Therapy implies the curing of a disease or malfunction of the body and covers prophylactic treatment, e.g. immunisation against a certain disease (see T 19/86) or the removal of plaque (see T 290/86). It is concerned with bringing the body from a pathological state back into its normal, healthy state or preventing a pathological state. Where a method is directed to the treatment of a human or animal body that is in a normal, healthy state and, even if subject to some discomfort, not likely to develop a pathological state due to the discomfort, providing relief from the discomfort is not necessarily a therapy. For example, cooling an animal subject to hot weather conditions does not cure or lessen the symptoms of any disorder or malfunction of the animal's body, nor does it reduce the possibility of contracting any disorder or malfunction, since no such disorder or malfunction would normally occur if the animal were not cooled (T 385/09).
A method for therapeutic purposes concerning the functioning of an apparatus associated with a living human or animal body is not excluded from patentability if no functional relationship exists between the steps related to the apparatus and the therapeutic effect of the apparatus on the body (see T 245/87).
As clinical trials have a therapeutic aspect for the human subjects undergoing them, an objection under Art. 53(c) is raised if a claim includes a step relating to a method of treatment of the human body by therapy (see G‑II, 4.2.2).
The exclusion under Art. 53(c) applies to multi-step methods which comprise or encompass at least one therapeutic step. The non-patentable subject-matter must be removed from the scope of the claim. This may be done either by means of a disclaimer or by omitting the step of treatment by therapy from the wording of the claim (G 1/07). For the general principles governing disclaimers, see H‑V, 3.5, and H‑V, 4. The overall patentability of the amended claim will however depend on its compliance with the other requirements of the EPC, which are assessed on a case-by-case basis.
If a method claim directed to therapy is open to objection under Art. 53(c), this also applies to a corresponding claim directed to a computer-implemented therapeutic method (T 1680/08). In this respect, the same observations as in G‑II, 18.104.22.168, for computer-implemented surgical methods apply.