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FDA
July 12, 2001
When an Invention Report is submitted (PHS Form 6364) by a Center/ORA Scientist it must be approved by the Center/ORA and then goes to an FDA Technology Development Coordinator (TDC) for review and recommendation re patenting (HFA-500). The FDA TDC sends the invention report to OTT/NIH and the case is docketed. At this point the report goes out both for Marketing/Licensing analysis and for Patentability Assessment (which involves three things: determination of rights, inventorship determination, and patentability analysis). The report now goes for patent and licensing review. Then a patent application can be filed or it may not be filed. In the latter case, government rights may be waived to the inventor or the invention may be dedicated to the public by publication.
Note: Every invention may not result in a patent.