Europe’s highest court to revisit the allowability of combination SPCs
How should Article 3(c) be applied to an SPC for a combo-product where the patent already supports an SPC for a mono-product?

A Finnish court has referred an important question to the CJEU, the highest court in the EU, asking whether a second SPC for a combination of active ingredients can validly be granted when a first SPC for one of the active ingredients alone has already been granted on the same patent. As combination SPCs are highly valuable additional rights, which may expire many years after the mono SPCs, the answer to the referred question could have a considerable impact on the filing and enforcement strategy of patentees.

The case considered by the Finnish Market Court concerned an SPC granted to Merck Sharp & Dohme Corp. (“MSD”) for the combination product sitagliptin and metformin (Janumet®), which is due to expire in April 2023. MSD has another granted SPC in Finland for the mono-product sitagliptin (Januvia®), which is due to expire in September 2022. Both SPCs are based on the same patent (EP1412357), which specifically claims sitagliptin, as well as a pharmaceutical composition comprising both sitagliptin and metformin.

Teva B.V. and Teva Finland Oy (“Teva”) challenged the validity of MSD’s combination SPC at the Finnish Market Court on the basis of various provisions of the SPC Regulation. In particular, Teva argued that the combination of sitagliptin and metformin was not protected by the basic patent contrary to Article 3(a) and, in view of the granted mono-product SPC for sitagliptin alone, had already been the subject of an SPC contrary to Article 3(c).

Following the hearing, the Finnish Market Court announced that it intends to refer a question to the CJEU. The wording of the referral has not yet been finalised, but we understand that it will concern the interpretation of Article 3(c) based on the note published by the Finnish firm representing MSD.

This new CJEU reference is the latest in a line of references relating to the allowability of combination SPCs – a topic which has caused headaches for courts, patent offices and practitioners alike over the years. Questions on whether Articles 3(a) and (c) preclude the grant of a combination SPC when there is an earlier mono-product SPC on the same patent have previously been answered by the CJEU in decisions C‑443/12 (Actavis I) and C‑577/13 (Actavis II). In these decisions the CJEU decided that Articles 3(a) and/or (c) of the SPC Regulation preclude the grant of a combination SPC in situations where the “core inventive advance” or “subject-matter of the invention” of the patent relates to one novel active ingredient, but not to a combination of that active ingredient with a known active ingredient.

More recently, however, in decisions C‑121/17 (Teva) and C‑650/17 (Royalty Pharma), the CJEU has firmly rejected the “core inventive advance” test as part of the assessment of Article 3(a). Instead, Teva and Royalty Pharma establish that a combination product is protected by a patent if the combination is expressly mentioned in the claims of the patent, or if the combination falls under the invention covered by the patent and if each component of the combination is specifically identifiable.

While Teva and Royalty Pharma provided much-needed clarity in relation to Article 3(a), it is unclear how to rationalise these decisions with the earlier case law.

Arguably, a tension now exists as to how “the product” should be interpreted when assessing whether a combination SPC meets the requirements of Articles 3(a) and 3(c). While it is clear from Teva and Royalty Pharma that both components of a combination need to be considered part of the product, this seems to be at odds with the conclusion in Actavis I and Actavis II that an earlier SPC for a mono-product relates to the same product as a combination SPC. Moreover, it is unclear how relevant Actavis I and Actavis II remain given that these decisions rely on the “core inventive advance” test which was firmly rejected in Teva and Royalty Pharma when assessing Article 3(a).

In view of the above inconsistencies in the CJEU’s decisions, national courts of EU member states have reached conflicting decisions when determining the validity of combination SPCs. For example, in parallel litigation in Germany, the German Federal Patent Court recently invalidated MSD’s combination SPC for sitagliptin and metformin for non-compliance with Article 3(c). In a separate series of cases relating to combination products, the French and Irish courts decided that MSD’s combination SPC for ezetimibe and simvastatin (based on the same patent as a mono-product SPC for ezetimibe alone) contravenes Articles 3(a) and (c). By contrast, the Portuguese and Belgian courts decided that the combination SPC for ezetimibe and simvastatin meets the requirements of Articles 3(a) and (c).

Clearly, national courts are struggling to reach a uniform position on the validity of combination SPCs under Article 3(a) and 3(c). We hope that the Finnish Market Court’s reference will provide some much-needed clarity on this point.