The Technical Board of Appeal of the European Patent Office has attempted to clarify further its position on the patentability of diagnostic methods. This follows the issue of decision G1/04 of the Enlarged Board of Appeal (see our previous article http://www.withersrogers.co.uk/content/view/73/73/ ).

In Decision T1197/02 (12 July 2006), the Technical Board of Appeal concerned stated that:

‘In a claim concerning a diagnostic method, only the steps strictly describing:

(i) the examination phase involving the collection of data,

(ii) the comparison of these data with standard values,

(iii) the finding of any significant deviation and

(iv) the attribution to a clinical picture

have to be taken into account for determining the diagnostic character of the claimed method.’(emphasis added)

The Applicant argued that the opinion G1/04 states that, in order for a method to be excluded from patentability, all method steps which are of a technical nature must also be practised on the human or animal body. The Applicant believed that at least 3 steps of the 8-step method were of a technical nature but not practised on the human body in the sense that the presence of the body was not required. Consequently, the Applicant argued that the claimed method was not excluded from patentability.

The Board of Appeal disagreed with the Applicant. It explained that stages (ii)-(iv) set out above are generally of a non-technical nature and not normally practised on the body. Accordingly, these steps should not generally be considered when looking at the technical steps of a claimed method. Furthermore, any intermediate steps appearing in the claim (e.g. to ensure the clarity and/or sufficiency of the claim) should also be ignored since these are not part of steps (i)-(iv) above. The technical nature, or otherwise, of such intermediate steps is therefore irrelevant. The Board believed that although the 3 steps (which the Applicant alleged to be technical but not practised on the body) were of a technical nature, they were not part of any of the steps (i)-(iv) above. These steps were therefore of no relevance for making the medical diagnosis and consequently were not to be considered when determining whether or not the claim referred to a diagnostic method. For this reason, the Board believed that the claimed method was excluded from patentability.

The Applicant also included an auxiliary request which included claims to an apparatus for performing the diagnostic method. Such claims are not excluded in principle from patentability. Consequently, the Board referred these claims to the Examining Division for further examination.

This decision largely confirms our previous understanding of the European Patent Office’s approach to diagnostic methods. It also highlights the importance, whenever possible, of including sufficient detail in the description to support claims to an apparatus.

If you need any further information regarding the patentability of methods of diagnosis, please ask your usual Life Sciences & Chemistry group contact.

Rachel Williams & Nicholas Jones
January 2007