A recent decision of the Australian Federal Court has cast doubt
on the widely-accepted notion that a "paper anticipation"
is insufficient to invalidate a patent claim.
In Albany Molecular Research Inc v Alphapharm Pty Ltd 
FCA 120, Albany sued Alphapharm (amongst other generics
manufacturers) for infringement of Australian Patent No. 699799.
This patent claimed fexofenadine hydrochloride in substantially
pure form – and also pharmaceutical compositions and
methods of treating allergic conditions using such compounds.
Alphapharm was allegedly selling antihistamine products comprising
the claimed compounds. In response, Alphapharm counter-claimed for
revocation of AU 699799, on grounds including novelty and
The decision in relation to both novelty and obviousness is
considered somewhat controversial. Both arguments relied on the
same two prior art documents that described, inter alia,
fexofenadine and methods for its synthesis. What the prior art
lacked, however, was an enabling disclosure as to how one could
obtain fexofenadine in substantially pure form. Thus,
there was a mere "paper anticipation", which, Albany
contended, should have resulted in the counter-claim being thrown
The Court nonetheless rejected such arguments. Jessup J, sitting
alone, felt bound by recent decisions of the Full Federal Court
(e.g., Lundbeck v Alphapharm Pty Ltd  FCAFC 70; and
Apotex v Sanofi Aventis  FCAFC 134), which were
factually similar to the present case. His Honour held that the
"disclosure of a compound by exact naming in the prior art is
sufficient, of itself, to constitute anticipation", at
As suggested above, this decision would appear ripe for Appeal
based on the proposition that Lundbeck and Apotex
were applied incorrectly – a possibility alluded to
earlier in his Honour's judgment.
His Honour then went on to consider whether the claims were
obvious – in other words, whether fexofenadine in
substantially pure form was obvious over fexofenadine, per
se, based either on the teaching of the prior art, or the
routine abilities of one nominally skilled in the art. It was held
that the prior art did not teach a means of preparing fexofenadine
in a substantially pure form – and that, on evidence,
such compounds could not have been obtained by mere routine. The
judge found that the synthetic method described in the patent
(i.e., wherein the substantially pure fexofenadine hydrochloride
was isolated from two undesired regioisomers that are by-products
of the synthetic methods otherwise described) would not have been
obvious to one of ordinary skill in the art in Australia.
His Honour thereby concluded that claims to substantially pure
fexofenadine, whilst lacking in novelty, were indeed inventive.
This proposition is something of a misnomer and in our opinion
further tempts Appeal in that it appears to have moved Australian
law out of kilter with most other major jurisdictions.
On 13 April 2011, in a largely unsurprising development, Albany
appealed the decision. The matter will now be heard by the Full
Bench of the Federal Court.
We will continue to monitor developments in this case. For
completeness, we note that the ground of "false
suggestion" was also raised in relation to the actions of
Albany's predecessor in title during initial prosecution
before the Australian Patent Office. Watch this space.
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