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Merck Serono SA v Comptroller-General of Patents, Designs, and Trade Marks (Rev1)
Factual and Procedural Background
This appeal concerns an application by the Appellant, Company A, for a supplementary protection certificate ("SPC") relating to a pharmaceutical product containing cladribine, based on a patent for the use of cladribine in treating multiple sclerosis. The application relied on a 2017 marketing authorisation for a medicinal product indicated for a specific form of multiple sclerosis. The application was refused because earlier marketing authorisations existed for products containing cladribine for different therapeutic uses, namely for hairy cell leukaemia, issued in 1995 and 2004 respectively, which engaged Article 3(d) of Regulation (EC) No. 469/2009.
The matter raised the legal question of the relationship between second medical use patents and the SPC regime, particularly in light of the Court of Justice of the European Union ("CJEU") judgment in Neurim Pharmaceuticals v Comptroller (C-130/11). The appeal was heard by the Comptroller’s Hearing Officer in 2023, who refused the application following the later CJEU decision in Santen (C-673/18), which overruled Neurim. The Appellant’s subsequent appeal to the Patents Court was dismissed, and the present appeal to the Court of Appeal challenges the correctness of the Santen decision and whether the Court of Appeal can depart from it.
Legal Issues Presented
- Whether the Court of Appeal can depart from the CJEU decision in Santen, given the binding effect of retained EU case law and the Court of Appeal’s own prior decision in Newron Pharmaceuticals v The Comptroller applying Santen.
- Whether the teleological interpretation of Article 3(d) of Regulation (EC) No. 469/2009, as established in Neurim, should be preferred over the literal interpretation in Santen, thereby allowing SPCs for second medical uses despite earlier marketing authorisations for the same active ingredient.
Arguments of the Parties
Appellant's Arguments
- The teleological approach adopted in Neurim is correct and aligns with the objectives of the SPC Regulation to encourage pharmaceutical research, particularly for second medical uses of known active ingredients.
- There is inconsistency and lack of cogency in the CJEU case law concerning Article 3(d), which justifies departing from Santen.
- The literal and restrictive interpretation in Santen is regressive and offers no practical benefit to the Patent Office or the public.
- The UK Court of Appeal should depart from Santen despite its prior decision in Newron, which followed Santen.
Respondent's Arguments
- The Court of Appeal is bound by the decision in Newron, which applies Santen and forms part of the binding retained EU case law under the European Union (Withdrawal) Act 2018 and related regulations.
- The teleological approach in Neurim created legal uncertainty and inconsistency, whereas Santen restored coherence to the SPC regime.
- The statutory framework and precedent require adherence to Santen, and the Court of Appeal lacks jurisdiction to depart from it in this case.
- The policy objectives of the SPC Regulation include balancing innovation incentives with public health and legal certainty, which support the literal interpretation in Santen.
Table of Precedents Cited
| Precedent | Rule or Principle Cited For | Application by the Court |
|---|---|---|
| Neurim Pharmaceuticals v Comptroller (C-130/11) | Allowed teleological interpretation of Article 3(d) permitting SPCs for second medical uses despite earlier marketing authorisations for the same active ingredient. | Discussed as the earlier CJEU approach, overturned by Santen, and the subject of the appeal seeking to depart from Santen. |
| Santen SAS v Directeur général de l'Institut national de la propriété industrielle (C-673/18) | Held that a marketing authorisation for a new therapeutic application of an active ingredient is not the first marketing authorisation if an earlier authorisation exists for a different therapeutic use; overruled Neurim. | Applied as binding retained EU law; the Court declined to depart from this decision. |
| Newron Pharmaceuticals S.p.A. v The Comptroller General [2024] EWCA Civ 128 | Applied Santen and confirmed it as binding precedent on the Court of Appeal regarding SPC interpretation. | Held to be binding on the Court of Appeal; departure from Santen not open. |
| Pharmacia Italia SpA (C-31/03) | Earlier marketing authorisation for the same active ingredient precludes grant of SPC for a later authorisation regardless of therapeutic use. | Reviewed as part of the consistent earlier CJEU case law prior to Neurim. |
| Yissum Research and Development Company of the Hebrew University of Jerusalem v Comptroller-General of Patents (C-202/05) | Confirmed that the intended use is not relevant when considering the product for SPC purposes. | Part of the CJEU line of cases overturned by Neurim and later restored by Santen. |
