Patenting “Natural Products” Down-Under Post-Myriad

iStock_000063710003_SmallAlthough the Australian High Court held that claims to naturally occurring DNA (e.g., BRCA1 nucleic acid) were not patent eligible because they were not a “manner of manufacture,” since the encoded information therein was not “made” by human action, in contrast to the USPTO, the Australian Patent Office issued “Examination Practice” guidelines dealing with the requirements to patent products of nature. The Guidelines generally left their Bergy-like examination standards intact outside of the nucleic acid arena. A copy of those guidelines can be found at the end of this post.

Naturally occurring nucleic acid molecules derived from genetic material or synthesized, including fragments thereof like primers, probes and iRNA, as well as cDNA are not patent-eligible since they “merely replicate the genetic information of a naturally occurring organism.”

More encouraging is the reaffirmation by the Australian PTO that “technical subject matter” including recombinant or isolated proteins, pharmaceuticals, methods of treatment and “applications of computer technology” remain patent-eligible, as do plant and microorganisms. The key factor seems to lie in determining whether or not the substance of the claims was “made” – created or modified by human action – or is “artificial.” Merely “artificial” is a bar, but it appears to include inspecting the claim for replicants – Dolly? — or synthetic versions of naturally occurring materials. While the physical difference between the claim and the material in its natural state is one factor to be weighed, the heartening sentence is that “[i]solation or purification can represent making or modification when the substance of a claim is properly directed to a chemical product.”

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One Response to Patenting “Natural Products” Down-Under Post-Myriad

  1. Paul Cole says:

    I re-read the oral argument in Myriad recently, and am astonished at the level of knowledge and expertise demonstrated not so much by the Justices as by Counsel.

    Isolated wild-type BRCA1 is not a composition of matter because it is neither a mixture of substances made by man nor is it a molecule made by man from simpler substances. If it qualifies at all it is as a manufacture. Hence the importance of Hartranft which although a tariff case was all about distinguishing natural products from manufactures. But nobody mentioned Hartranft in the oral argument, though Justice Thomas did when he wrote his opinion. Its significance is still greatly underestimated in discussions about 101.

    The discussion about cutting pieces of wood from trees was not as naive as it seems at first sight. Do you have a log of wood or a baseball bat? From the point of view of “manufacture” this is a key question.

    If we go to the Ariosa facts, the starting point paternal nucleotides were put into an form where they could be amplified and were not in their natural state, and the multiplied short sequences were concentrated to a level where they could be detected which the natural product was not. Both at the starting point and at the end point the hand of man is involved – if you do not have a centrifuge you are not in business! I think the Australian reaction is more considered than that in the US, although the original decision will repay detailed study.

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