In a twist to the tale of drug patent infringement cases in the United States, Indian drug company Lupin has sued Ranbaxy Laboratories, which is now controlled by Japanese drug major Daiichi Sankyo, in an American court.
This is the first incident in which an Indian company, which has turned innovator, sued another homegrown generic drug maker for infringing the patent rights to launch a copycat version of a drug in the US market.
The court document accessed by Business Standard said Lupin's Swiss subsidiary, Lupin Atlantis Holdings, sued Ranbaxy Laboratories, its US subsidiaries and French innovator Ethypharm for infringing the patent of Antara (fenofibrate), a cholesterol lowering drug.
Lupin had acquired the US rights of this drug from bankrupt Oscient Pharmaceuticals in September 2009 for $38.61 million (Rs 185 crore). Antara had recorded net sales of $70 million in 2008.
Generic companies, such as Ranbaxy, Dr Reddy's Laboratories and Lupin, had challenged numerous patents of innovator multinational companies, such as Pfizer, GSK, Novartis and Sanofi-Aventis, in the past to boost their US drug sales. Ranbaxy and Dr Reddy's were the pioneers from India to file such patent-infringement suits.
A first to challenge opportunity gives the generic player a six month exclusive sales in the US market upon patent expiry.
Lupin, which filed the case in the US District Court for the Eastern District of Pennsylvania on August 4, said Ranbaxy's abbreviated new drug application (ANDA) to market fenofibrate capsules in the strength of 43 mg and 130 mg infringes the patent rights of Antara. Ranbaxy had informed Lupin on June 24 about the Paragraph IV certified ANDA, which notifies a patent challenge as per the US rules for generic drug sales.
Lupin had previously filed an ANDA for the same drug, before acquiring the product. On September 21, 2009, prior to the acquisition of Antara, Lupin sold its ANDA to Dr Reddy's Laboratories. Lupin also had settled and resolved the pending litigations regarding the ANDA product with Oscient.
Interestingly, Lupin has also sued Ethypharm, which is the owner of the patent in question. Lupin Atlantis holds a license for the patent from Ehtypharm. "Although requested to file suit as co-plaintiff, Ethypharm has not, as of the date of the filing of this action, agreed to do so. For that reason, Ethypharm is named as a defendant," Lupin informed the court.
Lupin has also requested the court to realign defendant Ethypharm as a plaintiff in the case.
Antara's patent was granted in the US in 2006 and has validity beyond 2020. The fenofibrate products have a market of over $1.9 billion in the US. Antara has 4.5 per cent share of this market and grows over 20 percent every year. The drug is prescribed for adjunct treatment of hypercholesterolemia (high blood cholesterol) and hyper-triglyceridemia (high triglycerides). Analysts expect Lupin to gain about $80 million from the sale of this drug in 2010-11.
