GSK patent not infringed

A federal judge for the United States District Court (USDC) for the Northern District of Illinois (Chicago) has ruled in GSK's litigation with TorPharm Pharmaceuticals, a wholly owned subsidiary of Apotex, over GSK's anti-depressant drug, Paxil (paroxetine hydrochloride). He ruled that GSK's patent in the US covering the hemihydrate form of Paxil is valid but not infringed by Apotex's product. The patent expires in 2006. GSK says it will appeal against the ruling of non-infringement.

Although the judge did find it likely there would be some hemihydrate in Apotex' product, he found that GSK did not show hemihydrate would be present in sufficient amounts to infringe the patent under his interpretation.

The action by GSK represents one element of the current legal action between it and Apotex, which is seeking to market an anhydrate form of paroxetine hydrochloride. The company is continuing to pursue litigation for infringement of other patents relating to Paxil against Apotex and other generic companies in the USDC for the Eastern District of Pennsylvania (Philadelphia).

Possible timing of a generic Paxil product launch remains unclear with the Philadelphia trial still pending and the Chicago decision now moving towards appeal. Consequently, GSK's published business performance earnings per share guidance for 2003 remains unchanged. However, if a generic launch of paroxetine hydrochloride became imminent, GSK said it would have to reassess this guidance.