Patents: interpretation of SPC Regulation

Background

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.

Facts

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…