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December 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
- a method falls under this exception from patentability, if only one
essential step for diagnosis is practised "on the body" (e.g.
providing a blood sample from a patient); this would go along the line of a
recent decision of the Appeal Boards of the EPO (T 964/99; OJ EPO 2002, 4), or
- all essential steps of the method have to be performed "on the
body" in order to fall under this exception (so that methods which
comprise an in vitro analysis of a patient's sample are patentable; this would
comply with established case law of the Appeal Boards of EPO.
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)):"
- In order that the subject-matter of a claim relating to a diagnostic method
practised on the human or animal body falls under the prohibition of
Article 52(4) EPC, the claim is to include the features relating to:
(i) the diagnosis for curative purposes stricto sensu representing the
deductive medical or veterinary decision phase as a purely intellectual
exercise,
(ii) the preceding steps which are constitutive for making that diagnosis,
and
(iii) the specific interactions with the human or animal body which occur when
carrying those out among these preceding steps which are of a technical nature.
- Whether or not a method is a diagnostic method within the meaning of
Article 52(4) EPC may neither depend on the participation of a medical or
veterinary practitioner, by being present or by bearing the responsibility,
nor on the fact that all method steps can also, or only, be practised by
medical or technical support staff, the patient himself or herself or an
automated system. Moreover, no distinction is to be made in this context
between essential method steps having diagnostic character and non-essential
method steps lacking it.
- In a diagnostic method under Article 52(4) EPC, the method steps of a
technical nature belonging to the preceding steps which are constitutive for
making the diagnosis for curative purposes stricto sensu must satisfy the
criterion "practised on the human or animal body".
- Article 52(4) EPC does not require a specific type and intensity of
interaction with the human or animal body; a preceding step of a technical
nature thus satisfies the criterion "practised on the human or animal
body" if its performance implies any interaction with the human or animal
body, necessitating the presence of the latter."
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