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 (http://www.austlii.edu.au/au/cases/cth/federal_ct/2006/1787.html), 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. [2005] 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…." (http://decisions.fct-cf.gc.ca/en/2006/2006fc1471/2006fc1471.html) Callinan Lawrie were the Patent Attorneys representing Ranbaxy Australia in these

Source: http://www.callawrie.com.au/downloads/Ranbaxy%20Decision%20Report.pdf