Ranbaxy Products would be
used by medical practitioners for
treating the same conditions as
indicated for Lipidil ® . But despite
finding this, Justice Nicholas also
found that there was insufficient
evidence that the Ranbaxy
Products were manufactured
with the intention of being used
for the treatment of diabetic
(including the Product Information)
retinopathy. Mere knowledge
– and the reasonably foreseeable
that the medicament is suitable
uses for the medicament.
for such use was not sufficient.
The Full Court considered that
On appeal, the Full Court
despite claiming bioequivalence
unanimously rejected this ‘mental
to Lipidil ® , there was a substantial
element’ approach to infringement,
therapeutic use for the Ranbaxy
holding that the relevant question
Products in the treatment of the
when assessing infringement of
disorders listed in the Product
Swiss-style claims is whether the
Information. While not disclaimed,
medicament is for the specified
diabetic retinopathy was not one
therapeutic purpose. Intention,
of the indications. Ultimately, had
while relevant, is only one of
the Swiss-style claims been valid
the factors to be considered.
the Full Court was not persuaded
Relevantly, although Lipidil ® was
the evidence established that,
indicated for the treatment of
as manufactured, the Ranbaxy
diabetic retinopathy, the Product
Products were medicaments for the
Information for the Ranbaxy
treatment of diabetic retinopathy.
Products (which was amended
In relation to the cross claim
during the proceedings) did not
seeking revocation, the Full Court
include any such indication.
upheld Justice Nicholas’ inventive
The Full Court held that the objective step analysis in finding certain of
intention of the manufacturer is
the claims in suit invalid for lack
not an essential feature in the
of inventive step. Their Honours
construction of Swiss-style claims.
confirmed that the assessment
Infringement is concerned with
of inventive step, and in particular
whether the medicament is for the
the application of the reformulated
relevant therapeutic treatment.
Cripps question, does not require
Their Honours held that a number
certainty of outcome. Rather, it
of factors are to be considered,
requires that the skilled addressee
none of which are determinative
be directly led as a matter of course
in and of themselves, including
to try the claimed invention in
the manufacturer’s intention, the
the expectation that a particular
physical characteristics of the
research path “might well produce”
medicament, its packaging, labelling a useful result - it does not require
the skilled addressee to know that
the steps will produce a useful
result (see paragraph 502).
Their Honours stated that:
“…reasoning to such a conclusion is
not assisted by a percentage-based
analysis. The reformulated Cripps
question is but an aid to answering
the statutory question posed by
s 7(2)…It, too, involves the exercise
of an evaluative judgment...we are
not persuaded that, when answering
the question he had posed, the
primary judge erred in concluding
that a percentage-based analysis
was not useful, especially when
expressed in terms of ‘no better than
fifty-fifty’…” (see paragraph 148).
The evidence in this case was said
to support the proposition that
the skilled addressee would have
had a reasonable expectation but
not a certainty that the approach
would work. However, in eschewing
any quantitative threshold in
the assessment of whether an
approach “might well produce” a
useful result, it would appear
that Full Court has left open the
possibility that a claimed invention
may well be obvious if the skilled
addressee considered a particular
option to have any chance of
success (even a very low one)
provided that it was obvious to try.
David Longmuir | Principal
BSc(Hons) LLB(Hons) LLM FIPTA
david.longmuir@pof.com.au Inspire October 2020
The Full Court
held that the objective
intention of the
manufacturer is not
an essential feature
in the construction of
Swiss-style claims.
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