Patenting Diagnostic Methods in Europe and Beyond

Both the European Patent Convention and the UK Patents Act exclude from patentability “diagnostic methods practised on the human or animal body”. The intention behind this exclusion is to allow medical and veterinary practitioners to act in the best interests of their patients without fear of patent infringement.  

While at first sight this exclusion appears to rule out obtaining any patent protection within the diagnostics sphere, with careful patent drafting many diagnostic inventions can still be protected. 

What cannot be patented?

Although, in Europe diagnostic methods practised on the human or animal body are excluded from patentability, methods are only excluded if they include the following four steps:

  1. the collection of data;
  2. the comparison of these data with standard values;
  3. the finding of a significant deviation during the comparison; and
  4. the attribution of the deviation to a particular clinical picture.