The Situation: In a Hatch-Waxman litigation, the claims recite oxymorphone with less than 0.001% of an impurity called 14-hydroxymorphinone. The prior art includes confidential communications from the FDA to oxymorphone...more
Introduction - In proving a patent invalid (or infringed), all claim limitations must be considered. A recent case illustrates this maxim for both derivation under 35 U.S.C. § 102(f) and obviousness under 35 U.S.C. §...more
The Federal Circuit decision in Cumberland Pharmaceuticals Inc. v. Mylan Institutional LLC may be more interesting for what Mylan argued than for what the Federal Circuit decided. However, it could be an important decision...more