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Evolution of the Patent Infringement Safe Harbor

By Sarah A. Bennington and Anthony M. Insogna

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 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.

Although some argue that the provision was intended to provide a narrow exception to patent infringement to facilitate the development of generic drugs, many court decisions have expanded the scope of the safe harbor over time. Other appellate cases have attempted, with some success, to set limits. A recent Southern District of California decision in Isis Pharms., Inc. v. Santaris Pharma A/S Corp., No. 3:11-cv-2214-GPC-KSC, 2014 U.S. Dist. LEXIS 26148, (S.D. Cal. Feb. 27, 2014), reconsideration denied , 2014 U.S. Dist. LEXIS 72755, suggests a renewed desire to reign in the scope of the safe harbor and set a minimum threshold for exemption.

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