Introduction

In the realm of intellectual property, few decisions resonate as profoundly as the Court of Appeal's ruling in Merck Serono S.A. v Comptroller-General of Patents, Designs and Trade Marks, ([2025] EWCA Civ 45). This case, not only pivotal for its implications on Supplementary Protection Certificates (SPCs), also serves as a touchstone for the interpretation of retained EU law in the post-Brexit legal landscape. As the dust settles on this significant ruling, it's essential to explore its background, the legal arguments presented, the court's reasoning, and the implications for future cases. At the core of this case lies Merck Serono S.A., a pharmaceutical giant. Merck sought SPC protection for cladribine, an active ingredient used in treating multiple sclerosis, following the approval of its product MAVENCLAD in 2017. This was not Merck’s first interaction with cladribine; the ingredient had previously been authorized for other indications under different marketing authorizations, namely LEUSTAT (1995) and LETAK (2004), which were aimed at treating hairy cell leukaemia. An SPC is essential for patent holders as it extends patent protection for medicinal products in the EU for up to five additional years, compensating for time spent in regulatory procedures. In 2018, when Merck applied for an SPC, the UK's Intellectual Property Office (IPO) turned down their application, citing Article 3(d) of the SPC Regulation, which holds that a marketing authorization for a new therapeutic use does not qualify as the “first authorization” when an earlier authorization for the same active ingredient exists.

The Procedural Journey

The case made its way through various layers of the UK judiciary. Initially rejected by the IPO under Comptroller’s Hearing Officer, Deputy Director, Mary Taylor, this decision was upheld by the Patents Court, underscoring the challenges Merck faced. The court concluded that the existing earlier marketing authorizations stood in the way of granting a SPC for the new therapeutic use of cladribine, raising questions about the balance between innovation in the pharmaceutical sector and existing legal frameworks. In its appeal, Merck raised critical issues, particularly questioning whether the Court of Appeal could depart from the precedent set by the Court of Justice of the European Union (CJEU) in Santen SAS v Directeur général de l’Institut national de la propriété industrielle, C-673/18, given the context of the UK’s post-Brexit legal framework, as outlined in the EU (Withdrawal) Act 2018.

Two key issues emerged during the appeal process:

·       Departure from Santen: Can the Court of Appeal diverge from the conclusions established by the CJEU, particularly in light of Newron Pharmaceuticals S.p.A. v The Comptroller General of Patents, Trademarks and Designs [2024] EWCA Civ 128, which presents a binding interpretation of EU law in the UK?

·       Validity of Neurim Precedents: If deviation were permissible, should the Court apply the teleological approach from Neurim Pharmaceuticals v Comptroller C-130/11 [2012] RPC 23, which would allow SPCs for new therapeutic uses despite prior marketing authorizations?

These questions were not just legal technicalities; they spoke directly to the heart of intellectual property protection for pharmaceuticals and the legal certainty required for companies navigating this complex regulatory landscape.

The Court's Reasoning and Decision

In a unanimous decision delivered by Lord Justice Birss, with agreement from Lords Justices Arnold and Lewison, the Court of Appeal ultimately ruled against Merck. The judges established that the existing post-Brexit precedents, particularly Newron, are binding and reaffirm the CJEU’s Santen decision as applicable. The court determined that Article 3(d) fundamentally assesses the “first authorization” at the level of the active ingredient product. Subsequently, even if the Court possessed the authority to deviate from Santen, the majority opinion would favour maintaining the existing precedent due to Santen providing clarity and coherence to the SPC regime.  

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Core Legal Principles Established

The ruling elucidated several core principles surrounding the SPC landscape:

·       “First Authorisation” is Defined Broadly: When determining a “first authorisation”, the assessment is grounded at the active ingredient level. Therefore, a later marketing authorization for a new therapeutic use will not qualify as the first if an earlier marketing authorization for the same active ingredient already exists.

·       Binding Precedents: The Court of Appeal is required by post-transition decisions, particularly those applying retained EU law, to adhere to existing authoritative legal interpretations. This binding nature limits judicial flexibility, an essential point of contention in Merck's appeal.

·       Legislation Over Judicial Interpretation: The court highlighted the systemic uncertainty that could arise from applying a more lenient approach to SPC applications. It emphasized that any significant changes to accommodate second medical use SPCs should stem from legislative action rather than judicial reinterpretation.

Implications and Future Considerations

The outcome for Merck was a significant blow; their SPC application for cladribine was refused, solidifying the notion that earlier marketing authorizations can preclude new therapeutic use applications under the SPC regulations. This ruling doesn't just affect Merck; it sends a clear message to the pharmaceutical industry regarding the interpretation and enforcement of SPCs within the UK’s legal system. The decision also reinforces the notion of stability and predictability in intellectual property law post-Brexit. The reliance on established CJEU precedents aims to avoid the uncertainties that could arise if courts were to reinterpret laws and frameworks in a more fragmented British legal context.

Conclusion

Merck Serono S.A. v Comptroller-General of Patents stands as a critical case in understanding the interaction between intellectual property law and EU law within the UK. The ruling illustrates the caution inherent in navigating the complexities of patent law, particularly concerning therapeutic innovations against a backdrop of previous authorizations. The precedent set not only clarifies the current legal landscape but also shapes how pharmaceutical companies approach patent applications in the future. With legislative frameworks sure to evolve, the landscape of intellectual property rights in pharmaceuticals will continue to be a focal point of legal discourse, underscoring the tension between fostering innovation and ensuring legal clarity. As we move forward, it will be crucial to monitor how subsequent cases build upon this ruling and whether legislative changes will arise to address any perceived gaps created by this ruling, particularly in the context of second medical use patents.