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Art. 53(c) EPC states that European patents shall not 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.
Consequently, the exclusion of methods of treatment and diagnostic methods formerly referred to in Art. 52(4) EPC 1973 has been added to the two exceptions to patentability and reappears in the new Art. 53(c) EPC. While these surgical or therapeutic methods constitute inventions, they were excluded from patentability by the fiction of their lack of industrial applicability. It was undesirable to uphold this fiction since methods of treatment and diagnostic methods are excluded from patentability in the interests of public health. lt was therefore preferable to include these inventions in the exceptions to patentability in order to group the three categories of exceptions to patentability together in Art. 53(a), (b) and (c) EPC. Thus, a change in the EPO's current practice regarding these inventions is not envisaged (confirmed in G 1/07, OJ 2011, ***, point 3.3.2.1 of the Reasons).
Further, as Art. 27(3)(a) TRIPs states that "diagnostic, therapeutic and surgical methods for the treatment of humans or animals" may be excluded from patentability, it was appropriate to transfer Art. 52(4) EPC 1973 to Art. 53(c) EPC with the aim of bringing the EPC into line with the TRIPs agreement (MR/2/00, p. 45).
In three (almost) identical decisions G 1/83 in German, G 5/83 in English and G 6/83 in French, the Enlarged Board stated that the intention of Art. 52(4) EPC 1973 (now Art. 53(c) EPC) was only to prevent non-commercial and non-industrial medical and veterinary activities from being restrained by patent rights (applied, e.g. in T 245/87, OJ 1989, 171).
In G 1/04 (OJ 2006, 334) the Enlarged Board of Appeal stated, with reference to diagnostic methods, that their exclusion from patentability under Art. 52(4) EPC 1973 (now Art. 53(c) EPC) seemed actually to be based on socio-ethical and public health considerations. Medical and veterinary practitioners should be free to take the action they considered suited to diagnosing illnesses by means of investigative methods. Consequently, the policy behind the legal fiction in Art. 54(4) EPC 1973 appeared to be aimed at ensuring that those who carried out diagnostic methods as part of the medical treatment of humans or veterinary treatment of animals were not inhibited by patents (referring to T 116/85).
In G 1/07, a decision concerning treatment by surgery, the Enlarged Board noted that the exclusion under Art. 52(4) EPC 1973 had been deliberately maintained by the legislator, thereby confirming the principle that medical and veterinary practitioners' freedom to use the best available treatments to the benefit of their patients, uninhibited by any worry that some treatment might be covered by a patent, should be protected by excluding these activities from patentability.