SangStat wins U.K. cyclosporine case

SANG said the High Court in London ruled that the Medicines Control Agency acted properly in granting marketing approval for SangCya Oral Solution, SANG's cyclosporine to prevent rejection following solid organ transplant. A Novartis (SWX:NOVN) suit had alleged that SangCya, a bioequivalent of NOVN's Neoral, infringed NOVN's U.K. Patent No. GB2200048B covering an intravenous formulation of cyclosporine (see BioCentury July 26, 1999). The MCA approved SangCya in January 1999.

NOVN also has been seeking a permanent injunction to prevent U.S. marketing of SangCya, alleging it infringes U.S. Patent No. 5,389,382 (see BioCentury, Feb. 16) . In a preliminary hearing last December, the U.S. District Court for the District of Columbia stated that NOVN had not shown sufficient evidence to challenge FDA approval of SangCya. The FDA granted SANG marketing approval in November 1998. ...