This post is an attempt to present the details of a preliminary ruling by the CJEU on Case C-181/24 (Genmab A/S vs Budapest High Court) on the interpretation of Articles 3(b) and (d) of Supplementary Protection Certificate (SPC) Regulation (EC) No 469/2009, in a Q & A format.
The parties to the main proceedings1
Genmab A/S vs Budapest High Court, Hungary
What are Supplementary Protection Certificates (SPCs) and how are they used?1
An SPC is a sui generis intellectual property right that can extend by up to five years, the protection conferred by a patent (“the basic patent”), but only with respect to the medicinal product that is covered by the related marketing authorisation2.
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
An innovator (patent holder) can apply for an SPC on a product’s “basic” patent within 6 months of obtaining marketing authorisation in any EU member state.
You can read more about SPCs in this blog post.
What is the current legal basis of SPCs for medicinal products in the EU?1
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.
Background to the case1
- Genmab is the holder of the European patent EP 328 4753, designating the Republic of Hungary.
- That patent, entitled ‘Human monoclonal antibodies against CD20 for the treatment of multiple sclerosis’ (‘the basic patent’), is currently in force in Hungary and covers, inter alia, the active ingredient ‘ofatumumab’.
- Genmab marketed its first medicinal product, Arzerra, containing this active ingredient used in a therapy for untreated chronic lymphocytic leukaemia.
- On 21 April 2010, Genmab was granted an MA for that medicinal product (‘the prior MA’). However, it withdrew that MA on 27 February 2019.
- On 29 March 2021, Genmab was granted an MA for the medicinal product Kesimpta of which ofatumumab is also the active ingredient (‘the subsequent MA’). That medicinal product is indicated for the treatment of relapsing-remitting multiple sclerosis.
- On 7 July 2021, on the basis of the basic patent and the subsequent MA, Genmab applied to the National Intellectual Property Office for a Supplementary Protection Certificate (SPC).
- That application was rejected on the basis that the subsequent MA was not the first MA, as provided for in Article 3(d) of Regulation No 469/2009, for ofatumumab
What was the basis for the rejection of the SPC application for Kesimpta by the National Intellectual Property Office, Hungary?1
Arzerra and Kesimpta had an identical active ingredient, namely ofatumumab, and the only difference between the two medicinal products lies in their respective therapeutic indications.
- Relying on the judgments of 21 March 2019, Abraxis Bioscience (C‑443/17, ‘the Abraxis judgment’, EU:C:2019:238) and of 9 July 2020, Santen (C‑673/18, ‘the Santen judgment’, EU:C:2020:531), the National Intellectual Property Office took the view that it is the identical nature of the active ingredients rather than the difference in therapeutic applications that is decisive for the purposes of Article 3(d) of Regulation No 469/2009 in identifying which is the first MA within the meaning of that provision.
- Accordingly, the prior MA (for the product Arzerra) should have been regarded as the first MA.
- It was irrelevant that it had been withdrawn and that it was no longer in force on the date when the application for an SPC was lodged, because the question as to when a given MA can be regarded as the first MA would depend only on the definition of the ‘product’.
What did Genmab do following the rejection of the SPC request National Intellectual Property Office, Hungary?1
Genmab brought an appeal before the Budapest High Court, the referring court, against the decision of the National Intellectual Property Office.
What was Genmab’s reasoning in bringing the appeal before the Budapest High Court, the referring court?1
- Genmab submits that the first MA, within the meaning of Article 3(d) of Regulation No 469/2009, can only be an MA in force on the date of lodging the application for an SPC.
- The National Intellectual Property Office was therefore wrong to hold that the first MA for the product ofatumumab as a medicinal product, was the MA which had been granted for the medicinal product Arzerra because that MA was no longer in force on the date of lodging the application for the SPC.
- The Abraxis and Santen judgments are irrelevant, since neither address the question of the validity of the prior MA.
- Genmab submits, moreover, that in the cases that gave rise to those judgments, the MAs in question were in force.
- Genmab refers to the English-language version of Article 3(b) and (d) of Regulation No 469/2009, which would make the granting of the SPC conditional on a valid and first MA on the day of lodging the application for that certificate.
