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Case Briefing
TRO Issued in First-to-File Market Exclusivity Battle
Alpharma Inc. has announced that its wholly owned subsidiary, Purepac Pharmace, was granted a temporary restraining order Oct. 29 in a lawsuit in the U.S. District Court for the District of Columbia. Purepac brought this suit seeking first-to-file status on its version of Glucophage XR, a Bristol-Myers Squibb Type 2 diabetes drug. On Oct. 28, Ivax Corp. had announced it had received final approval and confirmation of its first-to-file status on its Abbreviated New Drug Application from the FDA. In obtaining the restraining order, Purepac effectively removed Ivax's product from the market, at least in the short term. Under the terms of the temporary restraining order, the FDA has been instructed to delay the effective date of approval of Ivax's ANDA on extended-release metformin hydrochloride tablets until mid-November, when a hearing on Purepac's claims can be held.
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.