Ranbaxy Laboratories Limited announced that the Federal Court of Canada has handed down a favourable decision in the company's case against Pfizer by finding invalid Pfizer's Canadian patent CA 2,021,546 on atorvastatin, a cholesterol-lowering drug that is marketed by Pfizer as Lipitor.
The Honourable Justice von Finckenstein dismissed Pfizer's application to deny issuance of a Notice of Compliance (NoC) as regards Pfizer's Canadian patent CA 2,021,546, finding the patent invalid for not "correctly and fully describing the invention." The Minister of Health Canada was ordered not to issue NoC until expiry of the other contested Pfizer patent (CA 1,268,768), which is May 7, 2007.
The Court's ruling followed a hearing in Toronto, which took place from January 8 to 11, 2007. Specifically, Justice von Finckenstein found that the "false suggestion of a ten-fold increase in activity cannot be backed up by the data provided." Technically, the case was brought against Warner Lambert, the original patentee of the two patents in Canada, which has been acquired by Pfizer in 2000.
The Warner Lambert/Pfizer's Canadian patent 2,021,546 was found to be invalid for insufficient disclosure, while Ranbaxy's proposed product was found to infringe Warner Lambert/Pfizer's Canadian patent 1,268,768. The broadest claims of that patent were found to cover Ranbaxy's enantiomeric product, according to sources.
Jay Deshmukh, Ranbaxy's senior vice president - Global Intellectual Property, noted, "We are pleased with this decision as it stands, as it allows the entry of Ranbaxy's generic atorvastatin in Canada upon marketing approval."
The company's foray into Novel Drug Delivery Systems has led to proprietary "platform technologies", resulting in a number of products under development. The Company is serving its customers in over 125 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 49 countries and manufacturing operations in 9 countries.