Dr Reddy’s Laboratories may have lost a $100 million profit opportunity with the US Court of Appeals for the Federal Circuit on Monday
BANGALORE: Dr Reddy’s Laboratories may have lost a $100 million profit opportunity with the US Court of Appeals for the Federal Circuit on Monday ruling that its abbreviated new drug application (ANDA) and that of Israel’s Teva Pharmaceuticals had infringed on Eisai Co’s patent on acidity-treating drug Aciphex. Dr Reddy’s will not be able to launch a copycat version till May 2013.
Aciphex, which is Eisai’s brandname for the drug rabeprazole, had sales of $1.63 billion in 2008. It is used for the treatment of persistent heartburn and other symptoms associated with acid reflux disease.
Rabeprazole is in a class of drugs called proton-pump inhibitors (PPIs) which block the enzyme that produces digestive acid in the stomach. This allows ulcers in the stomach and oesophagus to heal. The drug is Tokyo-based Eisai’s second-biggest product, behind its best-selling Alzheimer’s treatment Aricept.
Mylan Inc, which had taken over Hyderabad-based Matrix Laboratories more than a year ago, had also filed an ANDA on the drug, and had agreed to go by the outcome of the lawsuit against Teva and Dr Reddy’s.
“We have lost the case but we are exploring various options,” a Dr Reddy’s spokesperson, who did not wish to be named, told DNA Money.
The official did not elaborate on what these options were. G V Prasad, chief executive officer of Dr Reddy’s, told Bloomberg Television there is a possibility to appeal against the ruling. The company will continue to try to bring affordable medicine to customers, he said.
“So far, the barbarians have been kept at the gate,” lawyer Joseph O’Malley of Paul Hastings in New York, who represents Eisai in both the Aricept and Aciphex cases, told Bloomberg.
Earlier, Dr Reddy’s had received a setback in May 2007 after the US district court upheld Eisai’s patent.
A win would have implied a $75-$100 million profit opportunity, a company representative had said at that time.
A further appeal, if that is possible, would mean further legal expenses for Dr Reddy’s which said on Monday its sales and administrative expenses, comprising mainly legal costs, accounted for 31% of the revenues in Q1 of the current year compared to 26% in the same period last year.
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
)
){kind=small}
){kind=small}
)
)
)
)
)
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}