Inspire September 2018
First of its kind: Injunction
restraining launch of
biosimilar granted in Australia
03 The first interlocutory
injunction restraining the
launch of a biosimilar
pharmaceutical product was granted
by the Federal Court of
Australia in a decision
on 12 June 2018 1 .

The law applicable to
interlocutory relief
The two main principles
concerning the grant of
interlocutory relief are:
whether the applicant for
relief has established a
prima facie case
whether the balance of
convenience and justice
favours the grant or
refusal of an injunction.

Background The decision concerns the
monoclonal antibody rituximab, a
biologic therapy which is prescribed
in Australia to treat a number of
immunology conditions including
lymphoma, chronic lymphocytic
leukaemia and rheumatoid arthritis.

The applicants, F. Hoffman-La Roche
AG and its Australian subsidiary
Roche Products Australia Pty Ltd
(Roche), own four patents relating
to methods of use of rituximab
in the treatment of a number of
specified medical conditions. They
supply a number of products in
Australia under the MABTHERA
brand which have rituximab
as their active ingredient.

The respondent, Sandoz Pty Ltd
(Sandoz), are planning to launch
two biosimilar products called
RIXIMYO. They have obtained
regulatory approval of similar
scope to MABTHERA. Sandoz
also applied to have RIXIMYO
listed on the Pharmaceutical
Benefits Scheme (PBS), with a
view to launch later this year.

Roche, concerned that the effect
of the PBS listing would be to
cause a sequence of irreversible
and harmful consequences to
it, sought interlocutory relief
preventing Sandoz from infringing
five claims of four of their
patents relating to rituximab.

The question of arguable case
For the purposes of the present
application, Sandoz accepted
that its proposed conduct
would have infringed Roche’s
asserted claims. Nevertheless,
Sandoz contended they had
established a strong case
that the asserted claims are
invalid for lack of inventive step.

Roche responded that the case
advanced by Sandoz on the cross-
claim was arguable, but no more,
submitting that the overwhelming
strength of its infringement case
is not weakened by the existence
of a merely arguable cross-claim.

With the question of Roche’s
claim of infringement made out,
the question before the Court was
the strength of Sandoz’s invalidity
challenge. Upon consideration of
conflicting evidence from a range
of experts in relation to all four
patents, Burley J surmised that
the evidence did not permit any
provisional conclusion as to the
strength of the validity case beyond
the observation that it is arguable.

F.Hoffman-La Roche AG v Sandoz
Pty Ltd [2018] FCA 874
1
The decision
concerns the
antibody rituximab,
which is prescribed
in Australia to
treat a number
of immunology
conditions. The balance of convenience
Roche submitted that several factors
favoured granting interlocutory
relief - particularly that the
launch of a generic rituximab
would cause losses to Roche
that could not be adequately
calculated or compensated by
an award of damages. These
included, for example, a 16%
price drop mandated by the
PBS, as well as loss of market
share and loss of goodwill.

Sandoz submitted that the potential
losses outlined by Roche were
overblown and that its own losses
by the granting of an injunction,
which may later be overturned,
would be harder to calculate and
would result in greater irreparable
harm. Ultimately, Burley J found that the
balance of convenience and justice
favoured granting an injunction
against Sandoz until 11 August 2019,
the date upon which the first of
the Roche patents is set to expire.

Roche have also been granted
leave to apply for continuation
beyond this date, depending on
circumstances at that time.

Dr Annabella Newton,
Associate MChem(Hons) MCommrclLaw PhD AMRSC MRACI
annabella.newton@pof.com.au