Healthcare Industry News:  Ranbaxy Laboratories 

Biopharmaceuticals Generics Litigation

 News Release - December 20, 2006

Australian Federal Court Grants Favorable Decision to Ranbaxy on Pfizer's Atorvastatin Patent

Pfizer's Representation to the Australian Patent Office Held to be False & Misleading

Overall Ruling Mixed as Court Also Upholds Another Pfizer Patent



PRINCETON, N.J., Dec. 20 (HSMN NewsFeed) -- Ranbaxy Laboratories Limited announced that the Federal Court of Australia today handed down a favorable decision in the company's case against Pfizer regarding Pfizer's Australian atorvastatin patent 628198. Atorvastatin is a cholesterol-lowering drug which is marketed by Pfizer as LipitorĀ®.



Justice Neil Young ruled that one of Pfizer's patents is invalid for false suggestion and misrepresentation in obtaining the grant of Australian patent 628198, but said that Ranbaxy's atorvastatin product infringes another Pfizer patent. The Court's ruling followed a trial in Melbourne which took place from October 9th to 23rd, 2006. The invalidity of Pfizer's Australian patent 628198 was principally based on Pfizer's representation to the Australian Patent Office that the potency of the R-enantiomer (atorvastatin) in relation to its ability to inhibit production of cholesterol was unexpectedly 10-fold more than that of the corresponding racemic material. This representation was held to be "false and misleading."

Jay Deshmukh, Ranbaxy's Senior Vice President -- Global Intellectual Property, noted, "We are pleased with this decision as it stands, as it advances the entry of Ranbaxy's generic atorvastatin in Australia to May 18, 2012."

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 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 Australia. Warner Lambert was acquired by Pfizer in 2000.

** Warner Lambert/Pfizer's Australian patent 628198 was found to be invalid for false suggestion and misrepresentation as noted above. Ranbaxy's proposed product was found to infringe Warner Lambert/Pfizer's Australian patent 601981. The broadest claims of that patent were found to cover Ranbaxy's "enantiomeric" product. Ranbaxy intends to appeal Justice Young's decision in respect of the "claim construction" of Australian patent 601981.


Source: Ranbaxy

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