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 NAFTA’s amendments to the Lanham Act require proof of actual consumer deception before a mark can be refused registration as primarily geographically deceptively misdescriptive, overturning a TTAB refusal of the CALIFORNIA INNOVATIONS mark.
The Federal Circuit held that a shrink-wrap license contractually prohibiting reverse engineering of software is enforceable and not preempted by federal copyright law, even though copyright law itself permits reverse engineering in certain circumstances.
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
The Federal Circuit held that a farmer who saved patented Roundup Ready soybean seeds from his harvest and replanted them violated Monsanto’s patent rights, because patent exhaustion does not apply to seeds that were copied rather than purchased from the patentee.