Evolution of the Patent Infringement Safe Harbor

Since its enactment in 1984, the scope of the "safe harbor" provision of the patent code has been in flux. The provision is intended to exempt from infringement certain acts related to the development of drugs and medical devices that are subject to FDA regulatory approval, to enable competitors to immediately enter the market upon patent expiration. However, the contours and boundaries of the safe harbor have been a consistent source of controversy in the courts.

24 minute readSeptember 02, 2014 at 12:00 AM
By
Sarah A. Bennington
Anthony M. Insogna
Evolution of the Patent Infringement Safe Harbor

Since its enactment in 1984, the scope of the “safe harbor” provision of the patent code, codified at 35 U.S.C. '271(e)(1), has been in flux. The provision is intended to

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