[Ip-health] Aussie court rules against Ranbaxy on Lipitor Patent

[Ira Glazer]

http://www.dnaindia.com/report.asp?NewsID=3D1070405

MUMBAI: The Australian Federal Court in Victoria on Wednesday upheld the
exclusivity of Pfizer=92s basic patent covering atorvastatin, the main
ingredient in Lipitor, world=92s largest selling drug.

The ruling, on a lawsuit filed in 2005 by Ranbaxy, preserved Lipitor=92s
patent coverage in Australia through May 2012. Ranbaxy can appeal the
decision.

The court found that Ranbaxy=92s proposed drug would infringe Pfizer=92s
basic Lipitor patent.

However, the court ruled in favour of Ranbaxy for the second patent
covering the calcium salt of atorvastatin, which expires in September 2012.

For Ranbaxy, 2006 was a year of setbacks. In September, the District
Court of The Hague in the Netherlands barred Ranbaxy from launching its
drug before Lipitor=92s basic patent=92s expiry in November 2011. In June, =
a
British appellate court barred Ranbaxy, from launching a generic version
of Lipitor. Again, in October, Austrian Patent Office ruled in favour of
Pfizer preventing Ranbaxy from launching copycat version before the
expiry of Lipitor=92s basic patent in 2011.

However, according to experts, Ranbaxy=92s small victories for the patent
for salt of atrovastatin will not provide much satisfaction to the
company, as the basic patent for atrovastatin is with Pfizer.

Ranbaxy won patents for the salt in Norway and the US jurisdictions this
year. Ranbaxy has challenged Pfizer=92s patents on Lipitor in 17 markets
worldwide.


[compare the above report with Ranbaxy's Press Release below]:

http://biz.yahoo.com/prnews/061220/nyw111.html?.v=3D83&printer=3D1

Press Release Source: Ranbaxy Laboratories Limited

Australian Federal Court Grants Favorable Decision to Ranbaxy on
Pfizer's Atorvastatin Patent
Wednesday December 20, 12:36 pm ET
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 /PRNewswire/ -- 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 Lipitor=AE.

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.