CJEU clarifies “First” Marketing Authorization in SPC Applications

A Supplementary Protection Certificate (SPC) is an intellectual property right that serves as an extension to a patent right. It extends patent protection for medicinal products which must undergo testing and clinical trials before being authorised to be placed on the EU market. SPCs can last for up to five years, depending on the time needed for the testing and trial period. As an SPC certificate gives the same exclusive rights as the basic patent does, manufacturers usually rely on such IP right to secure an extension of their market exclusivity and to recoup the research and development investments.

SPCs are granted under strict cumulative conditions set out in Article 3 of the SPC Regulation (Regulation 469/2009):

1. the product is protected by a basic patent in force;
2. a valid Marketing Authorisation (MA) in respect of the product has been granted;
3. the product has not already been the subject of an SPC; and
4. the MA referred to in point (b) is the “first” MA for that product.

On 16 July 2024, the Court of Justice of the European Union (the CJEU) handed down a significant judgment on the interpretation of Article 3(d) of the SPC Regulation. The CJEU had to address the question of which MA should be regarded as the “first” MA for a medicinal product where the product was covered by a prior MA that had since been withdrawn.

BACKGROUND OF THE CASE

Genmab is the holder of EP 328 4753 (entitled “Human monoclonal antibodies against CD20 for the treatment of multiple sclerosis“; the Patent), in force in Hungary, which covers, inter alia, the active ingredient “ofatumumab”. On 21 April 2010, Genmab was granted an MA for Arzerra, its first medicinal product containing “ofatumumab”, which was indicated for the treatment of chronic lymphocytic leukaemia (the Prior MA). However, Genmab withdrew the Prior MA on 27 February 2019.

On 29 March 2021, Genmab was granted an MA for the medicinal product Kesimpta, which was indicated for the treatment of multiple sclerosis and had “ofatumumab” as the sole active ingredient (the Subsequent MA).

On 7 July 2021, on the basis of the Patent and the Subsequent MA, Genmab applied for an SPC covering the active ingredient “ofatumumab” in Hungary. The Hungarian National Intellectual Property Office(the Hungarian IPO) rejected this application, stating that the Subsequent MA was not the first MA for “ofatumumab” as required by Article 3(d) of the SPC Regulation. The Hungarian IPO held that the Prior MA should be regarded as the first MA even though it had been withdrawn and was no longer in force when the SPC application was lodged.

Genmab appealed against this decision to the Budapest High Court arguing that, within the meaning of Article 3(d) of the SPC Regulation, the first MA can only be an MA in force on the date of the SPC application, relying on the word “valid’ in Article 3 (b) of the SPC Regulation. The Budapest High Court stayed proceedings and referred the following question to the CJEU: “Must Article 3(b) and (d) of [the SPC Regulation] be interpreted as meaning that [an MA] predating the [MAJ appearing in the application for [an SPC] and referring to the same product must be regarded as the first [MAJ for the purposes of [the SPC Regulation], even where that prior [MA] was withdrawn prior to the submission of the application for the[SPC]?”.

The CJEU’S RULING

The CJEU held that Article 3(d) of the SPC Regulation precludes the MA submitted in support of an application for a SPC for a product from being regarded as the first MA, within the meaning of that provision, when a prior MA was granted for that same product notwithstanding this prior MA was withdrawn before the application for the SPC.

The CJEU ruled that according to (i) the wording of Article 3(d) of the SPC Regulation, (ii) the context in which that provision was set, (iii) the objectives pursued by the EU legislature, and (iv) the legislative history of the Regulation, the condition laid down in that provision is to be considered as an objective chronological criterion under which the first MA for the product, within the meaning of that provision, refers to the MA which was granted on the earliest date for that product, regardless of whether or not that MA is still in force. According to the Court, it was clear from the wording of Article 3 (d) that account must be taken of all MAs granted for the product before the date of lodging the SPC application.

The Court based this strict interpretation of Article 3(d) of the SPC Regulation on the objectives of the SPC Regulation, which are to protect research leading to the first MA of an active ingredient.

CONCLUSIONS AND LESSONS LEARNED

The CJEU held that Article 3(d) of the SPC Regulation must be interpreted as referring to the earliest MA granted for a product. This applies even in the situation where a prior MA was granted for the product but withdrawn before the SPC application was submitted.

Therefore, when navigating the SPC system, pharmaceutical companies should keep in mind the strict interpretation of the SPC Regulation, which does not allow them to obtain a new SPC even for a new therapeutic application and even when the first MA is withdrawn. Since the earliest MA, regardless of its status at the time of the SPC application, is the decisive factor, simply withdrawing a prior MA is not sufficient to secure a SPC for another version or therapeutic indication of a same product.