Spectrum Pharmaceuticals, Novartis cancer news

The U.S. District Court for the District of Nevada ruled that Spectrum’s U.S. Patent No. 6,500,829 covering cancer drug Fusilev levoleucovorin is invalid. The patent covers methods for preparing substantially pure diastereoisomers of derivatives of tetrahydofolate and the use of such diastereoisomers. Novartis’ Sandoz Inc. generics unit submitted an ANDA for “ready to use” levoleucovorin in 2011. The ANDA contained a Paragraph IV certification saying that the patents are invalid, unenforceable and/or would not be infringed by Sandoz’s product. The ‘829 patent expires on March 7, 2022. Spectrum said in a SEC filing that it intends to appeal the decision. ...