Full Court provides
guidance on infringement
of Swiss-style claims
Inspire October 2020
Swiss-style claims are an increasingly important part of a patentee’s
armoury against manufacturers of competing pharmaceutical products,
particularly those manufactured elsewhere and imported into Australia.
8 An enlarged bench of the Full Court
of the Federal Court of Australia
recently handed down its decision
in Mylan Health Pty Ltd v Sun
Pharma 1 , unanimously rejecting
an appeal by Mylan and providing
important direction in relation to the
infringement of Swiss-style claims
in Australia. The decision is also of
interest for the Full Court’s approach
to the question of inventive step.
Mylan initially sought to enforce
three patents covering formulations
of fenofibrate products, or methods
of treating diabetic retinopathy
using fenofibrate products against
Sun Pharma (formerly Ranbaxy
Australia) in respect of its proposal
to market a number of fenofibrate
products in Australia (the Ranbaxy
Products). Sun Pharma denied
infringement and cross-claimed
for revocation of the patents.
Justice Nicholas held at first
instance that relevant claims
for each of the three patents
were invalid on various grounds
including novelty and inventive
step and largely that Mylan had not
established threatened infringement.
An important aspect of the decision
was the question of infringement
of the Swiss-style claims in the
Mylan patents, relevantly directed
to the use of fenofibrate for the
manufacture of a medicament
for the prevention of diabetic
retinopathy in specified dosages.
Mylan alleged that by listing its
fenofibrate products on the ARTG as
bioequivalents to the Mylan product
Mylan Health Pty Ltd v Sun Pharma ANZ Pty Ltd [2020] FCAFC 116,
1
Lipidil ® which was indicated for the
treatment of diabetic retinopathy,
Sun Pharma infringed the relevant
claims of the Mylan patent.
In considering whether the Ranbaxy
Products infringed the Swiss-style
claims, Justice Nicholas held that
the question to be asked is whether
the manufacturer has the intention
that the medicament be used to
treat the relevant condition. The
intention was to be considered
objectively - based on the available
information such as the Product
Information, labelling and the nature
of the market for the medicines.
The relevant method of treatment
claims were found to be indirectly
infringed on the basis that it was
reasonably foreseeable that the
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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