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Australia takes genetic material patenting ban even further

In a decision that may introduce uncertainties into how patentability is determined, the Australia High Court has ruled that isolated genetic material is not patentable in a decision that appears to go even further than the US Supreme Court's decision in Myriad

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The Court handed down its decision on Wednesday in D'arcy v Myriad Genetics, which concerns the same invention that the US Supreme Court had held to be unpatentable.

The patent at the centre of the dispute (Australian patent 686004, held by Myriad Genetics) covers the isolated BRCA1 gene. Cancer Voices Australia challenged the validity of the patent, arguing that the isolated molecules were not materially different from the ones found in nature and thus the patent does not meet the manner of manufacture requirement.

Both the Federal Court and the Full Federal Court held that Myriad's patent was valid, finding that the requirement as articulated in National Research Development Corporation vs Commissioner of Patents is satisfied if the invention consists of an artificial state of affairs, has some discernible effect, and is of utility in a field of economic endeavour.

Information v structure

The Full Federal Court's decision was interesting because it directly addressed the US Supreme Court's decision, which had come a year earlier. As Tania Obranovich of Watermark in Melbourne had told Managing IP, while the US Supreme Court focused on the information contained in the molecules, the Australia Full Federal Court looked instead at the molecules' structure and functioning. Because the isolated genetic material behaved differently and had structural differences, the Court had found that the invention was patentable because it created an artificial state of affairs, as well as met all the other requirements articulated in NRDC.

On appeal, the High Court reversed, adopting an approach similar to the US Supreme Court's. Like its American sister court, the Australia High Court found that the information contained in the molecule is the core of the invention. Thus it held that the molecule is not an artificial state of affairs and ineligible for patent protection.

What's more, the Australian High Court appears to have gone even further than the US Supreme Court's approach. As Obranovich explained in a written note, while the US Supreme Court expressly found that a DNA molecule in which the order of the nucleotides is different from that of a corresponding naturally occurring molecule may still be patentable, the Australian High Court held that cDNA, which fits this description, is not patentable.

Questioning a foundational test

The Australia High Court also questioned the lower courts' application of NRDC, which is often cited as a foundational test for determining the method of manufacture.

The High Court said that the Full Federal Court and the Federal Court had adopted an "unduly narrow" reading of NRDC. Rather than applying that case as a strict test for patentability, it should instead be treated as a "verbal formula" because the Court there "did not prescribe a well-defined pathway for the development of the concept of 'manner of manufacture' in its application to unimagined technologies with unimagined characteristics and implications."

Thus, "there may be cases in which the court will decide that the implications of patentability of a new class of inventionare such that the invention as claimed should not be treated as patentable by judicial decision", the Court wrote.

A world of uncertainty

Practitioners have expressed concern about the effects of this decision. Obranovich wrote that the finding that cDNA is not patentable is extremely concerning, because there are many new versions of naturally occurring molecules "which omit functionally unnecessary regions, but which may provide highly useful benefits such as those which are inherent in generating and using a cDNA molecule rather than the large and unwieldy corresponding genomic molecule" which may now be found unpatentable. She noted that there is now considerable uncertainty, as it may well turn on "determining at what point the structural changes to a molecule are sufficient to render it patentable".

On the other hand, an update from Allens noted that despite invalidating Myriad's patent on the isolated molecule, the High Court made a point of sending a "strong signal" that genetic tests and diagnostic methods are still patent eligible. The firm pointed to a quote from Justice Gageler and Nettle's opinion, which stated that "it is not disputed that a process or method of detecting the increased likelihood of certain kinds of malignancy by isolating the BRCA1 gene and examining it for the presence of any of the specified mutations and polymorphisms may be patentable subject matter as a process".

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