SA v. Comptroller-General of Patents [2025] EWCA Civ. 45 |
Santen restored coherence and reduced uncertainty caused by Neurim. |
The Court respectfully agreed with that analysis, while noting that the case concerned issues arising from the United Kingdom’s withdrawal from the EU. [50][51] |
Court’s Reasoning and Analysis
The Court treated the appeal as a full rehearing, unconstrained by the Defendant’s reasoning, but based on the materials available to the Defendant. [7]
Article 3 requires, among other things, that the product be protected by a basic patent, have a valid marketing authorisation, not have previously received an SPC, and have the first authorisation to place the product on the market. The dispute principally concerned Article 3(d). [52][8]
Under Article 1(b), “product” means the active ingredient or combination of active ingredients. The Court therefore distinguished the Article 3(a) question—whether the basic patent protects the product—from the Article 3(d) question—whether the active ingredient has previously been authorised. [53][54][43]
The Court considered the development of the CJEU case law. It concluded that Neurim represented a departure from the earlier strict approach, while Santen was intended to restore clarity and predictability by rejecting reliance on a later authorisation for a new therapeutic application of an already authorised active ingredient. [55][56][48][49]
Although Mavenclad’s dosage regimen was protected by the basic patent and its therapeutic use differed from Litak, those matters did not alter the identity of the active ingredient for Article 3(d). The active ingredient in both products was cladribine, and the Litak authorisation was therefore an earlier authorisation for the same product. [42][57]
The Court rejected the argument based on Mavenclad’s distinct pharmacological and therapeutic effects. The statutory inquiry required identification of the active ingredient, not an assessment of whether that ingredient produced different effects in another medicinal product. [17][58]
The Court also rejected the policy argument that refusing an SPC failed to compensate the Plaintiff for time spent obtaining Mavenclad’s authorisation. Any change to the balance struck by the Regulation was a matter for the EU legislature, not the Court. [20][59]
Finally, the Court found Santen sufficiently clear and saw no basis for a preliminary reference to the CJEU. The Plaintiff’s concerns related to the policy consequences of the Regulation rather than uncertainty about its interpretation. [11]
Holding and Implications
APPEAL REFUSED. The Defendant was correct to refuse the SPC because Mavenclad’s authorisation was not the first authorisation for cladribine as a medicinal product. [60][61]
The Plaintiff therefore did not obtain the requested SPC, and the proposed reference to the CJEU was unnecessary. The Court provisionally considered that the Defendant should receive its costs, subject to any final submissions and adjudication if required. [11][61]
No broader implications beyond the application of existing authority were identified; the decision applied the existing interpretation in Santen and did not state that a new precedent was being established. [20][51]