The SPC alphabet: Are combination product SPCs precluded by Article 3(a), (c) and/or (d)?

A new referral to the CJEU from the Finish Market Court seeks clarification on the interpretation of Article 3(c) of the SPC Regulation with respect to combination products. It might be doubted whether the referral will have much meaningful impact, given the major hurdles to combination product SPC protection represented by Articles 3(a) and (d). However, recent decisions from the national courts on Articles 3(a) and (d) suggest that the interpretation of even these sub-provisions may not yet be settled, despite what many took to be relatively clear direction from the CJEU in Santen (C-673/18) and Royalty Pharma (C-650/17). 

Are combination products ruled out from SPC protection under Article 3(d)?

Article 3 of the SPC Regulation is provided below (*) for reference. Article 3(d) states that an SPC must be based on "the first marketing authorisation" for the product. In Santen (C-673/18), the CJEU interpreted Article 3(d) as ruling out the possibility of an SPC for a product based on a second marketing authorisation of any form, regardless of whether the second authorization was for a new formulation, route of administration or indication. 

Given that many combination products will be based on monotherapies that have been previously approved, it was thought that the courts would interpret Santen as ruling out SPCs for the majority of combination therapies. However, in a decision of the Irish Court of Appeal in Merck v Clonmel [2021] IECA 54, an SPC for a combination product INEGY (ezetimibe and simvastatin) was found not to contravene Article 3(d). This was despite there having been a previous approval for one of the active ingredients, ezetimibe (EZETROL), used in the combination. The decision therefore raised questions over the applicability of Santen and Article 3(d) to combination products (IPKat). However, the SPC was nonetheless found invalid under Article 3(a).

In Finland

Are combination products ruled out from SPC protection under Article 3(a)?

Article 3(a) of the SPC Regulation states that the approved product for which an SPC is sought must be protected by the patent. In Royalty Pharma (C-650/17), the CJEU interpreted Article 3(a) as requiring the product to be "specifically identifiable" in the patent. Royalty Pharma was a contrast to previous CJEU decisions that had focused on whether a product could be said to be covered by the "core inventive concept" of the patent. 

In the INERGY Irish SPC case, the patent only related to one of the drugs in the combination therapy, ezetimibe. The patent (EP 0 720 599) did not specifically call out the possibility of combining ezetimibe with the second drug, simvastatin. According to the Irish Court of Appeal, the combination therapy could therefore not be said to be "specifically identifiable" in the patent. This was despite the combination being explicitly provided for in the dependent claims of the patent. 

For the Irish Court of Appeal, the mention of the combination in the dependent claims was necessary but not sufficient to satisfy the condition that the combination was protected by the patent. Instead the Irish Court of Appeal found that the combination did not fall under the invention of the patent, where the invention of the patent related to ezetimibe and not its use in combination with simvastatin.  Therefore, whilst the Irish court found the INEGY SPC valid under Article 3(d), the SPC was nonetheless found invalid under Article 3(a) (IPKat). The Paris Court of Appeal came to the same conclusion with respect to the corresponding French SPC (SPC Blog).

In contrast to the Irish decision, the Portuguese and Belgian courts both found the combination SPC for INEGY valid under Article 3(a). In the Belgian case, the fact that the combination was protected by the basic patent was not even contested (IPKat).

There is consequently disagreement between the National Courts over whether Royalty Pharma rules out SPCs for combination products based on a patent directed to the invention of only one active ingredient in the combination, where the combination is nonetheless specified in the dependent claims. Particularly, there still appears to be disagreement as to how much the "core invention" of the patent should be taken into account, as opposed to the subject matter of the claims. 

Are combination products ruled out from SPC protection under Article 3(c)?

