Wednesday, June 17th, 2009
Enabling Enantiomers
In a split decision, the Full Federal Court has upheld the validity of claims 1 to 4 of Australian patent 623144 in relation to the antidepressant escitalopram. H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70, also saw the Court uphold the trial judge’s decision that claim 5 of the patent lacked utility, but overturn the finding that claim 6, a method claim, was infringed. Finally, Lundbeck’s appeal against the decision that the patent was not entitled to an extension of term was dismissed.
Claim 1 of the patent recited “(+)-1-(3-dimethylaminopropyl)-1-(4’-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile and non-toxic acid addition salts thereof”. This was effectively a claim to the (+) enantiomer of citalopram, an existing pharmaceutical compound used in a racemic form.
Bennett J, with whom Middleton J agreed, adopted a construction similar to that of the trial judge. Her honour held that having regard to the context of the specification as a whole and the evidence of various expert witnesses, it was clear that the skilled addressee would understand the claim to be directed to the (+) enantiomer in a pure, isolated or separated form. However Bennet J was not prepared to read into the claim a limit on the purity of the (+) enantiomer of at least 95% as the trial judge had done.
Having so construed the claim, Bennett J then considered whether the prior art, including a patent directed to the racemic citalopram, deprived the claim of novelty. Her Honour reviewed in some detail the various authorities, both in Australia and the UK on the question of novelty and in particular the concept of “enabling disclosure” and concluded:
It follows that, where the prior publication is of the subsequently claimed invention, that is sufficient. Where the prior disclosure falls short of a complete disclosure, the question of the sufficiency of that disclosure arises. It is there that consideration must be given to the quality of a disclosure to the skilled addressee armed with common general knowledge. It is in that context that, in a limited fashion, questions of “enablement” can be said to arise. The use of that expression tends to cause confusion between anticipation and sufficiency. Rather, the Court, armed with the evidence of the skilled addressee as to terms of art and the nature and extent of the disclosure in the prior art document, must determine whether the prior disclosure is sufficient to enable the skilled addressee to perceive, understand and, where appropriate, apply the prior disclosure necessarily to obtain the invention.
It was therefore held that as neither the citalopram patent, nor any other prior art document specifically disclosed the isolated (+) enantiomer, nor enabled a skilled addressee to produce the isolated (+) enantiomer, there was no anticipation.
It is unclear what impact this judgement will have on the concept of enabling disclosure in Australia. On the one hand it seems to suggest that where a prior art document discloses something identical to what is subsequently claimed, it is irrelevant that the prior art would not have enabled the skilled addressee to implement the invention. On the other hand, the prior disclosure must be so precisely and explicitly coincident with what is subsequently claim that almost any prior art could be said not to “disclose” the claimed invention, thereby enlivening the “enablement” requirement.

