According to Regulation 1768/92/EEC supplementary protection certificates (SPCs) can be granted for novel medicines. They are intended to compensate for the reduced effective lifetime of patents covering such medicines.
Article 3 of the Regulation stipulates that an SPC shall be granted if the "product" is protected by a basic patent, has obtained marketing authorization and has not already been the subject of an SPC or of an earlier authorization. The "product" is defined in Article 1(b) of the Regulation as "the active ingredient" or "combination of active ingredients" of a medicinal product.
In the absence of a legal definition, it has hitherto been assumed that an "active ingredient" has to be understood as (a) pharmacologically active compound(s), which means that SPCs would only cover novel and first-to-the market drugs.
However, the German Surpreme Court (BGH) recently referred the question to the European Court of Justice (ECJ), i.e. whether a "combination of active ingredients" necessarily means at least two pharmacologically active compounds, or whether this term also covers the situation where one component exerts its pharmacological effect only when combined with another substance providing no pharmacological effect as such.
The case in question concerns the preparation "Gliadel" which is protected by European Patent 0 260 415. "Gliadel" comprises the cytotoxic drug carmustine embedded in a matrix made from the polymer polifeprosan.
The Federal Patent Court had rejected the SPC, stating that Gliadel did not comprise a combination of active ingredients but was rather an example of a new formulation for the already known active carmustine. The Court held that even if polifeprosan ensured the constant delivery of therapeutic amounts of carmustin, it would not act as an "active ingredient", but as an excipient.
The BGH referred the above questions to the EJC since the authorities in the UK, France and the Netherlands had interpreted the term differently and granted SPCs on Gliadel.
If the EJC decides that polifeprosan and carmustin constitute a "combination of active ingredients", this will pave the way at least for SPCs on novel formulations with a therapeutic advantage for a known drug. For the time being, patentees should thus seriously consider to request SPCs not only for new drugs, but also for novel formulations.
To discuss these topics further, please feel free to contact the authors Dr. Dirk Bühler (email@example.com) and Dr. Holger Glas (firstname.lastname@example.org) of Maiwald Patentanwalts GmbH (www.maiwald.de), Munich, Germany.
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