Introduction

In the landmark case of Newron Pharmaceuticals SPA v The Comptroller General of Patents, Trademarks And Designs ([2024] EWCA Civ 128), the England and Wales Court of Appeal addressed a pivotal question regarding the interpretation of the term "product" under Article 3(b) of Regulation (EC) No. 469/2009. This regulation pertains to Supplementary Protection Certificates (SPCs) for medicinal products, serving as an extension to compensate for the time lost during the authorization process of a pharmaceutical product. The core dispute involved whether the SPC for safinamide (marketed as Xadago) should cover safinamide alone or a combination of safinamide with levodopa and Peripheral Decarboxylase Inhibitor (PDI) in the treatment of Parkinson's disease.

Summary of the Judgment

The appellant, Newron Pharmaceuticals, challenged the refusal to grant an SPC for Xadago-safinamide, arguing that the marketing authorization should cover the combination of safinamide, levodopa, and PDI, as outlined in their patent (EP (UK) 1 613 296). However, the Hearing Officer and the High Court upheld the decision that the marketing authorization only covered safinamide as a standalone medicinal product, not the combination. The Court of Appeal affirmed this interpretation, emphasizing that the authorized product under the marketing authorization was safinamide alone. Consequently, the appeal was dismissed, maintaining that the combination of safinamide with levodopa and PDI did not qualify as the "product" for SPC purposes under the regulation.

Analysis

Precedents Cited

The judgment extensively referenced prior European Court of Justice (CJEU) cases to delineate the boundaries of what constitutes a "product" under the SPC Regulation:

• Pharmacia Italia SpA (C-31/03) and Massachusetts Institute of Technology (C-431/04): Established that "product" refers strictly to the active ingredient, excluding formulations or intended uses.
• Yissum Research (C-202/05): Reinforced that the definition remains confined to the active substance, disregarding any formulation or therapeutic application.
• Neurim Pharmaceuticals (C-130/11): Introduced the notion that the intended use might influence the interpretation of "product," suggesting a more flexible approach.
• Santen (C-673/18): Reiterated the strict interpretation of "product," explicitly rejecting the influence of therapeutic applications on the definition.
• Yeda v Comptroller (2010 RPC 29): Illustrated the application of the strict definition in practice, emphasizing that the combination of active ingredients in the patent does not align with the marketing authorization.
• Medeva v Comptroller (C-322/10): Addressed similar issues in vaccine compositions but did not alter the established strict interpretation.

These precedents collectively underscored a consistent judicial stance that "product" should be interpreted narrowly, focusing solely on the active ingredient(s) without considering formulations, intended uses, or combinations unless explicitly authorized.

Legal Reasoning

Lord Justice Birss, delivering the judgment, meticulously dissected the regulatory language and the interplay between patent claims and marketing authorizations. He emphasized that under Article 3(b) of the SPC Regulation, the "product" must align precisely between the patent and the marketing authorization. The key points in the legal reasoning include:

• Definition Consistency: The term "product" is consistently defined across the relevant articles of the SPC Regulation and harmonized with marketing authorization definitions.
• Strict Interpretation: Drawing from CJEU precedents, the court maintained that "product" refers strictly to the active ingredient(s), excluding any additional components or intended therapeutic uses.
• Marketing Authorization Scope: The marketing authorization in question explicitly authorized safinamide alone ("Xadago") and did not encompass the combination with levodopa or PDI.
• Regulatory Scheme Simplicity: The SPC Regulation aims for a straightforward administrative process, which would be undermined by a nuanced, case-by-case balancing of product definitions.

Consequently, the court concluded that since the marketing authorization did not cover the combination of safinamide with levodopa and PDI, the SPC could not be granted for the combination, affirming that "product" in this context is limited to safinamide alone.

Impact

This judgment reinforces the strict interpretation of "product" within the SPC Regulation, providing clear guidance for future cases involving SPC applications for pharmaceutical combinations. The decision:

• Affirms Consistency: Ensures uniform application of the definition of "product" across cases, reducing ambiguity in SPC grants.
• Limits SPC Scope: Prevents pharmaceutical companies from obtaining SPCs for combinations unless explicitly authorized, thereby safeguarding the balance intended by the regulation between innovation incentives and generic market entry.
• Guides Patent Strategy: Influences how pharmaceutical patents are drafted and how companies approach marketing authorizations to align with SPC eligibility.
• Clarifies Regulatory Compliance: Provides clarity to regulatory bodies and patent offices on assessing SPC applications, streamlining the approval process.

Complex Concepts Simplified

Supplementary Protection Certificates (SPCs)

SPCs are legal tools that extend the protection of patented medicinal products. Since obtaining marketing authorization (a government approval confirming a drug's safety and efficacy) can take several years, SPCs compensate for this delay by extending the patent term by up to five years. This extension allows companies to recoup their investments in research and development.

Marketing Authorization

A marketing authorization is an official approval granted by regulatory bodies (like the European Commission) that allows a pharmaceutical company to market a drug within a specific jurisdiction. It details the medicinal product's composition, usage, dosage, and other critical information.

Active Ingredient vs. Combination Products

An active ingredient is the substance in a medicinal product that provides the intended therapeutic effect. A combination product includes two or more active ingredients intended to work together. The distinction is crucial in SPC applications because the definition of "product" affects the eligibility for patent extensions.

Peripheral Decarboxylase Inhibitor (PDI)

PDIs are compounds used in combination with levodopa to prevent its breakdown before it reaches the brain, enhancing its therapeutic effect in treating Parkinson's disease. In this case, PDI is part of the treatment regimen but is not considered part of the "product" for SPC purposes.

Conclusion

The Court of Appeal's decision in Newron Pharmaceuticals SPA v The Comptroller General of Patents, Trademarks And Designs serves as a definitive affirmation of the strict interpretation of "product" within the SPC Regulation. By delineating that "product" encompasses only the active ingredient expressly authorized for marketing, the court has provided clear boundaries for SPC eligibility. This ensures that the SPC system remains a balanced mechanism encouraging pharmaceutical innovation while preventing undue extensions that could impede generic competition. Stakeholders in the pharmaceutical industry must heed this ruling when strategizing patent applications and marketing authorizations to align with regulatory requirements and optimize patent term protections.