New SPC referral to the CJEU on the interpretation of Art 3(a) and (c) for combination products (Merck v Clonmel)

The Supreme Court of Ireland has referred questions to the CJEU on the correct interpretation of the SPC Regulation as it pertains to combination products (Merck v Clonmel ([2022] IESC 11). This latest referral follows hot on the heels of the referral from the Finish Market Court on the correct interpretation of Article 3(c) of the SPC Regulation, also with respect to combination products (IPKat). The Irish referral relates to both Article 3(a) and Article 3(c). These recent referrals confirm the need for further guidance from the CJEU on the correct interpretation of Article 3 with respect to combination SPCs. 

Case Background: Merck v Clonmel

The Irish case related to Merck's SPC for its combination product INEGY, which contains the active ingredients ezetimibe and simvastatin. INEGY is approved as a cholesterol lowering agent. Ezetimibe was originally marketed as a monotherapy, EZETROL, and an  Irish SPC (SPC 2003/014) was granted for EZETROL following its approval. After further clinical trials, Merck subsequently obtained a second marketing authorisation for ezetimibe in combination with simvastatin formulated as a single medicine, INEGY. The question before the Irish Courts was whether a second SPC (SPC 2005/01) based on this combination product was valid. 

Prior to the development of EZETROL, it was common to treat excess cholesterol with statins such as simvastatin. The patent on which the INEGY SPC was based (EP(IE) 0720599) related to ezetimibe, and mentioned that ezetimibe may be administered in combination with a list of known statins, including simvastatin. A critical aspect of the case was that simvastatin was well-known at the priority date of the basic patent. Furthermore, the primary inventive contribution of the patent was the disclosure of ezetimibe, and not its combined use with simvastatin.

Supreme Court of Ireland

Article 3(a) and combination products

The Irish Court of Appeal found the INEGY SPC invalid under under Article 3(a). Article 3(a) requires that the approved product for which an SPC is sought must be protected by the patent. The most recent case law from the CJEU on the interpretation of Article 3(a) was provided in Royalty Pharma (C-650/17). According to Royalty Pharma, in order to satisfy Article 3(a), it is not sufficient for the product to merely fall under the scope of protection of the basic patent. However, neither is it necessary that the product in some way corresponds to the "core inventive concept" of the patent. Instead, the approved product must only be "specifically identifiable" in the patent. 

The Irish Court of Appeal found the INEGY SPC invalid under under Article 3(a), despite the fact that the combination of ezetimibe and simvastatin was specified in the dependent claims of the patent. Key to the Court of Appeal decision was its contention that it was necessary to look beyond the claims of a patent so as to take into account the disclosure of the patent as a whole. Merck argued that the Court of Appeal had thus erred in their application of the relevant case law. The Court of Appeal, Merck contended, had applied the out-dated "core inventive concept" criteria where the "specifically identifiable" test should have been applied. 

The INEGY SPCs have been challenged throughout Europe, inter alia on the basis of invalidity under Article 3(a), with varying success. The courts of both Belgium and Portugal have both found the INEGY SPC valid, whilst the courts of France (Cour d’appel de Paris), Germany (Federal Patent Court) and Spain have all found the INEGY SPC invalid.

The Supreme Court of Ireland found that there was sufficient lack of clarity surrounding the appropriate interpretation of Article 3(a) as applied to combination products to justify a referral. The Supreme Court observed that there was no dispute that the original patent related to a significant innovation, that of ezetimibe and its use as a cholesterol lowering agent. However, there was similarly no contention that the list of statins suggested in the patent for use in combination ezetimibe, including simvastatin, were by themselves not novel or inventive. Nonetheless, there could also be no dispute that the claims of the patent covered ezetimibe in combination with simvastatin. As such the Supreme Court observed:

If the requirement in Article 3(a) that the product “is protected by a basic patent in force” requires merely that the product be the subject of the SPC and marketing authorisation be identified or identifiable in a valid patent and covered by it, and therefore protected by the patent as a matter of national law, then the SPC is valid

        (paragraph 20, emphasis added) 

The Court of Appeal by contrast had applied the test that Article 3(a) required a narrower interpretation of "covered by basic patent", requiring an investigation into whether the combination product is covered by the "invention" of the patent. It was not clear to the Supreme Court from the case law which test was correct. 

Article 3(c) and combination products

The Irish Court of Appeal had also found the INEGY combination SPC invalid 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 CJEU has previously ruled that SPCs for combination products are not permitted by both Article 3(c) and Article 3(a) where the "core inventive concept" of the basic patent relates to only one of the active ingredients in a monotherapy. However, as discussed above, the CJEU had in Royalty Pharma moved away from the "core inventive concept" criteria in its application of Article 3(a). This disconnect between the interpretation of Article 3(a) and 3(c) led to the recent referral from the Finnish Court on whether the "core inventive concept criteria" is still applicable for Article 3(c) (IPKat). 

