The Court of Justice of the European Union (CJEU) has handled the Hungarian referral in case C-181/24 with a straightforward confirmation that an application for a supplementary protection certificate (SPC) must be based on the first marketing authorisation for the product.
In May 2024 we reported the referral by the Metropolitan Court of Hungary relating to the refusal of the Hungarian National Office of Intellectual Property to grant an SPC to Genmab on the basis of Novartis’ marketing authorisation for the antibody ofatumumab under the brand name KESIMPTA. Ofatumumab had first been authorised in April 2010 under the brand name ARZERRA, indicated for adult patients with previously untreated, relapsed or refractory chronic lymphocytic leukaemia (CLL), but that marketing authorisation was subsequently withdrawn in February 2019. Genmab’s July 2021 SPC application was filed based on the March 2021 KESIMPTA authorisation, indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS).
The question referred to the CJEU dealt with whether a marketing authorisation must still be considered the first marketing authorisation for that product even if it has been withdrawn.
REASONED ORDER
The CJEU issued a reasoned order in July 2024 that a marketing authorisation (MA) cannot be considered the first MA if there existed an earlier MA that was withdrawn before submission of the SPC application.
This confirms that the requirements of Article 3(d) of Regulation (EC) No 469/2009 (“SPC Regulation”) are absolute and objective, as the application must always be based on the first MA for the product.
The CJEU also commented that the objective of the SPC Regulation “to protect only research leading to the first MA of an active ingredient as a medicinal product... would be undermined if only the MAs in force were taken into account in order to determine the first MA for a given product. It would be sufficient to withdraw a prior MA in order to be granted an SPC for the latest marketed version of the product in question, which would allow pharmaceutical laboratories to choose which version of the product to favour. That would turn the objective criterion ... into a subjective criterion...” (paragraph 32).
COMMENTARY
Followers of SPC case law in Europe will be aware of the former CJEU decision in Neurim (C-130/11) that has since been overturned in the Abraxis (C-443/17) and Santen (C-673/18) cases, returning to a literal interpretation of Article 3(d). The Neurim decision had opened up the possibility for SPCs based on second medical uses, such that earlier MAs for different medical uses could be excluded from the assessment. With the closing of that opportunity, Genmab could not rely on the KESIMPTA MA being deemed the first falling within the scope of patent claims for a second medical use.
The CJEU’s order reinforces that the assessment of Article 3(d) should be simple and leaves little room for exceptions.
However, Article 3(d) refers back to Article 3(b) of the SPC Regulation. The CJEU gave little commentary on the interpretation of Article 3(b) that “at the date of [the SPC] application... a valid [MA] as a medicinal product has been granted...”, i.e. no clear guidance has been given whether an applicant may satisfy Article 3(b) if they refer to a MA that has been withdrawn before the date of submission of the SPC application in order to satisfy Article 3(d). Consider the scenario in which a first MA is withdrawn but a second MA is granted before the SPC application is submitted. The applicant would be obliged to refer to the first MA to satisfy Article 3(d) and could argue that Article 3(b) is satisfied because withdrawal does not change the fact that the first MA had been granted as a valid MA. Moreover, the applicant could argue that the product is nevertheless validly authorised at the date of filing the application even though it is via a second MA. Interestingly, the Hungarian language version of Article 3(b) of the SPC Regulation does not include a term corresponding to “valid”, which could be used to support the view that it does not matter for Article 3(b) if the MA has since been withdrawn. The UK Intellectual Property Office currently considers that “there appears to be no requirement that the authorisation should still be in force at the date of making the application for a certificate” (Manual of Patent Practice, SPM 3.03.3).
To some extent, reliance on multiple MAs is envisaged in Article 4 of the SPC Regulation, which permits the protection conferred by the SPC to extend to further uses of the product that are authorised before expiry of the SPC. This has also been purported to give rise to the possibility of a ‘zero-scope SPC’, i.e. one in which the medical use of a first MA is not covered by the basic patent, leaving the SPC holder to await grant of a future MA related to the basic patent in order for the SPC scope to materialise.
The SPC regulation does refer to certain scenarios in which an MA is withdrawn during its term, leading to lapse of the SPC (see Article 14 of the SPC Regulation). However, a lapsed SPC may nevertheless be revived in the event that a further MA for the product is granted (see, for example, the UK’s Manual of Patent Practice, SPM 14.06; also footnote 222 of Chapter 1 of European SPCs Unravelled: A Practitioner’s Guide to Supplementary Protection Certificates in Europe, Second Edition, ed. Ridderbusch & von Uexküll).
Hence, although the CJEU has now confirmed that an SPC application should always be based on a first MA for a given “product” regardless of whether it has been withdrawn, it may still be possible to secure SPC protection for the “product”, albeit with a reduced term.
In any event, reliance on the first MA is only one of several factors that must be considered when applying for an SPC, and in some cases the relative dates of the patent and MA will not result in any available term for an SPC.
Therefore, as withdrawal of an MA may create complications for extending exclusivity, originators should coordinate between their regulatory and intellectual property teams to avoid unwanted consequences.
Please contact our SPC and regulatory team if you have any questions about extending exclusivity for your pharmaceutical or plant protection products.
