The European Court of Justice (ECJ) has held that a supplementary protection certificate (SPC) cannot be granted for a different application of the same product for which an earlier marketing authorisation (MA) had been granted.
The purpose of an SPC is to re-establish a sufficient period of effective protection of the basic patent by permitting the holder to enjoy an additional period of exclusivity on the expiry of that patent. This is intended to compensate, partly, for the delay to the commercial exploitation of an invention caused by the time elapsed between the date on which the application for the patent was filed and the date on which the first MA in the EU was granted.
The grant of an SPC is governed by the SPC Regulation (469/2009/EC) (2009 Regulation). Article 1(b) of the 2009 Regulation (Article 1(b)) defines "product" as the active ingredient or combination of active ingredients of a medicinal product. "Basic patent" means a patent which protects a product, a process to obtain a product or an application of a product, and which is designated by its holder for the purpose of the procedure for grant of an SPC.
An SPC may be granted if, in the EU member state in which the application is submitted and at the date of that application, the product is protected by a basic patent in force, a valid MA has been granted, and that MA is the first to place the product on the market as a medicinal product (Article 3(1), 2009 Regulation) (Article 3).
The protection conferred by the SPC only extends to the product covered by a MA in the member state where SPC protection is being sought and for any use of the product that has been authorised before expiry of the SPC (Article 4, 2009 Regulation).
In Neurim Pharmaceuticals (1991) Ltd v Comptroller-General of Patents, the ECJ held that the mere existence of an earlier MA obtained for a veterinary medicinal product did not preclude the grant of an SPC for a different application of the same product for which an MA was granted, provided that the application was within the limits of the protection conferred by the basic patent (C-130/11).
S obtained an MA in 2015 for a medicinal product, the active ingredient of which was ciclosporin used to treat severe keratitis. S applied for an SPC on the basis of the basic patent protecting the medicinal protect and this MA.
The French intellectual property office rejected S's application on the grounds that the MA was not the first MA, for the purpose of Article 3, for ciclosporin. An MA had been granted in 1983 for a medicinal product which also had ciclosporin as its active ingredient for other therapeutic indications. S appealed.
The French Court of Appeal referred questions to the ECJ on the interpretation of Article 3.
The ECJ held that Article 3 should be interpreted as meaning that an MA cannot be considered to be the first MA where it covers a new therapeutic application of an active ingredient, or of a combination of active ingredients, and that active ingredient or combination has already been the subject of an MA for a different therapeutic application.
The first question was whether the concept of a "product" in Article 1(b) was dependent on the therapeutic application of the active ingredient and, in particular, whether a new therapeutic application of an active ingredient might be considered to be a product distinct from a different, already known, therapeutic application of the same active ingredient. The court held that the term "product" in Article 1(b) was not dependent on the manner in which that product was used, and the intended use of the medicinal product did not constitute a decisive factor for the grant of an SPC.
The second issue to be determined was whether an MA granted for a new therapeutic application of an active ingredient or of a combination of active ingredients might be regarded as being the first MA granted for that product as a medicinal product, for the purpose of Article 3. In the light of the strict definition of the term "product" within the meaning of Article 1(b), the analysis of the wording of Article 3 presupposed that the first MA for the product as a medicinal product meant the first MA for a medicinal product incorporating the active ingredient or the combination of active ingredients at issue, irrespective of the therapeutic application of that active ingredient, or combination of active ingredients, in respect of which that MA was obtained. It followed that, contrary to the decision in Neurim, when defining the concept of the first MA for the product as a medicinal product for the purpose of Article 3, there was no need to take into account the limits of the protection of the basic patent.
This interpretation was confirmed by an analysis of the objectives of the 2009 Regulation. The EU legislature intended, in establishing the SPC regime, not to protect all pharmaceutical research giving rise to the grant of a patent and the marketing of a new medicinal product, but rather to protect research leading to the first placing on the market of an active ingredient or a combination of active ingredients as a medicinal product. That objective would be undermined if it were possible to take into account solely the first MA to fall within the limits of the protection of the basic patent covering a new therapeutic application of a given active ingredient or combination of active ingredients, and to disregard an MA which had been granted previously for a different therapeutic application of the same active ingredient or combination.
This decision has ended the uncertainty caused by Neurim. The court here adopted a strict construction of the term "product", concluding that, for any active pharmaceutical ingredient or combination of active ingredients, only the first use for such ingredient or combination authorised by an MA may be granted an SPC.
Case: Santen SAS v Directeur général de l'Institut national de la propriété industrielle C 673/18.
First published in the September issue of PLC Magazine and reproduced with the kind permission of the publishers. Subscription enquiries 020 7202 1200.