As reported previously, courts in both Ireland (in February 2022, concerning Inegy®) and Finland (in November 2021, concerning Janumet®) have recently identified an apparent discrepancy in CJEU case law with respect to the interpretation of "product" in the SPC Regulation. In short, the courts in both countries determined a need for the CJEU to clarify whether the same criteria should apply for the purposes of Article 3(c) of the Regulation, as compared to Article 3(a), and also whether or not there should be any difference between the assessment of products comprising single active ingredients as compared to combinations.
Both the Irish and Finnish courts referred questions to the CJEU, in C141/22 and C-119/22, respectively. Despite being the earlier case, the Finnish Market Court referral was not formally submitted to the CJEU until a little later than the Irish Supreme Court referral, with the precise detail of the referred questions only becoming public later, in mid-February 2022. Those questions are reproduced in full at the end of this news item, together with the corresponding questions referred by the Irish Supreme Court that were also included with our previous news item.
As readers will appreciate, the courts in each country have used different, but overlapping and complementary, approaches to explore the same underlying problem. We believe it would be helpful for the CJEU to consider both approaches. However, we understand that the parties in Finland may now have reached a settlement. This would usually end the Finnish referral, although it is currently still listed as pending by the CJEU. Other national courts (e.g. in Germany) have declined to refer questions to the CJEU in corresponding cases concerned with Janumet®, so it may be that the Irish referral will be considered alone by the CJEU.
Whether or not the CJEU reviews the Finnish referral, a final point of interest raised by the Finnish court relates to the "core inventive advance" terminology used by the CJEU in C-443/12 (Actavis I). Whilst the English term is used consistently in that judgment, two different terms are used in the German and French versions, in paragraphs 30 and 41. Specifically: in German 'die zentrale erfinderische Tätigkeit' and 'Kern der erfinderischen Tätigkeit'; and in French 'l'activité inventive centrale' and 'le cSur de l'activité inventive'.
To some extent the CJEU has already partly clarified this terminology, indicating in C-577/13 (Actavis II) that the active ingredient "must constitute the subject-matter of the invention covered by that patent". Nonetheless, given that the extent to which the "core inventive advance" test may or may not be relevant to SPC validity remains unclear, further clarification would be welcome.
Whatever the CJEU ultimately decides in terms of interpretation of Article 3(c), 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.
For more information contact Graham Lewis or your usual J A Kemp adviser.
Questions referred by the Finnish Market Court in Teva and Teva Finland v Merck Sharp & Dohme Corp:
1. 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')?
2. 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?
3. 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.
4. 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:
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
(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?
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