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Guidelines for Examination

 
 
4.2
Surgery, therapy and diagnostic methods 

European patents are not to be granted in respect of "methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body; this provision shall not apply to products, in particular substances or compositions, for use in any of these methods." Hence, patents may be obtained for surgical, therapeutic or diagnostic instruments or apparatuses for use in such methods. The manufacture of prostheses or artificial limbs could be patentable. For instance, a method of manufacturing insoles in order to correct the posture or a method of manufacturing an artificial limb should be patentable. In both cases, taking the imprint of the footplate or a moulding of the stump on which an artificial limb is fitted is clearly not of a surgical nature and does not require the presence of a medically qualified person. Furthermore, the insoles as well as the artificial limb are manufactured outside the body. However, a method of manufacturing an endoprosthesis outside the body, but requiring a surgical step to be carried out for taking measurements, would be excluded from patentability under Art. 53(c) (see T 1005/98).

Patents may be obtained for new products, particularly substances or compositions, for use in these methods of treatment or diagnosis. According to Art. 54(4), where the substance or composition is known, it may only be patented for use in these methods if the known substance or composition was not previously disclosed for use in surgery, therapy or diagnostic methods practised on the human or animal body ("first medical use"). A claim to a known substance or composition for the first use in surgical, therapeutic and/or diagnostic methods should be in a form such as: "Substance or composition X" followed by the indication of the use, for instance "... for use as a medicament" or "... for use in therapy/diagnostics/surgery". If the known substance or composition was previously disclosed for use in surgery, therapy or diagnostic methods practised on the human or animal body ("further medical use"), the claim should be in the form: "Substance or composition X" followed by the indication of the specific therapeutical/diagnostic/surgical use, for instance, "... for use as an antibacterial agent" or "... for use in curing treating disease Y".