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Continuing the recent trend of court decisions expanding jurisdiction over declaratory judgment challenges to patents, the Court of Appeals for the Federal Circuit (the 'Federal Circuit' or the 'court') opened the door to increased challenges to drug patents in Teva Pharms. USA Inc. v. Novartis Pharms. Corp., 482 F.3d 1330 (Fed. Cir. 2007). The Federal Circuit ruled that a generic drug company could, under the appropriate circumstances, pre-emptively seek a declaratory judgment that certain drug patents listed in the FDA's Orange Book are invalid or not infringed. Generic drug companies thus can have a court resolve patent infringement issues before undertaking the expense of launching a generic drug under the threat of patent litigation and any resulting injunction or treble damages for willful infringement. The Teva decision is expected to increase declaratory judgment challenges by generic drug companies and help speed generic drugs to market when those challenges are successful.
Background
The DOJ's Criminal Division issued three declinations since the issuance of the revised CEP a year ago. Review of these cases gives insight into DOJ's implementation of the new policy in practice.
The parameters set forth in the DOJ's memorandum have implications not only for the government's evaluation of compliance programs in the context of criminal charging decisions, but also for how defense counsel structure their conference-room advocacy seeking declinations or lesser sanctions in both criminal and civil investigations.
This article discusses the practical and policy reasons for the use of DPAs and NPAs in white-collar criminal investigations, and considers the NDAA's new reporting provision and its relationship with other efforts to enhance transparency in DOJ decision-making.
Active reading comprises many daily tasks lawyers engage in, including highlighting, annotating, note taking, comparing and searching texts. It demands more than flipping or turning pages.
There is no efficient market for the sale of bankruptcy assets. Inefficient markets yield a transactional drag, potentially dampening the ability of debtors and trustees to maximize value for creditors. This article identifies ways in which investors may more easily discover bankruptcy asset sales.