European Patent Office (EPO) guidance on what methods of medical treatment can be protected was given just over 10 years ago (15 February 2010) on a case filed in 2007 (G 0001/07).
We were advised a medical method which “encompasses an invasive step representing a substantial physical intervention on the body which requires professional medical expertise to be carried out and which entails a substantial health risk” (even when carried out with the required professional care and expertise) is excluded from patentability. The exclusion operates via Article 53(c) EPC which prevents the patenting of methods for the treatment of the human or animal body by surgery or therapy.
Following this guidance, patent attorneys have been mindful to ensure any patent applications to protect medical methods did not include any step practised on the human body.
More recently, granted patent EP 1,901,676 was opposed and whilst the opponent withdrew from the opposition the EPO decided to continue with the proceedings of its own motion, which it is entitled to do, and so re-visit the Article 53(c) EPC exclusion.
In this granted patent, the claimed invention concerned dentistry and in particular replacing tooth parts using dental impressions and curable tooth replacement material. Whilst the claims of the granted patent focused on a method involving the production of the replacement tooth part from two complimentary impressions, the EPO decided that the method described in the application as a whole actually involved work on a patient’s tooth before the impressions could be made and the replacement tooth created. This meant that the preparation of the patient’s tooth formed part of the protected method, whether or not it was an explicit part of the claims. It also meant the claimed method involved a physical intervention on the human body (a tooth) clearly requiring professional medical expertise (a dentist). In these circumstances, the EPO ruled the Art. 53(c) EPC exclusion applied because the claimed invention necessarily involved a step of treatment by surgery.
This decision, given on 31 July 2020, indicates when considering the Art. 53(c) EPC exclusion, the EPO places emphasis on the actual working of the medical method as described in the entire patent document (rather than the steps mentioned in the patent claims per se), surgery is interpreted broadly and so encompasses tooth preparation, and the reference in the 2010 decision to a substantial health risk operates on a very shallow threshold.
The lesson to be learned is that one needs to be able to operate a medical method in isolation of, or without tampering with, a human body for it to be patented.