The Metropolitan Court of Hungary (Fővárosi Törvényszék) has referred a new question to the Court of Justice of the EU (CJEU) about the requirements for obtaining supplementary protection certificates (SPCs). Joel Beevers explains what we know so far in this emergent case.
REFERRAL TO THE CJEU
The present referral (case C-181/24) relates to a case between Danish antibody therapeutics company Genmab and the Hungarian National Office of Intellectual Property. At this stage, the CJEU has only confirmed the question that has been referred:
Must Article 3(b) and (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 be interpreted as meaning that a marketing authorisation predating the marketing authorisation appearing in the application for a supplementary protection certificate and referring to the same product must be regarded as the first marketing authorisation for the purposes of that regulation, even where that prior marketing authorisation was withdrawn prior to the submission of the application for the certificate?
Initial insights suggest that the case relates to an SPC application for the antibody ofatumumab.
SUPPLEMENTARY PROTECTION CERTIFICATES
SPCs provide up to an additional 5½ years of protection after a patent has expired for a medicinal product or plant protection product and are available in most countries in geographical Europe. They are intended to provide a form of compensation for patent term that was 'lost' while the product underwent the regulatory approval process.
The legal basis for SPCs for medicinal products in the European Union (EU) and European Economic Area (EEA) is Regulation (EC) No 469/2009 (hereafter the 'SPC Regulation'). Under that Regulation, a key component of an application for an SPC is a valid marketing authorisation (MA) for the product in that territory (Art. 3(b)). In particular, that MA must have been the first authorisation to place the product on the market as a medicinal product (Art. 3(d)).
EUROPEAN MARKETING AUTHORISATIONS FOR OFATUMUMAB
Ofatumumab, under the brand name ARZERRA, received an initial 5-year conditional European marketing authorisation (MA) in April 2010, which was renewed with unlimited validity in April 2015. Glaxo Group's ARZERRA was indicated for adult patients with previously untreated, relapsed or refractory chronic lymphocytic leukaemia (CLL).
In February 2019, the European Commission accepted the voluntary withdrawal of the MA by the subsequent holder, Novartis Europharm Limited. According to the accompanying public statement, the withdrawal was based on the holder's "decision to permanently discontinue the marketing of the product [in Europe] for commercial reasons".
A new European MA for ofatumumab, now under the brand name KESIMPTA, was subsequently granted to Novartis Ireland Limited in March 2021 for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS).
THE SPC APPLICATIONS
According to the SPC database of the Hungarian National Office of Intellectual Property, Genmab filed a first SPC application (number S1200013) in July 2012 based on European patent EP1558648B1. The basic patent had an expiry date in October 2023. It appears that the SPC application was finally refused in 2021, as would have been expected following the withdrawal of the original MA.
Genmab later filed a second SPC application (number S2100026) in July 2021 based on a European divisional patent EP3284753B1 having the same October 2023 expiry date. The present referral appears to relate to an August 2023 decision of the Hungarian Office to refuse this SPC application. In view of the referred question, we speculate that the Hungarian Office considered the MA for ARZERRA to be the first MA for ofatumumab, and therefore relevant under Art. 3(d) of the SPC Regulation, but that the Court required clarification from the CJEU.
COMMENTARY
The requirements of Art. 3(d) of the SPC Regulation have been the subject of several previous referrals to the CJEU, most recently dealt with in Santen (C-673/18) in which the Court took a restrictive stance on what must be considered the first marketing authorisation for an active ingredient or combination of active ingredients. In particular, the Court reversed earlier case law that had permitted an earlier marketing authorisation to be disregarded if the later marketing authorisation related to a new therapeutic use on which the SPC application was based. In doing so, the requirements of Art. 3(d) SPC Regulation appear to be absolute: the SPC application must be based on the earliest marketing authorisation for that active ingredient or combination of active ingredients.
In many cases this means that an applicant must base their SPC application on the earliest MA concerning the active ingredient(s), even if a later MA is more relevant to their commercial product. However, some consider the combined reading of Arts. 3(b) and 3(d) to require the earliest MA to be in effect at the date of making the SPC application. In the present case, the MA for ARZERRA had been withdrawn before Genmab filed its second SPC application, which may explain why the Hungarian database shows only the details of the MA for KESIMPTA. Hence, it is for the CJEU to consider whether the SPC Regulation precludes Genmab from obtaining any SPC protection or that some reinterpretation of the legislation is warranted.
We look forward to receiving more details once the detailed request and/or referring decision of the Hungarian court is made available on the CJEU database. In any event, it is usual for the CJEU to take 1-3 years to reach a decision on referrals relating to SPCs. We will continue to monitor this case alongside other developments about SPCs across Europe.
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