Diagnostic Methods

This article was taken from the Venner Shipley Newsletter edition 19.

Article 52(4) EPC excludes from patentability ‘methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body’.

Nevertheless, at least until recently, the European Patent Office considered methods for obtaining information (data, physical quantities) from the living human or animal body not to be excluded from patentability by Article 52(4) EPC, if the information obtained merely provides intermediate results which on their own do not enable a decision to be made on the treatment necessary. Generally such allowable methods include X-ray investigation, NMR studies and blood pressure measurements (see the Guidelines for Examination and Technical Board of Appeal Decision T385/86).

However, with Technical Board of Appeal Decision T964/99, the European Patent Office's attitude towards claims relating to diagnostic methods seems to be changing. In T964/99, the Technical Board refused claims directed to a method of sampling a substance from a human or animal body and analysing the concentration of the substance. The product to be protected by the patent application under consideration by the Technical Board in T964/99 is Cygnus' GlucoWatch®, a glucose monitor to be worn by diabetics like a wristwatch.

The GlucoWatch® is designed to monitor diabetics' glucose levels and not used to diagnose diabetes at all, since the diabetics intended to use the GlucoWatch® already know that they have diabetes.

Contrary to T385/86, the Technical Board in T964/99 held that the expression ‘diagnostic methods practised on the human or animal body’ in Article 52(4) EPC should not be considered to relate only to methods containing all steps involved in reaching a medical diagnosis. Moreover, the Technical Board held that Article 52(4) EPC is meant to exclude from patent protection all methods practised on the human or animal body which relate to diagnosis or which are of value for the purposes of diagnosis, a development in case law which must be a real worry to the pharmaceutical industry.

After much lobbying, the President of the European Patent Office has referred questions relating to this conflicting case law to the Enlarged Board of Appeal for consideration as case no. G1/04. The European Patent Office has indicated that following a period for comments by interested parties, a decision by the Enlarged Board can be expected shortly.

Allie Elend 01 Jul 2005

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