4.1. Introduction

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. Thus, 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.

In three (almost) identical decisions G 1/83, G 5/83 and G 6/83 (OJ 1985, 60, OJ 1985 64, OJ 1985 67), 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 (see also 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 seemed actually to be based on socio-ethical and public health considerations. In G 1/07 (OJ 2011, 134), a decision concerning treatment by surgery, the Enlarged Board noted that the exclusion under Art. 52(4) EPC 1973 (Art. 53(c) EPC) 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.