Chapter 6: Diagnostic Methods
A INTRODUCTION Article 53(c) of the European Patent Convention (EPC) also excludes from patent protection ‘diagnostic methods practised on the human or animal body’. Although not speciﬁcally a method of medical treatment, the exclusion of diagnostic methods is found in what is termed the ‘methods of medical treatment exclusion’ found in Article 53(c) EPC. This chapter will consider the scope of the exclusion of diagnostic methods and its necessity in light of the rationale for the exclusion of methods of medical treatment from patent protection.1 With the increasing complexity and technical sophistication associated with medical treatments, and by extension diagnostic methods, in this technologically advanced age, it is important that the exclusion in Article 53(c) EPC is not construed in a manner that stiﬂes appropriate research and development in this vital and essential area. The new age of technological advancement in the medical ﬁeld, using genetic testing and gene therapy, would not be sustainable if an appropriate balance is not struck when interpreting the exclusion.2 Therefore, it was not surprising that the recent revisions to the EPC in 2000 conﬁrmed that the exclusion for methods of medical treatment is here to stay,3 while, at the same time, providing a new statutory basis for second medical use patents.4 See generally, P. Lancon, ‘Patentability in the Field of Therapy and Diagnosis’ (1991) 22 IIC 893, W. De Smet, ‘Patentability in the Area of Therapy and Diagnosis under Belgian Law’ (1991) 22 IIC 888, K.E. Panchen,...
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