Editors Notes: Apart from a fine survey of the case law on patent-eligibility of not-so natural products, Paul Cole suggests that, in view of the incomplete and/or indirect description of the BRACA sequences that Myriad claimed, there may well be isolated, purified and sequenced fragments of the human genome that would meet the test of being markedly changed in character from their state as a portion of genomic DNA. In other words, perhaps this is not the time to throw in the towel on patenting probes and primers.
Whether or not there is a need for modification of the proposed USPTO natural product eligibility guidelines (a PDF is provided at the end of this post) depends on the interpretation of four Supreme Court opinions, Funk Brothers, Chakrabarty and Myriad which relate to products and Mayo which relates to treatment methods.
Inclusion of an example based on Funk Brothers is arguably unwise having regard to the internal conflicts within the majority opinion, the divisions within the Court and conflict with a number of earlier Supreme Court decisions. The majority opinion is arguably in conflict with Hartranft v.Wiegmann, cited in both Chakrabarty and in Myriad, and supporting the proposition that a product is likely to be regarded as involving human ingenuity if it has been put into a new form and new utility results. The evidential nature of a new effect or result has been known since at least 1822 in Evans v Eaton, see also Webster Loom v Higgins and Carnegie Steel v Cambria Iron, and the primary reason for rejection of that new result evidence in Funk Brothers was on the arbitrary ground, that what had been achieved was “hardly more than an advance in the packaging of inocculants” and a commercial rather than a technical benefit.