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Proveris Scientific Corp. v. Innovasystems, Inc.: Federal Circuit Addresses 'Safe-Harbor' Immunity
In Proveris Scientific Corp. v. Innovasystems, Inc., 536 F.3d 1256 (Fed. Cir. 2008), the Federal Circuit addressed whether the “safe-harbor” provision of the Hatch-Waxman Act (codified at 21 U.S.C. ”355, 360cc and 35 U.S.C. ”156, 271, 282) applies to immunize infringement if the accused product is reasonably related to the development and submission of information to the FDA for regulatory approval purposes. Analyzing the statutory language and Supreme Court and Federal Circuit precedent, the Federal Circuit concluded that the safe-harbor provision does not apply because neither the patented product nor the accused product are products requiring FDA approval, the type of products that the Hatch-Waxman Act intended to protect.
Factual Background
The DOJ's Corporate Enforcement Policy: One Year Later
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 DOJ's New Parameters for Evaluating Corporate Compliance Programs
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.
Use of Deferred Prosecution Agreements In White Collar 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.
Bankruptcy Sales: Finding a Diamond In the Rough
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.
A Lawyer's System for Active Reading
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.