Gyles J Takes Aim at Enabling Disclosure

In Apotex Pty Ltd (formerly GenRx Pty Ltd) v Sanofi-Aventis [2008] FCA 1194, previously mentioned here, Gyles J concluded his consideration of novelty with the comment that:

Anticipation is deadly but requires the accuracy of a sniper, not the firing of a 12 gauge shotgun.

However his Honour’s findings on novelty, and in particular the need for an enabling disclosure, suggest that the bullet may not only have a hollow point but be hollow in its entirety.

Gyles J commences by stating that the phrase enabling disclosure, while “reasonable shorthand in relation to the disclosure required for there to be anticipation of a process or method claim … has little, if any, relevance to anticipation of a product claim or a claim for a chemical compound by formula. Indeed, it is apt to mislead in relation to the latter.”

There follows a discussion of the traditional authorities relating novelty, including Hill v Evans, Flour Oxidizing Co Ltd v Carr and General Tire v Firestone which his Honour effectively distinguishes on the bases that they related to claims to processes rather than products.

His Honour then considers more recent UK decisions such as Re Genentech Inc’s (Human Growth Hormone) Patent and SmithKline Beecham (Paroxetine Methanesulfonate) Patent. These cases and the stated requirement for both enablement and disclosure are distinguished on the basis that:

at least in relation to product claims and claims for chemical compounds by formula, this is a departure from the law of Australia and from English law as it was applied up to 1977.

Accordingly, Gyles J held claim 1, directed to a particular enantiomer of a chemical compound, to be anticipated by an earlier patent describing how to produce the racemate of that compound and identifying the existence of the enantiomer, but giving no information as to how each enantiomer might be resolved.