Halozyme, Case no. C-456/24
Does the inclusion of a substance in the category of excipients in the marketing authorisation for a medicinal product exclude the possibility of that substance constituting an active ingrediënt?
The referring court is hearing an appeal in cassation brought by Halozyme, Inc. (‘the appellant’) against the judgment of the Prague City Court, dismissing the appellant’s action challenging the decision of the President of the Industrial Property Office, which upheld the Office’s decision to reject the appellant’s application for an SPC in respect of patent CZ/EP 2163643 for the product Herceptin SC, which was placed on the market as a medicinal product.
Subject matter and legal basis of the request
The referring court entertains doubts as to the interpretation of Regulation No 469/2009 in relation to the question of whether Herceptin SC constitutes a combination of two active ingredients and whether that combination of active ingredients is protected under patent CZ/EP 2163643. In that regard, the referring court submits six questions.
Questions referred
(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?
(2) If the answer to question 1 is in the negative, is Article 1(b) of Regulation No 469/2009 to be interpreted, in the light of Article 8(1) and Article 10(1) to (3) of that regulation, as meaning that a substance must be deemed to constitute an active ingredient if it has a therapeutic effect of its own which is included in the therapeutic indications of the marketing authorisation and which is also demonstrably identifiable from the basic patent and the documents mandatorily presented with the application for a certificate?
(3) If the answers to questions 1 and 2 are negative, is Article 1(b) of Regulation No 469/2009 to be interpreted as meaning that a substance must be deemed to constitute an active ingredient if it has a therapeutic effect of its own which is included in the therapeutic indications of the marketing authorisation and that a person skilled in the art would identify as documented as of the date of the basic patent application or the date of priority of that patent?
(4) Is Article 1(b) of Regulation No 469/2009 to be interpreted as meaning that, inter alia, an excipient must be deemed to constitute an active ingredient with a therapeutic effect of its own which is included in the therapeutic indications in the authorisation of a medicinal product for treating breast cancer, if it breaks down another substance that occurs naturally in the human body, thereby facilitating the effects of the product’s main active ingredient on cancerous cells in breast cancer, if, according to certain studies and scientific articles, that excipient or a substance related thereto has resulted, in and of itself, in vitro or in animal models, in arresting the growth of tumours of the same as well as another type, or to the shrinkage thereof, and if other scientific articles confirm its potentially similar effect in humans?
(5) Is Article 3(a) of Regulation No 469/2009, in conjunction with Article 1(b) thereof, to be interpreted as meaning that a product protected by a basic patent must also be deemed to include a combination of two active ingredients, if the subject of the invention to which the basic patent applies is only one of the two ingredients and the patent claims include its potential combination with other alternatively specified categories of active ingredients, one of which may include the other active ingredient, according to the opinion of a person skilled in the art based on the state of knowledge as at the date of the basic patent application or the priority date of that same patent?
(6) If the answer to question five is negative, is Article 3(a) of Regulation No 469/2009, in conjunction with Article 1(b) of that regulation, to be interpreted as meaning that a product protected by the basic patent may be considered as including a combination of two active ingredients, if the subject of the invention to which the basic patent applies is only one of the two substances and the patent claims include its potential combination with other alternatively specified categories of active ingredients, one of which included the only active ingredient that was the subject of the authorisation for the medicinal product, regardless of whether there were, as at that date, other substances falling into that same category?
The summary of the request for a preliminary ruling can be read in various languages here.
