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