The recent judgments of the European Court of Justice (July 28th), issued as a result of some interesting questions put by the High Court of Justice (England & Wales), serve as a base for correct enforcement of Article 2 of the Council Regulation (EEC) No. 1768/92, which governs the area of application of Supplementary Protection Certificates (herein SPC).
The subject of the litigation was a drug substance, galantamine, which has been used in the pharmaceutical industry to treat neuromuscular diseases for more than forty years. This drug substance received marketing authorization (MA) in Austria in 1963, granted under the Austrian 1947 medicines regulations, which did not comply with Directive 65/65.
Later, the same drug substance obtained a MA in Germany under its 1976 regulation on medicines, implementation of German directive 65/65, automatically granting a MA, with the sole requisite of prior notification.
Subsequent to this, a medicine containing the same drug substance, galantamine (known as "Nivalin") was launched in Sweden in 1999, to obtain a MA in accordance with all the criteria in directive 65/65, which was granted in March 2000. It was on the basis of this Swedish MA that on 7 December 2000, an application was made to the UK Patents Office for an SPC for galantamine. The basic patent expiry date was 16 January 2007 and the SPC was granted with a term of five years until January 2012.
Taking the view that the SPC’s date of expiry had not been calculated correctly a drug company brought an action for rectification of the register of patents. The case was heard by the High Court of Justice (England & Wales), which referred the questions to the ECJ for judgment.
In its judgment, the ECJ stated that the extended protection afforded by the SPC as a method of offsetting the reduction in the effective protection term provided by the patent (20 years), and due to the proof required by Directive 65/65, was not applicable to galantamine or memantine. This is not because marketing in the European Union began without having undergone safety and efficacy tests which, according to Directive 65/65, are mandatory.
The relevancy of the judgments on galantamine (and the memantine analogue) is that it eliminates the possibility of obtaining temporary extended protection (via SPC) in cases where the specific testing for obtaining a MA, and therefore the subsequent delay in marketing, have not been enforced.