GL G II 4.2.2 Methods for screening potential medicaments and clinical trials

Although in general a medical claim directed to tests carried out on "animals" must exclude from its scope the use of human beings as "test animals" (e.g. by means of a disclaimer), in some infrequent cases, a claim may, in the light of the description, be interpreted as exclusively relating to a clinical trial of an experimental medicament carried out on human beings. It is assumed that, unless there is evidence to the contrary, such trials are performed under strictly controlled conditions and with the informed consent of the patient concerned.

GL G II 4.2.1.3 Diagnostic methods

Diagnostic methods likewise do not cover all methods related to diagnosis.

To determine whether a claim is directed to a diagnostic method within the meaning of Art. 53(c) and thus excluded from patentability, it must first be established whether all of the necessary phases are included in the claim (G 1/04).

The claim must include method steps relating to all of the following phases:

GL G II 4.2.1.2 Therapy

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.

GL G II 4.2.1.1 Surgery

The meaning of the term "treatment by surgery" is not to be interpreted as being confined to surgical methods pursuing a therapeutic purpose (see G 1/07, Reasons 3.3.10). Accordingly, the term "surgery" defines the nature of the treatment rather than its purpose. Thus, for example, a method of treatment by surgery for cosmetic purposes or for embryo transfer is excluded from patentability, as well as surgical treatment for therapeutic purposes.

GL G II 4.2.1 Limitations of exception under Art. 53(c)

Exceptions under Art. 53(c) are confined to methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body.

GL G II 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.

GL G II 4.1.3 Economic effects

The EPO has not been vested with the task of taking into account the economic effects of the grant of patents in specific areas of technology and of restricting the field of patentable subject-matter accordingly (see G 1/98 Reasons 3.9, and T 1213/05). The standard to apply for an exception under Art. 53(a) is whether the commercial exploitation of the invention is contrary to "ordre public" or morality.

GL G II 4.1.2 Offensive and non-offensive use

Special attention must be paid to applications in which the invention has both an offensive and a non-offensive use, e.g. a process for breaking open locked safes, where use by a burglar is offensive and use by a locksmith in an emergency non-offensive. In such a case, no objection arises under Art. 53(a).

GL G II 4.1.1 Prohibited matter

Exploitation is not to be deemed to be contrary to "ordre public" or morality merely because it is prohibited by law or regulation in some or all of the contracting states. One reason for this is that a product could still be manufactured under a European patent for export to states in which its use is not prohibited.[Art. 53(a); ]

GL G II 4.1 Matter contrary to " ordre public " or morality

Any invention the commercial exploitation of which would be contrary to "ordre public" or morality is specifically excluded from patentability. The purpose of this is to deny protection to inventions likely to induce riot or public disorder, or to lead to criminal or other generally offensive behaviour (see also F‑II, 7.2). Anti-personnel mines are an obvious example.