| MIT (Massachusetts Institute of Technology) (C-431/04) | Defined "product" narrowly, excluding carriers or non-active ingredients from SPC protection. | Supported a restrictive interpretation of Article 3(d) consistent with Santen. |
| Abraxis Bioscience LLC v Comptroller-General [2017] EWHC 14 (Pat) | Discussed difficulties arising from Neurim and reinforced the need for clarity and coherence in SPC law. | Used to illustrate challenges caused by Neurim and support the reasoning in Santen. |
| Industrial Cleaning Equipment (Southampton) Ltd v Intelligent Cleaning Equipment Holdings Co Ltd [2023] EWCA Civ 1451 | Explained the binding nature of retained EU case law and the limits on courts' power to depart from it post-Brexit. | Applied to confirm that Newron and Santen bind the Court of Appeal. |
| Young v Bristol Aeroplane Co Ltd [1944] KB 718 | Sets out exceptions to the rule that the Court of Appeal is bound by its own previous decisions. | Considered in determining whether Newron could be departed from; court concluded it could not. |
| Austin v Southwark London Borough Council [2011] 1 AC 355 | Confirms the Supreme Court's power to depart from its own previous decisions under the Practice Statement. | Referenced in the context of the Practice Statement and departure from precedent principles. |
| Warner v TuneIn Radio [2021] EWCA Civ 441 | Discusses the application of the Practice Statement in departing from retained EU case law. | Used to explain the caution required in departing from precedent. |
| JTI Polska sp z oo v Jakubowski [2024] AC 621 | Reiterates that a previous statutory interpretation decision will not be departed from if it reflects a tenable view. | Supports the conclusion that Santen is tenable and should not be departed from. |
Court's Reasoning and Analysis
The court began by examining whether it was legally permissible for the Court of Appeal to depart from the CJEU decision in Santen, which had been applied in the Court of Appeal’s earlier decision in Newron. Under the European Union (Withdrawal) Act 2018 and related statutory instruments, retained (now assimilated) EU case law remains binding domestic law. The Court of Appeal is bound by its own prior decisions unless one of the limited exceptions in Young v Bristol Aeroplane applies. The court found that none of these exceptions applied to Newron, which expressly applied and upheld Santen.
The court then considered the substantive arguments on whether Santen was wrongly decided and whether the teleological approach of Neurim should be preferred. It reviewed the history of CJEU case law on SPCs for second medical uses, noting that earlier CJEU decisions (such as Pharmacia Italia, MIT, and Yissum) consistently rejected the relevance of the therapeutic use in defining the product for SPC purposes. Neurim represented a departure from this consistent line, adopting a teleological interpretation to encourage pharmaceutical innovation, but this led to legal uncertainty and conflicting interpretations.
The court analysed the policy objectives of the SPC Regulation, which include balancing incentives for innovation against public health and legal certainty. It found that Santen restored coherence by affirming a literal interpretation of Article 3(d), rejecting the teleological approach of Neurim. The court noted that the teleological approach could not be reconciled with other CJEU decisions and created administrative difficulties for patent offices.
Applying the principles from the Practice Statement (Judicial Precedent) and relevant case law on departure from precedent, the court concluded that even if it had the power to depart from Santen, it would not do so because Santen represents a tenable and coherent interpretation of the law. The court emphasized the importance of certainty and the absence of compelling reasons to depart from established binding precedent.
Holding and Implications
The Court of Appeal DISMISSED the appeal.
The court held that it is bound by its prior decision in Newron, which applied and affirmed the binding nature of the CJEU decision in Santen. The court found no basis to depart from Santen, either on jurisdictional grounds or on the merits. Consequently, the application for the SPC based on the second medical use patent was properly refused because earlier marketing authorisations for the same active ingredient precluded the grant under Article 3(d) of the SPC Regulation.
This decision maintains the legal certainty and coherence of the SPC regime in the United Kingdom and confirms that teleological interpretations, such as that in Neurim, are no longer applicable. No new precedent altering the interpretation of the SPC Regulation was established; the court reaffirmed adherence to the existing binding case law.
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