Opinion of Enlarged Board of Appeal to the patentability of diagnostic methods confirms EPO's established case law: diagnostic methods wherein not all essential technical steps are practised on the human or animal body are patentable.
December 1, 2005
The Enlarged Board of Appeal has published its Opinion in the case G 1/04 on the patentability of diagnostic methods. The essential question to be clarified by this Opinion was whether the exclusion of diagnostic methods practised on the human or animal body should be construed broadly of narrowly, i.e. whether
In the present Opinion, the EBA followed the second alternative - a narrow interpretation of this exception from patentability. Therefore, diagnostic methods wherein not all essential technical steps are performed on the human or animal body are still patentable; the EBA confirmed the established case law of the EPO.
In the present Opinion, the EBA has provided a thorough legal analysis of this kind of inventions. Apart from the conclusion that such methods are regarded as technical inventions according to Article 52(1) EPC, the EBA gave a detailled instruction with respect to the prerequisites that have to be fulfilled for such inventions to be patentable. This will be highly relevant for the future practice for filing and patenting of diagnostic inventions:
In the present Opinion it was first held that diagnostic treatments always include:
(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, i.e. a symptom, during the comparison, and (iv) the attribution of the deviation to a particular clinical picture, i.e. the deductive medical or veterinary decision phase.
First question was whether whether the diagnostic methods referred to in Article 52(4) EPC comprise only the deductive medical or veterinary decision phase consisting in attributing the detected deviation to a particular clinical picture, i.e. the diagnosis for curative purposes stricto sensu, or whether such excluded methods are also meant to include one or more of the preceding steps related to examination, data gathering and comparison. The EBA stated that the deductive medical or veterinary decision phase (iv) in itself is an intellectual exercise and is therefore not regarded as an invention within the meaning of Article 52(1) EPC, unless - as a result of developments in the field of diagnostic technology - a device capable of reaching diagnostic conclusions can be used.
If therefore the deductive medical or veterinary decision phase (iv) is a purely intellectual exercise, i.e. a step of a non-technical nature, such a method must necessarily further include preceding steps of a technical nature, in order to satisfy the requirements of Article 52(1) EPC. In doing so, it was irrelevant for the EBA whether the method as a whole comprises non-technical features as long as the method as a whole brings about a technical effect. The EBA insisted that if such a non-technical feature is essential, it has to be included in the independent claim in order to comply with Article 84 EPC with respect to completeness.
The EBA kept to the general principle that exceptions from patentability should - wherever possible - be interpreted in a narrow manner. This was also confirmed to be necessitated due to legal certainty. It was thus regarded as being justified to require that all method steps of a technical nature of such a method should satisfy the criterion "practised on the human or animal body", i.e. the performance of each and every one of these steps should imply an interaction with the human or animal body, necessitating the presence of the latter, in order to fall under this exception from patentability. It was, however, pointed out that it may not depend on who is involved in carrying out such method steps "on the body", e.g. the presence or necessity of the presence of a physician was not regarded as being necessary to qualify for practising "on the body". This was also mainly decided based on reasons of legal certainty.
The EBA also investigated whether the Opinion would differ in view of the EPC 2000 (coming into force in 2007), wherein the stipulation of Article 52(4) is transformed into a new Article 53(c) and the reasoning for exclusion differs (for reasons of public health instead of lack of industrial applicability). The EBA confirmed that the situation for the EPC 2000 is identical to the current wording of the EPC and that therefore the present Opinion is also fully applicable to the EPC 2000.
The published headnotes are as follows (however, if read isolated from the Opinion as a whole, a little bit confusing; in fact, the important answer is in headnote 3 requiring all method steps to be carried out on the body in order to be excluded under Art 52(4)):"