{"id":9004111222144683,"date":"2026-08-05T11:38:04","date_gmt":"2026-08-05T10:38:04","guid":{"rendered":"https:\/\/www.hgf.com\/?p=9004111222144683"},"modified":"2026-08-05T11:39:37","modified_gmt":"2026-08-05T10:39:37","slug":"spcs-for-combination-products-will-cjeu-need-to-look-again","status":"publish","type":"post","link":"https:\/\/www.hgf.com\/fr\/knowledge-hub\/spcs-for-combination-products-will-cjeu-need-to-look-again\/","title":{"rendered":"SPCs for Combination Products \u2013 Will CJEU need to look again?"},"content":{"rendered":"

Key takeaways<\/strong><\/p>\n

National courts have diverged on the interpretation of the EU Court of Justice\u2019s latest decisions on SPCs for combination products \u2013 in particular on whether data in the application as filed are required for a combination product to meet the CJEU\u2019s test of \u201cfalling under the invention\u201d of the basic patent and be eligible for SPC protection in the EU.\u00a0 A further referral to the CJEU appears necessary to provide clarification to the pharmaceutical industry.<\/p>\n

Background \u2013 patenting combination products<\/strong><\/p>\n

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.\u00a0 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. \u00a0In 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.<\/p>\n

SPC regulation and prior CJEU case law<\/strong><\/p>\n

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.\u00a0 However, what is meant by \u201cprotected\u201d<\/em> has been the subject of litigation in Europe for over a decade \u2013 particularly in relation to medicines which are a combination of active ingredients.<\/p>\n

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

(1) it \u201cfalls under the invention covered by that patent\u201d<\/em>; and<\/p>\n

(2) each component of the combination is \u201cspecifically identifiable\u201d<\/em> according to all the information in the basic patent.<\/p>\n

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. \u00a0In this decision, the Court ruled that it is always necessary to assess whether a combination product \u201cfalls under the invention\u201d<\/em> of the basic patent to determine its eligibility for SPC protection under part (1) of the Teva<\/em> test under Article 3(a).\u00a0 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.<\/p>\n

The CJEU\u2019s decision in the above case brought a degree of clarity, as previous decisions, in particular C-650\/17 (Royalty Pharma<\/em>) 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).\u00a0 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<\/em> test.\u00a0 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.<\/p>\n

Is a bare statement sufficient? France and Austria say yes \u2026<\/strong><\/p>\n

The question of what level of supporting information is required to meet part (1) of the Teva<\/em> test was considered in 2025 by national courts.\u00a0 In France and Austria, the Courts considered SPCs for the approved combination product Odefsey\u00ae, containing a combination of the active ingredients rilpivirine hydrochloride, emtricitabine, and tenofovir alafenamide.\u00a0 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.<\/p>\n

No supporting data for any particular combination were present in the basic patent.\u00a0 However, the specification did include the following statement:<\/p>\n

\u201cBy 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.\u201d<\/em><\/p>\n

The French and Austrian Patent Offices refused both SPCs, considering neither part (1) nor part (2) of the Teva<\/em> test for compliance with Article 3(a) was met. \u00a0However, on appeal, the Courts of both countries overturned the Patent Office\u2019s decisions, considering both parts of the test were met.\u00a0 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.<\/p>\n

But Sweden says no…<\/strong><\/p>\n