Watermark

30 June 2008
In Ranbaxy Australia Pty Ltd v Warner-Lambert Company LLC [2008] FCAFC 82 (28 May 2008), the Full Federal Court of Australia has upheld a lower Court finding that the claims of Warner Lambert’s patent directed to the enantiomer atorvastatin calcium should be revoked for false suggestion and misrepresentation. This finding perhaps is a portent of the manner in which revocation actions before Australian Courts may proceed in future, mirroring the common practice in US patent matters in which allegations of fraud on the Patent Office are commonplace.

Atorvastatin calcium is the active ingredient in a prescription medicine marketed in Australia under the product name Lipitor. Lipitor is prescribed to patients suffering from high levels of cholesterol in the blood in order to lower the level of cholesterol and thereby reduce the incidence of cardiovascular disease. Lipitor has been an extremely successful drug and thus this decision has potentially significant commercial ramifications. In 2004, Ranbaxy Australia Pty Ltd (Ranbaxy) proposed to import into Australia for sale a product containing atorvastatin calcium. Warner-Lambert alleged that the importation and sale of the product would constitute infringement of two of its patents covering Lipitor. Ranbaxy commenced a proceeding seeking, inter alia, an order revoking the narrower patent directed to an enantiomer of the active ingredient. Warner-Lambert filed a cross-claim in the proceeding claiming injunctions restraining Ranbaxy from infringing both the enantiomer patent and another patent covering the racemate of the compound.

The Full Federal Court stated that “if a representation that was false or misleading materially contributed to the Commissioner’s decision to grant a patent, even if other circumstances or causes also played a part in the making of that decision, it may be said that the patent was obtained by a false suggestion or misrepresentation. It is sufficient if the representation materially contributed to the Commissioner’s decision to grant the patent or was a material, inducing factor, which led to the grant”.

It was asserted by Ranbaxy that false suggestions or misrepresentations were made in the patent specification itself and in the patent prosecution process by statements made to the Examiner concerning the results of comparative testing of the enantiomer. The Full federal Court agreed. In particular, it found that the data in the patent specification do not correctly represent the results of tests that were carried out by Warner-Lambert and that, in fact, Warner Lambert had selected only that data which supported a case for patentability as a selection, and had withheld concurrently obtained data which show a significantly lesser degree of activity.  Further, in prosecuting the patent application, the patent attorney had highlighted the selected data and had asserted that the R enantiomer is ten times more active than its racemic mixture on the basis thereof. It was found that this was a false or misleading representation because, in fact, the R enantiomer is only approximately twice as active as its racemic mixture, which is the level of activity that would be expected of the active enantiomer as compared to the racemic mixture. Since it had been proven that Warner- Lambert had been in possession of, but had withheld data which contradicted this assertion, their actions were found to be material in misleading the Commissioner.

This brings into sharp focus the need for inventors to disclose full details of their experiments to their patent attorneys, and for patent attorneys to properly interrogate inventors, so that what is drafted into a patent specification is a truthful account of an invention rather than an attempt to obtain commercial advantage by half truth.