The Advocate General has delivered its non-binding opinion in Halozyme C-456/24. Should the European Court of Justice (CJEU) choose to follow the opinion, an ‘active ingredient’ in the context of the SPC Regulation must be determined by the classification of said ingredient in the relevant marketing authorisation.
Background
Halozyme sought SPC protection across various member states of the European Union (EU), together with the UK, for the combination of trastuzumab and rHuPH20 (recombinant human hyaluronidase PH20). The SPC application relies on European patent EP 2 163 643 and the marketing authorisation (MA) for Herceptin SC (also knowns as Herceptin Hylecta®).
Divergence on the allowability of this SPC application has emerged across the EU because different intellectual property offices have adopted a different interpretation of Article 1(b) of the SPC Regulation. Article 1(b) serves to define the ‘product’ eligible for an SPC as
“the active ingredient or combination of active ingredients of a medicinal product”.
The allowability of Halozyme’s SPC applications turns on whether a substance (rHuPH20) classified as excipient in regulatory documents, but alleged to have a therapeutic effect, can be regarded as an active ingredient per the definition of ‘product’ in Article 1(b) of the SPC Regulation. The product definition per Article 1(b) is critical as this will dictate which MA is the first MA for the purposes of Article 3(d) of the SPC Regulation. Article 3(d) requires that
“the [authorisation to place the product on the market as a medicinal product] is the first authorisation to place the product on the market as a medicinal product.”
Some patent offices, e.g. those in in Germany and Austria, considered rHuPH20 to be an active ingredient and thereby granted Halozyme’s SPC application. However, in a number of other EU countries (such as France, the Netherlands, and Ireland) the application was refused under Article 3(d) because (i) rHuPH20 was deemed not to be an active ingredient, and consequently (ii) the Herceptin SC MA is not the first MA directed to trastuzumab.
The refusal of Halozyme’s SPC application for non-compliance with Article 3(d) in the Czech Republic was appealed by Halozyme to the Supreme Administrative Court of the Czech Republic. The Supreme Administrative Court in turn referred several questions to the CJEU to seek guidance on the interpretation of Article 1(b).
The opinion of the Advocate General
The Supreme Administrative Court of the Czech Republic asked the CJEU to answer six questions. The first is the most critical to this case, and asks
“(1) Is Article 1(b) of Regulation (EC) No 469/2009 of the European Parliament and of the Council concerning the supplementary protection certificate for medicinal products to be interpreted as meaning that a substance expressly designated as an excipient, in the authorisation for a medicinal product, cannot be regarded as an active ingredient?”.
Questions 2 to 4 seek further guidance in the event that the answer to question 1 is negative, and in particular seek guidance as to the relevance of documents and evidence outside of the scope of the marketing authorisation. In brief, because the Advocate General answers the first question in the positive, questions 2 to 4 are not answered.
Questions 5 and 6 relate to Article 3(a) of the SPC Regulation (the requirement that the product is protected by a basic patent in force). The Advocate General indicates that he is under instruction from the CJEU not to answer these questions. This is likely due to the CJEU recognising that the divergence across Europe stems solely from inconsistent application of Article 1(b), rather than Article 3(a). Furthermore, the CJEU may consider that sufficient guidance on the interpretation of Article 3(a) was provided in joined cases in Teva II (C-119/22 and C-149/22; see our briefing on this decision).
Turning to the opinion in respect of question 1, the Advocate General answers firmly, “yes”. Notably, the Advocate General’s opinion does not appear to be limited to excipients-alone, but rather any substance not expressly designated as an active ingredient in the relevant MA.
The Advocate General sets out a great deal of analysis in arriving at his answer. However, the crux of the Advocate General’s reasoning stems from his opinion that the SPC regime is inextricably linked to the regulatory framework governing medicinal products and, in particular, to the Medicinal Products Directive (2001/83/EC).
The Advocate General inter alia points to Article 4 of the SPC regulation, which states that the protection conferred by an SPC ‘shall extend only to the product covered by the [MA] to place the corresponding medicinal product on the market’. Further, the Advocate General points to Recital 10 of the regulation, which is considered to likewise emphasis that SPCs should be ‘strictly confined to the product which obtained authorisation to be placed on the market as a medicinal product’.
With that in mind, the Advocate General considers it to be determinative that the Medicinal Products Directive treats ‘active substances’ and ‘excipients’ as distinct, mutually exclusive categories. This means that a substance classified as an excipient in the MA procedure cannot subsequently be reclassified as an active ingredient in the context of the SPC procedure.
Halozyme argued that the definition of a substance as an active ingredient should be reassessed autonomously in the context of the SPC procedure, principally relying on the CJEU’s earlier judgment in Forsgren (C‑631/13). The Advocate General disagreed, and further remarked that Forsgren is consistent with his line of reasoning concerning the connection between the Medical Product Directive and the SPC regulation in any event.
On the subject of evidence for potential re-classification of a substance as an active ingredient, the Advocate General notes that scientific findings which emerge after the grant of an MA, and which did not form part of its assessment, should not be taken into account for the purposes of granting an SPC.
Accordingly, taking these considerations together, the Advocate General is of the view that determination of whether a substance is an active ingredient for the purposes of the SPC Regulation must be made “exclusively” on the basis of the classification of said substance in the relevant MA. In other words, for a product to qualify as an “active ingredient” within the meaning of Article 1(b) of the SPC Regulation, the MA has to explicitly identify it as such.
Should the CJEU agree with the Advocate General’s opinion, practitioners will have greater certainty regarding the interpretation of Article 1(b) of the SPC Regulation. Such a conclusion to this case will also serve to further underline the importance of coordinating regulatory and IP strategy, particularly when SPC protection is to be sought for combination products.
We await the final decision of the CJEU in this case with interest.
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