Regulation

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• Surveys in Patent Infringement Litigation: The Next Frontier

  Most experienced intellectual property attorneys understand the significant role surveys play in trademark infringement and other Lanham Act cases, but relatively few are likely to have considered the use of such research in patent infringement matters. That could soon change in light of the recent admission of a survey into evidence in <i>Applera Corporation, et al. v. MJ Research, Inc., et al.</i>, No. 3:98cv1201 (D. Conn. Aug. 26, 2005). The survey evidence, which showed that 96% of the defendant's customers used its products to perform a patented process, was admitted as evidence in support of a claim of inducement to infringe. The court admitted the survey into evidence over various objections by the defendant, who had argued that the inducement claim could not be proven without the survey.

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• 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.

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• 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.

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• 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.

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• In the Spotlight

  On May 9, 2003, the U.S. Attorney's Office for the District of Massachusetts announced that Bayer Corporation, the pharmaceutical manufacturer, had been sentenced and ordered to pay a criminal fine of $5,590,800 stemming from its earlier plea of guilty to violating the Federal Prescription Drug Marketing Act by failing to list with the FDA its drug product, Cipro, that was privately labeled for an HMO. Such listing is required under the federal Food, Drug &amp; Cosmetic Act. The Federal Prescription Drug Marketing Act, Pub. L. 100-293, enacted on April 22, 1988, as modified on August 26, 1992 by the Prescription Drug Amendments (PDA) Pub. L. 102-353, 106 Stat. 941, amended sections 301, 303, 503, and 801 of the Federal Food, Drug, and Cosmetic Act, codified at 21 U.S.C. '' 331, 333, 353, 381, to establish requirements for distributing prescription drug samples.

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