that Dr Sherman was likely to have
instructed Apotex to procure the
listing of its clopidogrel products
on the PBS, and held that he
was not persuaded that Apotex
would have sought and obtained
a PBS listing of its clopidogrel
products even if the interlocutory
injunction had not been granted.

It followed, his Honour held,
that the Commonwealth’s
claim must be dismissed.

Did such loss flow
directly from the
interlocutory injunction?
Although the above finding
was sufficient to deal with the
Commonwealth’s application, his
Honour also would have rejected the
Commonwealth’s claim on the basis
that the loss it sustained did not
flow directly from the interlocutory
injunction, because the injunction
did not prevent Apotex from applying
for and obtaining PBS listing, but
rather was an indirect loss.

Was the loss sustained
by the Commonwealth
foreseeable at the time the
interlocutory injunction
was granted?
The Court did consider, however,
that the loss suffered by the
Commonwealth, although
indirect, was foreseeable.

What would the damages
have been if the claim
was successful?
The Court held that if the
interlocutory injunction had not
been granted, and assuming Apotex
obtained PBS listing in April 2008
and entered the market, then it
was likely to have only supplied
clopidogrel products until 19 August
2008 when the trial judge held that
the patent was valid and issued
a permanent injunction. This was
referred to as the “interrupted
supply counterfactual”. His Honour
rejected an alternative “continuous
supply counterfactual” pressed by
the Commonwealth which assumed
supply from March 2008 until March
2010, when the High Court refused
special leave to appeal.

In conclusion
Ultimately this case was decided
on its facts and in particular
due to the Commonwealth’s
failure to convince the judge that
Apotex would have entered the
market had it been free to do
so. In that sense it is of perhaps
limited general application.

An interesting aspect of the case
is that if Apotex had not settled
with Sanofi but pursued its claim
to decision, a finding in similar
terms to that made in relation to
the Commonwealth (that Apotex
would not have sought PBS listing
but for the interlocutory injunction),
would have seen Apotex’s claim
also dismissed. However, there is
little doubt that if Apotex had run
the matter to trial it would have led
other evidence which may well have
resulted in a different outcome.

The Court held that there was a 10% probability that the 12.5% price reduction
would not be reversed and so increased the amount to take that into account.

4 Sigma Pharmaceuticals (Australia) Pty Ltd v Wyeth [2018] FCA 1556, at [447]
3
Under the
interrupted supply
counterfactual, the
mandatory 12.5% price
reduction would have applied
between 1 April and 19 August
2008. However, the Court also held
that it was likely that when the
Apotex product would have
been withdrawn from the market
in August 2008, the 12.5% reduction
would have been reversed, and
so the Commonwealth’s losses
were confined to that period up
to 19 August 2008. The amount
was assessed at slightly over
$15.5 million 3 .

…the Court was not
persuaded that Apotex
would have sought
and obtained a PBS
listing of its clopidogrel
products even if the
interlocutory injunction
had not been
granted. Perhaps of more significance is
the secondary finding that the loss
sustained by the Commonwealth
was indirect rather than direct,
as this is likely to apply generally
in these sorts of cases, both to
claims made by third parties such
as the Commonwealth, and also
to the injuncted party. Nicholas J’s
decision in this regard is somewhat
at odds with comments made by
his sister judge Jagot J in the earlier
Sigma case 4 where her Honour
considered that it would be “artificial
in the extreme” to suggest that a
similar interlocutory injunction in
that case did not prevent Sigma
from seeking listing on the PBS.

Whether this and other issues
in the case are raised in an
appeal remains to be seen.

Malcolm Bell | Partner
BSc(Hons) LLB LLM FIPTA MRACI
malcolm.bell@pof.com.au Inspire July 2020
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