1-ranbaxy decision report.pdf
FEDERAL COURT LAYS DOWN THE LAW ON MISREPRESENTATION
AND FALSE SUGGESTION FOR PATENTS
Pfizer markets Lipitor globally. Lipitor is Australia's and the world's largest selling
prescription drug. Global sales exceeded A$15 billion in 2006. Lipitor is a member
of the statin class of drugs that lowers cholesterol.
Ranbaxy Australia had applied to the Federal Court of Australia to have Patent No.
628198 revoked.* Claim 6 of this patent was for atorvastatin calcium, the active
At the Federal Court trial held in October 2006, Ranbaxy submitted that the '198
patent should be revoked on three grounds:
the patent was obtained by misrepresentations or misleading information,
that the invention was not a manner of manufacture.
Young J, in his judgement handed down on 20 December, 2006
), held that the
patent should be revoked on the first two grounds. This article deals with this
With regard to the misrepresentation ground, this case addressed this ground in
considerable detail and was the central focus of the evidence and invalidity
submissions. Very few cases had previously dealt with this ground of revocation. In
an earlier case, Wm Wrigley Jr. Company v. Cadbury Schweppes Pty. Ltd. 
FCA 1035 (28 July, 2005), Heerey J had held the patent in suit to be invalid on this
ground. However, Heerey J also held that patent to be invalid on several other
____________________________________________________________________ * A further patent, 601981, was also the subject of these proceedings and Young J held that this patent was infringed by Ranbaxy.
grounds, and misrepresentation appears to have been of lesser importance. In that
case, the misrepresentation was the consequence of narrowing amendments to the
claims that were not reflected in any corresponding amendments to the patent
specification. If this had been a critical ground of invalidity, it appears that the
specification may have been able to be amended to correct the misrepresentations.
In the present case, Young J held that information which was material to the grant of
the invention and which was provided by the applicant in a patent specification must
be scientifically sound. Young J also held that if, in the period up to the time of the
grant of the patent, the applicant became aware of further information, material to the
grant of the invention, which may significantly alter the original information, the
applicant has a duty to provide that additional information to the examining Patent
Office. The duty therefore applies not only at the time of filing the patent
application, but continues until the patent is granted.
In the patent at suit, the critical issue was whether the representations in the patent
specification, based on CSI in vitro
data, were true. In particular, the critical issue
was whether it was true that the active enantiomer had of the order of ten times the
activity of the racemate. The scientific expectation was that there would have been
only a two-fold increase in activity. On the basis of the evidence before the Court,
the statements in the specification concerning the ten-fold activity increase
the representation that the CSI in vitro
data presented in the specification
reflected all the CSI in vitro
data available to the applicant and the
conclusion reached from the table were false and misleading,
the applicant's representations relating to this issue during the prosecution of
the patent application were false and misleading.
During the trial, evidence was provided by a number of technical experts, including
the inventor Dr. Roth. On several critical issues the judge did not accept the
This case has set standards that inventors and practitioners need to be aware. The
standard essentially amounts to a duty of candour in presenting technical information
that is material to the grant of the patent. This applies to information in the
application as filed and also information provided during prosecution. If an applicant
provides only technical data that is favourable to the grant of the patent and
withholds information that may be detrimental to the grant of the patent, there is a
real risk that the patent will be invalid for false suggestion and misrepresentation.
The judgements on both patents that were litigated have been appealed to the Full
Young J's findings of fact from the evidence in this case have been considered in
corresponding litigation in Canada where von Finckenstein held in referring to the
"Here we clearly have an assertion of a ten-fold increased activity on the face of the specification. This false suggestion of a ten-fold increase in activity cannot be backed up by the data provided…."
Callinan Lawrie were the Patent Attorneys representing Ranbaxy Australia in these
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