The Advocate General (AG) has delivered an opinion on the interpretation of Article 3 of the Supplementary Protection Certificate (SPC) Regulation (469/2009/EC) (2009 Regulation) (Article 3).
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 marketing authorisation in the EU was granted.
The grant of an SPC is governed by the 2009 Regulation. Article 1(b) of the 2009 Regulation 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 a certificate.
Article 3 provides that a certificate shall 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.
The European Court of Justice (ECJ) has held that a product composed of several active ingredients with a combined effect may be protected by a basic patent in force under Article 3(a) where, even if that combination was not expressly mentioned in the claims, those claims related necessarily and specifically to that combination (Teva two-part test) (Teva UK Ltd and others v Gilead Sciences Inc, see News brief "Patents: interpretation of Supplementary Protection Certificate Regulation", www.practicallaw.com/w-016-3653).
Markush claims represent large classes of compounds by means of a structural formula (Markush formulae). Under the European Patent Office (EPO) guidelines, Markush formulae can properly be used where the alternatives are of a similar nature, having a common property or activity and a common structure, for example, a significant structural element shared by all the alternatives.
G owned an SPC for a product marketed in Europe used in an anti-retroviral medication for the treatment of HIV and AIDS. The claims of the basic patent were based on a Markush formula. The estimated number of compounds covered by claim 1 of the patent was extremely large, but the number of compounds specifically disclosed was approximately 100. There was no reference to the product anywhere in the specification.
S brought proceedings to clear the way for the marketing of a generic product before the expiry of G's SPC. S argued that on the true construction of Article 3(a), it was not a product protected by the patent.
The Patents Court held that it was a product protected by the patent. S appealed, arguing that, given the large number of compounds covered by the claim the Teva two-part test was not satisfied.
The Court of Appeal stated that, as Teva related to a medicinal product composed of several active ingredients, it was unclear whether the Teva two-part test was applicable to medicinal products composed of a single active ingredient. It stayed the proceedings and referred questions to the ECJ on the interpretation of Article 3(a), in particular for clarity in the present situation with a single active ingredient product and Markush formula claims, whether the test should be that a skilled person considering the claims on the one hand and the structure of the product in question would immediately recognise that the active ingredient in question was one of those specified by the formula (an infringement analysis), or whether the specific substituents necessary to form the active ingredient of the product must be amongst those which the skilled person could derive, based on their common general knowledge, from a reading of the claims in the patent (a disclosure analysis).
In the AG's opinion the Teva two-part test applied both to products consisting of a single active ingredient and products composed of several active ingredients. The concept of the core inventive advance of the patent did not apply and was of no relevance in the context of Article 3(a).
Article 3(a) did not preclude the grant of an SPC for an active ingredient which was covered by a functional definition or a Markush formula provided that the Teva two-part test was satisfied. The Teva test is technologically neutral in nature: the form of a claim, whether functional or a Markush formula, is not relevant provided it satisfies the test.
The Teva two-part test must be applied from the point of view of a person skilled in the art and on the basis of the prior art at the priority date of the basic patent.
The first part of the Teva two-part test was not satisfied in respect of a product if, from the point of view of a person skilled in the art and on the basis of the prior art at the priority date of the basic patent, the claims in a patent in relation to that product were not required for the solution of the technical problem disclosed by a patent. In other words, the claims must provide the inventive advance: the description and drawings alone are not enough.
The second part of the Teva two-part test required that although the product does not have to be "specifically identifiable" in the claims, a person skilled in the art would have been able, in the light of all the information contained in a patent, on the basis of the prior art at the priority date of the patent in question, to derive the product in question. This was not so where, in the light of all the information contained in a patent, a product or constituent element of the product remained unknown to a person skilled in the art on the basis of the prior art at the priority date of the patent.
Unlike the referring courts, the AG considered that Teva was clear. The AG's opinion highlights once again a disclosure test in establishing whether a product is covered by the claims of a patent, rather than an infringement-based analysis. The message from the AG is that the Teva two-step test should be applicable to any form of claim, here a Markush formula, and cover both single and combination products.
Case: Royalty Pharma Collection Trust v Deutsches Patent-und-Markenampt C-650/17; Sandoz Ltd and another v GD Searle LLC and another C-114/18.
First published in the November issue of PLC Magazine and reproduced with the kind permission of the publishers. Subscription enquiries 020 7202 1200