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Federal Circuit Negative on Best-mode Defense
The U.S. Court of Appeals for the Federal Circuit has taken an increasingly dim view of an accused infringer's attempt to invalidate the claims of a patent-in-suit by alleging that the patentee failed to satisfy the best-mode requirement.
Recent Federal Circuit decisions, such as Eli Lilly & Co. v. Barr Labs. Inc., 251 F.3d 955 (Fed. Cir. 2001), and Bayer A.G. v. Schein Pharms. Inc., 301 F.3d 1306 (Fed. Cir. 2002), have, with near uniformity, converted the best-mode analysis into a narrow, quasi-legal inquiry that focuses on the scope of the claimed invention, with careful attention to just what is claimed. The specification of all patents, including those claiming pharmaceutical inventions, must 'set forth the best mode contemplated by the inventor of carrying out his invention.' 35 U.S.C. 112, 1. As the Eli Lilly court stated, this best-mode requirement embodies a quid pro quo whereby a 'patentee must not receive the right to exclude others unless at the time of filing he has provided an adequate disclosure of the best mode.' The penalty for failure to satisfy this requirement is harsh: The patent claims covering the subject matter for which the best mode was not disclosed are rendered invalid. See Amgen Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 1209 n.5 (Fed. Cir. 1991).
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.