Pharma companies will have a tougher time extending the patents for some of their products following a judgment by the European Court of Justice.
As an effect of the 4 May 2006 ruling pharma companies will not be able to file so-called supplementary protection certificate (SPC) for a number of products. This will enable generics makers that produce cheaper versions of drugs, for which the patents have expired, to enter the market at an earlier time.
In the case, the Massachusetts Institute of Technology (MIT) had asked for an SPC for a drug used to treat brain cancer. The product was an implanted wafer releasing a combination of an active chemotherapy agent (carmustin) and a second composite (polifeprosan) controlling the release of the first substance into a patient’s body. MIT argued that this constitutes a “combination of active ingredients of a medicinal product”. Under Article 1 (a) of Council Regulation 1768/92, this would qualify it for extended patent-like protection by an SPC for another five years.
In France and the UK, the SPC was granted, but the German Patents and Brands Office refused it in 2001, arguing that combinations of drugs qualify for SPC only if both components are active. MIT appealed against that decision with the German Federal Court of Justice. This highest appellate court in Germany suspended the case and referred the question whether a non-active component can be part of a “combination of active ingredients of a medicinal product” to the European Court of Justice.
The European Court of Justice ruled that this was not the case and that the wording “combination of active ingredients” is to be taken literally. It ruled that SPCs can not apply to two ingredients “only one of which has therapeutic effects of its own”, while the other renders “possible a pharmaceutical form of the medicinal product which is necessary for the therapeutic efficacy of the first substance”.
According to research commissioned by EGA, the European Generics Association, more than 8,000 SPCs for medicinal and plant protection products have been filed in Europe between 1991 and 2003.