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Federal Circuit Affirms ITC’s Non-Institution Decision, Offering Guidance for Future FDCA-Related Section 337 Claims

In its long-awaited decision in Amarin Pharma. v. ITC, the Federal Circuit provided guidance on the U.S. International Trade Commission’s discretion to decline to institute an investigation under section 337 of the Tariff Act (19 U.S.C. § 1337) and the interplay between section 337 claims and the Food, Drug, and Cosmetics Act (FDCA) – an increasingly common issue at the ITC. The opinion also addressed the Federal Circuit’s appellate jurisdiction to review the ITC’s non-institution decisions. Companies that litigate at the ITC, particularly those that manufacture, distribute, or import FDA-regulated products, should be aware of the implications of this decision.

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Amended Federal Rules of Civil Procedure Focus On E-Discovery


Time to Read: 1 minutes Practices: Litigation

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On December 1, 2006, amendments to the Federal Rules of Civil Procedure relating to pretrial discovery of electronic documents and data will go into effect. These rules codify obligations of parties and recipients of subpoenas in federal lawsuits to identify, preserve, and produce electronically stored information. In addition, they require parties at the outset of a case to confer about electronic discovery, develop a production plan, and bring to the court’s attention any unresolved issues relating to the preservation or production of electronically stored information. The rules also address two concerns that arise particularly in connection with electronic discovery: inadvertent production of privileged information and inadvertent destruction of relevant information. As a result of the new rules, companies will need to understand their information systems thoroughly and be in a position to educate outside counsel promptly about them when, if not before, litigation commences.

Click "Download PDF" for more information about the rules’ changes and their practical implication.

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