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Abstract

The use of research tools is critical for pharmaceutical companies to conduct timely and efficient research in the development of new drugs. Traditionally, the use of all patented inventions during drug development that are reasonably related to submission of information to the Food and Drug Administration for regulatory review has been protected under the section 271(e)(1) safe harbor provision. Recently, the Federal Circuit narrowed the scope of the safe harbor provision excluding the use of certain patented research tools. The effect of this decision on research tools may negatively impact the public by raising the cost of pharmaceutical companies’ research and development programs, ultimately raising the cost of drugs available to the public. Legislation specifically including the use of research tools within the safe harbor, or alternatively, judicially supplementing this modern test for safe harbor would resolve the consequences of this test.

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