Patentability of diagnostic methods under the European Patent Convention

Reference to Enlarged Board of Appeals

Considering the conflicting decision of Boards of Appeal regarding the meaning of diagnostic methods practised on human or animal body mentioned under Article 52(4) of the European Patent Convention, the President of the European Patent Office referred the issue to the Enlarged Board of Appeals.

Primary Questions referred to the Board

1. Are "diagnostic methods practised on the human or animal body" within the meaning of Article 52(4), EPC, only those methods containing all the procedural steps to be carried out when making a medical diagnosis or is a claimed method a diagnostic method even if it only contains one procedural step that can be used for diagnostic purposes or relates to the diagnosis?

2. If the answer to question 1 is in the affirmative: Does the claimed method have to be usable exclusively for diagnostic purposes or relate exclusively to the diagnosis? According to which criteria is this to be assessed?

Analysis

The Board started its analysis by stating that diagnostic methods practised on the human or animal body referred in Article 52(4) European Patent Convention (EPC) are inventions within the meaning of Article 52(1) EP, which by means of a legal fiction, are regarded as not susceptible of industrial application because of socioethical and public health considerations including impediment of medical or veterinary practitioners by such patents. It stated that as per the established jurisprudence of the European Patent Office (EPO), the method steps to be carried out when making a diagnosis as part of the medical treatment of humans or the veterinary treatment of animals for curative purposes include:

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

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

(iii)               the finding of any significant deviation and

(iv)              the attribution of the deviation to a particular clinical picture. 

The Board then pointed out that the question to be answered in the context was whether the diagnostic methods referred to in Article 52(4) of EPC comprise only the deductive medical or veterinary decision phase consisting in attributing the detected deviation to a particular clinical picture or whether they are also meant to include one or more of the preceding steps related to examination, data gathering and comparison.

To begin, the Board opined that the intelligent act of deduction of a disease condition is not patentable but if such a deduction is done by a diagnostic tool, it may be patentable. It then stated that the exclusion relating to diagnostic methods under article 52(4) should be interpreted narrowly because the article talks about diagnostic methods practised on the human or animal body but does not make reference to particular steps pertaining to such methods. The board then went on to state that the provision should be interpreted narrowly because it is very tough to define the group of medical or veterinary practitioners to whom the exclusion applies and the technology involvement in diagnosis is very high that the role of practitioners is limited and diagnostic tool companies require patent incentives.

It then differentiated methods of surgery or therapy from diagnostics by pointing out that a method of therapy or surgery can be defined by one step in the whole process, which is not the case in diagnosis that requires steps of data collection, comparison and deduction, thus necessitating a narrow interpretation It went on to state that steps of intermediate diagnosis would not be sufficient to form a diagnostic method and would not warrant exclusion from patentability. As defining an exclusion based on persons practising it rather than the method gives rise to legal uncertainty, the Board observed that a diagnostic method should be defined based on the steps involved, essential or non-essential, and not involvement of medical practitioners, technical staff or patients.  The Board went on to state that practise of a step on the human or animal body under article 52(4) should not be strictly construed as certain non-technical steps that require deduction are not applied on human or animal body and are completely intelligence based. It further stated that a step need not directly interact with the human body or have direct contact but if it can be implied that the step is linked with human or animal body or requires presence of human or animal body that would be enough.

It finally concluded that a diagnostic method practised on the human or animal body containing the feature pertaining to the diagnosis for curative purposes as a purely intellectual exercise representing the deductive medical or veterinary decision phase as well as the features relating to the preceding steps which are constitutive for making the diagnosis and  the specific interactions with the human or animal body which occur when carrying those out among said preceding steps which are of a technical nature are excluded from patentability under Article 52(4) of EPC.