IP opportunities in drug repurposing

Drug repurposing – the strategy for developing a new clinical application of a known investigational drug or drug approved for a different indication – bears high potential for patients. Even in cases where the drug compound already underwent extensive clinical investigation, repurposing such a drug will still involve significant investments. For example, clinical trials relating to the new indication are to be conducted. One way to secure investments in the development of a new indication, is to seek patent protection. Patent protection may be particularly important in situations where regulatory exclusivity periods will be limited. In many jurisdictions around the world, so-called further medical uses of a known drug can be patented. These possibilities are not limited to applications in a truly different therapeutic area; in general, the application of a drug for a new sub-indication, the treatment of a new patient group (including stratification) and/or new therapeutic regimens may be subject to patent protection, although there are significant differences across jurisdictions as to what is possible exactly. Patents for such medical use inventions can be based on any type of supporting data. In those situations where clinical trial data is needed, timing is of the essence, given that clinical trial protocols typically enter the public domain before results actually become available. Patent systems around the world accommodate for the intrinsic difficulties associated with (clinical) drug development. In order to make use of the possibilities in an optimal way it is essential to think of the patenting strategy early on in the process. Ideally, the patenting strategy is already part of the pre-clinical development phase and certainly factors into the preparations for first in man trials, including clinical trial protocol drafting.