Seconds out in fast-melt lawsuit

St Louis, USA-based KV Pharmaceutical says that the US District Court for the District of Minnesota has denied a motion for a preliminary injunction by two rival drug delivery companies in a patent dispute centring on its technology for fast-dissolving oral drug technology.

While still used in only a minority of oral medicines - with estimated annual sales of $1.7 billion (€1.43bn) in 2002 - fast-melt delivery is experiencing 40 per cent growth a year as companies turn to it to differentiate their products in the marketplace.

The suit was filed against KV and its subsidiary Ethex by CIMA Labs and Schwarz Pharma and sought to make KV cease marketing a fast-melt version of hyoscyamine sulphate, used to treat irritable bowel syndrome, launched by Ethex in January in direct competition to Schwarz' NuLev brand of the drug.

CIMA and Schwarz allege that KV and Ethex infringe CIMA's patented, orally dissolving drug delivery technology called DuraSolv. CIMA licenses a US patent (No 6,024,981) to Schwarz and other companies that wish to sell products that rely on the technology.

The denial of the motion for preliminary injunction allows Ethex to continue marketing the product.