Tag Archives: Articles

The FCPA in 2011: Five Answers and a Looming Question

The Department of Justice has been warning the Life Sciences industries – pharmaceutical and medical device companies – of its intent to focus "on the application of the Foreign Corrupt Practices Act" ("FCPA") on the pharmaceutical and related industries. (Lanny Breuer, Assistant U.S. Attorney for the Criminal Division, November 12, 2009). The FCPA prohibits, among … Continue Reading

Safe-Harbor Provision of Hatch-Waxman Act Does Not Protect Post-Approval Research Activities

By Gray Buccigross The Federal Circuit issued its opinion in Classen Immunotherapies, Inc. v. Biogen Idec, 2011 U.S. App. Lexis 18126, on August 31, 2011. As part of that decision it held that the safe-harbor provision of the Hatch-Waxman Act is limited to activities reasonably related to obtaining pre-marketing FDA approval of generic counterparts, and … Continue Reading
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