The Court of Justice’s New Ruling – Interpretation of Conditions for Obtaining a Supplementary Protection Certificate under Article 3(a) and 3(c) of the Regulation (EC) 469/2009

The Court of Justice of the European Union (the “Court of Justice”) handed down its judgment in joined cases C‑119/22 (Teva et al. v. Merck et al.) and C‑149/22 (Clonmel v. Merck) on 19 December 2024. The joined cases concerned the interpretation of Articles 3(a) and 3(c) of the Regulation (EC) No 469/2009 (“SPC Regulation”) regarding the conditions for obtaining a supplementary protection certificate (“SPC”).

The Court of Justice’s judgment affects the interpretation and application of conditions for obtaining a SPC across all EU jurisdictions. The Court of Justice’s judgment clarifies the assessment under Articles 3(a) and (3c) which require, respectively, that the product is protected by a basic patent in force (3(a)) and that the product has not already been the subject of a certificate (3(c)).

The case C-119/22 involves a basic patent that in general covers dipeptidyl peptidase IV (“DP-IV”) inhibitors, used e.g. in the treatment or prevention of type 2 diabetes. Sitagliptin is one such DP-IV inhibitor. The basic patent also provides that DP-IV inhibitors may be combined with other active ingredients, with metformin being mentioned in a claim. Two SPCs have been granted on the basis of the same basic patent: one for sitagliptin as the sole active ingredient (SPC No 343) and one for a combination of sitagliptin and metformin (SPC No 342).

The claimants brought an action for a declaration of invalidity of SPC No 342 before the Finnish Market Court on the basis of Articles 3(a), (c) and (d) of the SPC Regulation, Article 3(d) not being subject of the referral. The claimants have, inter alia, submitted that the combination of sitagliptin and metformin is not protected as such by the basic patent and that such combination product was already the subject of SPC No 343. The respondents contended that the action should be dismissed. The Market Court referred the case to the Court of Justice.

The case C-149/22 involves a basic patent based on which a medicinal product intended to reduce the blood level of LDL (low-density lipoprotein) cholesterol with a view to limiting the risk of atherosclerosis has been developed. Some of the claims of the basic patent relate to active ingredient ezetimibe alone whereas some claims relate to uses of ezetimibe in combination with other active ingredients, with a combination of ezetimibe and simvastatin being expressly mentioned in the claims. Two SPCs have been granted under that basic patent: one for ezetimibe as the sole active ingredient and a later one for a product consisting of ezetimibe and simvastatin.

The SPC holder had brought infringement proceedings against the counterparty in Ireland. The Irish High Court thereafter declared the combination SPC invalid taking the view that it did not satisfy the conditions laid down in Articles 3(a) and (c). The case ultimately proceeded to the Supreme Court of Ireland which referred the case to the Court of Justice.

The Court of Justice noted that in view of the evidence provided by the referring court the basic patent in case C-149/22 does not appear to disclose a combined effect of simvastatin with ezetimibe that would differ from the sum of the effects of each of those active ingredients taken separately.

It was not in dispute in either case that the other active ingredient, metformin or simvastatin respectively, was already in the public domain at the priority date of the basic patents at issue.

The Advocate General N. Emiliou delivered his opinion in the joined cases on 6 June 2024. In respect of Article 3(a), the Advocate General held inter alia that a speculative claim regarding a certain combination should not be rewarded simply because the patentholder has included such a combination in the claims. According to the Advocate General’s opinion, for Article 3(a) to be met a “product” must not only (i) be expressly mentioned or at least “specifically identifiable’ in the claims but also (ii) fall under the invention which is the subject matter of that patent.

In respect of Article 3(c), the Advocate General argued for a straightforward and literal construction and thus noted that the provision must be interpreted as meaning that it does not preclude the grant of an SPC for a combination of active ingredients where a previous SPC had been granted for one of those ingredients. The Advocate General further stated that the concepts of “core inventive advance” and “subject matter of the invention” are irrelevant for the purposes of the assessment of the condition laid down in Article 3(c).

The Court of Justice held that the concept of “product” is interpreted strictly in accordance with its earlier case law and clarified that this means that only the active ingredient or ingredients are compared. The Court of Justice further held that the concept of “product” must be assessed similarly regardless of the context in which it is relied on.

In respect of the different conditions for obtaining an SPC, the Court of Justice clarified that each condition under Article 3 is cumulative which means that they must be interpreted and applied independently. The Court of Justice differentiated Articles 3(a) and 3(c) by pointing out that Article 3(a) seeks to delimit the material scope of the SPC by reference to the basic patent whereas Article 3(c) seeks to limit the temporal scope of the supplementary protection conferred on a given product.

Regarding Article 3(c), the Court of Justice noted that the EU legislature intended to establish a simple system based on conditions which are, in principle, easy to verify. Therefore, the Court of Justice concluded that Article 3(c) must be interpreted as not precluding the grant of an 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.

Regarding Article 3(a), the Court of Justice clarified that the two-stage test in paragraph 52 of case C-121/17 (“Teva UK”) is of general scope and application. The Court of Justice justified this by referring to the objectives of the SPC Regulation which seek to, inter alia, take into account all the interests at stake.

The Court of Justice confirmed that it is not sufficient for the first stage of the Teva UK test that the patent includes a mere mention, even an express mention in the claims, of a product if the patent specification does not disclose how that product constitutes a technical feature required for the solution of the technical problem disclosed by that patent. The Court of Justice highlighted that the claims of the basic patent must be construed in light of the limits of the protected invention as appears from the description and the drawings.

The Court of Justice further clarified the assessment of products consisting of two active ingredients (A+B) under the Teva UK test. The Court of Justice concluded that an express mention of the two active ingredients comprising the product in the patent claims is sufficient only in the light of the second stage of the Teva UK test. Thus, the Court of Justice clarified that a mere mention, even if an express mention, in a claim of the basic patent of the possibility of combining an active ingredient disclosed by that patent with another known active ingredient cannot be sufficient to satisfy the first stage of the Teva UK test.

The Court of Justice further clarified that a combination including an active ingredient already in the public domain can satisfy the first stage of the Teva UK test if the basic patent discloses that the combination of the two active ingredients has a combined effect going beyond the mere addition of the effects of those two active ingredients and which contributes to the solution of the technical problem. If these criteria are met, the Court of Justice noted that it may be concluded that the combination of those two active ingredients necessarily falls under the invention covered by the basic patent.

See the exact ruling of the Court of Justice regarding Articles 3(a) and (c) via the first link above.

The Court of Justice’s ruling holds significant implications for the SPC regimen and the pharmaceutical industry. The interpretation of articles 3(a) and 3(c) of the SPC Regulation has been a hot topic in the patent community and has given rise to a substantial body of case law. This long-awaited ruling is expected to provide much-needed clarity and guidance on the application of these articles in the context of combination products. As the legal community begins to analyse and national courts to apply the decision in detail, it is hoped that this will resolve existing ambiguities and offer a more definitive framework for future SPC applications.

The Borenius lawyers named below would be delighted to answer any legal questions you may have regarding this judgment and its implications for your business. Please do not hesitate to contact us for more information.