Patents: interpretation of Supplementary Protection Certificate 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 their invention by reason of 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 additional period of exclusivity is to encourage research by ensuring that the investments put into such research are covered (recital 4, 2009 Regulation).

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 of the 2009 Regulation (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.

Facts

T challenged the validity of G's SPC for a product marketed by G on the ground that it did not comply with Article 3(a) of the 200 Regulation. G's product, an anti-retroviral medication used in the treatment of human immunodeficiency virus (HIV), is a combination product consisting of two active ingredients. The claims in G's basic patent mention expressly only the first of those two active ingredients, and the second can only be covered by the phrase ‘other therapeutic ingredients’ in the relevant claim of that patent.

The Patents Court referred to the ECJ the question of:

• What criteria decide whether the product is protected by a basic patent in force under Article 3.
• What the applicable rules of patent law were for this purpose.
• Whether satisfaction of that test was sufficient to establish that a product was protected by a basic patent for the purposes of the 2009 Regulation or whether something more was required, and if so, what.

Decision

The ECJ held that Article 3 must be interpreted as meaning that a product composed of several active ingredients with a combined effect is protected by a basic patent in force where, even if the combination of active ingredients of which that product is composed is not expressly mentioned in the claims of the basic patent, those claims relate necessarily and specifically to that combination. For that purpose, from the point of view of a person skilled in the art and on the basis of the prior art at the…