Eddie Bishop

April 2022

Questions on the European SPC Regulation, in particular in relation to SPCs for combination products, have been raised at the CJEU many times over the years. It is therefore hoped that this newest referral may provide some much-needed clarity.

Background

For an SPC to be obtained there are a number of criteria that must be met. Those most relevant for the present case are Articles 3(a) and 3(c) of the European SPC Regulation.

Article 3(a) of the European SPC Regulation requires that the approved product for which the SPC is sought is protected by a patent.

Article 3(c) of the European SPC Regulation requires that the product for which an SPC is granted is not already the subject of an SPC.

For many years, the so-called “infringement” test was considered to be the primary criterion for determining if the requirements of Article 3(a) were met – under this test it is sufficient that the product simply falls within the scope of the claims of the patent.

However, in 2011, Medeva (C-322/10), the CJEU rejected this test and introduced a new test, the “specifically identifiable” test where the approved product must not just fall within the scope of the claims, but must additionally be specifically identified in the patent.

The Actavis decisions (C-433/12 and C-577/13) in 2013 and 2015 then brought in a third test, the “central inventive concept” test, which, as the name suggests, requires that the approved product must be the central inventive concept of the patent. In the Actavis decisions, the CJEU found that SPCs are not permitted by Articles 3(a) and 3(c) for combination products where the “core inventive concept” of the patent only relates to one of the actives alone.

In 2018, in Teva v Gilead (C-121/17) a new two step test was introduced by the CJEU, requiring (1) that the combination product must fall under the scope of the claims (i.e. the “infringement” test), and additionally (2) that each of the active ingredients must be specifically identifiable (i.e. the “specifically identifiable” test).

In Royalty Pharma (C-650/17) in 2021, the “specifically identifiable” test appeared to be confirmed. However, the decisions of both Teva v Gilead and Royalty Pharma left questions on whether the “inventive advance” test still applied.

A recent referral to the CJEU from the Finnish Court in November 2021 addressed the disconnect between the recent Teva and Royalty Pharma cases and the earlier “inventive advance” test from the Actavis cases, asking whether the “core inventive concept” was still applicable for considering Article 3(c) despite the newer “specifically identifiable” test used to consider Article 3(a).

The Present Case

The patent in question (EP(IE)0720599) covers the drug ezetimibe alone as well as in combination with known statins, such as simvastatin. Ezetimibe was originally marketed as EZETROL and the proprietor (Merck) obtained an Irish SPC for EZETROL following its approval.

Merck subsequently obtained approval for ezetimibe in combination with simvastatin, marketed as INEGY. The question is now whether an SPC is valid for the combination product INEGY.

Article 3(a)

The Court of Appeal in the present case believed the INEGY SPC was not allowable under Article 3(a) despite the fact that the combination was mentioned in dependent claims. The Court of Appeal considered it necessary to look beyond the claims and to take in the disclosure as a whole.

Before the Supreme Court, Merck argued that the CoA had used the outdated “core inventive concept” approach instead of the newer “specifically identifiable” test.

The Supreme Court felt that on the one hand, there was no dispute the patent related to a significant innovation in using ezetimibe as a cholesterol lowering agent, however it was also clear that the patent disclosed ezetimibe in combination with simvastatin in the dependent claims.

The Supreme Court felt it was unclear whether the product must be identifiably protected by the patent or protected by the inventive part of the patent. As such, the Supreme Court determined that a referral to the CJEU was necessary.

Article 3(c)

In relation to Article 3(c) of the European SPC Regulation, the Irish Supreme Court agreed with the recent referral from the Finnish Court. They felt it was unclear whether the “core inventive concept” test still applied to Article 3(c) despite the newer “specifically identifiable” test being used to consider Article 3(a). The Supreme Court considered that this was particularly unclear since the “product” referred to in Articles 3(a) and 3(c) must be the same.

Therefore, the Supreme Court also felt the need for a referral to clarify Article 3(c) since the CJEU case law has not yet harmonised its interpretation of Article 3(a) under Royalty Pharma with its previous interpretations of Article 3(c) in the Actavis cases.

Referred Questions

Therefore, the Supreme Court referred to the following questions (summarised underneath):

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?

Summary:

1. (a) Is it sufficient for the product to be identified in the claims or must the proprietor also demonstrate novelty and inventiveness of the product?
   (b) If the latter, what must the proprietor show?
2.  Where the patent is to a particular drug, and the claims teach its use either alone or in a combination – can an SPC be granted for only the product alone, or can it also be granted for any combinations disclosed?
3. Is an SPC limited to a first marketing authorisation (either of a drug alone or a combination therapy) or can a second or further SPC be granted for other monotherapies / combination therapies other than the subject of the first 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, 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?

It will be interesting to see how the CJEU responds to these questions in due course – we hope the answers will provide the much needed clarity on the use of SPC’s for combination products.