27 September 2022

C-C-C-Combo Breaker! – Combination products and the SPC regulation

On referral from the Supreme Court of Ireland (‘IESC’) in Merck v Clonmel,[1] the CJEU will shortly consider the interpretation of the Supplementary Protection Certificate (SPC) Regulation[2], regarding combination products.

This is the second such referral in the past year, following the referral from the Finnish Market Court (‘FMC’) in December 2021. The Merck referral relates to Article 3(a) and 3(c), which are set out below:

Article 3

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;

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

The issue in this case is whether a combination product can validly obtain an SPC, if one of the constituent parts of the combination product has already had an SPC. Merck had already been granted an SPC for its combination product INEGY, which contains two active ingredients: ezetimibe and simvastatin and is used as a cholesterol-lowering agent. Ezetimibe was originally sold as a single product in its own right, EZETROL, which received an Irish SPC. After further research Merck combined ezetimibe with simvastatin to create INEGY.

A new issue then arose on the application, as to whether an SPC can be granted where the patent’s inventive concept was not to the combination:  The INEGY SPC application was based on the Ezetimibe patent, which mentioned that ezetimibe may be administered with a list of applicable statins, including simvastatin. Simvastatin was well-known at the priority date of the Ezetimibe patent and was not novel in and of itself – in fact simvastatin was already in the public domain. The primary inventive contribution of the Ezetimibe patent was the disclosure of the drug itself, not its combined use with simvastatin. The question then posed was whether Merck could get an SPC not only on the monotherapy ezetimibe, but also on any and all combination products in the claims under the patent.  If they can, then it includes combinations with non-novel drugs, such as INEGY.

Article 3(a)

To understand the developing issue it is necessary to understand how the case of Royalty Pharma[3] is being interpreted:  it held that products falling under a functional definition in a patent claim but developed only after the filing date of a patent, after an independent inventive step, are not ‘protected’ by that patent within the meaning of Article 3(a) of the SPC Regulation.  This focus is similar but not the same as a focus on the inventive contribution in a patent.  So where you seek an SPC on an active ingredient which is neither expressly mentioned in the claims nor provided as an embodiment in the patent, but which is covered by a functional definition in the claims of that patent, it is not ‘protected’ within the meaning of Article 3(a) of the SPC Regulation, even if that product was developed only after the filing date of the patent.

The relevant part of the CJEU decision is worth review:

“Article 3(a) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products must be interpreted as meaning that a product is protected by a basic patent in force, within the meaning of that provision, if it corresponds to a general functional definition used by one of the claims of the basic patent and necessarily comes within the scope of the invention covered by that patent, but is not otherwise indicated in individualised form as a specific embodiment of the method of that patent, provided that it is specifically identifiable, in the light of all the information disclosed by that patent, by a person skilled in the art, based on that person’s general knowledge in the relevant field at the filing date or priority date of the basic patent and on the prior art at that date.

“Article 3(a) of Regulation No 469/2009 must be interpreted as meaning that a product is not protected by a basic patent in force, within the meaning of that provision, if, although it is covered by the functional definition given in the claims of that patent, it was developed after the filing date of the application for the basic patent, following an independent inventive step.”

Following that interpretation by the CJEU in Royalty Pharma, the Irish Court of Appeal (‘IECA’) found that the SPC for INEGY was invalid under Article 3(a).  According to the Irish interpretation of the CJEU decision, in order to satisfy Article 3(a), the product must be protected by a patent in some way beyond merely falling within the scope of the basic patent.  Here there was no timing issue as in Royalty Pharma and this is not an invention/development after the patent, but nor was it wholly novel at the time of grant of the patent. However, the Court did not find that the product had to correspond to the ‘core inventive advance’[4] of the patent, but rather that it must be ‘specifically identifiable’[5] within the patent to a skilled person.

The combination of ezetimibe and simvastatin was specified in the dependent claims of the patent, but nevertheless, the IECA found the INEGY SPC invalid, because it was necessary to look beyond the claims of the patent and take into account the disclosure of the patent as a whole[6]. The IECA followed the comments of the judge at first instance who said that the addition of an existing compound to a novel compound cannot, without further novelty, make the combination product an invention in and of itself. If that was all that was required, it would mean that an SPC would automatically be available for any combination product containing a combination of a novel product disclosed in a patent and a pre-existing product available off the shelf.[7]

Merck argued that the IECA had erred in law, and used the outdated ‘core inventive advance’ test rather than the ‘specifically identifiable’ test. Given different national courts coming to different conclusions with regard to Article 3(a) (Belgium and Portugal found the INEGY SPC valid, but France, Germany and Spain all found it invalid), the IESC found that the lack of clarity on this point warranted a referral to the CJEU.

The IESC in its question to the CJEU observed that:

‘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[8].’

The IESC wanted to know if the IECA had erred by requiring a narrower interpretation of ‘covered by the basic patent’ and requiring evidence on whether the combination product is covered by the ‘core inventive advance’ of the patent.

Article 3(c)

Separate to its considerations under Article 3(a), the IECA also found that the INEGY SPC was invalid under Article 3(c) on the basis that the CJEU had previously ruled that SPCs for combination products are not permitted by both Article 3(c) and Article 3(a) where the ‘core inventive advance’ of the basic patent relates to only one of the active ingredients in a monotherapy. However, as discussed above with regard to Royalty Pharma, the CJEU has more recently decided to depart from the ‘core inventive advance’ test for Article 3(a), and instead set the requirement that the product must be ‘specifically identifiable’ within the patent to a skilled person.  Whether the test is different under Article 3 (a) and (c) is now being considered.  The CJEU has not ruled on the issue for Article 3(c), hence the referral now. The IESC agreed with the FMC is that it was unclear if the potential change of tack with regard to Article 3(a) also applied to Article 3(c) and so referred the question to the CJEU.

The full text of the four IESC questions referred to the CJEU can be found here.


While some might suggest that the referral to the CJEU with regard to Article 3(a) is due to the misinterpretation of Royalty Pharma by the IECA, it will certainly be useful to have definitive guidance, especially given the divergent approaches by the various European Union Member States. If only part of a patent is determinative for ‘coverage’ under the SPC Regulation, this will have significant ramifications. Some may argue that such a restrictive interpretation goes against the spirit and purpose for SPCs being enacted in the first place – to compensate for the time lost to clinical trials. Which route the Court will take, and/or whether they suggest that regulatory amendment needs to occur remains to be seen. However, if all it takes to garner another SPC is to combine a patented product with any off-the-shelf additional product, then it is highly likely that the use of SPCs will proliferate.

[1] [2022] IESC 11.

[2] Regulation (EC) No 469/2009.

[3] (C-650/17).

[4] Ibid. at 30. Akin English law’s ‘inventive concept’ focus.

[5] Ibid. at 43.

[6] Merck v Clonmel [2021] IECA 54 at 82.

[7] Ibid.

[8] Above n.1 at 20.

Authored by James Tumbridge