Further Referral to the CJEU on Combi-SPCs: concerning Article 3(a) and Article 3(c)

7 March 2022

Just over 3 months after we reported a referral from the Finnish Market Court concerning Article 3(c) for combination products (see our news item, here), the Irish Supreme Court has now made its own, similar referral. Both the Finnish and Irish referrals involve Merck Sharp & Dohme Corp as the SPC holder, although the Irish case is concerned with a different product (Inegy^® - a combination of ezetimibe and simvastatin), patent (EP0720599), and respondent (Clonmel Healthcare Limited).

In essence, and similar to their colleagues in Finland, the Irish court has identified that there is tension between the definition and interpretation of “product” in earlier decisions of the CJEU concerned primarily with Article 3(c), and an apparently contradictory approach taken in more recent decisions concerned primarily with Article 3(a).

Briefly, in C-443/12 (Actavis I), the CJEU held that Article 3(c) of the SPC regulation (which states that “A[n SPC] shall be granted if … the product has not already been the subject of a certificate”) must necessarily preclude grant from the same patent of both (i) a first SPC arising from a marketing authorisation (MA) for monotherapy using that active ingredient, and (ii) a second SPC arising from a (later) MA for combination therapy using that active ingredient in combination with another active ingredient, if the second active agent is not protected “as such” by the basic patent. C-577/13 (Actavis II) subsequently provided some clarification, stating that in order for a basic patent to protect an active ingredient “as such” within the meaning of Articles 1(c) and 3(a) of the SPC regulation, that active ingredient “must constitute the subject-matter of the invention covered by that patent” (a test that has become known more commonly as the “core inventive advance” test).

In more recent decisions C-121/17 (Teva) and C-650/17 (Royalty Pharma) concerned primarily with Article 3(a) of the SPC regulation, the CJEU has taken a different approach to assessing whether a product is “protected by a basic patent in force” (the requirement of Article 3(a)). In these decisions, the CJEU rejected the notion that a “core inventive advance” test should apply. Instead, the court ruled that what is determinative is whether (i) the [combination] product necessarily falls under the invention covered by the basic patent, and (ii) the skilled person can identify the [combination] product specifically in light of all the information disclosed in the patent.

Thus, the reasoning of the CJEU in these later “3(a) decisions” seems to contradict the approach taken in the “3(c)/(a) decisions” of Actavis I and II particularly in the context of a combination product. It is hoped that the Finnish and Irish referrals will help to resolve this apparent contradiction.

The precise questions to be referred by the Finnish court are yet to be published, but the four questions referred by the Irish court are reproduced in full below and the full text of the referring decision is also available here. The Irish decision includes a helpful summary both of the status of the Inegy^® SPCs around Europe (see paragraphs 46 and 47) and of the Finnish referral (see paragraph 48). It is evident from these paragraphs that, whilst the CJEU clearly view the Teva and Royalty Pharma decisions as the final word on at least Article 3(a), there is nonetheless still some way to go to ensure uniform application of the SPC Regulation across Europe, particularly with respect to combination products.

Whatever the CJEU ultimately decides, it is likely to have a considerable impact on protection strategies for medicinal products. SPCs for combination products are attractive to applicants because combinations are generally developed (and authorised) later than the associated monotherapies, and hence have later expiry dates. The pharmaceutical industry will of course be watching developments with interest.

Questions referred by the Irish Supreme Court in [2022] IESC 11 Merck V Clonmel:

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) …, does it suffice that the product … 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?

1. (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

And if any of the above, why?