SPCs for Combination Products – Will CJEU need to look again?

Key takeaways

National courts have diverged on the interpretation of the EU Court of Justice’s latest decisions on SPCs for combination products – in particular on whether data in the application as filed are required for a combination product to meet the CJEU’s test of “falling under the invention” of the basic patent and be eligible for SPC protection in the EU.  A further referral to the CJEU appears necessary to provide clarification to the pharmaceutical industry.

Background – patenting combination products

When preparing the first patent application directed to a pharmaceutical product, information regarding potential combination products is often included, especially those with a similar mode of action to the claimed product.  However, as research into combination products typically takes place later in the research and development cycle, supporting data for combination products are not always available at the time this first application is filed.  In the absence of such data, a statement is often included in the application based on current scientific or mechanistic rationale on the expected efficacy of the combination in order to provide support to claims to future combinations.

SPC regulation and prior CJEU case law

Article 3(a) of the EU medicinal products SPC Regulation (469/2009) requires a product to be protected by a basic patent in force in order to be eligible for SPC protection.  However, what is meant by “protected” has been the subject of litigation in Europe for over a decade – particularly in relation to medicines which are a combination of active ingredients.

In its decision C-121/17 (Teva v Gilead), the CJEU ruled that a combination product was protected the by basic patent for the purposes of Article 3(a) if:

(1) it “falls under the invention covered by that patent”; and

(2) each component of the combination is “specifically identifiable” according to all the information in the basic patent.

Further to this, at the end of 2024 the CJEU decided the combined cases C-119/22 and C-149/22, which resulted from Europe-wide litigation on SPCs on combination products.  In this decision, the Court ruled that it is always necessary to assess whether a combination product “falls under the invention” of the basic patent to determine its eligibility for SPC protection under part (1) of the Teva test under Article 3(a).  This assessment must be made regardless of whether the combination product also meets part (2) of the test and is expressly mentioned in the claims of the patent.

The CJEU’s decision in the above case brought a degree of clarity, as previous decisions, in particular C-650/17 (Royalty Pharma) had called into question whether compliance with part (1) of the test was still necessary for a combination product to meet the requirements of Article 3(a).  However, in reaching its decision, the Court seemingly left open the question of what level of evidence needs to be present in the basic patent to demonstrate whether a combination product meets part (1) of the Teva test.  In particular, the CJEU decision was silent on whether data supporting the effects of the combination, compared with the mono-product(s), must be present in the specification for this part of the test to be met, or if a simple, unsupported statement in the specification regarding the effects of the combination would suffice.

Is a bare statement sufficient? France and Austria say yes …

The question of what level of supporting information is required to meet part (1) of the Teva test was considered in 2025 by national courts.  In France and Austria, the Courts considered SPCs for the approved combination product Odefsey®, containing a combination of the active ingredients rilpivirine hydrochloride, emtricitabine, and tenofovir alafenamide.  The basic patent (EP 1632232B3), as amended following central limitation, claimed a solid pharmaceutical composition comprising rilpivirine hydrochloride, as well as combinations with other anti-retroviral drugs, specifically reciting emtricitabine and tenofovir.

No supporting data for any particular combination were present in the basic patent.  However, the specification did include the following statement:

“By administering the compounds of the present invention with other anti-viral agents which target different events in the viral life cycle, the therapeutic effect of these compounds can be potentiated. Combination therapies as described above exert a synergistic effect in inhibiting HIV replication because each component of the combination acts on a different site of HIV replication. The use of such combinations may reduce the dosage of a given conventional anti-retroviral agent which would be required for a desired therapeutic or prophylactic effect as compared to when that agent is administered as a monotherapy. These combinations may reduce or eliminate the side effects of conventional single anti-retroviral therapy while not interfering with the anti-viral activity of the agents. These combinations reduce potential of resistance to single agent therapies, while minimizing any associated toxicity. These combinations may also increase the efficacy of the conventional agent without increasing the associated toxicity.”

The French and Austrian Patent Offices refused both SPCs, considering neither part (1) nor part (2) of the Teva test for compliance with Article 3(a) was met.  However, on appeal, the Courts of both countries overturned the Patent Office’s decisions, considering both parts of the test were met.  Both Courts ruled that the basic patent envisages a synergistic effect of the combination, and the lack of any supporting data for the combination in the basic patent was not considered relevant.

But Sweden says no…

• Meanwhile, in Sweden, the Court considered an SPC for the product Xigduo®, containing a combination of the active ingredients dapagliflozin and metformin. In this case, the basic patent (EP1506211B1) claimed dapagliflozin, as well as combinations with other antidiabetic agents generally, specifically reciting metformin as a possible combination partner.

• Once again, no supporting data for any particular combination were present in the basic patent. However, the specification did include the following statement:

“It is believed that the use of [dapagliflozin] in combination with 1, 2, 3 or more other antidiabetic agents produces antihyperglycemic results greater than that possible from each of these medicaments alone and greater than the combined additive antihyperglycemic effects produced by these medicaments.”

• The Swedish Patent Office initially refused the SPC application. However, following the CJEU’s decision in C-119/22 and C-149/22, the Swedish Appeal Court dismissed the Applicant’s appeal. The Appeal Court considered part (2) of the Teva test met, but not part (1).  Although the Court noted the above supporting statement in the specification, they considered it a mere assumption, not substantiated by any data in the specification.

Next steps and practice points

It is arguable that the statement in the rilpivirine basic patent provides a mechanistic rationale as to why combination products, especially those having a different mode of action to rilpivirine, would be expected to be effective and/or safer than the mono-product, and therefore provides the skilled person with a more concrete teaching compared with the shorter statement regarding combination products in the dapagliflozin basic patent.

Nevertheless, diverging decisions have now been reached by national courts on the eligibility of combination products for SPCs, even though neither mono-product basic patent contained any data to support the combination “falling under the invention” of the basic patent. In view of this, a further referral to the CJEU may be necessary to decide on whether data in the specification are required for part (1) of the Teva test to be met.  If the CJEU takes a stricter view on any referral, and a mechanistic explanation is deemed insufficient, it may be difficult to base combination SPCs on basic patents lacking supporting data in the specification.  We will continue to monitor the case law and provide updates if any referral is made.

We would advise including relevant supporting data in all applications claiming combinations of active ingredients if at all possible, to support future SPC filings directed to combinations.  This need not be full clinical trial data – in vitro or pre-clinical data may be sufficient provided it supports an effect of the combination.

If no supporting data are available at the time of filing the mono-product application, it may be best to omit combination language from this filing entirely, and instead reserve it for a separate filing specifically directed to combinations.  If possible, such a filing should be made before the mono-product application publishes, for two reasons. Firstly, under EPO practice, the earlier mono-product application would then be citable only for novelty against the later combination filing.  Secondly, this guards against the risk of competitors filing their own applications to combinations once the mono-product application publishes.  The HGF SPC team would be happy to advise on suitable filing strategies.

This article was prepared by Partner & European and UK Patent Attorney, Garreth Duncan.