4.2 Surgery, therapy and diagnostic methods 

European patents are not to be granted for "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." This means that 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 designed to correct posture or a method of manufacturing an artificial limb is patentable because 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. Besides, both the insoles and the artificial limb are manufactured outside the body. However, a method of manufacturing an endoprosthesis which, although taking place outside the body, requires a surgical step 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 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 result from a new medical use in accordance with Art. 54(4) and (5).

Under Art. 54(4), a known substance or composition may still be patented for use in a method referred to in Art. 53(c) if it has not previously been disclosed for use in such a 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, e.g. "... for use as a medicament" or "... for use in therapy/in vivo diagnostics/surgery" (see G‑VI, 6.1).

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 in accordance with Art. 54(5) for any second or further use of the substance in these methods that 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 therapeutic/in vivo diagnostic/surgical use, e.g. "... for use in treating disease Y" (see G‑VI, 6.1).

Subject-matter in the description which is regarded as falling under one of the exceptions to patentability needs to be excised, reworded in such a way that it no longer falls under the exception or prominently marked as not being according to the claimed invention (see F‑IV, 4.3). In that last case, one way of amending the description in accordance with Art. 53(c) is to add a statement such as: "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".