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High Court To Review "Bolar Amendment" Protection For Preclinical Studies

This article was originally published in The Pink Sheet Daily

Executive Summary

Justices will decide whether the patent infringement "safe harbor" provided by Waxman/Hatch extends to preclinical research on potential new drug candidates or is limited to clinical research used to support FDA approval. The case stems from Integra Lifesciences' infringement lawsuit against Merck KGaA.
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