Patents: SPC for combination product

Summary

The Patents Court has held that a Supplementary Protection Certificate (SPC) for a combination product was invalid, following a ruling from the European Court of Justice (ECJ) on the meaning of Article 3 of the Supplementary Protection Certificate Regulation (469/2009/EC) (2009 Regulation) (Article 3).

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 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

G produced a medicine which consisted of two active ingredients. The claims in G's basic patent mentioned expressly only the first of those two active ingredients, and the second was only covered by the phrase "other therapeutic ingredients".

T challenged the validity of G's SPC on the ground that it did not comply with Article 3.

The Patents Court referred questions to the ECJ on the interpretation of Article 3.

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 (www.practicallaw.com/w-016-3653).

Following the ECJ ruling, T applied for final judgment in its favour.

G applied for permission to adduce further expert evidence and directions for a second trial.

Decision

The court refused G's application and held that the SPC was invalid and had to be revoked.
The two-part test was not a pure extent of protection test. More was required than that the product fell within the scope of the claim. The claims of a patent, and the issue whether the product which was the subject of the SPC necessarily fell under the invention covered by that patent, had to be interpreted from the perspective of a person skilled in the art, on the…