Four main topics will be dealt with.

First, it will be reminded the evolution of the EPO practice with respect to second medical use claims. Modern pharmaceutical industry nowadays bases scientific research of new drugs on affinity tests with biological receptors which mediate diseases. It will be shown in the light of the four decisions T 0143/94, T 0051/93, T 0241/95 and T 0254/93 of the Board of Appeals of the EPO that some answers can be given as to the patentability of claims pertaining to functionally defined drugs or diseases as well as of claims pertaining to pharmacodynamic inventions.

Secondly, the patentability of combinatorial libraries will be discussed in the light of ten years of practice at the EPO. Combinatorial libraries have been and are still used in pharmaceutical research. They are the material expression resulting from the consequences of the finding that most of the drug candidates are eliminated upon the first pharmacological tests. Why then test drug candidates separately and not together, in a batch? It may be more efficient to test a mixture or a cascade of products rather than separate compounds when the chance of success is low. The different types of combinatorial libraries will be determined and the patentability of the underlying inventions will be discussed, whereby it will appear that only methods of screening based on the use of such libraries have a reasonable chance of benefiting of patent protection.

Thirdly, the possibility of protection of bioinformatical inventions will be reviewed. The difficulties of doing so will be analysed. It will shown that a process for determining any drug capable of docking on a receptor is practically difficult to protect for the main following reasons: the conditions necessary for characterising such a process are difficult to fulfil as they require inter alia

1. An unambiguous definition of the critical docking site

2. A 3-D spatial definition of the latter as well as

3. An indication of the affinity degree which must be achieved

4. A demonstration of the feasibility of the process (at least one molecule new for the use found).

Fourthly, an attempt will be made to answer the question “What should be the interpretation of claims relating to a few classical pharmaceutical and biopharmaceutical claims?”. Concrete tentative examples in the field of classical pharmacy and biopharmacy will be given after a short reminder of the basic rules for the interpretation of European Patent under Art. 69 EPC.