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Where New Matter Actually Comes From: CIP Trigger Points in FDA Drug Development Why Preclinical Polymorphs and Phase I Formulation Data Drive Most Secondary Patent Filings The FDAs five-stage development pathway discovery, preclinical, Phase I, Phase II, Phase III and post-approval does not generate patentable new matter at uniform rates

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Understanding its legal status and sourcing requirements is essential for protecting both research integrity and regulatory compliance

The business impact has been limited for most of those initiatives