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