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The Preclinical Research Statutory Infringement Exemption: How Far Back Is 'Reasonably Related'?
On June 13, 2005, the U.S. Supreme Court expanded the safe harbor provision of 35 U.S.C. '271(e)(1) to the “use of patented compounds in preclinical studies … as long as there is a reasonable basis for believing that the experiments will produce 'the types of information that are relevant to an [Investigational New Drug application ("IND")] or [New Drug Application ("NDA")].'” Merck KGaA v. Integra Lifesciences I, Ltd., __ U.S. __, 125 S.Ct. 2372, 2383-84 (U.S. 2005) (quoting Brief of U.S. as Amicus Curiae 23) (“Integra II“).
Integra Lifesciences I, Ltd. (“Integra”) sued Merck KGaA and Scripps Research Institute (collectively, “Merck”) for infringement of five patents related to methods for contacting cells with tripeptides of the sequence Arg-Gly-Asp (“RGD peptides”). See, e.g., U.S. Patent No. 4,988,621. The patented methods promote cell adhesion, inhibit cell proliferation, and selectively detach malignant cells, amongst other claimed results.
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.
Compliance Officers: Recent Regulatory Guidance and Enforcement Actions and Mitigating the Risk of Personal Liability
This article explores legal developments over the past year that may impact compliance officer personal liability.