Lupin sues Ranbaxy in US for patent

infringement

RFC Case Number: P-L10-659R

Court Case Number: 1:10-cv-00659-UNA

File Date: Friday, August 06, 2010

Plaintiff: Lupin Atlantis Holdings SA.

Defendant: Ranbaxy Laboratories Limited
Ranbaxy Pharmaceuticals Inc.
Ranbaxy Inc.
Ethypharm SA
Cause: 35:271 Patent Infringement

Court: Delaware District Court

Indian drug company Lupin has sued Ranbaxy Laboratories, which is now controlled by
Japanese drug major Daiichi Sankyo, in a US court.

LUPIN and Ranbaxy Laboratories along with its parent company Daiichi Sankyo have
slapped patent infringement charges against each other to stop one another from
launching low-cost versions of their respective original drugs in the US.

Lupin sued Ranbaxy after the latter sought American drug regulators nod to sell its
generic version of Lupins cholesterol drug fenofibrate (brand Antara) in the US.Although
it is common for original drugmakers to sue generic challengers in the US,an Indian
generic company suing another local drugmaker for an alleged patent infringement in
the worlds largest drugmaker is rare.

The Lupin Atlantis Holdings SA, the Swiss subsidiary of the Mumbai-based Lupin Ltd,
has filed a Para IV patent infringement lawsuit against Ranbaxy Laboratories Ltd and its
US subsidiaries for alleged attempt to manufacture and market generic version of its
cholesterol-lowering drug Antara (fenofibrate), for which the former has acquired
marketing license from Oscient Pharmaceuticals nearly an year from now.

According to a petition filed with the District Court for the Eastern District of
Pennsylvania, Lupin Atlantis alleges that by filing an Abbreviated New Drug Application
(ANDA) with the US FDA to market fenofibrate 43 mg and 130 mg, Ranbaxy and its US
subsidiaries - Ranbaxy Pharmaceuticals Inc and Ranbaxy Inc - has infringed the patent
right of the company. The patent in suit is US Patent No 7,101,574 (the `574 patent) for
Pharmaceutical Composition Containing Fenofibrate and the Preparation Method,
issued on September, 2006. The `574 patent is set to expire in 2020.

Besides, the owner of the `574 patent, Ethypharm SA has also named as a defendant in
the suit, since the company does not join the complainant in filing suit against Ranbaxy,
though it was contractually obligated to cooperate with Lupin in such legal actions. The
Lupin Atlantis holds a license from Ethypharm, the owner of the patent-in-suit and
licensor of the patent to the company, under the `574 patent which contains provisions
concerning the right to enforce the patent in case of an ANDA filing by a third party,
added the complaint.

Lupin, which earlier filed an ANDA with the US FDA to market generic version of
fenofibrate capsules 43 mg and 130 mg, acquired the marketing rights from Oscient
Pharma on September 25, 2009, under the procedures of the US Bankruptcy Court
paying an amount of US $ 38.61 million for the product and related assets inclusive of
inventory.

Lupin, in September 2009, announced that the fenofibrate products market is US$ 1.9
billion for the previous 12 months, in which Antara has 4.5 per cent share of this market
and grew 20 per cent in revenue this past year. Antara is prescribed for adjunct
treatment of hypercholesterolemia (high blood cholesterol) and hyper-triglyceridemia
(high triglycerides) in combination with diet. The product gathered sales of US$ 85
million for Oscient in the year ended June 2009, says reports.

Lupin has demanded sales and litigation damages if Ranbaxy were to launch its generic
version before Antaras patent expires.Incidentally,before it bought Antara,Lupin was the
first company to file an application to sell its generic version.
It eventually sold that right to another Indian company Dr Reddys laboratories for an
undisclosed amount,days before it acquired Antara.

A recent analysis from IDFC Securities, a leading financial services group that offers
Institutional Equities and Investment Banking services, Lupin is poised to reach US$ 70
to 80 million sales for Antara by financial year 2011. The company has increased its
field force in US from 70 to 170 by end of fourth quarter of financial year 2010 to
promote Antara and its new product, Allernase, to be launched in the second quarter of
current financial year.
Lupin will be looking to place an injunction on Ranbaxy's product in order to recoup and
gain increased revenues from Antara before its patent expiry in August 2020. Ranbaxy
will automatically get a 30-month stay while the case is heard. With more than five years
to patent expiry, it is highly unlikely that the courts will rule in favour of Ranbaxy to
launch the product before nearer to the time of expiry. However if the companies reach
a settlement, it could see Ranbaxy launch its generic versions earlier than if an
injunction is applied, thereby being able to attain revenues and market shares before
patent expiry.

Meanwhile,in a separate case filed with the district Court of Delaware,New Jersey late
last month,Japans Daiichi Sankyo slapped a similar patent suit against Lupin.This is
after the Mumbai-based company made its Para IV application to launch a low-cost
version of Daiichi Sankyos type II diabetes medicine colesevelam hydrochloride sold
under the brand Welchol,before its patent expiry in 2015.Daiichi Sankyo has asked the
court for a permanent injunction to stop Lupin from indulging in any activity to sell its
generic version in the US.Like Lupin,it has also sought damages if the Indian company
went ahead with its proposed launch plans.In 2009,Welchol posted annual sales of
$252 million.

Submittet by:

Mohoni Gandhi (32)

Anuja Doiphode (33)

Yugesh Ganeshe (31)

PGDM-BTM II year