This post is an attempt to to provide information on recent progress concerning two cases, one from the Finnish Market Court C-119/22 (Teva v MSD) and the other from the Irish Supreme Court C-149/22 (MSD v Clonmel).
Both cases concern the conditions under which Supplementary Protection Certificates (SPCs) may be granted in the European Union for combinations of active substances used in medicinal products.1
Specifically, this post concerns the non-binding opinion on the interpretation of EU law about supplementary protection certificates for combination medicinal products handed down on 6 June 2024 by Advocate General (AG) Emiliou of the Court of Justice of the EU (CJEU).
What are supplementary Protection Certificates SPCs and how are they used?
Supplementary protection certificates (SPCs) are an intellectual property right that serve as an extension to a patent right. They apply to specific pharmaceutical products that have been authorised by regulatory authorities.
- SPCs aim to offset the loss of patent protection for pharmaceutical products that occurs due to the compulsory lengthy testing and clinical trials these products require prior to obtaining regulatory marketing approval.3
- An SPC can extend a patent right for a maximum of five years.3
- A six-month additional extension is available in accordance with Regulation (EC) No 1901/2006 if the SPC relates to a medicinal product for children for which data has been submitted according to a Paediatric Investigation Plan (PIP).3
- On 27 April 2023, the Commission proposed a comprehensive reform of the SPC regime, with new regulation proposals (two of which apply to medicinal products).
- At a plenary session in March 2024, the European Parliament adopted its negotiating position on legislative reforms that, if implemented, would provide the underlying legal framework for unitary SPCs in the EU.4
- This reform will replace the existing SPC regulation by new ones, for medicinal products .
- Each will include the current national procedure as well as a new centralised procedure for the granting of national SPCs, available where the basic patent is a European patent, and the products has a market authorisation.3
What is the current legal basis of SPCs for medicinal products in the EU?
The legal basis for SPCs for medicinal products in the European Union (EU) and European Economic Area (EEA) is Regulation (EC) No 469/2009. Article 3 of the regulation states:
A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application:
(a) the product is protected by a basic patent in force;
(b) a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as appropriate;
(c) the product has not already been the subject of a certificate;
(d) the authorisation referred to in point (b) is the first authorisation to place the product on the market as a medicinal product.
Basic information about the two cases
Both of the cases were referred to the European Court of Justice (CJEU).
| Case | Companies | single ingredient product | combination ingredient product | About the case |
|---|---|---|---|---|
| C-119/22 from the Finnish Market Court | Teva v MSD | Januvia® (sitagliptin) for the treatment of type 2 diabetes | Janumet® (a combination product of sitagliptin and metformin hydrochloride) for the treatment of type 2 diabetes. | Teva challenged the validity of MSDs Supplementary Protection Certificate (SPC) for Janumet® arguing that the combination product was not ‘protected’ within the meaning of Art. 3(a), and that since MSD had already been granted an earlier SPC for sitagliptin alone (Januvia®), Art. 3(c) precluded the grant of another SPC for sitagliptin in combination with metformin.2 Both SPCs are based on the same European patent (EP1412357).2 Further information on the referral of this case ot the CJEU, here. |
| C-149/22 from the Irish Supreme Court Further information here. | MSD v Clonmel | Ezetrol® (ezetimibe) for lowering cholesterol | Inegy® (a combination product of ezetimibe and simvastatin) to lower cholesterol. | Following an infringement action brought by MSD upon launch of a generic version of MSDs Inegy® by Clonmel, the latter counterclaimed invalidity of Merck’s SPC arguing that the combination product was not ‘protected’ within the meaning of Art. 3(a), and that since Merck had already been granted an earlier SPC for ezetimibe alone (Ezetrol®), Art. 3(c) precluded the grant of another SPC for ezetimibe in combination with simvastatin.2 Both SPCs are based on the same European patent (EP0720599).2 Further information on the referral of this case to the CJEU here. |
What do the requests for a preliminary ruling (from both, the Finnish and Irish courts) concern?
The present requests for a preliminary ruling, from the markkinaoikeus (Market Court, Finland) and the Supreme Court (Ireland) respectively, concern the conditions for the grant of a supplementary protection certificate (‘SPC’) for medicinal products, set out in Article 3 of Regulation (EC) No 469/2009 (‘the SPC Regulation’).1
In essence, those courts wonder whether, and to what extent, an SPC may be granted for a combination of active ingredients used in such a product, where a previous SPC has already been granted for one of those ingredients.1
In that context, they seek guidance on the interpretation of two of those conditions, namely that such a combination be ‘protected by a basic patent in force’ (Article 3(a)) and that it ‘has not already been the subject of [an SPC]’ (Article 3(c)).1
The opinion from Advocate General Emiliou
The two cases were joined and received a combined non-binding opinion.
Advocate General Emiliou concluded:
In the light of all the foregoing considerations, I propose that the Court answer the question referred by the markkinaoikeus (Market Court, Finland) and the Supreme Court (Ireland) as follows:1
(1) Article 3(a) 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 products1
must be interpreted as meaning that to be regarded as ‘protected by a basic patent’ within the meaning of that provision, 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.1
(2) Article 3(c) of Regulation (EC) No 469/2009
must be interpreted as meaning that it does not preclude the grant of a supplementary protection certificate (SPC) for a combination of active ingredients where a previous SPC had been granted for one of those ingredients. 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 that provision.1
Note:
The AG’s opinion is not binding but provides a suggestion to the Court for how they should decide the joined cases.2
According to Joel Beevers et al of Potter Clarkson (Reference No 2 below), if the Court aligns its decision with the AG’s opinion, it will become more difficult for companies to obtain SPCs for combination medicinal products, at least in the scenario in which a single patent discloses both a single active ingredient and combination(s) with one or more other active ingredients.2
To better understand the Advocace General’s opinion
In order to develop a better, or more thorough understanding of the Advocate General’s non-binding opinion, you would do well to read at least section V. Analysis (starting at paragraph 33) of the non-binding opinion as well as references 2 and 4 below.
Next steps
The CJEU’s decision will now be awaited in these joined cases.
References
1. Opinion of Advocate General Emiliou delivered on 6 June 2024 – Joined Cases C‑119/22 and C‑149/22 – 6 June 2024
2. Reconfiguring the two-part test: Advocate General proposes SPC solution in favour of generics – Joel Beevers et al, Potter Clarkson.
3. Supplementary protection certificates for pharmaceutical and plant protection products – European Commission
4. MEPs adopt position on introduction of unitary SPCs – Judith Krens et al, 15 March 2024, Pinsent Masons.
5. Advocate General points the way to interpretation of SPC regulation – Konstanze Richter, 14 June 2024, juve-patent.com