Introduction

The case of Merck Serono SA v Comptroller-General of Patents, Designs, and Trade Marks ([2025] EWCA Civ 45) adjudicated by the England and Wales Court of Appeal (Civil Division) on January 28, 2025, centers on Merck's application for a Supplementary Protection Certificate (SPC) for its pharmaceutical product, cladribine. The core issue revolves around the compatibility of this application with existing SPC regulations, particularly in light of earlier marketing authorizations and recent interpretations by the Court of Justice of the European Union (CJEU) in cases like Neurim Pharmaceuticals and Santen SAS. The parties involved include Merck Serono SA as the appellant and the Comptroller-General of Patents, Designs, and Trade Marks as the respondent.

Summary of the Judgment

Lord Justice Birss dismissed Merck's appeal, upholding the Comptroller's refusal of the SPC application. The refusal was grounded in the existence of prior marketing authorizations for cladribine, which did not satisfy the criteria under Article 3(d) of Regulation (EC) No. 469/2009. Merck's attempt to argue for a departure from the CJEU's decision in Santen, which overruled Neurim, was unsuccessful. The court emphasized adherence to retained EU law post-Brexit and rejected Merck's assertions that the teleological approach of Neurim should prevail. Consequently, the appeal was dismissed, reaffirming the restrictive interpretation of SPC eligibility in similar contexts.

Analysis

Precedents Cited

The judgment extensively references key CJEU cases that have shaped the interpretation of SPC regulations:

• Pharmacia Italia SpA C-31/03 (2004): Established that prior marketing authorizations for different uses of the same active ingredient can bar SPC applications.
• MIT C-431/04 (2006): Clarified the definition of "product" in SPC terms, excluding combinations where not all components are active ingredients.
• Yissum C-202/05 (2007): Reinforced the narrow interpretation of "product," emphasizing that intended use does not alter the active ingredient definition.
• Neurim Pharmaceuticals C-130/11 (2012): Temporarily shifted the interpretation to allow SPCs based on new therapeutic uses, invoking a teleological approach.
• Newron Pharmaceuticals v The Comptroller [2024]: Applied Santen to clarify that it overruled Neurim, maintaining a restrictive stance on SPC eligibility.
• Santen C-673/18 (2020): Overruled Neurim, reaffirming the narrow interpretation of SPC regulations and rejecting teleological flexibility.

Additionally, the judgment refers to domestic precedents and statutory instruments governing the application of retained EU law post-Brexit, such as the European Union (Withdrawal) Act 2018.

Legal Reasoning

The court's legal reasoning hinges on the interpretation of Article 3(d) of Regulation (EC) No. 469/2009, which mandates that an SPC cannot be granted if there exists an earlier marketing authorization for the same product, regardless of the intended therapeutic use. The appellant argued for a departure from Santen, advocating that the teleological approach of Neurim better serves the objectives of encouraging pharmaceutical innovation. However, the court emphasized the importance of legal certainty and coherence, especially post-Brexit, where retained EU law continues to bind domestic courts.

The court also analyzed the legislative framework, highlighting that departures from retained EU case law require substantial justification, particularly when such departures could lead to legal uncertainty or undermine the regulatory framework established by the CJEU.

Impact

This judgment reinforces the restrictive interpretation of SPC eligibility, limiting the scope for SPC applications based on new therapeutic uses of existing active ingredients. It underscores the supremacy of retained EU law in the UK post-Brexit and sets a precedent for future cases where applicants may seek to diverge from established CJEU interpretations. The decision may deter pharmaceutical companies from pursuing SPCs in similar contexts, thereby affecting strategies around patent extensions and market exclusivity.

Complex Concepts Simplified

Supplementary Protection Certificate (SPC)

An SPC is a legal mechanism that extends the protection of a medicinal product's patent to compensate for the time taken to obtain regulatory approval. It effectively prolongs the patent term to allow the company to recoup its investment in drug development.

Article 3(d) of Regulation (EC) No. 469/2009

This article stipulates conditions under which an SPC can be granted, including the requirement that the product must not have previously received a marketing authorization for the same active ingredient, even if for a different therapeutic use.

Teleological Approach

A method of statutory interpretation that focuses on the purpose and objectives of the law, rather than just the literal text. In this context, it refers to considering the broader goals of encouraging pharmaceutical innovation when interpreting SPC regulations.

Per Incuriam

A Latin term meaning "through lack of care," used in legal contexts to indicate that a court decision was made in ignorance of a relevant law or precedent, thereby potentially invalidating the decision.

Conclusion

The Court of Appeal's decision in Merck Serono SA v Comptroller-General of Patents, Designs, and Trade Marks solidifies the United Kingdom's adherence to a restrictive interpretation of SPC regulations, aligning with the CJEU's rulings post-Santen. By dismissing Merck's appeal, the court underscores the primacy of retained EU law and the importance of legal certainty in the pharmaceutical sector. This judgment limits the avenues for SPC extensions based on new therapeutic uses of existing drugs, potentially impacting future pharmaceutical innovations and the strategies companies employ to protect their intellectual property.

The case exemplifies the complexities introduced by Brexit in the interplay between domestic and EU law, particularly in specialized areas like patent protection for pharmaceuticals. It also highlights the judiciary's cautious approach to departing from established precedents, ensuring that regulatory frameworks remain coherent and predictable.