Posts Tagged: "Confirmatory Genetic Diagnostic Testing"

PTO Report on Confirmatory Genetic Testing: A Worthwhile Effort But Not Far Enough

The USPTO has released its ‘Report on Confirmatory Genetic Diagnostic Testing,’ which was prepared to fulfill the requirements of §27 of the Leahy-Smith America Invents Act. The USPTO did make an interesting observation that has been reflected in its patent examining guidelines. The USPTO Report concludes that ‘it is unlikely that exclusive provision of a diagnostic test, whether for an original diagnosis or to confirm the original result, will be possible based on patenting and licensing behavior.’ This statement reinforces the USPTO’s prior broad interpretations of the Court’s findings in Mayo and Myriad. Of note is that in the USPTO Report, the USPTO adopts the Supreme Court’s factually and scientifically unsupported distinction between genomic DNA and cDNA.