Article 3(c) of the SPC Regulation states that the product for which an SPC is granted must not have already been the subject of an SPC. The most recent decisions we have from the CJEU on Article 3(c) are Actavis I (C-443/12) and Actavis II (C-577/13) (IPKat). In these decisions, the CJEU found that an SPC for combination products are not permitted by both Article 3(c) and Article 3(a) where the "core inventive concept" of the patent only relates to one of the active ingredients in a monotherapy. 

As we have seen, however, the CJEU has since moved away from the "core inventive concept" requirement with respect to Article 3(a). Particularly, in Royalty Pharma (C-650/17) the CJEU changed its interpretation of Article 3(a) to being that the product must be "specifically identifiable" in the patent. However, the CJEU has not yet addressed whether the interpretation of Article 3(c) should be similarly understood. Particularly, should the interpretation of Article 3(c) be revisited in the same way as that of Article 3(a)?

The meaning of Article 3(c) with respect to combination products was referred to the CJEU in Novartis (C-354/19) (IPKat). However, the Swedish patent court subsequently withdrew its request for the referral. The SPC in question was found invalid in view of Article 3(d) following Santen (C-673/18).  

Meanwhile, there have been conflicting decisions from the national courts on the interpretation of Article 3(c) with regards to combination products. In the Irish INEGY combination SPC case, the SPC was found to contravene Article 3(c). By contrast (as with Article 3(a)), the Portuguese and Belgian courts found the combination SPC for INEGY valid under Article 3(c). 

New referral to the CJEU on Article 3(c)

The latest referral stems from the Finish case brought by Teva against Merck's SPC for its combination product of sitagliptin and metformin (JANUMET) (SPC No. 342). An SPC had been previously granted to Merck for sitagliptin monotherapy (JANUVIA), based on the same patent (EP1412357) but a different marketing authorisation. Teva argued that the second SPC was not permitted under Article 3(c) because Merck's earlier SPC to sitagliptin alone (SPC No. 343) amounted to an earlier SPC for the same “product”. Teva also argued for good measure that the SPC was invalid under Article 3(a) and 3(d). 

In view of the changed interpretation of Article 3(a) in Royalty Pharma, the Finnish Market Court found that further clarification was needed on appropriate interpretation of Article 3(c). The Finnish firm representing Merck report that the matter has thus been referred to the CJEU. We await further details of the referral. 

Final thoughts

The continuance of conflicting decisions from the national courts on all three Articles (a), (c) and (d), put pay to any expectation that the decisions in Santen and Royalty Pharma were the end of the matter. Central to the current disputes surrounding the interpretation of Article 3 is whether the same definition of product should be used throughout. Particularly, can the decision of the CJEU on the interpretation of Articles 3(a) and (d) be applied to Article 3(c)? 

Whilst not the subject of the latest CJEU referral, there also still seems to be a need for clarification on how Royalty Pharma should be applied to combination products. Particularly, are the decisions of the Irish and French courts to invalidate an SPC based on Article 3(a) in line with the decision in Royalty Pharma that it is not the inventive concept that matters but whether a product is "specifically identified" in the patent? 

Clarification of the case law on all of these questions is hampered by the interaction with the separate sub-provisions of Article 3. If a SPC for a combination product cannot be clearly invalidated with one sub-provision, it often seems that another sub-provision will often do as well.

Further reading

28 June 2019: SPCs based on a second marketing authorisation - the fight continues (Novartis C-354/19)

13 September 2019: Article 3(a) just keeps on giving: AG Opinion in SPC referrals C-650/17 and C-114/18

17 May 2021: Does the Irish Court of Appeal in Merck v Clonmel part ways from the CJEU's Santen Article 3(d) decision?

13 July 2021: Keeping up with Belgian patent litigation: Year case law review 2020

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*Article 3, SPC Regulation

Conditions for obtaining a certificate

A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application: 

(a) the product is protected by a basic patent in force; 

(b) a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as appropriate; 

(c) the product has not already been the subject of a certificate; 

(d) the authorisation referred to in point (b) is the first authorisation to place the product on the market as a medicinal product.