The best method of
clearing a path for
generic market entry
A recent interlocutory decision 1 of Justice Beach has
considered various ways to accelerate litigation through use
of strike out motions, summary dismissal and expedited trial.

Inspire June 2021
The decision also provides important
guidance on the Court’s approach
to the increasingly potent ground
of best method as a means of
attacking patents and some insights
for pharmaceuticals on ‘clearing
the way for generic pharmaceutical
market entry’.

12 The Dispute
Celgene is the patentee of the term
extended Australian patent 715779
(‘779) and several related method
of treatment patents.

In order to clear the way for the
future launch of their generic
pharmaceutical products, Juno
Pharmaceuticals Pty Ltd and Natco
Pharma Limited (Juno) brought a
revocation action against relevant
‘compound’ claims of the ‘779 patent
on the grounds of failure to disclose
the best method, lack of inventive
step and false suggestion. Celgene
cross-claimed for infringement.

This decision follows a number
of interlocutory applications filed
by the parties, most relevantly
an application by Celgene for
summary dismissal of Juno’s
invalidity attack concerning
the alleged failure to
disclose the best method
and false suggestion.

Although Celgene
was unsuccessful, the
decision provides some
useful information on how
the Courts will assess a best
method attack and the court’s
willingness to expedite proceedings.

The Patent
The ‘compound’ claims of ‘779 relate
to a Markush formula, and one of the
18,000 compounds in their scope is
the pharmaceutical ‘lenalidomide’.

This patent also contains claims to
methods of reducing undesirable
levels of tumor necrosis factor-α
(TNFα). TNFα is a cell signalling
protein implicated in mediating
many physiological conditions.

The ‘779 patent had been
successfully extended by the
maximum five year term open to
users of the Australian patent system
who have encountered a delay in
obtaining regulatory approval.

1 Juno Pharmaceuticals Pty Ltd v Celgene
Corporation [2021] FCA 236



Regulatory Hurdles
In order to fast track regulatory
approval by piggybacking on an
innovator’s clinical trial data, a generic
must show that their competing
product is ‘bioequivalent’ and declare
that that their product does not
infringe any existing patents. This
is a key driver for generics seeking
to clear the way for launch.

On the flip side, an innovator’s
motivation to stave off generic entry
is explained by the fact that the
first generic registration of a given
pharmaceutical triggers a price
reduction by the PBS and of course,
a loss of market share.

Clearing the Way by Patent
Revocation– Australia’s
“Best Method” of
Invalidation? A specification in Australia must “…
disclose the best method known to the
applicant of performing the invention 4 ”
Although, long a requirement under
Australian patent law, an invalidity
attack for failure to disclose the best
method has been gaining momentum
in recent times, particularly amongst
generic and biosimilar companies
because of its potential to render
whole patents invalid 5 .

The Characterisation
of “the Invention” is Key
An assessment of whether a
specification discloses the best
method necessarily involves
ascertaining what ‘the invention’
is, a process which goes beyond
simply looking at the claims.

In this instance, the parties’
competing claim constructions and
how those constructions related to
characterising the “boundaries and
content of the invention” was key 6 .

Juno asserted the invention could
be characterised as non-polypeptide
compounds that, when administered
In order to fast track
regulatory approval
by piggybacking on
an innovator’s clinical
trial data, a generic
must show that their
competing product is
‘bioequivalent’ decrease TNFα levels 7 , such that the
best method requirement could only
be met by a disclosure of which of
the compounds were known to ‘most
effectively’ decrease levels of TNFα.

Celgene asserted that the invention
resided in a newly discovered class
of non-polypeptide compounds, one
of which is lenalidomide and that
the ‘best method’ is satisfied by the
specification and knowledge of the
skilled person of how to make it 8 .

A n exception is that methods of making pharmaceuticals by recombinant technologies
are eligible for term extension.

3 Australian Patents Act 1990 (Cth) s 78
4 IBID s 40 (2)(aa)
5 See for example: Les Laboratoires Servier v Apotex Pty Ltd [2016]; 247 FCR 61 Gilead
Sciences Pty Ltd v Idenix Pharmaceuticals LLC [2016]117 IPR 252; Idenix Pharmaceuticals
LLC v Gilead Sciences Pty Ltd [2017] 134 IPR 1 Bluescope Steel Ltd v Dongkuk Steel Mill Co
Ltd (No 2) [2019] 152 IPR 195; and Pfizer Overseas Pharmaceuticals v Eli Lilly and Company
[2005] 225 ALR 416.

6 Juno Pharmaceuticals Pty Ltd v Celgene Corporation [2021] FCA 236 paragraphs [25], [80], [85]
7 Ibid [30]
8 Juno Pharmaceuticals Pty Ltd v Celgene Corporation [2021] FCA 236 paragraphs [32]-[33]
9 Cuthbert A (2003). The Oxford Companion to the Body. Oxford University Press. p. 682.

doi:10.1093/acref/9780198524038.001.0001. ISBN 9780198524038
10 Australian Patent number AU 715779 C page 6, line 2
11 Juno Pharmaceuticals Pty Ltd v Celgene Corporation [2021] FCA 236 paragraphs [51]-[52]
Clearly, establishing the best
method of making a pharmaceutical
that bears more than a passing
resemblance to infamous drug
thalidomide, which has been made
en mass since the 1950s, is a less
arduous a task than having to show
which compound was known to the
patentee to be the most active 9 .

There is some tension in Celgene’s
position in that although no features
of the compound claims relate
to TNFα activity, the ‘promise’
statements in the ‘799 patent do
suggest that this is the ultimate aim
of the invention 10 .

At this juncture at least, Celgene’s
position seems to be the stronger
one - his Honour stating it was
strongly arguable that the claims
are directed to the ‘compounds
simpliciter’, and agreeing that no
integers of the claims related to the
reduction of levels of TNFα.

Although Juno’s position may be
based on a problematic construction
of the invention 11 , the decision is
yet another reminder that the best
method requirement is a uniquely
onerous one in Australia. It requires
keen attention when asserting
and defending rights and may be
burdensome for patent owners
and lead to onerous discovery
obligations. Expedited outcome
Notably, although Juno was
unsuccessful in its own application
to strike out parts of the cross-claim
for infringement, it was successful
in seeking an expedited trial of the
invalidity challenge in order to clear
the way for its launch if ultimately
successful. The trial is to be set
down in August of this year, with his
Honour to deliver judgment within
a month. The decision provides
a good indication that the court
is increasingly willing to expedite
proceedings launched by generic
pharmaceuticals to ‘clear the way’.

2 Inspire June 2021
In Australia, only claims to
pharmaceuticals themselves can
have their term extended - the
extension regime does not apply to
most methods relating to, or uses
of pharmaceutical compounds 2 .

A corollary of this is that during
the extended term, a patentee’s
rights reside in the pharmaceutical
compound claims, and thus Juno’s
invalidity action was limited to those
claims of the ‘779 patent 3 .

13 Dr James Burnley | Associate
MSci, PhD MIPLaw
james.burnley@pof.com.au