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Products of Nature

Post-Ariosa, the district courts and the Federal Circuit have increasingly used this decision to justify application of the Mayo/Alice rule to deny the patentability of claims directed to diagnostic methods and products of nature. Apart from the CellzDirect decision, which was characterized as a new method of making freeze/thaw resistant cells, the Court has been resistant to allowing diagnostic claims that arise from the discovery of a naturally occurring correlations. In Meriel, and in Cleveland Clinic, the diagnostic conclusions were dismissed as being no more than natural phenomenon, detected and evaluated using "routine steps". The court has reiterated that the "inventive concept" required by the Mayo/Alice Rule cannot be provided by recognition of the importance of a natural correlation, even while recognizing that the rule renders many important advances in diagnostic medicine patent-ineligible. At least one district court has held that claims to unit dosage forms of naturally occurring compounds, such as vitamins, are patent-ineligible attempts to claim natural products. While the Patent Office continues to allow method of treatment claims, it may not be long before the Federal Circuit takes another look at Myriad and bans these claims as well.

October 17, 2017

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