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

Last year's CJEU decision in Santen (C-673/18) was an usually clear judgment on a question that had dogged SPC case law for years: whether there are any circumstances in which an SPC may be based on a second marketing authorisation for a product. In Santen (C-673/18) the CJEU rejected its own previous reasoning on this question and appeared to rule out the possibility of SPCs based on 2nd marketing authorisations (The SPC Blog).

The CJEU decision Santen (C-673/18) has now been applied by the Court of Appeal of Ireland (Merck v Clonmel [2021] IECA 54). The case related to Merck's Ireland SPC for its cholesterol lowering combo-product Inegy (ezetimibe + simvastatin). Interestingly, given the apparent uncompromising position of the CJEU in Santen (C-673/18), the Irish Court of Appeal found that Article 3(d) did not necessarily exclude SPCs based on a marketing authorisations for combination product, even when both of the individual active ingredients in the combination product were covered by previous authorisations.

"First marketing authorisation" - Article 3(d) and Santen

SPCs are national rights that provide an additional period of patent protection (max 5 years) for a medicinal product. The SPC for a particular product must be based on "the first marketing authorisation" for the product (Article 3(d) SPC Regulation).

There is a long history of the CJEU tying itself in knots on the definition of "first marketing authorisation" in Article 3(d). Part of the issue with the interpretation of Article 3(d) has been a perceived disconnect between a strictly literal interpretation of "first marketing authorisation" and the proclaimed purpose of the SPC Regulation, i.e. that of compensating a patentee for the time taken to receive regulatory approval. In many of the cases put before the CJEU on the interpretation of Article 3(d), first marketing authorisations were granted early in the life of the product for relatively non-valuable uses. Considerable time and resources were then required to achieve a further marketing authorisation for a different, more challenging, indication or beneficial formulation.

Early CJEU decisions on Article 3(d) found that SPCs based on 2nd marketing authorisations were not permitted (see C-202/05 (Yissum)). The spanner in the works came with the CJEU's decision in Neurim (C-130/11) (IPKat). In Nerium, the CJEU ruled that an SPC based on a 2nd marketing authorisation was permitted in the case where the 1st marketing authorisation was for veterinary use, and the 2nd marketing authorisation was for human use, and the product was a new formulation of the same active ingredient (melatonin). There was much speculation after Neurim (C-130/11) as to how applicable the decision was to other situations. For example, did the decision in Neurim only apply in the case of a 1st veterinary marketing authorisation and a 2nd human marketing authorisation? or did Neurim only apply when the product had been reformulated?

Further confusion came with Abraxis (C-443/17) (IPKat). In this case, the 1st and 2nd marketing authorisations were for the same use, but the patent and the 2nd marketing authorisation were for a different formulation of the product (paclitaxel). The CJEU ruled that an SPC based on the 2nd marketing authorisation and the new formulation was not permitted. Abraxis therefore contradicted at least part of Neurim. The CJEU did not expressly address this contradiction in Abraxis.

The legal uncertainty following Neurim and Abraxis lead to another referral to the CJEU: Santen (C-673/18). In Santen, both the formulation and indication of the product were different for the 1st and 2nd marketing authorisations. The 1st marketing authorisation was for an oral solution of cyclosporin, whilst the 2nd was for an eye drop of cyclosporin. In its decision, the CJEU resoundingly rejected its previous reasoning in Neurim and appeared to rule out the possibility of SPCs based on 2nd marketing authorisations.

Regardless of your opinion on the merits or otherwise of the CJEU's reasoning in Santen (C-673/18), the decision did at least provide some much-needed clarity. The contradictory decisions in Neurim (C-130/11) and Abraxis (C-443/17) were not conducive to the harmonisation of the SPC law across Europe.

Article 3(d) and combination products

The decision in Santen (C-673/18) was taken by many to unequivocally rule out the possibility of SPCs for a product based on a 2nd marketing authorisation relating to the product in any form. However, a recent decision of the Court of Appeal of Ireland ([2021] IECA 54) suggests that there may yet be circumstances where an SPC is permitted even if an active ingredient has been subject to a previous marketing authorisation. The case related to Merck's SPC for Inegy, a combination product containing ezetimibe and simvastatin (a statin) for the treatment of high cholesterol.

First and second

Merck already had an SPC for ezetimibe monotherapy (Ezetrol). Both the Ezetrol and Inegy SPCs were based on the same Irish patent (EP (IE) 0 720 599). The patent was directed to compounds for the treatment of atherosclerosis, and explicitly claimed ezetimibe. The known statin simvastatin was mentioned in the description of the patent. Simvastatin had been previously approved for medicinal use. The patent did not explicitly disclose a combo-product comprising ezetimibe and simvastatin. The Irish Court of Appeal therefore found the Inegy SPC invalid under Article 3(a) SPC Regulation as interpreted by the CJEU in Royalty Pharma (C-650/17), whereby a product must be specifically identifiable in the patent on which the SPC is based. The Irish Court of Appeal decision on this point was in line with the Paris Court of Appeal decision on the French Inegy SPC application (as reported by the SPC blog).

Despite already finding the Inegy SPC invalid under Article 3(a), the Irish Court of Appeal also considered whether the SPC complied with Article 3(d). The question was whether the marketing authorisation for Inegy (ezetimibe + simvastatin) was the 1st marketing authorisation to place the product on the market, given the previous approval for Ezetrol (ezetimibe monotherapy). Notably, the Ezetrol marketing authorisation permitted patients to take statins, including simvastatin, in combination with Ezetrol (ezetimibe monotherapy). Nonetheless, the Court of Appeal found that the co-administration of two separate products, ezetimibe and a statin, could not be equated to a marketing authorisation for the comb-product, Inegy. The Court of Appeal thus found that the Inegy SPC did not contravene Article 3(d) of the SPC Regulation.

Final thoughts

The decision of the Court of Appeal of Ireland in Merck v Clonmel [2021] IECA 54 provides an important nuance to the interpretation of the Article 3(d) SPC Regulation following Santen (C-673/18). It will be interesting to see if other national courts (and patent offices) follow suit. At the very least, the decision in Merck v Clonmel [2021] IECA 54 reveals the initial characterisation of Santen as excluding all SPCs based on second marketing authorisations for an active ingredient, to be a possible over-simplification.