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 withHartranft 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.

The new form/utility test is arguably called for in Chakrabarty and approval of a patent granted to Louis Pasteur and claiming yeast, free from organic germs of disease, as an article of manufacture is noted. Freedom from contamination also featured in Kuehmsted v Farbenfabriken of Elberfeld Co (aspirin) and natural product purification featured in Parke-Davis & Co. v. H.K. Mulford Co (adrenalin). The opinion in Myriad is consistent with these earlier cases, the absence of new utility for the isolated full-length BRCA1 and BRCA2 genes arguably being they key basis for the finding of non-eligibility. Accordingly, it is submitted that:

  • Myriad provides authority for the proposition that a DNA sequence that has merely been isolated and has no new utility but only that utility which is a consequence of its possession is not patent-eligible.
  • Myriad does not provide authority for the proposition that a sequence that has not only been isolated but also has new utility is not patent-eligible: e.g. that a naturally-occurring DNA sequence e.g. of length ~5000 kb that has been isolated or is enabled to be isolated e.g. from a prokaryote as a real physical molecule and that has new utility insofar as it can be multiplied by PCR and incorporated into other organisms that can subsequently be cultured to produce new and valuable medicaments or other chemical species is not patent-eligible.
  • Nor does Myriad provide authority for the proposition that new chemical species, e.g. the macrolide antibiotic rapamycin, which have been extracted from the environment and provided in new and concentrated form are patent-ineligible.

Mayo claims no more than the inventors’ own published method of analysis plus new information but no further process step and was therefore rejected using the analysis in Diehr and Flook. The opinion was expressed in cautious and conservative terms, and it is doubted whether any new rule of law was intended.

It is therefore concluded that the Guidance is more restrictive than can legitimately be inferred from the above decisions. The full text of the posting can be downloaded here:

USPTO Patent Eligibility Guidelines