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 first, then commit to multi-year public trials.


MPEP s2107 V, Safety and Efficacy Considerations, addresses pharmacological and medically therapeutic safety issues in patent applications. MPEP s2107 V's intent is to preserve USPTO's distinction from FDA. Its logic is based on case law that underscores scientific evidence.


MPEP s2107 V concludes that, "while an applicant may on occasion need to provide evidence to show that an invention will work as claimed, it is improper for Office personnel to request evidence of safety in the treatment of humans, or regarding the degree of effectiveness." This statement does not properly explain case law logic.


MPEP s2107 V is based on six USPQ cases. These cases make clear the evidence the USPTO does not seek is clinical, or trial, evidence. Two other kinds of evidence, affidavits and scientific literature evidence, are in fact critical to decisions in all six cases.

This evidence does not conflict with FDA, and provides sufficient basis to validate whether devices are safe enough for utility.


In re Anthony, 414 F.2d 1383, 1394-95, 56 CCPA 1443, 1456-57, 162 USPQ 594, 603-04 (1969) remains the most important Patent Court case regarding safety in medicines. It established that safety has to be valued in context of utility and common sense. The USPTO must accept affidavit and literature evidence that show whether a composition is safe within its proposed manner of use. In re Anthony concludes that only "a sufficient PROBABILITY of safety" need be demonstrated about a drug, not the "degree of 'proof'" found in "CLINICAL evidence" (emphasis in original.) This sentence should be added to MPEP s2107 V.



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Idea No. 258