SPC for a product consisting of two active ingredients even if one has already been disclosed by the basic patent

The SPC regulation must be interpreted as not precluding the grant of a supplementary protection certificate (SPC) for a product consisting of two active ingredients even if one of those two active ingredients has already been, alone, the subject of an earlier SPC and it is the only one to have been disclosed by the basic patent, whereas the other active ingredient was known at the filing date or priority date of that patent.


Joined cases C‑119/22 and C‑149/22

The company MSD has obtained Supplementary Protection Certificate No. 342 (hereinafter: SPC No. 342) in Finland for a medicinal product intended for the treatment and prevention of diabetes. Two legal entities—collectively referred to as Teva—have brought an action against MSD seeking the invalidation of SPC No. 342. According to Teva, SPC No. 342 was granted in violation of the conditions set out in Article 3 of the SPC Regulation. Teva argues before the referring court, among other things, that an SPC had previously been granted for (certain) active ingredients covered by SPC No. 342, thereby failing to meet the requirement under Article 3(c) of the SPC Regulation.

To resolve the dispute, the referring court seeks guidance from the EU Court of Justice on the criteria for determining whether an SPC has not previously been obtained for a product within the meaning of Article 3(c) of the SPC Regulation. In this context, the court also seeks clarification on the relevance of the EU Court’s case law regarding Article 3(a) of the SPC Regulation for the interpretation of Article 3(c). Furthermore, the court asks how the concepts derived from the aforementioned case law should be understood when applied to a product consisting of a single active ingredient (a so-called monopreparation) or a product comprising a combination of active ingredients (a so-called combination product).

Questions in case C-119/22
 

(1)      What criteria must be applied to determine when a product has not already been granted [an SPC] within the meaning of Article 3(c) of Regulation [No 469/2009]?

(2)      Must the assessment of the condition set out in Article 3(c) of [Regulation No 469/2009] 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 [Regulation No 469/2009] in the judgments of [25 July 2018, Teva UK and Others (C‑121/17, EU:C:2018:585)] and [in Royalty Pharma] be regarded as relevant to the assessment of the condition in Article 3(c) of [that] 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 [that] 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 [Regulation No 469/2009] and, if any or all of those concepts are relevant, how are they to be understood for purposes of interpreting Article 3(c) of [that] 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 in C-149/22

(1)(a)      For the purpose of the grant of [an SPC], and for the validity of that SPC in law, under Article 3(a) of Regulation [No 469/2009] 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 [an MA], 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 [MA] 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 [Regulation No 469/2009] 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 [Regulation No 469/2009] 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?

Answers

1.      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

must be interpreted as not precluding the grant of a supplementary protection certificate (SPC) for a product consisting of two active ingredients even if one of those two active ingredients has already been, alone, the subject of an earlier SPC and it is the only one to have been disclosed by the basic patent, whereas the other active ingredient was known at the filing date or priority date of that patent.

2.      Article 3(a) of Regulation No 469/2009

must be interpreted as meaning that it does not suffice that a product is expressly mentioned in the claims of the basic patent in order for that product to be regarded as being protected by that patent, within the meaning of that provision. It is also necessary, in order to satisfy the condition laid down in that provision, that that product necessarily fall, from the point of view of a person skilled in the art, and in the light of the description and drawings of that patent, under the invention covered by that patent at the filing date or priority date.

3.      Article 3(a) of Regulation No 469/2009

must be interpreted as meaning that a product consisting of two active ingredients (A+B) is protected by a basic patent, within the meaning of that provision, where A and B are expressly mentioned in the claims of that patent and the specification of that patent teaches that A may be used as a medicinal product for human use alone or in combination with B, which is an active ingredient in the public domain at the filing date or priority date of that patent, provided that the combination of those two active ingredients necessarily falls under the invention covered by the same patent.

IPPT version will follow anytime soon

ECLI:EU:C:2024:1039 - joined case C-119/22, C-149/22