EPO Decision on Diagnostic Methods G1/04

This article was taken from the Venner Shipley Newsletter edition 20

The Enlarged Board of Appeal at the European Patent Office has now published its Opinion on the patentability of diagnostic methods (G1/04). In doing so, the Enlarged Board has laid down the criteria that allow a practitioner to assess whether a diagnostic method is excluded from patentability under the provisions of the European Patent Convention (EPC).

According to Article 52(4) EPC, diagnostic methods practised on the human or animal body are not patentable because they are not susceptible of industrial application. The theory behind this legal fiction is that medical and veterinary practitioners should be free to perform diagnoses without falling foul of granted European patents.

Before G1/04, the Technical Boards of Appeal at the European Patent Office had discussed at length how Article 52(4) EPC should be interpreted. In T 385/86, the exclusion was interpreted narrowly such that all essential steps of the method at hand had to be performed ‘on the body’ in order for the method to be excluded from patentability. However, in T 964/99, the Board held that the exclusion should be interpreted broadly such that a method is excluded from patentability if only one essential step for diagnosis is practised ‘on the body.’

In light of these conflicting decisions, it was sometimes quite difficult to assess whether a given diagnostic method would be patentable or not. The President of the European Patent Office therefore referred the matter to the Enlarged Board to clarify the situation.

The Enlarged Board submitted that a diagnostic method comprises a number of steps that are constitutive for making a diagnosis. In its view, these steps are followed by a deductive medical or veterinary decision phase in which the actual diagnosis is reached. Since the latter phase is a purely intellectual exercise, the Enlarged Board decided that at least some of the preceding steps must be of a technical nature in order for the method as a whole to have technical character (and so be potentially patentable).

Following on from this, the Enlarged Board decided that, in order for a diagnostic method to be excluded from patentability, all of the method steps of a technical nature that are constitutive for subsequently reaching the diagnosis must be performed on the human or animal body. Thus, diagnostic methods in which at least one of the essential technical steps is performed away from the human or animal body are patentable.

The Enlarged Board confirmed that the type and intensity of interaction with the human or animal body does not matter, nor does the exclusion depend on the participation of a medical or veterinary practitioner or on the person or device that performs the method. All that is required for a diagnostic method to be excluded from patentability is for each and every one of the technical steps necessary for making a diagnosis to be practised on the body.

In adopting this narrow interpretation of the exclusion in Article 52(4) EPC, the Enlarged Board has followed T 385/86. The restrictive manner in which the Enlarged Board has construed the exclusion clause should encourage inventors in the field of diagnostic technology to file patent applications in Europe, as the decision clarifies that new methods consisting exclusively of the collection of clinical data from a patient or consisting of data processing will not be considered by the European Patent Office to be ‘diagnostic methods’. Rather, they will be considered as methods of data acquisition or processing, which are not excluded by Article 52(4) EPC. Applications can also be filed for multi-step diagnostic methods in which a sample is taken from a patient and treated or analysed in vitro before a subsequent diagnosis is made.

However, applicants should take care when choosing the language of the claims for their patent applications, as any attempts to circumvent the patent exemption

of Article 52(4) EPC by not reciting an essential method step practised on the body will be met with an objection on the ground that the claim is unclear. We can, of course, provide advice to our clients in this field, to ensure that suitably worded applications are filed at the European Patent Office.

Thus, a change in European Patent Office practice is now expected. Examination will also be resumed for any application that was subjected to suspension of proceedings whilst the Enlarged Board reached its conclusion. Practice at the UK Patent Office could be affected now too, as a similar restriction on diagnostic methods is applied under UK law.

Please contact us if you require any further information or if you would like advice on a particular issue.

Tanya Heare

Tanya Heare 02 Oct 2006

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