Canadian Federal Court Grants Favorable Decision to Ranbaxy on Pfizer’s Atorvastatin Patent

Canadian Federal Court Grants Favorable Decision to Ranbaxy on Pfizer’s Atorvastatin Patent

Ranbaxy Laboratories Limited announced that the Federal Court of Canada today handed down a favorable decision in the company’s case against Pfizer by finding invalid Pfizer’s Canadian atorvastatin patent CA 2,021,546. Atorvastatin is a cholesterol- lowering drug which is marketed by Pfizer as Lipitor®.

The Honorable 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 an 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 8th to 11th, 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.”

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.”

Ranbaxy Laboratories Limited, headquartered in India, is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies.

Ranbaxy’s continued focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. 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.

Note to Editors

*Technically the case was brought against Warner Lambert, the original
patentee of the two patents in Canada. Warner Lambert was acquired by
Pfizer in 2000.

** Warner Lambert/Pfizer’s Canadian patent 2,021,546 was found to be
invalid for insufficient disclosure as noted above. 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.

For further information please contact:

Ramesh L. Adige
Executive Director- Corporate Affairs and Global Corporate Communications
Ranbaxy Laboratories Ltd.
Plot 90, Sector 32, Gurgaon
Haryana 122001, India
Tel: +91-124-4135000
e-mail: ramesh.adige {at} ranbaxy(.)com

or

Raghu Kochar
Director-Corporate Communications
Ranbaxy Laboratories Ltd.
Plot 90, Sector 32, Gurgaon
Haryana 122001, India
Tel: +91-124-4135141
Mobile: 9811617256
e-mail: raghu.kochar {at} ranbaxy(.)com

or

Krishnan Ramalingam
Sr.Manager- Corporate Communications
Plot 90, Sector 32, Gurgaon
Haryana122001, India
Tel: +91-124-4135143
Mobile: 9810042540
e-mail: krishnan.ramalingam {at} ranbaxy(.)com

or

Charles M. Caprariello
Vice President, Corporate Communications
Ranbaxy Inc.
(609) 720-5615

or

Edwige Buteau
RF Binder Partners Inc.
(212) 994-7517

or

Anuj Baveja
RF Binder Partners Inc.
(212) 994-7552