TEVA PHARMACEUTICALS USA, INC., v. SANDOZ, INC.
Sandoz, Inc., (Sandoz) and Mylan Pharmaceuticals, Inc. (Mylan) submitted Abbreviated New Drug Applications (ANDAs) to the Food and Drug Administration (FDA) to produce and market generic versions of Copaxone, a drug used to treat Multiple Sclerosis. Teva Pharmaceuticals USA, Inc., the manufacturer of the original drug, sued Sandoz and Mylan and used two different types of claims that are based on different ways to use molecular weight to distinguish between polymer samples. The district court did not distinguish between the different methods of using molecular weight and held that the claims were not indefinite as Sandoz and Mylan argued. After a bench trial, the district court held that the Sandoz and Mylan products infringed on Teva’s patent.
The U.S. Court of Appeals for the Federal Circuit held that the district court did not error in holding that the patents were infringed, but that some of the claims had not been effectively shown to be definite.
Can a district court’s finding of fact in the construction of a patent claim be reviewed de novo, as though for the first time, which the U.S. Court of Appeals for the Federal Circuit requires and did in this case?