6. Scientific data supporting your claimed invention
Your claimed invention needs to be supported by scientific data. If you claim novel compounds, it is advisable to provide, for example, potency data for all specific compounds included in the patent application, since patent authorities around the world are strict on the inclusion of data already in the patent application as filed. It is also advisable to make a statement in the specification that the compounds of the invention have a potency within a certain numerical range.
If your invention is directed to a new medical use of a known compound, you can prove your invention on the basis of in vitro data or animal data—clinical data is not required if unavailable.
If your invention concerns, for example, a combination of two drugs, the type of data required is monotherapy data for each compound (drug) and data resulting from combining the two compounds (drug).