The Federal Circuit held that Schering’s patent on a metabolite of Claritin (loratadine) was invalid because the metabolite is necessarily and inherently formed when a patient takes a dose of the previously patented loratadine — establishing that inherent anticipation does not require recognit
The Federal Circuit reversed a declaratory judgment of non-infringement, holding that the doctrine of claim differentiation creates a strong presumption that an independent claim has a broader scope than its dependent claims, and that the narrow limitation in a dependent claim should not be read bac
The Federal Circuit reversed summary judgments of non-infringement and invalidity, holding that the district court improperly added a negative limitation to patent claims without intrinsic evidence support, and that prosecution disclaimer applies only when a patentee makes clear and unmistakable sur
The Federal Circuit held that the Hatch-Waxman safe harbor of § 271(e)(1) does not immunize basic pre-clinical research conducted by drug companies even when the research might eventually lead to FDA submissions, adopting a narrow reading later reversed by the Supreme Court.
The Federal Circuit held that an ANDA applicant seeking approval to sell a generic drug for an FDA-approved use does not infringe a method-of-use patent claiming an unapproved, off-label use of the same drug — establishing important limits on Hatch-Waxman patent infringement actions.
The Federal Circuit affirmed rejection of claims for a nickel-base superalloy composition, holding that a prior art reference disclosing a range that overlaps a claimed range establishes a prima facie case of obviousness, and that the normal desire of scientists to optimize within known ranges provi
The Federal Circuit affirmed the validity of Amgen’s erythropoietin (EPO) patents covering recombinant human erythropoietin, finding the claims satisfied written description and enablement requirements, while remanding certain issues for further consideration.
The Federal Circuit sharply limited the common-law experimental use defense by holding that universities infringe patents when they use patented technology in their research programs, even without profit motive, because such use advances the university’s legitimate business objectives.
The Federal Circuit held that dictionaries, encyclopedias, and technical treatises are valuable starting points for determining the ordinary and customary meaning of patent claim terms, and should be consulted before examining the specification for limitations.
The Federal Circuit held that the written description requirement is separate from the enablement requirement and that a deposit of biological materials in a recognized depository can satisfy written description — setting an important standard for biotechnology patent claims directed to biological s