Patents: no supplementary protection certificate for second medical use

By Audrey Horton


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

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