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2100 Patentability

Safety and Efficacy Considerations - evidence clarification

Medical products have been given some leeway by the USPTO, in terms of product safety. Their safety is regulated by another government division, the Food and Drug Administration (FDA). Medical product makers do not want to "publicize" inventions prior to patenting. If USPTO demanded FDA approval, that would allow other companies to copy the invention while it was being tested for the FDA. It makes more sense to patent... more »


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