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. The company sold its ANDA to Dr Reddy's Laboratories four days before the acquisition and has resolved the pending litigation regarding the ANDA product, according to reports.

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.

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.