Grand Chamber of the Court of Justice rules on Supplementary Protection Certificates

21/09/18

One of the problems with the patent system is that a long period of time can elapse between filing an application for a patent for a new drug and the product obtaining marketing authorisation. As patents generally only last 20 years from filing, many medicinal products only get a fraction of the period of protection given the time needed to undergo clinical trials. The EU legislature therefore introduced a supplementary protection certificate regime in order to provide for an additional period of patent-like protection where there has been a delay in granting marketing authorisation.

Under the present legislation (Regulation (EC) 469/2009) it is necessary for the product to be “protected by a basic patent in force” at the time of application for the SPC. The Court of Justice has ruled a number of times on the meaning of that phrase over the last 15 years. Case C-121/17 Teva v Gilead was heard by the Grand Chamber of 15 judges following a reference from the English court which highlighted some of the inconsistencies in that case law.

The Teva case concerned a product described in the SPC as ‘Composition containing both Tenofovir disoproxil… together with Emticitabine’. It covers a product sold by Gilead called Truvada which is an anti-retroviral medication used in the treatment of HIV. Gilead claimed that the combination of products described in the SPC was protected by the basic patent but Teva and a number of other generics companies disputed that.

The Grand Chamber ruled at the end of July that, even if the combination is not expressly mentioned in the claims of the patent, a product can still be “protected by a basic patent in force” if the claims of the patent relate necessarily and specifically to the combination. Each of the active ingredients must be specifically identifiable in the light of all the information disclosed by the patent.

Yesterday Mr Justice Arnold gave judgment on the effect of the CJEU ruling. He held that “In a nutshell, what the Court is saying is that the purpose of the SPC Regulation is to enable the holder of the basic patent to obtain supplementary protection for what the patentee actually invented and not for what the patentee did not invent” but noted that the court had used language derived from patent law in its ruling but not in accordance with its usual meaning in that field.

The CJEU judgment is here.

The Arnold J judgment is here.