Divergent National Court Rulings on SPC Eligibility for Combination Products Signal Possible CJEU Reconsideration

The interpretation of Supplementary Protection Certificates (SPCs) for combination pharmaceutical products has become a contentious issue among national courts in Europe, following recent rulings by the Court of Justice of the European Union (CJEU). The core question centers on whether data supporting the combination product must be present in the basic patent application to satisfy the CJEU’s test for SPC eligibility under Article 3(a) of Regulation (EC) No 469/2009.

Pharmaceutical patent applications often include information on potential combination products, especially those sharing a similar mode of action with the claimed product. However, because research into combination therapies typically occurs later in development, supporting data for such combinations may not be available at the time of the initial patent filing. Applicants frequently include mechanistic or scientific rationale statements to support claims to future combinations, despite lacking empirical data.

Article 3(a) of the EU SPC Regulation mandates that a product must be "protected by a basic patent" in force to qualify for SPC protection. The precise meaning of "protected" has been litigated extensively, particularly for combination medicines.

In the landmark CJEU decision C-121/17 (Teva v Gilead), the Court established a two-part test for combination products to be considered protected by the basic patent: (1) the combination product must "fall under the invention" of the patent, and (2) each component must be "specifically identifiable" from the patent information.

More recently, in the combined cases C-119/22 and C-149/22 decided at the end of 2024, the CJEU reaffirmed that the assessment of whether a combination product "falls under the invention" (part (1) of the Teva test) is always necessary, regardless of whether the combination is expressly claimed (part (2)). This ruling clarified earlier uncertainty caused by case C-650/17 (Royalty Pharma), which had cast doubt on the necessity of part (1).

Despite this clarification, the Court did not specify the evidentiary standard required within the basic patent to satisfy part (1). In particular, it remained unclear whether the patent specification must contain empirical data demonstrating the combination’s effects compared to individual components, or if a mechanistic statement without supporting data would suffice.

This ambiguity has led to divergent national court decisions in 2025. In France and Austria, courts reviewed SPC applications for Odefsey®, a combination product comprising rilpivirine hydrochloride, emtricitabine, and tenofovir alafenamide. The basic patent (EP 1632232B3), as amended, claimed solid pharmaceutical compositions including rilpivirine hydrochloride and combinations with other antiretroviral agents, explicitly naming emtricitabine and tenofovir.

Although the patent contained no supporting data for specific combinations, it included a detailed statement describing the expected synergistic effects of combining compounds targeting different stages of the HIV life cycle. The statement highlighted potential benefits such as enhanced efficacy, reduced dosage, minimized side effects, and lowered resistance risk.

Initially, the French and Austrian Patent Offices refused the SPCs, finding that neither part (1) nor part (2) of the Teva test was met. However, on appeal, both countries’ courts overturned these refusals, ruling that the patent’s mechanistic rationale was sufficient to meet both parts of the test. The courts concluded that the basic patent envisaged a synergistic effect of the combination, and the absence of empirical data was not determinative.

Conversely, in Sweden, the Court considered an SPC for Xigduo®, a combination of dapagliflozin and metformin. The basic patent (EP 1506211B1) claimed dapagliflozin and its combinations with other antidiabetic agents, specifically mentioning metformin.

Similar to the Odefsey® case, the patent lacked supporting data for the combination but included a statement asserting a belief that combining dapagliflozin with other antidiabetic agents yields superior antihyperglycemic effects beyond additive results.

The Swedish Patent Office initially refused the SPC, and following the CJEU’s 2024 decision, the Swedish Appeal Court dismissed the applicant’s appeal. The court found that while part (2) of the Teva test was satisfied, part (1) was not. It regarded the patent’s statement as a mere assumption unsupported by data, insufficient to demonstrate that the combination product fell under the invention.

The contrasting outcomes between the French and Austrian courts and the Swedish court may hinge on the relative specificity and mechanistic detail of the patent statements. The rilpivirine patent provided a more concrete rationale for synergy and safety benefits, whereas the dapagliflozin patent offered a shorter, less substantiated assertion.

These conflicting decisions underscore the ongoing uncertainty in interpreting the evidentiary requirements for SPC eligibility of combination products under Article 3(a). The pharmaceutical industry faces potential challenges in securing SPC protection for combination therapies when basic patents lack supporting data.

Given this divergence, a further referral to the CJEU appears likely to clarify whether data must be present in the basic patent specification to satisfy part (1) of the Teva test. Should the Court adopt a stricter standard, mechanistic explanations alone may prove insufficient, complicating SPC filings based on patents without empirical support.

In the interim, patent applicants are advised to include relevant supporting data for combination products whenever possible. Such data need not be full clinical trial results; in vitro or preclinical evidence demonstrating the combination’s effect may suffice to bolster future SPC applications.