Court of Appeal Defines Strict Interpretation of Product in SPC Regulation for Medicinal Products

Introduction

In the case of Newron Pharmaceuticals SpA v The Comptroller General of Patents, Trademarks and Designs before the Court of Appeal, significant legal questions were examined concerning the interpretation of “product” under the Regulation (EC) No. 469/2009, which pertains to supplementary protection certificates (SPCs) for medicinal products. This case highlights the complexities involved in patent law, particularly when it comes to the pharmaceutical industry and the extension of patent protection through SPCs.

Key Facts

The case revolves around a treatment for Parkinson’s disease using safinamide under the brand name Xadago. An SPC was sought by Newron Pharmaceuticals on the basis of a patent (EP (UK) 1 613 296) and a marketing authorisation by the European Commission. The marketing authorisation identified the medicinal product as Xadago (safinamide) but specified its use as an add-on therapy with Levodopa, potentially in combination with other Parkinson’s disease medicines, including Peripheral Decarboxylase Inhibitors (PDI).

Legal Principals

A pivotal issue in this case was the definition of the term “product” as stipulated in Article 1(b) of the SPC Regulation. This term is defined as the active ingredient or combination of active ingredients of a medicinal product. To qualify for an SPC, various conditions listed in Article 3 must be satisfied, including that the product is protected by a basic patent in force (Article 3(a)); and that a valid authorisation to place the product on the market as a medicinal product has been granted (Article 3(b)).

Central to the court’s analysis was whether references to the therapeutic use in the marketing authorisation could influence the definition of “product.” The court referred to several CJEU cases including C-31/03 Pharmacia Italia SpA, C-431/04 MIT, and C-673/18 Santen which established that the “product” is strictly the active ingredient itself, and not its formulation or intended use.

However, the court also noted the change of position by the CJEU in C-130/11 Neurim Pharmaceuticals that allowed the therapeutic use to influence the product definition. Despite this, the court recognized that later in C-673/18 Santen, the CJEU reverted to the strict interpretation of “product,” not taking into account the therapeutic use.

The court equally considered domestic decisions like Yeda v Comptroller [2010] RPC 29, which handled similar issues, and endorsed the approach that the intended use does not alter the identification of the product itself.

Outcomes

Applying these principles, it was concluded that the marketing authorisation did not authorise the combination of safinamide with Levodopa and PDI to be placed on the market as a medicinal product, but only safinamide (Xadago) as a single ingredient. Hence, the marketing authorisation and patent did not match for the purposes of granting an SPC per Article 3(b) of the Regulation.

The court further deliberated on an additional but tangential ground related to whether PDI could be considered an active ingredient and part of the authorised combination. The court found that since safinamide alone was the product authorised, and that product did not include Levodopa or PDI, this second ground was moot.

Conclusion

The Court of Appeal’s decision in Newron Pharmaceuticals SpA v The Comptroller General of Patents, Trademarks and Designs underscores the interpretive strictness to be applied to the term “product” within the SPC Regulation. It delineates a clear demarcation between the product as the active ingredient or combination of active ingredients and its intended use, which the court determined does not influence the definition. The case reaffirms the legal principle that, for purposes of SPC eligibility, it is the product as authorised to be placed on the market that must directly relate to the product as protected by the relevant patent, not the therapeutic application or use of the product. This judgment has a significant impact on the analysis of future applications for SPCs by clarifying that the marketing authorisation must authorise the exact product, as defined by its active ingredients, for which the SPC protection is sought.