CMC and clinical patent strategy and execution

Within CMC development as well as clinical development it is imperative to have the appropriate patent strategy in place and that it is fully implemented. The reasons being that :

  • You will be testing a lot of solutions and doing lots of decisions – all involving and crystallizing lots of patentable subject matter.
  • Publication of parts of your CMC and clinical development is likely to follow from regulatory law and perhaps even internal business and science functions – a red flag reminding you of when to file your patents.
  • Your competitors are likely to follow and map your trail of publications and you should not leave your competitors room to act prior to your own actions.

CMC and clinical development are expensive and time consuming, hence you would like to :

  • benefit from your R&D by patent protection, and 
  • not having to repeat or discard part of it due to competitor patents or publications preventing patent protection. 

We assist clients in setting up and implementing CMC and clinical patent strategies, as well as improvement activities to existing strategies.

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