The Irish Supreme Court agreed with the Finnish Court that the correct interpretation of Article 3(c) with respect to combination products was unclear, given that the “product” referred to in Article 3(a) and Article 3(c) must be the same product. Consequently, "if the product [...] satisfies the requirement of Article 3(a), the only question under Article 3(c) is whether the combination product has already been the subject of the certificate" (paragraph 43, emphasis added). However, as noted in the Finnish decision, CJEU case law has not yet harmonised interpretation of Article 3(a) under Royalty Pharma and its previous interpretations of Article 3(c), as in Actavis I (C-443/12) and Actavis II (C-577/13) (IPKat).

The referral

The Supreme Court of Ireland referred 4 questions to the CJEU, the full text of which are provided in full below* ([2022] IESC 11). The first question asks generally how Article 3(a) should be interpreted. Particularly, Question 1 asks whether Article 3(a) requires only that the product is expressly identified in the patent claims of the basic patent, or whether it is also necessary for the product to fall within the narrower concept of "the invention" of the patent. If the latter is the case, the referral asks how "falling under the invention of the patent" should be established by the patent holder.

The next 3 questions relate to the specific situation in which the basic patent for which an SPC is sought relates primarily to a novel active ingredient "A" but which also includes claims to the combination of A with an active ingredient in the public domain "B":

Question 2 asks whether an SPC can only be granted for A, or whether A+B may also be granted an SPC under Article 3(a). Question 3 does not reference an Article, but asks whether, if an SPC is granted for A, this precludes the subsequent grant of an SPC for A+B, and vice versa. Question 4 asks whether Article 3(c) limits the grant of an SPC to (a) only A, if A is marketed as a product, (b) the first marketing of a product covered by the patent, regardless of whether this is A or A+B, or (c) whether both (a) and (b) are permitted at the discretion of the patent holder, "and if any of the above, why?". 

Final thoughts

It could be argued that the referral from the Irish Supreme Court on the interpretation of Article 3(a) results more from misinterpretation of Royalty Pharma by the Irish Court of Appeal as opposed to a genuine lack of clarity in the latest CJEU guidance. Nonetheless, the divergent approaches taken by other national courts in the corresponding INEGY SPC disputes highlight genuine confusion as to the consequences of Royalty Pharma in view of previous CJEU and national court decisions, or at least a reluctance to ignore these previous decisions.  

The national courts often find it difficult to secure a sure footing in the shifting ground of SPC case law. The CJEU itself is faced with the ongoing problem of honouring both the literal wording of the SPC regulation and raison d'etre of the SPC Regulation to provide compensation to patent right holders for the patent term lost to clinical trials. The machinations on the application of Article 3 to combination SPCs is just yet another example of the hazy ground that can open up between these two imperatives.

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 Dec 2021: The SPC alphabet: Are combination product SPCs precluded by Article 3(a), (c) and/or (d)?

___________________________________________________

*Referred questions

 1. (a)  For the purpose of the grant of a supplementary protection certificate, and for the validity of that SPC in law, under Article 3(a) of Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products [2009] OJ L152/1, does it suffice that the product for which the SPC is granted is expressly identified  in the patent claims, and covered by it; or is it necessary for the grant of an SPC that the patent holder, who has been granted a marketing authorisation, also demonstrate novelty or inventiveness or that the product falls within a narrower concept described as the invention covered by the patent?

(b) If the latter, the invention covered by the patent, what must be established by the patent holder and marketing authorisation holder to obtain a valid SPC ?

2. Where, as in this case, the patent is for a particular drug, ezetimibe, and the claims in the patent teach that the application in human medicine may be for the use of that drug alone or in combination with another drug, here, simvastatin, a drug in the public domain, can an SPC be granted under Article 3(a) of the Regulation only for a product comprising ezetimibe, a monotherapy, or can an SPC also be granted for any or all of the combination products identified in the claims in the patent?

3. Where a monotherapy, drug A, in this case ezetimibe, is granted an SPC, or any combination therapy is first granted an SPC for drugs A and B as a combination therapy, which are part of the claims in the patent, though only drug A is itself novel and thus patented, with other drugs being already known or in the public domain; is the grant of an SPC limited to the first marketing of either that monotherapy of drug A or that first combination therapy granted an SPC, A+B, so that, following that first grant, there cannot be a second or third grant of an SPC for the monotherapy or any combination therapy apart from that first combination granted an SPC?

4. If the claims of a patent cover both a single novel molecule and a combination of that molecule with an existing and known drug, perhaps in the public domain, or several such claims for a combination, does Article 3(c) of the Regulation limit the grant of an SPC;

(a) only to the single molecule if marketed as a product  ;

(b) the first marketing of a product covered by the  patent whether this is the monotherapy of the drug covered by the basic patent in force or the first combination therapy, or

(c) either (a) or (b) at the election of the patentee irrespective of the date of market authorisation?

And if any of the above, why?