‘Substance X for use in a method of treating condition Y’
Medical use claims can additionally
be limited in many different ways including:
-
administration schedule
-
dosage
-
coadministration with another substance
-
patient group
In theory medical use claims can
be limited in any way that a method of treatment claim (using a substance)
could be limited. In practice though there are limits to what the EPO will
accept.
2.
Can substance X be defined as any therapeutic substance
and/or Y as any condition? That might
for example be required when the invention relates to a new delivery method
that can be applied to any substance and condition. Examiners are cautious about allowing
substances or disease conditions to be defined functionally in claims, and so
this can turn into a difficult issue, but not an unwinnable one.
3. Does X have to be a chemical substance? At the moment it does seem that way. So X cannot be an electrical impulse,
electromagnetic radiation or a device.
However there does seem to be some hope that the present EPC2000 medical
use claim could allow X to be a device.
4.
Can a patient group which overlaps with a prior
art patient group confer novelty?
According to previous case law yes, but it seems that this could change
(see this).
5.
Can a medical claim use refer to other physical
steps, such as selecting a patient, screening for the therapeutic substance or
a method of making the substance? It is difficult to be certain about this
issue. It requires the case law to
develop further.
6.
Remember that the exclusion concerning surgical
methods is interpreted broadly at the EPO, and so it can be possible to fall
foul of when referring to injecting or carrying our other physical treatments
of the body.
7.
A medical use claim cannot be rendered novel by
reference to the (previously unknown) mechanism of action of a known
therapy. In order to confer novelty, knowledge
of the mechanism must be correlated with action(s) that would be done
differently compared to the prior art, such as the timing of therapy or the
patient group, and the claim must be limited by features that reflect the
difference(s).
