Hoffman La Roche sues Mylan over alleged patent violation
15 Apr 2009
Hoffman La Roche has sued Mylan over its attempts to market a generic version of breast and colorectal cancer chemotherapy, Xeloda.
The firm, Roche's prescription drug unit, alleged that Mylan infringed one of its patents by filing an abbreviated new drug application (ANDA) with the US Food and Drug Administration (FDA).
Mylan expects to qualify for 180 days of sole marketing exclusivity for the drug once FDA approval is gained, however, as it believes it is the first company to have submitted the ANDA with a paragraph four certification.
Xeloda tablets in 150mg and 500mg doses generated around $447 million (£299 million) worth of sales last year, according to data from IMS Health.
Mylan currently has 117 ANDAs which are awaiting FDA approval, 33 of which it believes to be potential first-to-file opportunities.
Last week, the company settled patent litigation with Schering-Plough after being accused of breaching intellectual property rules covering Clarinex allergy medication.
