The Enlarged Board of the European Patent Office has been asked to provide guidance on what constitutes a “surgical method”, under pending referral G1/07.
The Enlarged Board’s findings will ultimately have a bearing on the
type and nature of medical procedures that can be patented via the
European Patent Office.
Article 52(4) of the European Patent Convention states that “methods of
treatment of the human or animal body by surgery” are not to be
regarded as inventions. As a result, patent protection cannot be
obtained for claims to such subject matter.
The Technical Board of Appeal (BOA) in T0992/03 had to consider whether
a method of imaging pulmonary and cardiac vasculature and evaluating
blood flow using magnetic resonance techniques was a method of
treatment by surgery – if the method covered a step of introducing a
contrasting agent, polarised 129Xe, by injection into a region of the
heart. The Technical BOA analysed the case law and found that where a
physical intervention such as injection forms part of the method there
was a split in the approach to assessing whether the method was
excluded from patent protection.
On the one hand, certain BOA decisions, and indeed the EPO guidelines,
emphasised that the nature of the physical intervention was key. As a
result of this approach, all steps requiring the use of surgical
instruments would likely be objected to as methods of treatment by
surgery.
On the other hand, certain cases required determining the purpose of
the intervention, and stated that only those interventions that aimed
at maintaining or restoring the health of the patient were
objectionable. This was the view expressed in the previous decision
G1/04 of the Enlarged Board.
The Technical BOA found the two approaches inconsistent, and held that
opposing judgements could result for one and the same physical
intervention. They argued that the injection of a medicament for
treating disease would be excluded, but an injection of a substance for
reducing wrinkles for cosmetic purposes might not be excluded, as it is
not suitable for maintaining or restoring health.
The questions referred to the Enlarged Board were as follows:
1.Is a claimed imaging method for a diagnostic purpose (examination
phase, within the meaning given in G1/04), which comprises or
encompasses a step consisting in physical intervention practised on the
human or animal body (in the present case, an injection of a contrast
agent into the heart) to be excluded from patent protection as a
“method for treatment of the human or animal body by surgery” pursuant
to Article 52(4) EPC if such a step does not per se aim at maintaining
life and health?
2. If the answer to question 1 is in the affirmative, could the
exclusion from patent protection be avoided by amending the wording of
the claim so as to omit the step at issue, or disclaim it, or let the
claim encompass it without being limited to it?
3. Is a claimed imaging method for a diagnostic purpose (examination
phase within the meaning given in G1/04) to be considered as being a
constitutive step of a “treatment of the human or animal body by
surgery” pursuant to Article 52(4) EPC if the data obtained by the
method immediately allow a surgeon to decide on the course of action to
be taken during a surgical intervention.
The full text of the Technical Board of Appeal decision is here
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