Recent cases addressing the statutory safe harbor for research related to FDA submissions (35 USC � 271(e)(1)) will be discussed.  The discussion will focus on cases decided since the Supreme Court's 2005 decision in Merck v. Integra and how the courts have further interpreted � 271(e)(1), sometimes creating bright lines and sometimes blurring them.  Based on these cases, guidelines for which activities fall under the safe harbor will be presented.

A ship in the harbor is safe, but that's not what ships are built for: Recent developments in 271(e)(1)

245th National Meeting (2013)

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