- Such an interpretation is confirmed by the German- and French-language versions of those provisions.
- Genmab points out that in the present case, the subsequent MA was the first relevant MA, within the meaning of Article 3(d) of that regulation, since, at the date on which the application for the SPC was lodged, it was the only MA in force for the active ingredient ofatumumab, as a medicinal product, in Hungary.
Deliberations of the Budapest High Court1
The referring court essentially endorses Genmab’s line of argument.
- It points out that the Court of Justice has previously been asked about cases in which the SPC applications in question concerned medicinal products containing the same active ingredient as another medicinal product which has a prior MA and which is only distinguished from that medicinal product by its therapeutic indications or by the composition of that active ingredient.
- However, in those cases, all the MAs were still currently valid.
- Accordingly, the Court had not yet addressed the question of which MA must be regarded as the first MA for the product in question as a medicinal product, within the meaning of Article 3(b) and (d) of Regulation No 469/2009, where that product was already covered by a prior MA, but that MA has been withdrawn.
Why was the Budapest High Court uncertain about the concept of ‘first MA for the product’?1
- While noting that the Hungarian-language version of the wording of Article 3(b) of Regulation No 469/2009 does not contain the equivalent of the English-language term ‘valid’, the referring court is nevertheless of the view that a teleological interpretation of that provision suggests that only the speciality medicinal products containing the active ingredient in question which are actually on the market on the date on which the application for an SPC is lodged must be taken into consideration.
- That interpretation follows from paragraph 55 of the Santen judgment, according to which the EU legislature intended, in establishing the SPC regime, to protect not all pharmaceutical research giving rise to the grant of a patent and the marketing of a new medicinal product, but to protect research leading to the first placing on the market of an active ingredient or a combination of active ingredients as a medicinal product.
- That being the case, in view of the diametrically opposed views held by Genmab and the National Intellectual Property Office, the referring court is uncertain as to the correct interpretation of the concept of ‘first MA for the product’.
What did the Budapest High Court do in view of its uncertainty about the correct interpretation of of the concept of ‘first MA for the product’?1
In those circumstances, the Budapest High Court decided to stay the proceedings and to refer the following question to the Court of Justice for a preliminary ruling:
‘Must Article 3(b) and (d) of [Regulation No 469/2009] be interpreted as meaning that [an MA] predating the [MA] appearing in the application for [an SPC] and referring to the same product must be regarded as the first [MA] for the purposes of that regulation, even where that prior [MA] was withdrawn prior to the submission of the application for the [SPC]?’
By its single question, the referring court asks, in essence, whether Article 3(d) of Regulation No 469/2009 must be interpreted as precluding the MA submitted in support of an application for an SPC for a product from being regarded as the first MA, within the meaning of that provision, if a prior MA was granted for that same product but was withdrawn before the application for the SPC was submitted.1
What was the preliminary ruling of the CJEU1
On 16 July 2024, The Court (Eighth Chamber) ruled:
Article 3(d) 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, as amended by Regulation (EU) 2019/933 of the European Parliament and of the Council of 20 May 2019
must be interpreted as precluding the marketing authorisation submitted in support of an application for a supplementary protection certificate for a product from being regarded as the first marketing authorisation, within the meaning of that provision, if a prior marketing authorisation was granted for that same product but was withdrawn before the application for the supplementary protection certification was submitted.
It is well worth reading the conclusions and lessons learned in a write up on this case by Fernand de Visscher et al of Simont.4
You can read the details of the case up to the preliminary ruling in full here.
References
2. COMMISSION STAFF WORKING DOCUMENT: EVALUATION of the Regulation (EC) No 469/2009 of the European Parliament and of the Council concerning the supplementary protection certificate for medicinal products, and Regulation (EC) No 1610/96 of the European Parliament and of the Council concerning the creation of a supplementary protection certificate for plant protection products. {SWD(2020) 293 final}
3. Economic Analysis of Supplementary Protection Certificates in Europe – Margaret Kyle January 30 2017
4. CJEU clarifies “First” Marketing Authorization in SPC Applications, Fernand de Visscher et al , 24 September 2024 Simont – Braun
Further reading:
1. Preliminary ruling proceedings – recommendations to national courts -Eurlex