The High Court of Australia has today unanimously held that isolated nucleic acids are not a manner of manufacture under Australian law1. This follows an appeal by Yvonne D’Arcy from a decision of the Full federal Court of Australia2  that  isolated nucleic acids are a manner of manufacture and hence constitute patentable subject matter.  This High Court decision is unexpected in that it unanimously overturns a previous, unanimous decision of the Full Federal Court.

The High Court applied the manner of manufacture test set out in the National Research Development Corporation v Commissioner of Patents (“NRDC“) case3  as did the Full Federal Court, but came to an entirely different conclusion. The High Court focussed on the sequence information content of isolated nucleic acids and found that because the sequence is not “made” by humans but is instead naturally-occurring,  isolation was the only man-made aspect of the invention which in the High Court’s view is not sufficient to constitute an artificially created state of affairs in the sense required by NRDC. The majority opinion of French CJ , Kiefel, Bell and Keane JJ stated that “ Although it may be said in a formal sense that the invention as claimed, referring to isolated nucleic acids, embodies a product created by human action, that is not sufficient to support its characterisation as a manner of manufacture. The substance of the invention as claimed and the considerations flowing from its substance militate against that characterisation. To include it within the scope of a “manner of manufacture” involves an extension of that concept, which is not appropriate for judicial determination”.

In a separate concurring opinion, Nettle and Gageler JJ  took a different approach arguing that the manner of manufacture test invokes a requirement for an “inventiveness threshold” as well as the requirement for artificiality and economic usefulness. According to this test, Nettle and Gageler JJ held that isolated nucleic acids are not “sufficiently artificial, or in other words different from nature, to be regarded as patentable”.

In a further concurring opinion, Gordon J focussed on what constitutes “an invention” and opined that Myriad did not invent or “work out” the coding function of isolated nucleic acids, nor “That the specific mutations and polymorphisms are indicative of a predisposition to breast cancer and ovarian cancer” .  According to Gordon J, this correlation is a fact that existed before Myriad discovered it.  In her opinion, Claim 1 directed to an isolated nucleic acid did not “embody” the idea or principle that underlies the invention, namely to carry out genetic testing of patients to determine susceptibility to breast cancer. On this basis, the isolated nucleic acids of Claim 1 do not constitute a manner of manufacture.

The High Court also expressed concern about the scope of monopoly conferred by product claims to isolated nucleic acids and questioned when infringement of such a claim actually occurs. As explained by French CJ , Kiefel, Bell and Keane JJ: “When proper regard is paid to their emphasis on genetic information, the subject matter of the claims lies at the boundaries of the concept of “manner of manufacture”. That it does lie at the boundaries is further evidenced by the odd consequence that if the claims are properly the subject of a patent, the patent could be infringed without the infringer being aware of that fact. That consequence coupled with the very large, indeed unquantified size of the relevant class of isolated nucleic acids, all of which bear the requisite information, raises the risk of a chilling effect upon legitimate innovative activity outside the formal boundaries of the monopoly and risks creating a penumbral de facto monopoly impeding the activities of legitimate improvers and inventors”. Nettle, Gageler and Gordon JJ also objected to the breadth of monopoly sought by these claims.

This decision clearly enunciates that isolated nucleic acids are not a manner of manufacture, without making any exceptions to this rule. Unlike the corresponding US Supreme Court’s Myriad decision, there was no holding that cDNA or other nucleic acids sufficiently modified by human intervention would constitute patentable subject matter. Thus, the High Court decision is potentially more far-reaching than the US Supreme Court’s decision. The only positive statement as to what might be patentable subject matter was issued by Gordon J in relation to probes that are used to investigate whether a patient expresses a mutant BRCA gene that is indicative of cancer. However, these claims were not at issue in this case.