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 is 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. 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).

The exception under Art. 53(c) does not extend to new products, particularly substances or compositions, for use in these methods of treatment or diagnosis.

Where a substance or composition is already known, (notional) novelty can be derived from a new medical use in accordance with Art. 54(4) and (5).

Pursuant to Art. 54(4), a known substance or composition may still be patented for use in a method referred to in Art. 53(c) if the known substance or composition has not previously been disclosed for use for any such method ("first medical use"). A claim to a known substance or composition for the first use in surgical, therapeutic and/or diagnostic methods must 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/in vivo diagnostics/surgery" (see G‑VI, 7.1).

Furthermore, if the known substance or composition was previously disclosed for use in surgery, therapy or diagnostic methods practised on the human or animal body, a patent may still be obtained according to Art. 54(5) for any second or further use of the substance in these methods provided that said use is novel and inventive ("further medical use"). A claim to a further medical use of a known substance must be in the form: "Substance or composition X" followed by the indication of the specific therapeutical/in vivo diagnostic/surgical use, for instance, "... for use in treating disease Y" (see G‑VI, 7.1).

Subject-matter in the description regarded as an exception to patentability needs to be excised, reworded such that it does not fall under the exceptions to patentability or prominently marked as not being according to the claimed invention (see F‑IV, 4.3). For the latter case, in accordance with Art. 53(c), the description may for example be amended by adding an indication as follows: "The references to the methods of treatment by therapy or surgery or in vivo diagnosis methods in examples X, Y and Z of this description are to be interpreted as references to compounds, pharmaceutical compositions and medicaments of the present invention for use in those methods".