Another Referral to the CJEU on the Validity of SPCs for Combination Therapy Products

14 February 2023

Last year we reported two referrals from the Finnish and Irish courts concerning SPCs for combination therapy products (“Combi-SPCs”). Those referring decisions 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).

Now it appears that the Swedish courts will follow suit and also refer questions to the CJEU relating to the interpretation of (in particular) Article 3(c) when applied to Combi-SPCs, following a recent decision of the Swedish Supreme Court.

By way of background, 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.

The expected referral from Sweden arises from an SPC application filed by AstraZeneca for the marketed product Xigduo^® - a combination of dapagliflozin and metformin. The Swedish Patent Office rejected the application for non-compliance with Article 3(c) – in line with the CJEU’s Actavis I and II decisions – on the basis that an earlier SPC had been granted to the product Forxiga^®, a monotherapy containing dapagliflozin, based on the same patent. This decision was upheld on appeal to both the Swedish Patent and Market Court, and subsequently to the Swedish Patent and Market Court of Appeal (“Court of Appeal”).

Despite the Court of Appeal not granting AstraZeneca leave for appeal, unusually the Swedish Supreme Court accepted a further appeal and set the Court of Appeal’s decision aside on grounds of a serious legal error.

In particular, the Supreme Court noted that:

the existing CJEU case law on Article 3(c) imposes greater restrictions on SPC applications than the literal wording of Article 3(c) itself would suggest; making it difficult to know the extent to which the conclusions in e.g. Actavis I and II should be applied to cases having a different fact pattern;
the more recent Teva and Royalty Pharma decisions on Article 3(a) might affect the interpretation of Article 3(c), and the CJEU has not yet had an opportunity to comment on this discrepancy;
there is apparent inconsistency in the application of Article 3(c) between different Member States; and
the facts of the present case showed similarities with the recent Finnish and Irish referrals.

For these reasons, the Supreme Court concluded that the Court of Appeal should have itself referred questions to the CJEU on the interpretation of Article 3(c), and the failure to do so was a serious legal error.

In due course, the Court of Appeal is expected to refer further questions to the CJEU seeking to clarify the interpretation of Article 3(c) in the context of combination therapy products. The wording of these questions is not yet known. However, along with the pending referrals from the Finnish and Irish courts (the questions of which are reproduced in full below), it is hoped that the expected Swedish referral may help to resolve the apparent inconsistencies in existing CJEU case law. Whatever the outcomes of these three referrals, there is likely to be a considerable impact on strategies adopted to maximise IP protection for medicinal products. The pharmaceutical industry will be watching developments with interest.

Questions referred by the Finnish Market Court in Teva and Teva Finland v Merck Sharp & Dohme Corp:

What criteria must be applied to determine when a product has not already been granted a supplementary protection certificate within the meaning of Article 3(c) 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 (‘SPC Regulation’)?
Must the assessment of the condition set out in Article 3(c) of the SPC Regulation be regarded as being different from the assessment of the condition set out in Article 3(a) of that regulation, and if so, in what way?
Must the statements on the interpretation of Article 3(a) of the SPC Regulation in the judgments of the Court in Case C-121/17 (Teva) and Case C-650/17 (Royalty Pharma) be regarded as relevant to the assessment of the condition in Article 3(c) of the SPC Regulation and, if so, in what way? In that connection, particular attention should be paid to the statements made in those judgments regarding Article 3(a) of the SPC Regulation, specifically:
- the essential meaning of patent claims; and
- the assessment of the case from the point of view of a person skilled in the art and in the light of the prior art at the filing date or priority date of the basic patent.
Are the concepts ‘core inventive advance’, ‘central inventive step’ and/or ‘subject matter of the invention’ of the basic patent relevant to the interpretation of Article 3(c) of the SPC Regulation and, if any or all of those concepts are relevant, how are they to be understood for purposes of interpreting Article 3(c) of the SPC Regulation? For the purposes of applying those concepts, does it make any difference whether the product in question consists of a single active ingredient (‘mono-product’) or a combination of active ingredients (‘combination product’) and, if so, in what way? How is the latter question to be assessed in a case in which the basic patent contains, on the one hand, a patent claim for a mono-product and, on the other hand, a patent claim for a combination product, the latter patent claim relating to a combination of active ingredients consisting of the active ingredient of the mono-product plus one or more active ingredients from the known prior art?

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

(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?
(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 ?
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?
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?
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?