Legal cannons roll out in cyclosporine wars
In a long-expected move to protect its cyclosporine franchise, Novartis Pharmaceuticals Corp. sued SangStat Medical Corp. alleging that SANG's SangCya infringes Novartis' U.S. Patent No. 5,389,382 and seeking a permanent injunction to prevent marketing of SangCya.
Novartis also took aim at the FDA, simultaneously filing a suit alleging that the agency violated its own statutes in approving SangCya as a generic equivalent of Novartis's Neoral cyclosporine because SangCya is not identical to Neoral.
The FDA action, filed in the U.S. District Court for the District of Columbia, alleges that the FDA violated Food, Drug & Cosmetic Act regulations in approving SangCya as a generic form of Neoral because SangCya's dosage form differs from Neoral's. The pharma company argues that the agency is required to follow a separate procedure for products that are